45 CFR Parts 160 & 164 (CFR Annual Edition) the date the Govern- ment’s right to collect the debt first accrued, and that the creditor agency’s regulations implementing 5 U.S.C. 5514 have been approved by the Office of Personnel Management. (2) If the collection is to be made in installments, the creditor agency must also advise the Department of the num- ber of installments to be collected, the amount or percentage of disposable pay to be collected in each installment, and the commencement date of the install- ments, if a date other than the next of- ficially established pay period is re- quired. (3) Unless the employee has con- sented in writing to the salary deduc- tions or signed a statement acknowl- edging receipt of the required proce- dures and the written consent or state- ment is forwarded to the Department, the creditor agency must advise the Department of the action(s) taken under 5 U.S.C. § 5514, and give the date(s) the action(s) was taken. (b) Requests for recovery. (1) Complete claim. When the Department receives a properly certified debt claim from a creditor agency, deductions should be scheduled to begin prospectively at the next officially established pay interval. The employee must receive written no- ti a properly certified debt claim from a creditor agency, deductions should be scheduled to begin prospectively at the next officially established pay interval. The employee must receive written no- tice as described in § 33.10 that the De- partment has received a certified debt claim from the creditor agency, includ- ing the amount, and written notice of the date deductions from salary will commence and the amount of such de- ductions. (2) Incomplete claim. When the Depart- ment receives an incomplete debt claim from a creditor agency, the Sec- retary shall return the debt claim with a notice that procedures under 5 U.S.C. 5514 and 5 CFR part 550, subpart K, must be provided and a properly cer- tified debt claim received before action will be taken to collect from the em- ployee’s current pay account. (c) Review. The Secretary is not re- quired or authorized to review the mer- its of the determination with respect to the amount or validity of the debt certified by the creditor agency. (d) Employees separating. If an em- ployee begins separation action before the Department collects the total debt due the creditor agency, the following actions will be taken: (1) To the extent possib (d) Employees separating. If an em- ployee begins separation action before the Department collects the total debt due the creditor agency, the following actions will be taken: (1) To the extent possible, the bal- ance owed the creditor agency will be liquidated from a final salary check, or other final payments of any nature due the employee from the Department; 123 § 33.13 45 CFR Subtitle A (10–1–24 Edition) (2) The Secretary will certify the total amount of the Department’s col- lection on the debt and send a copy of the certification to the employee and another copy to the creditor agency; and (3) If the Department’s collection does not fully satisfy the debt, and the Secretary is aware that the employee is entitled to payments from the Civil Service Retirement and Disability Fund, or other similar payments that may be due the employee from other Federal Government sources, the Sec- retary will provide written notification of the outstanding debt to the agency responsible for making such payments to the employee. The written notifica- tion shall state that the employee owes a debt, the amount of the debt, and that the provisions of this section have been fully complied with. The such payments to the employee. The written notifica- tion shall state that the employee owes a debt, the amount of the debt, and that the provisions of this section have been fully complied with. The Depart- ment shall furnish a copy of this writ- ten notification to the creditor agency so that it can file a properly certified debt claim with the agency responsible for making such payments. (e) Employees who transfer to another paying agency. If, after the creditor agency has submitted a debt claim to the Department, the employee trans- fers from the Department to a different paying agency before the debt is col- lected in full, the Secretary shall: (1) Certify the total amount of the collection made on the debt; and (2) Furnish a copy of the certification to the employee and another copy to the creditor agency along with notice of the employee’s transfer. § 33.13 Interest, penalties, and admin- istrative costs. Debts owed to the Department shall be assessed interest, penalties and ad- ministrative costs in accordance with 45 CFR 30.18. § 33.14 Non-waiver of rights. An employee’s involuntary payment of all or any portion of a debt collected under this part shall not be construed a - ministrative costs in accordance with 45 CFR 30.18. § 33.14 Non-waiver of rights. An employee’s involuntary payment of all or any portion of a debt collected under this part shall not be construed as a waiver of any rights which the em- ployee may have under 5 U.S.C. 5514 or any other provision of law or contract, unless there are statutory or contrac- tual provisions to the contrary. § 33.15 Refunds. (a) The Secretary shall promptly re- fund any amounts paid or deducted under this part when: (1) A debt is waived or otherwise found not owing to the United States; or (2) The employee’s paying agency is directed by administrative or judicial order to refund amount deducted from the employee’s current pay. (b) Unless required or permitted by law or contract, refunds shall not bear interest. § 33.16 Additional administrative col- lection action. Nothing contained in this part is in- tended to preclude the use of any other appropriate administrative remedy. PART 34—CLAIMS FILED UNDER THE MILITARY PERSONNEL AND CIVIL- IAN EMPLOYEES ACT Sec. 34.1 Purpose and scope. 34.2 Definitions. 34.3 Filing procedures and time limits. 34.4 Allowable claims. 34.5 Unallowable claims. 34.6 Reconsiderat MILITARY PERSONNEL AND CIVIL- IAN EMPLOYEES ACT Sec. 34.1 Purpose and scope. 34.2 Definitions. 34.3 Filing procedures and time limits. 34.4 Allowable claims. 34.5 Unallowable claims. 34.6 Reconsideration or appeal. 34.7 Payment procedures. 34.8 Computation of award and settlement. 34.9 Claims involving carriers or insurers. AUTHORITY: 31 U.S.C. 3721. SOURCE: 69 FR 13257, Mar. 22, 2004, unless otherwise noted. § 34.1 Purpose and scope. (a) Purpose. This part prescribes po- lices and procedures for handling claims not in excess of $40,000.00 filed by employees against the Department of Health and Human Services under the Military Personnel and Civilian Employees Claims (MPCE) Act of 1964, 31 U.S.C. 3721, for damage to, or loss of, property against the Department. Under the MPCE Act, the Secretary may approve claims made against the Government by a federal government employee for damage to or loss of per- sonal property that is incident to em- ployment when the loss or damage is not due to any negligence on the part of employee. (b) Scope. This part applies to all De- partmental Operating Divisions and 124 Dept. of Health and Human Services § 34.3 Regional Offices that process and re- o any negligence on the part of employee. (b) Scope. This part applies to all De- partmental Operating Divisions and 124 Dept. of Health and Human Services § 34.3 Regional Offices that process and re- view claims under the MPCE Act. Nothing in this part shall be construed to bar other types of claims that are payable under other statutory author- ity such as, but not limited to, the Federal Tort Claims Act (28 U.S.C. 2671–2680). § 34.2 Definitions. In this part, unless the context oth- erwise requires: Claim means any claim filed by or on behalf of an employee for damage to, or loss of, property that is incident to the claimant’s employment. This defini- tion includes claims where the claim- ant is not the legal owner of the prop- erty in question, but has obtained au- thorization from the legal owner to posses or control the property. Claimant means an employee who has filed a claim with the Department under the MPCE Act. Damage or loss means total or partial destruction or loss of the item claimed. Department means the Department of Health and Human Services. Employee means an officer or em- ployee of the Department. Quarters means a house, apartment or other residence assigned b e item claimed. Department means the Department of Health and Human Services. Employee means an officer or em- ployee of the Department. Quarters means a house, apartment or other residence assigned by the gov- ernment to an employee of the Depart- ment. § 34.3 Filing procedures and time lim- its. (a) Who may file a claim. A claim may be filed by the following individuals: (1) An employee; (2) An authorized agent or represent- ative of an employee or employee’s es- tate, regardless of whether the claim arose before or concurrent with an em- ployee’s death; and (3) A former employee or his author- ized agent or representative if damage or loss occurred prior to the separation from the Department. (b) Requirements. A claim submitted under this part must be presented in writing to the Claims Officer (See para- graph (c) of this section). Claims may be submitted on a HHS–481 form, Em- ployee Claim for Loss or Damage to Personal Property. All claims must be signed by the claimant or his author- ized agent or representative. The HHS- Form can be obtained from the Claims Officer or downloaded from the Pro- gram Support Center’s webpage at www.psc.gov. All claims must include the following hor- ized agent or representative. The HHS- Form can be obtained from the Claims Officer or downloaded from the Pro- gram Support Center’s webpage at www.psc.gov. All claims must include the following: (1) Name and address of the claimant; (2) The office in which the claimant was employed at the time of loss, cur- rent office, if different, and telephone number; (3) Date of loss or damage; (4) Amount of claim; (5) Description of the property, in- cluding but not limited to type, design, model number, date acquired, value when acquired, value when lost, and es- timation of repair or replacement cost; (6) Description of incident; and (7) If property was insured when loss or damage occurred, a statement indi- cating whether a claim was filed with an insurance carrier. (c) Where to file your claim. (1) Claim- ants employed with the Regional Of- fices should submit claims to the Chief Regional Counsel, Office of the General Counsel, within the claimant’s Region. (2) All other claimants must submit claims to the Office of the General Counsel, General Law Division, Claims and Employment Law Branch, 330 Inde- pendence Ave., SW., Room 4760, Cohen Building, Washington, DC 20201. (d) Evidence submit claims to the Office of the General Counsel, General Law Division, Claims and Employment Law Branch, 330 Inde- pendence Ave., SW., Room 4760, Cohen Building, Washington, DC 20201. (d) Evidence required. You must sub- mit the following: (1) Not less than two itemized signed estimates for the cost of repairs, or an itemized bill of repair for the damaged property; (2) In the event the property is not economically repairable or is totally lost or destroyed, proof of this fact, its market value before or after loss, pur- chase price, and date of acquisition of the property; (3) Proof of ownership or right to re- cover for the damage such as a receipt; (4) Police/incident report; (5) If property is insured, insurance information, such as insurance carrier, type of coverage, deductible, and whether claim has been filed and/or paid; (6) Travel orders, if applicable; (7) Any citations or traffic tickets, if applicable; and (8) Any other evidence required by the claims officer not specified above. (e) Time limit. (1) A claim filed under this section must be filed in writing 125 § 34.4 45 CFR Subtitle A (10–1–24 Edition) with the Department within two years from the date of the incid fied above. (e) Time limit. (1) A claim filed under this section must be filed in writing 125 § 34.4 45 CFR Subtitle A (10–1–24 Edition) with the Department within two years from the date of the incident. tive equipment or furnishings owned or managed by the Department. (2) If the claim accrues in the time of war or in the time of armed conflict in which any armed forces of the United States are engaged or if such a war or armed conflict occurs within two years after the claim accrues, and if good cause is shown, the claim shall be pre- sented no more than two years after that cause ceases to exist, or two years after the war or armed conflict is ter- minated, whichever is earlier. (3) All required evidence in support of a claim submitted under this section must be forwarded to the claims officer within sixty days after request. Failure to do so will be deemed as an abandon- ment of the claim and the claim will be disallowed. § 34.4 Allowable claims. (a) What you can claim. (1) Claims for damage or loss may be allowed where possession of the property was lawful and reasonable under circumstances. (2) Claims for property damage or loss by fire, flood, hurricane, theft, or other seri for damage or loss may be allowed where possession of the property was lawful and reasonable under circumstances. (2) Claims for property damage or loss by fire, flood, hurricane, theft, or other serious occurrence may be al- lowed when the property is located in- side: (i) Quarters that have been assigned or provided by the government; or (ii) Quarters outside the United States whether assigned by the govern- ment or not, except when a civilian employee outside the U.S. is a local in- habitant. (3) Claims for damage to, or loss of, property may be allowed when caused by: (i) Marine, air disaster, enemy action or threat thereof, or other extraor- dinary risks incurred incident to the performance of official duties by the claimant; and (ii) Efforts by the claimant to save human life or government property. (4) Property used for the benefit of the government. Claims may be al- lowed for damage to, or loss of, prop- erty used for the benefit of the govern- ment at the request, or with the knowledge and consent of, superior au- thority. (5) Claims for clothing and acces- sories may be allowed when loss or damage was caused by faulty or defec- (6) Claims for stolen property, only if it knowledge and consent of, superior au- thority. (5) Claims for clothing and acces- sories may be allowed when loss or damage was caused by faulty or defec- (6) Claims for stolen property, only if it is determined that the claimant ex- ercised due care in protecting his prop- erty and there is clear evidence that a burglary or theft occurred. (7) Claims for automobiles, only when required to perform official business or parked on a government-owned or oper- ated parking lot or garage incident to employment. This subsection does not include claims for damage or loss when traveling between place of residence and duty station, or when the loss or damage was caused by the negligence of a third party. If the automobile is a total loss, the maximum amount al- lowed is the value of the vehicle at the time of loss as determined by the Na- tional Automobile Dealer Association Appraisal Guide or similar publica- tions. (8) Claims for any other meritorious claims in exceptional cases may be al- lowed by the Claims Officer. (9) Transportation or travel losses. Damage or loss of personal property, including baggage and household items, while being transported by a carrier, agent or agency of th owed by the Claims Officer. (9) Transportation or travel losses. Damage or loss of personal property, including baggage and household items, while being transported by a carrier, agent or agency of the govern- ment, or private conveyance, may be allowed only if the property is shipped under orders or in connection with travel orders. (b) [Reserved] § 34.5 Unallowable claims. (a) What you cannot claim. (1) Claims for money or currency, such as intan- gible property (i.e. bankbooks, check, money orders, promissory notes, stock certificates, etc.). (2) Worn-out or unserviceable prop- erty. (3) Easily pilferable articles, such as jewelry, cameras, watches, and bin- oculars when they are shipped with household goods by a moving company or unaccompanied baggage. This does not apply to checked property or prop- erty in personal custody of the claim- ant or his agent provided proper secu- rity measures have been taken. (4) Government property. (5) Appraisal or estimate fees. (6) Automobiles, except when re- quired to perform official business or 126 Dept. of Health and Human Services § 34.9 parked on a government-owned or oper- ated parking lot or garage incident to employment. (7) Loss or xcept when re- quired to perform official business or 126 Dept. of Health and Human Services § 34.9 parked on a government-owned or oper- ated parking lot or garage incident to employment. (7) Loss or damage caused in whole or in part by the negligent or wrongful act of the claimant or his agent or em- ployee. (8) Claims under $30.00. (9) Stolen property when it’s deter- mined that claimant failed to exercise due care in protecting his or her prop- erty. (10) Sales Tax. Reimbursements for the payment of sales tax incurred in connection with repairs or replacing an item will not be allowed. (b) [Reserved] § 34.6 Reconsideration or appeal. (a) Requests for reconsideration or appeal shall be forwarded to the Asso- ciate General Counsel, General Law Di- vision, Office of the General Counsel, within sixty days from the date of the Claims Officer’s decision along with any new evidence supporting the claim. (b) A voucher or a supplemental voucher will be prepared by the Claims Officer if it is determined that the claimant’s request for reconsideration should be allowed. § 34.7 Payment procedures. (a) For all claims that are approved in whole or part, the claims officer shall prepare and m s determined that the claimant’s request for reconsideration should be allowed. § 34.7 Payment procedures. (a) For all claims that are approved in whole or part, the claims officer shall prepare and mail a payment voucher to the claimant. (b) This voucher shall be mailed to the claimant with appropriate instruc- tions. (c) Upon receipt of the signed pay- ment voucher, the claims officer shall sign and forward the signed voucher to the office where the claimant is or was employed for processing. (d) Upon receipt of the signed pay- ment voucher, the office in which the claimant is or was employed will sub- mit the voucher for transmission to the Treasury Department for issuance of a check in the sum allowed. (e) Funds paid for settlement of al- lowed claims shall be made from appro- priations of the office in which the claimant is or was employed. § 34.8 Computation of award and set- tlement. (a) The amount awarded on any item of property shall not exceed the ad- justed cost of the item based on the cost of replacing it with a similar one of the same quality minus the appro- priate depreciation rate. The amount normally payable on property damaged beyond economical repair shall not e based on the cost of replacing it with a similar one of the same quality minus the appro- priate depreciation rate. The amount normally payable on property damaged beyond economical repair shall not ex- ceed its depreciated value. If the cost of repairs is less than the depreciated value it shall be considered economi- cally repairable and the costs of repairs shall be the amount payable. (b) Depreciation in value of an item shall be determined by considering the type of article involved, its replace- ment cost, condition when lost or dam- aged beyond economical repair, and the time elapsed between the date of acqui- sition and the date of accrual of the claim. (c) Notwithstanding any other provi- sion of law, settlements of claims under the MPCE Act are final and con- clusive. The acceptance of a settlement constitutes a complete release of any claim against the United States and any employee of the government whose act or omission gave rise to the claim by reason of the same claim. § 34.9 Claims involving carriers or in- surers. (a) Carriers. (1) If property is dam- aged, lost or destroyed while being shipped pursuant to authorized travel orders, the owner shall file a written cl 34.9 Claims involving carriers or in- surers. (a) Carriers. (1) If property is dam- aged, lost or destroyed while being shipped pursuant to authorized travel orders, the owner shall file a written claim for reimbursement against the carrier no later than nine months from the date of delivery or should have been made according to the terms of the contract. It shall be filed before or concurrent with submitting a claim against the government under this part. (2) The demand shall be made against the responsible carrier if more than one contract was issued, a separate de- mand shall be made against the last carrier on each such document, unless claimant knows which carrier was in possession of the property when the damage or loss occurred. (b) Insurers. (1) If property which is damaged, lost, or destroyed incident to the claimant’s service is insured in 127 Pt. 35 45 CFR Subtitle A (10–1–24 Edition) whole or in part, the claimant shall in- form the Claims Officer whether a claim was made with the insurance carrier. (2) The claimant shall inform the claims officer if he or she received a re- imbursement from the insurance car- rier for the item that was damaged or lost. The exact amoun with the insurance carrier. (2) The claimant shall inform the claims officer if he or she received a re- imbursement from the insurance car- rier for the item that was damaged or lost. The exact amount of the reim- bursement must be reported. (3) If the claimant receives a reim- bursement for the lost or damaged property from an insurance carrier, the maximum amount that can be recov- ered from the Department is the dif- ference between an appropriate award under this regulation and the amount recovered from the insurance carrier. The claimant is responsible for submit- ting to the Department documentation that identifies the exact amount of the reimbursement. PART 35—TORT CLAIMS AGAINST THE GOVERNMENT Subpart A—General Sec. 35.1 Scope of regulations. Subpart B—Procedures 35.2 Administrative claim; when presented; place of filing. 35.3 Administrative claim; who may file. 35.4 Administrative claims; evidence and in- formation to be submitted. 35.5 Investigation, examination, and deter- mination of claims. 35.6 Final denial of claim. 35.7 Payment of approved claims. 35.8 Release. 35.9 Penalties. 35.10 Limitation on Department’s author- ity. AUTHORITY: Sec. 1(a), 80 Stat. 306; 28 U.S. mination of claims. 35.6 Final denial of claim. 35.7 Payment of approved claims. 35.8 Release. 35.9 Penalties. 35.10 Limitation on Department’s author- ity. AUTHORITY: Sec. 1(a), 80 Stat. 306; 28 U.S.C. 2672; 28 CFR Part 14. SOURCE: 32 FR 14101, Oct. 11, 1967, unless otherwise noted. Subpart A—General § 35.1 Scope of regulations. The regulations in this part shall apply only to claims asserted under the Federal Tort Claims Act, as amended, 28 U.S.C. sections 2671–2680, accruing on or after January 18, 1967, for money damages against the United States for damage to or loss of property or per- sonal injury or death caused by the negligent or wrongful act or omission of any employee of the Department of Health and Human Services while act- ing within the scope of his office or em- ployment. Subpart B—Procedures § 35.2 Administrative claim; when pre- sented; place of filing. (a) For purposes of the regulations in this part, a claim shall be deemed to have been presented when the Depart- ment of Health and Human Services re- ceives, at a place designated in para- graph (b) of this section, an executed Standard Form 95 or other written no- tification of an incident accompanied by a claim nt of Health and Human Services re- ceives, at a place designated in para- graph (b) of this section, an executed Standard Form 95 or other written no- tification of an incident accompanied by a claim for money damages in a sum certain for damage to or loss of prop- erty, for personal injury, or for death, alleged to have occurred by reason of the incident. A claim which should have been presented to the Department but which was mistakenly addressed to or filed with another Federal agency, shall be deemed to be presented to the Department as of the date that the claim is received by the Department. A claim mistakenly addressed to or filed with the Department shall forthwith be transferred to the appropriate Federal agency, if ascertainable, or returned to the claimant. (b) A claim presented in compliance with paragraph (a) of this section may be amended by the claimant at any time prior to final action by the De- partment Claims Officer or prior to the exercise of the claimant’s option to bring suit under 28 U.S.C. 2675(a). Amendments shall be submitted in writing and signed by the claimant or his duly authorized agent or legal rep- resentative. Upon the timely filing of an amendme to bring suit under 28 U.S.C. 2675(a). Amendments shall be submitted in writing and signed by the claimant or his duly authorized agent or legal rep- resentative. Upon the timely filing of an amendment to a pending claim, the Department shall have 6 months in which to make a final disposition of the claim as amended and the claim- ant’s option under 28 U.S.C. 2675(a) shall not accrue until 6 months after the filing of an amendment. (c) Forms may be obtained and claims may be filed, with the office, local, regional, or headquarters, of the constituent organization having juris- diction over the employee involved in the accident or incident, or with the 128 Dept. of Health and Human Services § 35.4 Department of Health and Human Services Claims Officer, Washington, DC 20201. [32 FR 14101, Oct. 11, 1967, as amended at 35 FR 4517, Mar. 13, 1970] § 35.3 Administrative claim; who may file. (a) A claim for injury to or loss of property may be presented by the owner of the property interest which is the subject of the claim, his duly au- thorized agent, or his legal representa- tive. (b) A claim for personal injury may be presented by the injured person, his duly authorized agent, or his hich is the subject of the claim, his duly au- thorized agent, or his legal representa- tive. (b) A claim for personal injury may be presented by the injured person, his duly authorized agent, or his legal rep- resentative. (c) A claim based on death may be presented by the executor or adminis- trator of the decedent’s estate or by any other person legally entitled to as- sert such a claim under applicable state law. (d) A claim for loss wholly com- pensated by an insurer with the rights of a subrogee may be presented by the insurer. A claim for loss partially com- pensated by an insurer with the rights of a subrogee may be presented by the insurer or the insured individually, as their respective interests appear, or jointly. Whenever an insurer presents a claim asserting the rights of a subrogee, he shall present with his claim appropriate evidence that he has the rights of a subrogee. (e) A claim presented by an agent or legal representative shall be presented in the name of the claimant, be signed by the agent or legal representative, show the title or legal capacity of the person signing, and be accompanied by evidence of his authority to present a claim on behalf of the claima mant, be signed by the agent or legal representative, show the title or legal capacity of the person signing, and be accompanied by evidence of his authority to present a claim on behalf of the claimant as agent, executor, administrator, parent, guardian, or other representative. § 35.4 Administrative claims; evidence and information to be submitted. (a) Death. In support of a claim based on death, the claimant may be required to submit the following evidence or in- formation: (1) An authenticated death certifi- cate or other competent evidence show- ing cause of death, date of death, and age of the decedent. (2) Decedent’s employment or occu- pation at time of death, including his monthly or yearly salary or earnings (if any), and the duration of his last employment or occupation. (3) Full names, addresses, birth dates, kinship, and marital status of the dece- dent’s survivors, including identifica- tion of those survivors who were de- pendent for support upon the decedent at the time of his death. (4) Degree of support afforded by the decedent to each survivor dependent upon him for support at the time of his death. (5) Decedent’s general physical and mental condition before deat of his death. (4) Degree of support afforded by the decedent to each survivor dependent upon him for support at the time of his death. (5) Decedent’s general physical and mental condition before death. (6) Itemized bills for medical and bur- ial expenses incurred by reason of the incident causing death, or itemized re- ceipts of payments for such expenses. (7) If damages for pain and suffering prior to death are claimed, a physi- cian’s detailed statement specifying the injuries suffered, duration of pain and suffering, any drugs administered for pain and the decedent’s physical condition in the interval between in- jury and death. (8) Any other evidence or information which may have a bearing on either the responsibility of the United States for the death or the damages claimed. (b) Personal injury. In support of a claim for personal injury, including pain and suffering, the claimant may be required to submit the following evidence or information: (1) A written report by his attending physician or dentist setting forth the nature and extent of the injury, nature and extent of treatment, any degree of temporary or permanent disability, the prognosis, period of hospitalization, and g physician or dentist setting forth the nature and extent of the injury, nature and extent of treatment, any degree of temporary or permanent disability, the prognosis, period of hospitalization, and any diminished earning capacity. In addition, the claimant may be re- quired to submit to a physical or men- tal examination by a physician em- ployed or designated by the Depart- ment or the constituent organization. A copy of the report of the examining physician shall be made available to the claimant upon the claimant’s writ- ten request provided that claimant has, upon request, furnished the report re- ferred to in the first sentence of this subparagraph and has made or agrees to make available to the Department 129 § 35.5 45 CFR Subtitle A (10–1–24 Edition) or the operating agency any other phy- sician’s reports previously or there- after made of the physical or mental condition which is the subject matter of his claim. (2) Itemized bills for medical, dental, and hospital expenses incurred, or itemized receipts of payment for such expenses. (3) If the prognosis reveals the neces- sity for future treatment, a statement of expected duration of and expenses for such treatment. (4) ncurred, or itemized receipts of payment for such expenses. (3) If the prognosis reveals the neces- sity for future treatment, a statement of expected duration of and expenses for such treatment. (4) If a claim is made for loss of time from employment, a written statement from his employer showing actual time lost from employment, whether he is a full or part-time employee, and wages or salary actually lost. (5) If a claim is made for loss of in- come and the claimant is self-em- ployed, documentary evidence showing the amount of earnings actually lost. (6) Any other evidence or information which may have a bearing on either the responsibility of the United States for the personal injury or the damages claimed. (c) Property damage. In support of a claim for damage to or loss of property, real or personal, the claimant may be required to submit the following evi- dence or information: (1) Proof of ownership. (2) A detailed statement of the amount claimed with respect to each item of property. (3) An itemized receipt of payment for necessary repairs or itemized writ- ten estimates of the cost of such re- pairs. (4) A statement listing date of pur- chase, purchase price, market value perty. (3) An itemized receipt of payment for necessary repairs or itemized writ- ten estimates of the cost of such re- pairs. (4) A statement listing date of pur- chase, purchase price, market value of the property as of date of damage, and salvage value, where repair is not eco- nomical. (5) Any other evidence or information which may have a bearing either on the responsibility of the United States for the injury to or loss of property or the damages claimed. (d) Time limit. All evidence required to be submitted by this section shall be furnished by the claimant within a rea- sonable time. Failure of a claimant to furnish evidence necessary to a deter- mination of his claim within three months after a request therefor has been mailed to his last known address may be deemed an abandonment of the claim. The claim may be thereupon disallowed. § 35.5 Investigation, examination, and determination of claims. When a claim is received, the con- stituent agency out of whose activities the claim arose shall make such inves- tigation as may be necessary or appro- priate for a determination of the valid- ity of the claim and thereafter shall forward the claim, together with all pertinent mat im arose shall make such inves- tigation as may be necessary or appro- priate for a determination of the valid- ity of the claim and thereafter shall forward the claim, together with all pertinent material, and a recommenda- tion based on the merits of the case, with regard to allowance or disallow- ance of the claim, to the Department Claims Officer to whom authority has been delegated to adjust, determine, compromise and settle all claims here- under. § 35.6 Final denial of claim. (a) Final denial of an administrative claim shall be in writing and sent to the claimant, his attorney, or legal representative by certified or reg- istered mail. The notification of final denial may include a statement of the reasons for the denial and shall include a statement that, if the claimant is dissatisfied with the Department’s ac- tion, he may file suit in an appropriate U.S. District Court not later than 6 months after the date of mailing of the notification. (b) Prior to the commencement of suit and prior to the expiration of the 6-month period after the date of mail- ing, by certified or registered mail of notice of final denial of the claim as provided in 28 U.S.C. 2401(b), a claim- ant, t and prior to the expiration of the 6-month period after the date of mail- ing, by certified or registered mail of notice of final denial of the claim as provided in 28 U.S.C. 2401(b), a claim- ant, his duly authorized agent, or legal representative, may file a written re- quest with the Department for recon- sideration of a final denial of a claim under paragraph (a) of this section. Upon the timely filing of a request for reconsideration the Department shall have 6 months from the date of filing in which to make a final disposition of the claim and the claimant’s option under 28 U.S.C. 2675(a) to bring suit shall not accrue until 6 months after the filing of a request for reconsider- ation. Final Department action on a 130 Dept. of Health and Human Services § 36.1 request for reconsideration shall be ef- fected in accordance with the provi- sions of paragraph (a) of this section. [32 FR 14101, Oct. 11, 1967, as amended at 35 FR 4517, Mar. 13, 1970] § 35.7 Payment of approved claims. (a) Upon allowance of his claim, claimant or his duly authorized agent shall sign the voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attor (a) Upon allowance of his claim, claimant or his duly authorized agent shall sign the voucher for payment, Standard Form 1145, before payment is made. (b) When the claimant is represented by an attorney, the voucher for pay- ment (SF 1145) shall designate both the claimant and his attorney as ‘‘payees.’’ The check shall be delivered to the at- torney whose address shall appear on the voucher. § 35.8 Release. Acceptance by the claimant, his agent or legal representative, of any award, compromise or settlement made hereunder, shall be final and conclusive on the claimant, his agent or legal rep- resentative and any other person on whose behalf or for whose benefit the claim has been presented, and shall constitute a complete release of any claim against the United States and against any employee of the Govern- ment whose act or omission gave rise to the claim, by reason of the same subject matter. § 35.9 Penalties. A person who files a false claim or makes a false or fraudulent statement in a claim against the United States may be liable to a fine of not more than $10,000 or to imprisonment of not more than 5 years, or both (18 U.S.C. 287.1001), and, in addition, to a for- feiture o t in a claim against the United States may be liable to a fine of not more than $10,000 or to imprisonment of not more than 5 years, or both (18 U.S.C. 287.1001), and, in addition, to a for- feiture of $2,000 and a penalty of double the loss or damage sustained by the United States (31 U.S.C. 231). § 35.10 Limitation on Department’s au- thority. (a) An award, compromise or settle- ment of a claim hereunder in excess of $25,000 shall be effected only with the prior written approval of the Attorney General or his designee. For the pur- poses of this paragraph, a principal claim and any derivative or subrogated claim shall be treated as a single claim. (b) An administrative claim may be adjusted, determined, compromised or settled hereunder only after consulta- tion with the Department of Justice when, in the opinion of the Depart- ment: (1) A new precedent or a new point of law is involved; or (2) A question of policy is or may be involved; or (3) The United States is or may be entitled to indemnity or contribution from a third party and the Department is unable to adjust the third party claim; or (4) The compromise of a particular claim, as a practical matter, will or may control th to indemnity or contribution from a third party and the Department is unable to adjust the third party claim; or (4) The compromise of a particular claim, as a practical matter, will or may control the disposition of a re- lated claim in which the amount to be paid may exceed $25,000. (c) An administrative claim may be adjusted, determined, compromised or settled only after consultation with the Department of Justice when it is learned that the United States or an employee, agent or cost plus con- tractor of the United States is involved in litigation based on a claim arising out of the same incident or trans- action. PART 36—INDEMNIFICATION OF HHS EMPLOYEES § 36.1 Policy. (a) The Department of Health and Human Services may indemnify, in whole or in part, its employees (which for the purpose of this regulation in- cludes former employees) for any ver- dict, judgment or other monetary award which is rendered against any such employee, provided that the con- duct giving rise to the verdict, judg- ment or award was taken within the scope of his or her employment with the Department and that such indem- nification is in the interest of the United States, as determined by the Secretary, ct, judg- ment or award was taken within the scope of his or her employment with the Department and that such indem- nification is in the interest of the United States, as determined by the Secretary, or his or her designee, in his or her discretion. (b) The Department of Health and Human Services may settle or com- promise a personal damage claim against its employee by the payment of available funds, at any time, provided the alleged conduct giving rise to the personal damage claim was taken with- in the scope of employment and that 131 Pt. 46 45 CFR Subtitle A (10–1–24 Edition) such settlement or compromise is in the interest of the United States, as de- termined by the Secretary, or his or her designee, in his or her discretion. (c) Absent exceptional cir- cumstances, as determined by the Sec- retary or his or her designee, the De- partment will not entertain a request either to agree to indemnify or to set- tle a personal damage claim before entry of an adverse verdict, judgment or monetary award. (d) When an employee of the Depart- ment of Health and Human Services be- comes aware that an action has been filed against the employee in his or her individual capacity as a result r monetary award. (d) When an employee of the Depart- ment of Health and Human Services be- comes aware that an action has been filed against the employee in his or her individual capacity as a result of con- duct taken within the scope of his or her employment, the employee should immediately notify the Department that such an action is pending. (e) The employee may, thereafter, re- quest either (1) indemnification to sat- isfy a verdict, judgment or award en- tered against the employee or (2) pay- ment to satisfy the requirements of a settlement proposal. The employee shall submit a written request, with documentation including copies of the verdict, judgment, award or settlement proposal, as appropriate, to the head of his employing component, who shall thereupon submit to the General Coun- sel, in a timely manner, a rec- ommended disposition of the request. The General Counsel shall also seek the views of the Department of Justice. The General Counsel shall forward the request, the employing component’s recommendation and the General Counsel’s recommendation to the Sec- retary for decision. (f) Any payment under this section either to indemnify a Department of Health and Human employing component’s recommendation and the General Counsel’s recommendation to the Sec- retary for decision. (f) Any payment under this section either to indemnify a Department of Health and Human Services employee or to settle a personal damage claim shall be contingent upon the avail- ability of appropriated funds of the em- ploying component of the Department of Health and Human Services. (Authority: 5 U.S.C. 301) [53 FR 11280, Apr. 6, 1988] PART 46—PROTECTION OF HUMAN SUBJECTS Subpart A—Basic HHS Policy for Protection of Human Research Subjects Sec. 46.101 To what does this policy apply? 46.102 Definitions for purposes of this pol- icy. 46.103 Assuring compliance with this pol- icy—research conducted or supported by any Federal department or agency. 46.104 Exempt research. 46.105–46.106 [Reserved] 46.107 IRB membership. 46.108 IRB functions and operations. 46.109 IRB review of research. 46.110 Expedited review procedures for cer- tain kinds of research involving no more than minimal risk, and for minor changes in approved research. 46.111 Criteria for IRB approval of research. 46.112 Review by institution. 46.113 Suspension or termination of IRB ap- proval of research. 46.11 imal risk, and for minor changes in approved research. 46.111 Criteria for IRB approval of research. 46.112 Review by institution. 46.113 Suspension or termination of IRB ap- proval of research. 46.114 Cooperative research. 46.115 IRB records. 46.116 General requirements for informed consent. 46.117 Documentation of informed consent. 46.118 Applications and proposals lacking definite plans for involvement of human subjects. 46.119 Research undertaken without the in- tention of involving human subjects. 46.120 Evaluation and disposition of applica- tions and proposals for research to be conducted or supported by a Federal de- partment or agency. 46.121 [Reserved] 46.122 Use of Federal funds. 46.123 Early termination of research sup- port: Evaluation of applications and pro- posals. 46.124 Conditions. Subpart B—Additional Protections for Preg- nant Women, Human Fetuses and Neonates Involved in Research 46.201 To what do these regulations apply? 46.202 Definitions. 46.203 Duties of IRBs in connection with re- pregnant women, involving search fetuses, and neonates. 46.204 Research involving pregnant women or fetuses. 46.205 Research involving neonates. 46.206 Research involving, after n connection with re- pregnant women, involving search fetuses, and neonates. 46.204 Research involving pregnant women or fetuses. 46.205 Research involving neonates. 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal ma- terial. 46.207 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or alleviate a serious 132 Dept. of Health and Human Services § 46.101 problem affecting the health or welfare of pregnant women, fetuses, or neonates. program. For further information see 47 FR 9208, Mar. 4, 1982. Subpart C—Additional Protections Per- taining to Biomedical and Behavioral Research Involving Prisoners as Sub- jects Subpart A—Basic HHS Policy for Protection of Human Research Subjects 46.301 Applicability. 46.302 Purpose. 46.303 Definitions. 46.304 Composition of Institutional Review Boards where prisoners are involved. 46.305 Additional duties of the Institutional Review Boards where prisoners are in- volved. 46.306 Permitted research involving pris- oners. Subpart D—Additional Protections for Children Involved as Subjects in Research 46.401 To what do these regulations apply? 46.402 Definitions. 46.403 IRB duties. 4 itted research involving pris- oners. Subpart D—Additional Protections for Children Involved as Subjects in Research 46.401 To what do these regulations apply? 46.402 Definitions. 46.403 IRB duties. 46.404 Research not involving greater than minimal risk. 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual sub- jects. 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition. 46.407 Research not otherwise approvable which presents an opportunity to under- stand, prevent, or alleviate a serious problem affecting the health or welfare of children. 46.408 Requirements for permission by par- ents or guardians and for assent by chil- dren. 46.409 Wards. Subpart E—Registration of Institutional Review Boards 46.501 What IRBs must be registered? 46.502 What information must be provided when registering an IRB? 46.503 When must an IRB be registered? 46.504 How must an IRB be registered? 46.505 When must IRB registration informa- tion be renewed or updated? AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 2 stering an IRB? 46.503 When must an IRB be registered? 46.504 How must an IRB be registered? 46.505 When must IRB registration informa- tion be renewed or updated? AUTHORITY: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v–1(b). EDITORIAL NOTE: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to dem- onstration projects, approved under section 1115 of the Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid SOURCE: 82 FR 7259, 7273, Jan. 19, 2017, un- less otherwise noted. § 46.101 To what does this policy apply? (a) Except as detailed in § 46.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative ac- tion to make the policy applicable to such research. This includes research conducted by Federal civilian employ- ees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an his includes research conducted by Federal civilian employ- ees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an adminis- trative standpoint. It also includes re- search conducted, supported, or other- wise subject to regulation by the Fed- eral Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this pol- icy. (b) [Reserved] (c) Department or agency heads re- tain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exer- cised consistent with the ethical prin- ciples of the Belmont Report.62 (d) Department or agency heads may require that specific research activities or classes of research activities con- ducted, supported, or otherwise subject to regulation by the Federal depart- ment or agency but not otherwise cov- ered by this policy comply with some or all of the requirements of this pol- icy. 62 The National Commission for the Protec- tion of Human Subjects of Biomedical and Beha agency but not otherwise cov- ered by this policy comply with some or all of the requirements of this pol- icy. 62 The National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research.– Belmont Report. Washington, DC: U.S. Department of Health and Human Services. 1979. 133 § 46.101 45 CFR Subtitle A (10–1–24 Edition) (e) Compliance with this policy re- quires compliance with pertinent fed- eral laws or regulations that provide additional protections for human sub- jects. (f) This policy does not affect any state or local laws or regulations (in- cluding tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may oth- erwise be applicable and that provide additional protections for human sub- jects. (g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that pro- vide additional protections to human subjects of research. (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these cir- cumstances, if a department o place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these cir- cumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the de- partment or agency head may approve the substitution of the foreign proce- dures in lieu of the procedural require- ments provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the FEDERAL REGISTER or will be otherwise published as provided in department or agency procedures. (i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific re- search activities or classes of research activities otherwise covered by this policy, provided the alternative proce- dures to be followed are consistent with the principles of the Belmont Re- port.63 Except when otherwise required by statute or Executive Order, the de- partme policy, provided the alternative proce- dures to be followed are consistent with the principles of the Belmont Re- port.63 Except when otherwise required by statute or Executive Order, the de- partment or agency head shall forward advance notices of these actions to the Office for Human Research Protec- tions, Department of Health and Human Services (HHS), or any suc- cessor office, or to the equivalent office 63 Id. within the appropriate Federal depart- ment or agency, and shall also publish them in the FEDERAL REGISTER or in such other manner as provided in de- partment or agency procedures. The waiver notice must include a state- ment that identifies the conditions under which the waiver will be applied and a justification as to why the waiv- er is appropriate for the research, in- cluding how the decision is consistent with the principles of the Belmont Re- port. (j) Federal guidance on the require- ments of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appro- priate), with other Federal depart- ments and agencies that have adopted this policy, unless such consultation is not feasible. (k) [Reserved] (l) Compliance dates harmonization (to the extent appro- priate), with other Federal depart- ments and agencies that have adopted this policy, unless such consultation is not feasible. (k) [Reserved] (l) Compliance dates and transition provisions: (1) Pre-2018 Requirements. For pur- poses of this section, the pre-2018 Re- quirements means this subpart as pub- lished in the 2016 edition of the Code of Federal Regulations. (2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Pro- tection of Human Subjects require- ments contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for § 46.114(b) (coopera- tive research) of the 2018 Requirements is January 20, 2020. (3) Research subject to pre-2018 require- ments. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accord- ance with paragraph (l)(4) of this sec- tion: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Req sec- tion: (i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019; (ii) Research for which IRB review was waived pursuant to § 46.101(i) of the pre-2018 Requirements before January 21, 2019; and (iii) Research for which a determina- tion was made that the research was exempt under § 46.101(b) of the pre-2018 Requirements before January 21, 2019. 134 Dept. of Health and Human Services § 46.102 (4) Transitioning research. If, on or after July 19, 2018, an institution plan- ning or engaged in research otherwise covered by paragraph (l)(3) of this sec- tion determines that such research in- stead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination. (i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall: (A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Require- ments, except that the research shall comply with the following: (1) Section 46.102(l) of the 2018 Re- quirements (definition of research) (in- stead of § 46.102(d) of the pre-2018 Re- quirements); (2) Secti except that the research shall comply with the following: (1) Section 46.102(l) of the 2018 Re- quirements (definition of research) (in- stead of § 46.102(d) of the pre-2018 Re- quirements); (2) Section 46.103(d) of the 2018 Re- quirements (revised certification re- quirement that eliminates IRB review of application or proposal) (instead of § 46.103(f) of the pre-2018 Requirements); and (3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of § 46.103(b), as related to the require- ment for continuing review, and in ad- dition to § 46.109, of the pre-2018 Re- quirements); and (B) Beginning on January 21, 2019, comply with the 2018 Requirements. (ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, com- ply with the 2018 Requirements. (5) Research subject to 2018 Require- ments. The 2018 Requirements shall apply to the following research: (i) Research initially approved by an IRB on or after January 21, 2019; (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and earch: (i) Research initially approved by an IRB on or after January 21, 2019; (ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and (iii) Research for which a determina- tion is made that the research is ex- empt on or after January 21, 2019. (m) Severability: Any provision of this part held to be invalid or unen- forceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision per- mitted by law, unless such holding shall be one of utter invalidity or unen- forceability, in which event the provi- sion shall be severable from this part and shall not affect the remainder thereof or the application of the provi- sion to other persons not similarly sit- uated or to other dissimilar cir- cumstances. [82 FR 7259, 7273, Jan. 19, 2017, as amended at 83 FR 28518, June 19, 2018] § 46.102 Definitions for purposes of this policy. (a) Certification means the official no- tification by the institution to the sup- porting Federal department or agency component, in accordance with the re- quirements of this policy, that a re- search project or activi ans the official no- tification by the institution to the sup- porting Federal department or agency component, in accordance with the re- quirements of this policy, that a re- search project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (b) Clinical trial means a research study in which one or more human sub- jects are prospectively assigned to one or more interventions (which may in- clude placebo or other control) to evaluate the effects of the interven- tions on biomedical or behavioral health-related outcomes. (c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated. (d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human sub- jects it conducts, supports, or other- wise reg than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human sub- jects it conducts, supports, or other- wise regulates (e.g., the U.S. Depart- ment of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) con- ducting research: (i) Obtains information or biospeci- mens through intervention or inter- action with the individual, and uses, 135 § 46.102 45 CFR Subtitle A (10–1–24 Edition) studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private infor- mation or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research pur- poses. gathered are (3) Interaction includes communica- tion or interpersonal contact between investigator and subject. (4) Private information includes infor- mation about behavior that occur ch pur- poses. gathered are (3) Interaction includes communica- tion or interpersonal contact between investigator and subject. (4) Private information includes infor- mation about behavior that occurs in a context in which an individual can rea- sonably expect that no observation or recording is taking place, and informa- tion that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). (5) Identifiable private information is private information for which the iden- tity of the subject is or may readily be ascertained by the investigator or asso- ciated with the information. (6) An identifiable biospecimen is a bio- specimen for which the identity of the subject be or may ascertained by the investigator or asso- ciated with the biospecimen. readily is (7) Federal departments or agencies implementing this policy shall: (i) Upon consultation with appro- priate experts (including experts in data matching and re-identification), reexamine the meaning of ‘‘identifiable private information,’’ as defined in paragraph (e)(5) of this section, and ‘‘identifiable biospecimen,’’ as defined in parag ta matching and re-identification), reexamine the meaning of ‘‘identifiable private information,’’ as defined in paragraph (e)(5) of this section, and ‘‘identifiable biospecimen,’’ as defined in paragraph (e)(6) of this section. This reexamination shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal departments and agencies implementing this policy. If appro- priate and permitted by law, such Fed- eral departments and agencies may alter the interpretation of these terms, including through the use of guidance. (ii) Upon consultation with appro- priate experts, assess whether there are analytic technologies or techniques that should be considered by investiga- tors to generate ‘‘identifiable private information,’’ as defined in paragraph (e)(5) of this section, or an ‘‘identifi- able biospecimen,’’ as defined in para- graph (e)(6) of this section. This assess- ment shall take place within 1 year and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal de- partments and agencies implementing this policy. Any such technologies or tec r and regularly thereafter (at least every 4 years). This process will be conducted by collaboration among the Federal de- partments and agencies implementing this policy. Any such technologies or techniques will be included on a list of technologies that produce identifiable private informa- tion or identifiable biospecimens. This list will be published in the FEDERAL REGISTER after notice and an oppor- tunity for public comment. The Sec- retary, HHS, shall maintain the list on a publicly accessible Web site. techniques or (f) Institution means any public or private entity, or department or agen- cy (including federal, state, and other agencies). (g) IRB means an institutional review board established in accord with and for the purposes expressed in this pol- icy. (h) IRB approval means the deter- mination of the IRB that the research has been reviewed and may be con- ducted at an institution within the constraints set forth by the IRB and by other institutional and federal require- ments. (i) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- ti ents. (i) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospec- tive subject to the subject’s participa- tion in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual rec- ognized by institutional policy as ac- ceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) in- volved in the research. (j) Minimal risk means that the prob- ability and magnitude of harm or dis- comfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of rou- tine physical or psychological exami- nations or tests. 136 Dept. of Health and Human Services § 46.103 (k) Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, i erritory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted au- thority, that is responsible for public health matters as part of its official mandate. (l) Research means a systematic in- vestigation, including research devel- opment, testing, and evaluation, de- signed to develop or contribute to gen- eralizable knowledge. Activities that meet this definition constitute re- search for purposes of this policy, whether or not they are conducted or supported under a program that is con- sidered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research: (1) Scholarly and journalistic activi- ties (e.g., oral history, journalism, bi- ography, literary criticism, legal re- search, and historical scholarship), in- cluding the collection and use of infor- mation, that focus directly on the spe- ci (e.g., oral history, journalism, bi- ography, literary criticism, legal re- search, and historical scholarship), in- cluding the collection and use of infor- mation, that focus directly on the spe- cific individuals about whom the infor- mation is collected. (2) Public health surveillance activi- ties, including the collection and test- ing of information or biospecimens, conducted, supported, requested, or- dered, required, or authorized by a pub- lic health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate poten- tial public health signals, onsets of dis- ease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in dis- eases, or increases in injuries from using consumer products). Such activi- ties include those associated with pro- viding timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). (3) Collection and analysis of infor- mation, biospecimens, or records by or for a criminal justice agency for activi- ties authorized by law or c lic health (including natural or man-made disasters). (3) Collection and analysis of infor- mation, biospecimens, or records by or for a criminal justice agency for activi- ties authorized by law or court order solely for criminal justice or criminal investigative purposes. (4) Authorized operational activities (as determined by each agency) in sup- port of intelligence, homeland secu- rity, defense, or other national secu- rity missions. (m) Written, or in writing, for purposes of this part, refers to writing on a tan- gible medium (e.g., paper) or in an elec- tronic format. § 46.103 Assuring compliance with this policy—research conducted or sup- ported by any Federal department or agency. (a) Each institution engaged in re- search that is covered by this policy, with the exception of research eligible for exemption under § 46.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the exist- ence of a current assurance, appro- pr will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the exist- ence of a current assurance, appro- priate for the research in question, on file with the Office for Human Re- search Protections, HHS, or any suc- cessor office, and approved for Federal- wide use by that office. When the exist- ence of an HHS-approved assurance is accepted in lieu of requiring submis- sion of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal depart- ments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institu- tion has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification required by § 46.103(d)). is (b) The assurance shall be executed by an individual authorized to act for 137 § 46.104 45 CFR Subtitle rch has been reviewed and approved by an IRB (if such certification required by § 46.103(d)). is (b) The assurance shall be executed by an individual authorized to act for 137 § 46.104 45 CFR Subtitle A (10–1–24 Edition) the institution and to assume on behalf of the institution the obligations im- posed by this policy and shall be filed in such form and manner as the depart- ment or agency head prescribes. (c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the as- surance. (d) Certification is required when the research is supported by a Federal de- partment or agency and not otherwise waived under § 46.101(i) or exempted under § 46.104. For such research, insti- tutions shall certify that each proposed research study covered by the assur- ance and this section has been reviewed and approved by the IRB. Such certifi- cation must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research cov- ered by this section be initiated prior to receipt of the certification that the research has been reviewed and ap- proved by the IR ent supporting the research. Under no condition shall research cov- ered by this section be initiated prior to receipt of the certification that the research has been reviewed and ap- proved by the IRB. (e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to § 46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the in- stitution, the institution and the orga- nization operating the IRB shall docu- ment the institution’s reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by imple- mentation of an institution-wide policy directive providing the allocation of re- sponsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a re- search protocol). (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.104 Exempt research. (a) Unless s not affiliated with the institution, or as set forth in a re- search protocol). (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.104 Exempt research. (a) Unless otherwise required by law or by department or agency heads, re- search activities in which the only in- volvement of human subjects will be in one or more of the categories in para- graph (d) of this section are exempt from the requirements of this policy, except that such activities must com- ply with the requirements of this sec- tion and as specified in each category. (b) Use of the exemption categories for research subject to the require- ments of subparts B, C, and D: Applica- tion of the exemption categories to re- search subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. Each of the exemptions at this section may be applied to re- search subject to subpart B if the con- ditions of the exemption are met. (2) Subpart C. The exemptions at this section do not apply to research sub- ject to subpart C, except for research aimed at involving a broader subject population that only incidentally in- cludes prisoners. (3) Subpart D. The exemp this section do not apply to research sub- ject to subpart C, except for research aimed at involving a broader subject population that only incidentally in- cludes prisoners. (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to re- search subject to subpart D if the con- ditions of the exemption are met. Para- graphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not partici- pate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved] (d) Except as described in paragraph (a) of this section, the following cat- egories of human subjects research are exempt from this policy: (1) Research, conducted in estab- lished or commonly accepted edu- cational settings, that specifically in- volves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effec- tiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research that only includes inter- involving educational tests aptitude, procedures, actions (cognitive, achievement), diagnostic, survey 138 Dept. of Health and Human Services § 46.104 interview procedures, or observation of public behavior (including visual or au- ditory recording) if at least one of the following criteria is met: (i) The information obtained is re- corded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human sub- jects’ responses outside the research would not reasonably place the sub- jects at risk of criminal or civil liabil- ity or be damaging to the subjects’ fi- nancial standing, employability, edu- cational advancement, or reputation; or (iii ould not reasonably place the sub- jects at risk of criminal or civil liabil- ity or be damaging to the subjects’ fi- nancial standing, employability, edu- cational advancement, or reputation; or (iii) The information obtained is re- corded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, di- rectly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the deter- mination required by § 46.111(a)(7). (3)(i) Research involving benign be- havioral interventions in conjunction with the collection of information from an adult subject through verbal or written (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collec- tion and at least one of the following criteria is met: responses (A) The information obtained is re- corded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human sub- jects’ responses outside the research would not reasonably place the sub- jects at risk of criminal or ed, directly or through identifiers linked to the subjects; (B) Any disclosure of the human sub- jects’ responses outside the research would not reasonably place the sub- jects at risk of criminal or civil liabil- ity or be damaging to the subjects’ fi- nancial standing, employability, edu- cational advancement, or reputation; or (C) The information obtained is re- corded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, di- rectly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the deter- mination required by § 46.111(a)(7). (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting im- pact on the subjects, and the investi- gator has no reason to think the sub- jects will find the interventions offen- sive or embarrassing. Provided all such criteria are met, examples of such be- nign behavioral interventions would in- clude having the subjects play an on- line game, having them solve puzzles under various noise conditions, or hav- ing them decide how et, examples of such be- nign behavioral interventions would in- clude having the subjects play an on- line game, having them solve puzzles under various noise conditions, or hav- ing them decide how to allocate a nominal amount of received cash be- tween themselves and someone else. authorizes (iii) If the research involves deceiv- ing the subjects regarding the nature or purposes of the research, this ex- emption is not applicable unless the subject deception through a prospective agreement to participate cir- cumstances in which the subject is in- formed that he or she will be unaware of or misled regarding the nature or purposes of the research. research the in in (4) Secondary research for which con- sent is not required: Secondary re- search uses of identifiable private in- formation or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private informa- tion or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is re- corded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers li may include information about biospecimens, is re- corded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the inves- tigator will not re-identify subjects; (iii) The research involves only infor- mation collection and analysis involv- ing the investigator’s use of identifi- able health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘re- search’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health ac- tivities and purposes’’ as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or 139 § 46.104 45 CFR Subtitle A (10–1–24 Edition) agency using government-generated or government-collected information ob- tained for nonresearch activities, if the research generates identifiable private information that is or will be main- tained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 350 rates identifiable private information that is or will be main- tained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information col- lected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. (5) Research and demonstration projects that are conducted or sup- ported by a Federal department or agency, or otherwise subject to the ap- proval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to con- duct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service pro- grams, including procedures for obtain- ing benefits or services under those programs, possible changes in or alter- natives to those programs or proce- dures, or possible changes in methods or levels of payment f ing procedures for obtain- ing benefits or services under those programs, possible changes in or alter- natives to those programs or proce- dures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or con- sulting cooperative agreements, or grants. Exempt projects also include waivers of otherwise man- datory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. arrangements, (i) Each Federal department or agen- cy conducting or supporting the re- search and demonstration projects must establish, on a publicly accessible Federal Web site or in such other man- ner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. (ii) [Reserved] (6) Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods wi st be published on this list prior to commencing the research involving human subjects. (ii) [Reserved] (6) Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without addi- tives are consumed, or (ii) If a food is consumed that con- tains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environ- mental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agri- culture. (7) Storage or maintenance for sec- ondary research for which broad con- sent is required: Storage or mainte- nance of identifiable private informa- tion or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 46.111(a)(8). (8) Secondary research for which broad consent is required: Research in- volving the use of identifiable private information or identifiable biospeci- mens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, h in- volving the use of identifiable private information or identifiable biospeci- mens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private informa- tion or identifiable biospecimens was obtained with § 46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed con- sent or waiver of documentation of consent was obtained in accordance with § 46.117; accordance in (iii) An IRB conducts a limited IRB review and makes the determination required by § 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The in- vestigator does not include returning individual research results to subjects as part of the study plan. This provi- sion does not prevent an investigator from abiding by any legal requirements to return individual research results. (Approved by the Office of Management and Budget under Control Number 0990–0260) 140 Dept. of Health and Human Services § 46.108 § 46.105–46.106 [Reserved] § 46.107 IRB membership. (a) Each IRB shall ha pproved by the Office of Management and Budget under Control Number 0990–0260) 140 Dept. of Health and Human Services § 46.108 § 46.105–46.106 [Reserved] § 46.107 IRB membership. (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly con- ducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, in- cluding race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to pro- mote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institu- tional commitments (including policies and resources) and regulations, appli- cable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledge- able in these areas. If an IRB regularly reviews research that involves a cat- egory of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with ledge- able in these areas. If an IRB regularly reviews research that involves a cat- egory of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally dis- advantaged consideration persons, shall be given to the inclusion of one or more individuals who are knowledge- able about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affili- ated with the institution and who is not part of the immediate family of a person who is affiliated with the insti- tution. (d) No IRB may have a member par- ticipate in the IRB’s initial or con- tinuing review of any project in which the member has a conflicting interest, except to provide information re- quested by the IRB. (e) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition rmation re- quested by the IRB. (e) An IRB may, in its discretion, in- vite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. § 46.108 IRB functions and operations. (a) In order to fulfill the require- ments of this policy each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB’s re- view and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and any employment or other relationship between each mem- ber and the institution, for example, full-time employee, part-time em- ployee, member of governing panel or board, stockholder, paid or unpaid con- sultant; (3) Establish and follow written pro- cedures for: (i) Conducting its initial and con- tinuing review of research and for re- porting its findings and actions to the investigator and the institution; (ii) De ablish and follow written pro- cedures for: (i) Conducting its initial and con- tinuing review of research and for re- porting its findings and actions to the investigator and the institution; (ii) Determining which projects re- quire review more often than annually and which projects need verification from sources other than the investiga- tors that no material changes have oc- curred since previous IRB review; and (iii) Ensuring prompt reporting to the IRB of proposed changes in a re- search activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and ap- proved by the IRB, except when nec- essary to eliminate apparent imme- diate hazards to the subject. (4) Establish and follow written pro- cedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Re- search Protections, HHS, or any suc- cessor office, or the equivalent office within the appropriate Federal depart- ment or agency of (i) Any unanticipated problems in- volving risks to subjects or others or 141 § 46.109 45 CFR Sub suc- cessor office, or the equivalent office within the appropriate Federal depart- ment or agency of (i) Any unanticipated problems in- volving risks to subjects or others or 141 § 46.109 45 CFR Subtitle A (10–1–24 Edition) any serious or continuing noncompli- ance with this policy or the require- ments or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is used (as described in § 46.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the re- search to be approved, it shall receive the approval of a majority of those members present at the meeting. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.109 IRB review of research. (a) An IRB shall review and have au- thority to approve, require modifica- tions in (to secure approval), or dis- approve all research activities covered by this policy, including exempt re- search activities under § 46.104 for which limited IRB review is a condi- (under tion § 46.10 (to secure approval), or dis- approve all research activities covered by this policy, including exempt re- search activities under § 46.104 for which limited IRB review is a condi- (under tion § 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)). exemption of (b) An IRB shall require that infor- mation given to subjects (or legally au- thorized representatives, when appro- priate) as part of informed consent is in accordance with § 46.116. The IRB may require that information, in addi- tion to that specifically mentioned in § 46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protec- tion of the rights and welfare of sub- jects. (c) An IRB shall require documenta- tion of informed consent or may waive in accordance with documentation § 46.117. (d) An IRB shall notify investigators and the institution in writing of its de- cision to approve or disapprove the pro- posed research activity, or of modifica- tions required to secure IRB approval of the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica- tion a statement of the reasons for its decision and give the in RB approval of the research activity. If the IRB de- cides to disapprove a research activity, it shall include in its written notifica- tion a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appro- priate to the degree of risk, not less than once per year, except as described in § 46.109(f). (f)(1) Unless an IRB determines oth- erwise, continuing review of research is not required in the following cir- cumstances: (i) Research eligible for expedited re- view in accordance with § 46.110; (ii) Research reviewed by the IRB in accordance with the limited IRB re- view described § 46.104(d)(2)(iii), in (d)(3)(i)(C), or (d)(7) or (8); (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (2) [Reserved] (g) An IRB shall ifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (2) [Reserved] (g) An IRB shall have authority to observe or have a third party observe the consent process and the research. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.110 Expedited review procedures for certain kinds of research involv- ing no more than minimal risk, and for minor changes in approved re- search. (a) The Secretary of HHS has estab- lished, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after con- sultation with other federal depart- ments and agencies and after publica- tion in the FEDERAL REGISTER for pub- lic comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any suc- cessor office. (b)(1) An IRB may use the expedited review procedure to review the fol- lowing: 142 Dept. of Health and Human Services § 46.111 (i) So e for Human Research Protections, HHS, or any suc- cessor office. (b)(1) An IRB may use the expedited review procedure to review the fol- lowing: 142 Dept. of Health and Human Services § 46.111 (i) Some or all of the research ap- pearing on the list described in para- graph (a) of this section, unless the re- viewer determines that the study in- volves more than minimal risk; (ii) Minor changes in previously ap- proved research during the period for which approval is authorized; or (iii) Research for which limited IRB review is a condition of exemption under § 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). (2) Under an expedited review proce- dure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the re- search. A research activity may be dis- approved only after review in accord- ance with the nonexpedited procedure set forth in § 46.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members adv proved only after review in accord- ance with the nonexpedited procedure set forth in § 46.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of re- search proposals that have been ap- proved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institu- tion’s or IRB’s use of the expedited re- view procedure. § 46.111 Criteria for IRB approval of research. (a) In order to approve research cov- ered by this policy the IRB shall deter- mine that all of the following require- ments are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are con- sistent with sound research design and that do not unnecessarily expose sub- jects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treat- ment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may res if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distin- guished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long- range effects of applying knowledge gained in the research (e.g., the pos- sible effects of the research on public policy) as among those research risks that fall within the purview of its re- sponsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cog- nizant of the special problems of re- search that involves a category of sub- jects who are vulnerable to coercion or undue influence, such as children, pris- oners, individuals with impaired deci- sion-making capacity, or economically or educationally disadvantaged per- sons. (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized rep impaired deci- sion-making capacity, or economically or educationally disadvantaged per- sons. (4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representa- tive, in accordance with, and to the ex- tent required by, § 46.116. (5) Informed consent will be appro- priately documented or appropriately waived in accordance with § 46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to en- sure the safety of subjects. (7) When appropriate, there are ade- quate provisions to protect the privacy of subjects and to maintain the con- fidentiality of data. (i) The Secretary of HHS will, after consultation with the Office of Man- agement and Budget’s privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assess- ing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data. IRB (ii) [Reserved] (8) For purposes of conducting the limited required by review § 46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make (ii) [Reserved] (8) For purposes of conducting the limited required by review § 46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations: (i) Broad consent for storage, mainte- nance, and secondary research use of information or identifiable private 143 § 46.112 45 CFR Subtitle A (10–1–24 Edition) identifiable biospecimens is obtained in accordance with the requirements of § 46.116(a)(1)–(4), (a)(6), and (d); (ii) Broad consent is appropriately documented or waiver of documenta- tion is appropriate, in accordance with § 46.117; and (iii) If there is a change made for re- search purposes in the way the identifi- able private information or identifiable biospecimens are stored or maintained, there are adequate provisions to pro- tect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economi- cally or educationally disadvantaged persons, additional safeguards have been included in the study to pro such as children, prisoners, individuals with impaired decision-making capacity, or economi- cally or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these sub- jects. § 46.112 Review by institution. Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those offi- cials may not approve the research if it has not been approved by an IRB. § 46.113 Suspension or termination of IRB approval of research. An IRB shall have authority to sus- pend or terminate approval of research that is not being conducted in accord- ance with the IRB’s requirements or that has been associated with unex- pected serious harm to subjects. Any suspension or termination of approval shall include a statement of the rea- sons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.114 Cooperative research. (a) Cooperative research pro institutional officials, and the department or agency head. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.114 Cooperative research. (a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. (b)(1) Any institution located in the United States that is engaged in coop- erative research must rely upon ap- proval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal depart- ment or agency supporting or con- ducting the research or proposed by the lead institution subject to the accept- ance of the Federal department or agency supporting the research. (2) The following research is not sub- ject to this provision: (i) Cooperative research for which more than single IRB review is re- quired by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Fed for which more than single IRB review is re- quired by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the par- ticular context. (c) For research not subject to para- graph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrange- ment, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. § 46.115 IRB records. (a) An institution, or when appro- priate an IRB, shall prepare and main- tain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals re- viewed, scientific evaluations, if any, that accompany the proposals, ap- proved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show at- tendance at the meetings; actions taken by the IRB; the vote on these ac- tions including the numb of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show at- tendance at the meetings; actions taken by the IRB; the vote on these ac- tions including the number of members voting for, against, and abstaining; the basis for requiring changes in or dis- approving research; and a written sum- mary of the discussion of controverted issues and their resolution. (3) Records of continuing review ac- tivities, including the rationale for 144 Dept. of Health and Human Services § 46.116 conducting continuing review of re- search that otherwise would not re- quire continuing review as described in § 46.109(f)(1). (4) Copies of all correspondence be- tween the IRB and the investigators. (5) A list of IRB members in the same detail as described in § 46.108(a)(2). (6) Written procedures for the IRB in in the same detail as described § 46.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as re- quired by § 46.116(c)(5). (8) The rationale for an expedited re- viewer’s under determination § 46.110(b)(1)(i) that research appearing on the expedited review list described in § 46.110(a) is more than minimal risk. (9) Documentat he rationale for an expedited re- viewer’s under determination § 46.110(b)(1)(i) that research appearing on the expedited review list described in § 46.110(a) is more than minimal risk. (9) Documentation specifying the re- sponsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in § 46.103(e). (b) The records required by this pol- icy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at rea- sonable times and in a reasonable man- ner. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.116 General requirements for in- formed consent. (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in ac- cordance with the requirements set forth in p ent. (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in ac- cordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be ob- tained in lieu of informed consent ob- tained in accordance with paragraphs (b) and (c) of this section only with re- spect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in para- graph (e) of this section. General waiv- er or alteration of informed consent is described in paragraph (f) of this sec- tion. Except as provided elsewhere in this policy: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally ef- fective informed consent of the subject or the subject’s legally authorized rep- resentative. consent only under (2) An investigator shall seek in- formed cir- cumstances that provide the prospec- tive subject or t ed consent of the subject or the subject’s legally authorized rep- resentative. consent only under (2) An investigator shall seek in- formed cir- cumstances that provide the prospec- tive subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influ- ence. (3) The information that is given to the subject or the legally authorized representative shall be in language un- derstandable to the subject or the le- gally authorized representative. (4) The prospective subject or the le- gally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed de- cision about whether to participate, and an opportunity to discuss that in- formation. (5) Except for broad consent obtained in accordance with paragraph (d) of this section: (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or le- gally authorized representative in un- derstanding the reasons why one might or might not want to participate in the n of the key information that is most likely to assist a prospective subject or le- gally authorized representative in un- derstanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and pre- sented in a way that facilitates com- prehension. (ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of iso- lated facts, but rather facilitates the prospective subject’s or legally author- ized representative’s understanding of the reasons why one might or might not want to participate. 145 § 46.116 45 CFR Subtitle A (10–1–24 Edition) (6) No informed consent may include any exculpatory language through which the subject or the legally au- thorized representative is made to waive or appear to waive any of the subject’s legal rights, or releases or ap- pears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking in- forme he sponsor, the institution, or its agents from liability for negligence. (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking in- formed consent the following informa- tion shall be provided to each subject or the legally authorized representa- tive: (1) A statement that the study in- volves research, an explanation of the purposes of the research and the ex- pected duration of the subject’s partici- pation, a description of the procedures to be followed, and identification of any procedures that are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others that may rea- sonably be expected from the research; (4) A disclosure of appropriate alter- native procedures or courses of treat- ment, if any, that might be advan- tageous to the subject; (5) A statement describing the ex- tent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an ex- planation as to whether any medical treat ecords identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any compensation and an ex- planation as to whether any medical treatments are available if injury oc- curs and, if so, what they consist of, or where further information may be ob- tained; (7) An explanation of whom to con- tact for answers to pertinent questions about the research and research sub- jects’ rights, and whom to contact in the event of a research-related injury to the subject; (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue par- ticipation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and (9) One of the following statements about any research that involves the collection of identifiable private infor- mation or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable bio- specimens and that, after such re- moval, the information or biospeci- mens could be used for future rese at identifiers might be removed from the identifiable private information or identifiable bio- specimens and that, after such re- moval, the information or biospeci- mens could be used for future research studies or distributed to another inves- tigator for future research studies without additional informed consent from the subject or the legally author- ized representative, if this might be a possibility; or (ii) A statement that the subject’s in- formation or biospecimens collected as part of the research, even if identifiers are removed, will not be used or dis- tributed for future research studies. (c) Additional elements of informed con- sent. Except as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of in- formation, when appropriate, shall also be provided to each subject or the le- gally authorized representative: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may be- come pregnant) that are currently un- foreseeable; (2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without reg if the subject is or may be- come pregnant) that are currently un- foreseeable; (2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s or the legally representative’s consent; authorized (3) Any additional costs to the sub- ject that may result from participation in the research; (4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue par- ticipation will be provided to the sub- ject; (6) The approximate number of sub- jects involved in the study; (7) A statement that the subject’s biospecimens (even if identifiers are re- moved) may be used for commercial profit and whether the subject will or 146 Dept. of Health and Human Services § 46.116 will not share in this commercial prof- it; (8) A statement regarding whether clinically relevant research results, in- cluding individual research results, will be disclosed to subjects, and if so, under what conditions; and mercial prof- it; (8) A statement regarding whether clinically relevant research results, in- cluding individual research results, will be disclosed to subjects, and if so, under what conditions; and (9) For research involving biospeci- mens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen). (d) Elements of broad consent for the storage, maintenance, and secondary re- search use of identifiable private informa- tion or identifiable biospecimens. Broad consent for the storage, maintenance, and secondary research use of identifi- able private information or identifiable biospecimens (collected for either re- search studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the in- formed consent requirements in para- graphs (b) and (c) of this section. If the subject or the legally authorized rep- resentative is asked to provide broad consent, the following shall be provided to each subject or the subject’s legally authorized representative: (1) The information required in para- graph ized rep- resentative is asked to provide broad consent, the following shall be provided to each subject or the subject’s legally authorized representative: (1) The information required in para- graphs (b)(2), (b)(3), (b)(5), and (b)(8) and, when appropriate, (c)(7) and (9) of this section; (2) A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This descrip- tion must include sufficient informa- tion such that a reasonable person would expect that the broad consent would permit the types of research con- ducted; (3) A description of the identifiable private information or identifiable bio- specimens that might be used in re- search, whether sharing of identifiable private information or identifiable bio- specimens might occur, and the types of institutions or researchers that might conduct research with the iden- tifiable private information or identifi- able biospecimens; (4) A description of the period of time that the identifiable private informa- tion or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a de- scription of the period of t period of time that the identifiable private informa- tion or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a de- scription of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite); (5) Unless the subject or legally au- thorized representative will be pro- vided details about specific research studies, a statement that they will not be informed of the details of any spe- cific research studies that might be conducted using the subject’s identifi- able private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies; (6) Unless it is known that clinically relevant research results, including in- dividual research results, will be dis- in all cir- closed to the subject cumstances, a statement that such re- sults may not be disclosed to the sub- ject; and (7) An explanation of whom to con- tact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable pri sults may not be disclosed to the sub- ject; and (7) An explanation of whom to con- tact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable private information or identifiable biospeci- mens, and whom to contact in the event of a research-related harm. (e) Waiver or alteration of consent in research involving public benefit and serv- ice programs conducted by or subject to the approval of state or local officials—(1) Waiver. An IRB may waive the require- ment to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (e)(3) of this section. If an individual was asked to provide broad consent for the storage, maintenance, and sec- ondary research use of identifiable pri- vate information or identifiable bio- specimens in accordance with the re- quirements at paragraph (d) of this sec- tion, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private informa- tion or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or r the storage, maintenance, or secondary research use of the identifiable private informa- tion or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of 147 § 46.116 45 CFR Subtitle A (10–1–24 Edition) informed consent set forth in para- graphs (b) and (c) of this section pro- vided the IRB satisfies the require- ments of paragraph (e)(3) of this sec- tion. An IRB may not omit or alter any of the requirements described in para- graph (a) of this section. If a broad con- sent procedure is used, an IRB may not omit or alter any of the elements re- quired under paragraph (d) of this sec- tion. (3) Requirements for waiver and alter- ation. In order for an IRB to waive or alter consent as described in this sub- section, the IRB must find and docu- ment that: (i) The research or demonstration project is to be conducted by or subject to the approval of state or local gov- ernment officials and is designed to study, evaluate, or otherwise examine: (A) Public benefit or service pro- grams; (B) Procedures for obtaining benefits or services under those programs; (C) Possible changes in or alter- natives to o study, evaluate, or otherwise examine: (A) Public benefit or service pro- grams; (B) Procedures for obtaining benefits or services under those programs; (C) Possible changes in or alter- natives to those programs or proce- dures; or (D) Possible changes in methods or levels of payment for benefits or serv- ices under those programs; and (ii) The research could not prac- ticably be carried out without the waiver or alteration. (f) General waiver or alteration of con- sent—(1) Waiver. An IRB may waive the requirement to obtain informed con- sent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section. If an in- dividual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifi- able private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private informa- tion or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or a the storage, maintenance, or secondary research use of the identifiable private informa- tion or identifiable biospecimens. (2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in para- graphs (b) and (c) of this section pro- vided the IRB satisfies the require- ments of paragraph (f)(3) of this sec- tion. An IRB may not omit or alter any of the requirements described in para- graph (a) of this section. If a broad con- sent procedure is used, an IRB may not omit or alter any of the elements re- quired under paragraph (d) of this sec- tion. (3) Requirements for waiver and alter- ation. In order for an IRB to waive or alter consent as described in this sub- section, the IRB must find and docu- ment that: (i) The research involves no more than minimal risk to the subjects; (ii) The research could not prac- ticably be carried out without the re- quested waiver or alteration; (iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or bio- specimens in an identifiable format; (i es using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or bio- specimens in an identifiable format; (iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) Whenever appropriate, the sub- jects or legally authorized representa- tives will be provided with additional pertinent information after participa- tion. (g) Screening, recruiting, or determining eligibility. An IRB may approve a re- search proposal in which an investi- gator will obtain information or bio- specimens for the purpose of screening, recruiting, or determining the eligi- bility of prospective subjects without the informed consent of the prospective subject or the subject’s legally author- ized representative, if either of the fol- lowing conditions are met: (1) The investigator will obtain infor- mation through oral or written com- munication with the prospective sub- ject or legally authorized representa- tive, or (2) The investigator will obtain iden- tifiable private information or identifi- able biospecimens by accessing records or stored identifiable biospecimens. (h legally authorized representa- tive, or (2) The investigator will obtain iden- tifiable private information or identifi- able biospecimens by accessing records or stored identifiable biospecimens. (h) Posting of clinical trial consent form. (1) For each clinical trial con- ducted or supported by a Federal de- partment or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a 148 Dept. of Health and Human Services § 46.117 publicly available Federal Web site that will be established as a repository for such informed consent forms. (2) If the Federal department or agen- cy supporting or conducting the clin- ical trial determines that certain infor- mation should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. (3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruit- ment, and no later than 60 days after the last study visit by any subject, as required by the protocol. ( ent form must be posted on the Federal Web site after the clinical trial is closed to recruit- ment, and no later than 60 days after the last study visit by any subject, as required by the protocol. (i) Preemption. The informed consent requirements in this policy are not in- tended to preempt any applicable Fed- eral, state, or local laws (including tribal laws passed by the official gov- erning body of an American Indian or Alaska Native tribe) that require addi- tional information to be disclosed in order for informed consent to be le- gally effective. (j) Emergency medical care. Nothing in this policy is intended to limit the au- thority of a physician to provide emer- gency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or local law (including tribal law passed by the offi- cial governing body of an American In- dian or Alaska Native tribe). (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.117 Documentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form ap- proved by the IRB and s cumentation of informed consent. (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form ap- proved by the IRB and signed (includ- ing in an electronic format) by the sub- ject or the subject’s legally authorized representative. A written copy shall be given to the person signing the in- formed consent form. (b) Except as provided in paragraph (c) of this section, the informed con- sent form may be either of the fol- lowing: (1) A written informed consent form that meets the requirements of § 46.116. The investigator shall give either the subject or the subject’s legally author- ized representative adequate oppor- tunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject’s legally authorized rep- resentative. (2) A short form written informed consent form stating that the elements of informed consent required by § 46.116 have been presented orally to the sub- ject or the subject’s legally authorized representative, and that the key infor- mation required by § 46.116(a)(5)(i) was presented first to the subject, before other inform esented orally to the sub- ject or the subject’s legally authorized representative, and that the key infor- mation required by § 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was pro- vided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized rep- resentative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject’s legally authorized representa- tive. However, the witness shall sign both the short form and a copy of the summary, and the person actually ob- taining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject’s legally authorized representative, in addition to a copy of the short form. (c)(1) An IRB may waive the require- ment for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the fol- lowing: (i) That the only record linking the subject and the research would be the informed consent form and the prin- cipal risk would be potential harm re- sulting from a breach of confiden- tiality lowing: (i) That the only record linking the subject and the research would be the informed consent form and the prin- cipal risk would be potential harm re- sulting from a breach of confiden- tiality. Each subject (or legally author- ized representative) will be asked whether the subject wants documenta- tion linking the subject with the re- search, and the subject’s wishes will govern; (ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally re- quired outside of the research context; or (iii) If the subjects or legally author- ized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more 149 § 46.118 45 CFR Subtitle A (10–1–24 Edition) than minimal risk of harm to subjects and provided there is an appropriate al- ternative mechanism for documenting that informed consent was obtained. (2) In cases in which the documenta- tion requirement is waived, the IRB may require the investigator to provide subjects or legally authorized rep- resentatives with a written statement regarding the research. (Approved by the cumenta- tion requirement is waived, the IRB may require the investigator to provide subjects or legally authorized rep- resentatives with a written statement regarding the research. (Approved by the Office of Management and Budget under Control Number 0990–0260) § 46.118 Applications and proposals lacking definite plans for involve- ment of human subjects. Certain types of applications for grants, cooperative agreements, or con- tracts are submitted to Federal depart- ments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution’s responsi- bility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instru- ments, prior animal studies, or purifi- cation of compounds. Except for re- search waived under § 46.101(i) or ex- empted under § 46.104, no human sub- jects may be involved in any project supported by these awards until the project purifi- cation of compounds. Except for re- search waived under § 46.101(i) or ex- empted under § 46.104, no human sub- jects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the in- stitution, to the Federal department or agency component supporting the re- search. § 46.119 Research undertaken without the intention of involving human subjects. Except for research waived under § 46.101(i) or exempted under § 46.104, in the event research is undertaken with- out the intention of involving human subjects, but it is later proposed to in- volve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal de- partment or agency component. § 46.120 Evaluation and disposition of applications and proposals for re- search to be conducted or sup- ported by a Federal department or agency. (a) The department or agency head will eval omponent. § 46.120 Evaluation and disposition of applications and proposals for re- search to be conducted or sup- ported by a Federal department or agency. (a) The department or agency head will evaluate all applications and pro- posals involving human subjects sub- mitted to the Federal department or agency through such officers and em- ployees of the Federal department or agency and such experts and consult- ants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the impor- tance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. § 46.121 [Reserved] § 46.122 Use of Federal funds. Federal funds administered by a Fed- eral department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. § 46.123 Early termination of research support: Evaluatio ral department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. § 46.123 Early termination of research support: Evaluation of applications and proposals. (a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program re- quirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about sup- porting or approving applications or proposals covered by this policy the de- partment or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the 150 Dept. of Health and Human Services § 46.202 applicant has been subject to a termi- nation or suspension under paragraph (a) of this section and whether the ap- plicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, mate- rially failed to discharge responsibility ns who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, mate- rially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation). § 46.124 Conditions. With respect to any research project or any class of research projects the de- partment or agency head of either the conducting or the supporting Federal department or agency may impose ad- ditional conditions prior to or at the time of approval when in the judgment of the department or agency head addi- tional conditions are necessary for the protection of human subjects. Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates In- volved in Research SOURCE: 66 FR 56778, Nov. 13, 2001, unless otherwise noted. § 46.201 To what do these regulations apply? (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates of un- certain viability, or nonviable neo- nates conducted or supported by the Department of Health and Human Services (D art applies to all research involving pregnant women, human fetuses, neonates of un- certain viability, or nonviable neo- nates conducted or supported by the Department of Health and Human Services (DHHS). This includes all re- search conducted in DHHS facilities by any person and all research conducted in any facility by DHHS employees. (b) The exemptions at § 46.101(b)(1) through (6) are applicable to this sub- part. (c) The provisions of § 46.101(c) through (i) are applicable to this sub- part. Reference to State or local laws in this subpart and in § 46.101(f) is in- tended to include the laws of federally recognized American Indian and Alas- ka Native Tribal Governments. (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part. § 46.202 Definitions. The definitions in § 46.102 shall be ap- plicable to this subpart as well. In ad- dition, as used in this subpart: (a) Dead fetus means a fetus that ex- hibits neither heartbeat, spontaneous respiratory spontaneous activity, movement of voluntary muscles, nor pulsation of the umbilical cord. (b) Delivery means complete separa- tion of the fetus from the woman by expulsion or extrac aneous respiratory spontaneous activity, movement of voluntary muscles, nor pulsation of the umbilical cord. (b) Delivery means complete separa- tion of the fetus from the woman by expulsion or extraction or any other means. (c) Fetus means the product of con- ception from implantation until deliv- ery. (d) Neonate means a newborn. (e) Nonviable neonate means a neonate after delivery that, although living, is not viable. (f) Pregnancy encompasses the period of time from implantation until deliv- ery. A woman shall be assumed to be pregnant if she exhibits any of the per- tinent presumptive signs of pregnancy, such as missed menses, until the re- sults of a pregnancy test are negative or until delivery. (g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the De- partment of Health and Human Serv- ices to whom authority has been dele- gated. (h) Viable, as it pertains to the neonate, means being able, after deliv- ery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heart- beat and respiration. The Secretary may from time to time, taking into ac- count medical advances, publish in th benefit of available medical therapy) to the point of independently maintaining heart- beat and respiration. The Secretary may from time to time, taking into ac- count medical advances, publish in the FEDERAL REGISTER guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be in- cluded in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part. 151 § 46.203 45 CFR Subtitle A (10–1–24 Edition) § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all ap- plicable sections of this subpart and the other subparts of this part. § 46.204 Research involving pregnant women or fetuses. Pregnant women or fetuses may be involved in research if all of the fol- lowing conditions are met: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical stud- ies, including studies on nonpregna h if all of the fol- lowing conditions are met: (a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical stud- ies, including studies on nonpregnant women, have been conducted and pro- vide data for assessing potential risks to pregnant women and fetuses; (b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the re- search is the development of important biomedical knowledge which cannot be obtained by any other means; (c) Any risk is the least possible for achieving the objectives of the re- search; (d) If the research holds out the pros- pect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the de- velopment of important biomedical knowledge that cannot be obtained by any other means, her consent is ob- tained in accord etus is not greater than minimal and the purpose of the research is the de- velopment of important biomedical knowledge that cannot be obtained by any other means, her consent is ob- tained in accord with the informed con- sent provisions of subpart A of this part; (e) If the research holds out the pros- pect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent pro- visions of subpart A of this part, except that the father’s consent need not be obtained if he is unable to consent be- cause of unavailability, incompetence, or temporary incapacity or the preg- nancy resulted from rape or incest. (f) Each individual providing consent under paragraph (d) or (e) of this sec- tion is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; (g) For children as defined in § 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part; (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy; (i) Individuals engaged in the re- search will have no part in any deci- sions as to the of subpart D of this part; (h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy; (i) Individuals engaged in the re- search will have no part in any deci- sions as to the timing, method, or pro- cedures used to terminate a pregnancy; and (j) Individuals engaged in the re- search will have no part in determining the viability of a neonate. § 46.205 Research involving neonates. (a) Neonates of uncertain viability and nonviable neonates may be in- volved in research if all of the fol- lowing conditions are met: (1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for as- sessing potential risks to neonates. (2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed regarding the reasonably foreseeable impact of the research on the neonate. (3) Individuals engaged in the re- search will have no part in determining the viability of a neonate. (4) The requirements of paragraph (b) or (c) of this section have been met as applicable. (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a neonate may not be invol s of paragraph (b) or (c) of this section have been met as applicable. (b) Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research cov- ered by this subpart unless the fol- lowing additional conditions are met: (1) The IRB determines that: (i) The research holds out the pros- pect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least pos- sible for achieving that objective, or (ii) The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no 152 Dept. of Health and Human Services § 46.207 added risk to the neonate resulting from the research; and (2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent incom- because of unavailability, petence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized rep- resentative is obtained in accord with subpart A of this part, except that the consent of the father or his legally au- thorized representative need not be ob- either parent’s legally authorized rep- resentative is obtained in accord with subpart A of this part, except that the consent of the father or his legally au- thorized representative need not be ob- tained if the pregnancy resulted from rape or incest. (c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this subpart un- less all of the following additional con- ditions are met: (1) Vital functions of the neonate will not be artificially maintained; (2) The research will not terminate the heartbeat or respiration of the neonate; (3) There will be no added risk to the neonate resulting from the research; (4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and (5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart A of this part, except that the waiver and alteration provisions of § 46.116(c) and (d) do not apply. However, if either par- ent is unable to consent because of un- availability, incompetence, or tem- porary incapacity, the informed con- sent of one parent of a nonviable neonate will suffice to meet t owever, if either par- ent is unable to consent because of un- availability, incompetence, or tem- porary incapacity, the informed con- sent of one parent of a nonviable neonate will suffice to meet the re- quirements of this paragraph (c)(5), ex- cept that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The con- sent of a legally authorized representa- tive of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this para- graph (c)(5). (d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of sub- parts A and D of this part. § 46.206 Research involving, after de- livery, the placenta, the dead fetus or fetal material. (a) Research involving, after deliv- ery, the placenta; the dead fetus; mac- erated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such ac- tivities. (b) If information associated with material described in paragraph (a) shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such ac- tivities. (b) If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living indi- viduals can be identified, directly or through identifiers linked to those in- dividuals, those individuals are re- search subjects and all pertinent sub- parts of this part are applicable. § 46.207 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al- leviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. The Secretary will conduct or fund research that the IRB does not believe meets the requirements of § 46.204 or § 46.205 only if: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem af- fecting the health or welfare of preg- nant women, fetuses or neonates; and (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example: science, medi- cine, ethics, law) and following oppor- tunity ant women, fetuses or neonates; and (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example: science, medi- cine, ethics, law) and following oppor- tunity for public review and comment, including a public meeting announced in the FEDERAL REGISTER, has deter- mined either: (1) That the research in fact satisfies the conditions of § 46.204, as applicable; or (2) The following: (i) The research presents a reasonable opportunity to further the under- standing, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates; (ii) The research will be conducted in accord with sound ethical principles; and 153 § 46.301 45 CFR Subtitle A (10–1–24 Edition) (iii) Informed consent will be ob- tained in accord with the informed con- sent provisions of subpart A and other applicable subparts of this part. Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects SOURCE: 43 FR 53655, Nov. 16, 1978, unless otherwise noted. § 46.301 Applicability. (a) The regulations in this subpart are applicable to all biomedical and be- havioral research co soners as Subjects SOURCE: 43 FR 53655, Nov. 16, 1978, unless otherwise noted. § 46.301 Applicability. (a) The regulations in this subpart are applicable to all biomedical and be- havioral research conducted or sup- ported by the Department of Health and Human Services involving pris- oners as subjects. (b) Nothing in this subpart shall be construed as indicating that compli- ance with the procedures set forth herein will authorize research involv- ing prisoners as subjects, to the extent such research is limited or barred by applicable State or local law. (c) The requirements of this subpart are in addition to those imposed under the other subparts of this part. § 46.302 Purpose. Inasmuch as prisoners may be under constraints because of their incarcer- ation which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is the purpose of this subpart to provide additional safeguards for the protec- tion of prisoners involved in activities to which this subpart is applicable. § 46.303 Definitions. As used in this subpart: (a) Secretary means the Secretary of Health and Human Services and any other officer isoners involved in activities to which this subpart is applicable. § 46.303 Definitions. As used in this subpart: (a) Secretary means the Secretary of Health and Human Services and any other officer or employee of the De- partment of Health and Human Serv- ices to whom authority has been dele- gated. (b) DHHS means the Department of Health and Human Services. (c) Prisoner means any individual in- voluntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending ar- raignment, trial, or sentencing. (d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine med- ical, dental, or psychological examina- tion of healthy persons. § 46.304 Composition of Institutional Review Boards where prisoners are involved. In addition to satisfying the require- ments in § 46.107 of this part, an I ological examina- tion of healthy persons. § 46.304 Composition of Institutional Review Boards where prisoners are involved. In addition to satisfying the require- ments in § 46.107 of this part, an Insti- tutional Review Board, carrying out responsibilities under this part with re- spect to research covered by this sub- part, shall also meet the following spe- cific requirements: (a) A majority of the Board (exclu- sive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the Board. (b) At least one member of the Board shall be a prisoner, or a prisoner rep- resentative with appropriate back- ground and experience to serve in that capacity, except that where a par- ticular research project is reviewed by more than one Board only one Board need satisfy this requirement. [43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981] § 46.305 Additional duties of the Insti- tutional Review Boards where pris- oners are involved. (a) In addition to all other respon- sibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by this subpart and approve such research only if i (a) In addition to all other respon- sibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by this subpart and approve such research only if it finds that: (1) The research under review rep- resents one of the categories of re- search permissible under § 46.306(a)(2); (2) Any possible advantages accruing to the prisoner through his or her par- ticipation in the research, when com- pared to the general living conditions, medical care, quality of food, amen- ities and opportunity for earnings in the prison, are not of such a magnitude 154 Dept. of Health and Human Services § 46.306 that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is im- paired; (3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner vol- unteers; (4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbi- trary intervention by prison authori- ties or prisoners. Unless the principal investigator provides to the Board jus- tification in writing for following some other p l prisoners and immune from arbi- trary intervention by prison authori- ties or prisoners. Unless the principal investigator provides to the Board jus- tification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that par- ticular research project; (5) The information is presented in language which is understandable to the subject population; (6) Adequate assurance exists that parole boards will not take into ac- count a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly in- formed in advance that participation in the research will have no effect on his or her parole; and (7) Where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sen- tences, and for informing participants of this fact. (b) The Board shall carry out such other duties as may be assigned by the Secretary. (c) The institution shall certify to the idual prisoners’ sen- tences, and for informing participants of this fact. (b) The Board shall carry out such other duties as may be assigned by the Secretary. (c) The institution shall certify to the Secretary, in such form and man- ner as the Secretary may require, that the duties of the Board under this sec- tion have been fulfilled. § 46.306 Permitted research involving prisoners. (a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if: (1) The institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the re- search under § 46.305 of this subpart; and (2) In the judgment of the Secretary the proposed research involves solely the following: (i) Study of the possible causes, ef- fects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than mini- mal risk and no more than inconven- ience to the subjects; (ii) Study of prisons as institutional structures or of prisoners as incarcer- ated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects; ( ii) Study of prisons as institutional structures or of prisoners as incarcer- ated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects; (iii) Research on conditions particu- larly affecting prisoners as a class (for example, vaccine trials and other re- search on hepatitis which is much more prevalent in prisons than else- where; and research on social and psy- chological problems such as alco- holism, drug addiction and sexual as- saults) provided that the study may proceed only after the Secretary has consulted with appropriate experts in- cluding experts in penology medicine and ethics, and published notice, in the FEDERAL REGISTER, of his intent to ap- prove such research; or (iv) Research on practices, both inno- vative and accepted, which have the in- tent and reasonable probability of im- proving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols ap- proved by the IRB to control groups which may not benefit from the re- search, the study may proceed only after the Secretary has consulted with appropriate experts, inclu onsistent with protocols ap- proved by the IRB to control groups which may not benefit from the re- search, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology medicine and ethics, and published notice, in the FEDERAL REG- ISTER, of his intent to approve such re- search. (b) Except as provided in paragraph (a) of this section, biomedical or behav- ioral research conducted or supported by DHHS shall not involve prisoners as subjects. 155 § 46.401 45 CFR Subtitle A (10–1–24 Edition) Subpart D—Additional Protections for Children Involved as Sub- jects in Research SOURCE: 48 FR 9818, Mar. 8, 1983, unless oth- erwise noted. § 46.401 To what do these regulations apply? (a) This subpart applies to all re- search involving children as subjects, conducted or supported by the Depart- ment of Health and Human Services. (1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such non- substantive, procedural modifications as may be appropriate from an admin- istrative standpoint. (2) It also includes research con- ducted or supported by the Departmen Department may adopt such non- substantive, procedural modifications as may be appropriate from an admin- istrative standpoint. (2) It also includes research con- ducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (e) of § 46.101 of sub- part A, waive the applicability of some or all of the requirements of these reg- ulations for research of this type. subpart. The (b) Exemptions at § 46.101(b)(1) and (b)(3) through (b)(6) are applicable to this exemption at § 46.101(b)(2) regarding educational tests is also applicable to this subpart. How- ever, the exemption at § 46.101(b)(2) for research involving survey or interview procedures or observations of public be- havior does not apply to research cov- ered by this subpart, except for re- search involving observation of public behavior when the investigator(s) do not participate in the activities being observed. (c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of § 46.101 of subpart A are applicable to this sub- part. [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; ns, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of § 46.101 of subpart A are applicable to this sub- part. [48 FR 9818, Mar. 8, 1983; 56 FR 28032, June 18, 1991; 56 FR 29757, June 28, 1991] § 46.402 Definitions. The definitions in § 46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this sub- part: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the re- search will be conducted. (b) Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, ab- sent affirmative agreement, be con- strued as assent. (c) Permission means the agreement of parent(s) or guardian to the participa- tion of their child or ward in research. (d) Parent means a child’s biological or adoptive parent. (e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. § 46.403 IRB duties. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review res cable State or local law to consent on behalf of a child to general medical care. § 46.403 IRB duties. In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all ap- plicable sections of this subpart. § 46.404 Research not involving great- er than minimal risk. HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is pre- sented, only if the IRB finds that ade- quate provisions are made for solic- iting the assent of the children and the permission of their parents or guard- ians, as set forth in § 46.408. § 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a mon- itoring procedure that is likely to con- tribute to the subject’s well-being, only if the IRB finds that: (a) The risk is justified by the antici- pat benefit for the individual subject, or by a mon- itoring procedure that is likely to con- tribute to the subject’s well-being, only if the IRB finds that: (a) The risk is justified by the antici- pated benefit to the subjects; (b) The relation of the anticipated benefit to the risk is at least as favor- able to the subjects as that presented by available alternative approaches; and 156 Dept. of Health and Human Services § 46.408 (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 46.408. § 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual sub- jects, but likely to yield generaliz- able knowledge about the subject’s disorder or condition. HHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that: (a) The risk represents a minor in- crease over minimal risk; (b) T ubject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that: (a) The risk represents a minor in- crease over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or ex- pected medical, dental, psychological, social, or educational situations; (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condi- tion which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guard- ians, as set forth in § 46.408. § 46.407 Research not otherwise ap- provable which presents an oppor- tunity to understand, prevent, or al- leviate a serious problem affecting the health or welfare of children. HHS will conduct or fund research that the IRB does not believe meets the requirements of § 46.404, § 46.405, or § 46.406 only if: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, p h that the IRB does not believe meets the requirements of § 46.404, § 46.405, or § 46.406 only if: (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem af- fecting the health or welfare of chil- dren; and (b) The Secretary, after consultation with a panel of experts in pertinent dis- ciplines (for example: science, medi- cine, education, ethics, law) and fol- lowing opportunity for public review and comment, has determined either: (1) That the research in fact satisfies the conditions of § 46.404, § 46.405, or § 46.406, as applicable, or (2) The following: (i) The research presents a reasonable opportunity to further the under- standing, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) The research will be conducted in accordance with sound ethical prin- ciples; (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 46.408. § 46.408 Requirements for permission by parents or guardians and for as- sent by children. (a) In addition to the determinations requi rmission of their parents or guardians, as set forth in § 46.408. § 46.408 Requirements for permission by parents or guardians and for as- sent by children. (a) In addition to the determinations required under other applicable sec- tions of this subpart, the IRB shall de- termine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of pro- viding assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be in- volved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB deter- mines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure in- volved in the research holds out a pros- pect of direct benefit that is important to the health or well-being of the chil- dren and is available only in the con- text of the research, the assent of the children is not a necessary condition for proceeding with the research. Even w t to the health or well-being of the chil- dren and is available only in the con- text of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the sub- jects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with § 46.116 of subpart A. (b) In addition to the determinations required under other applicable sec- tions of this subpart, the IRB shall de- termine, in accordance with and to the 157 § 46.409 45 CFR Subtitle A (10–1–24 Edition) extent that consent is required by § 46.116 of subpart A, that adequate pro- visions are made for soliciting the per- mission of each child’s parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is suffi- cient for research to be conducted under § 46.404 or § 46.405. Where research is covered by §§ 46.406 and 46.407 and permission is to be obtained from par- ents, both parents must give their per- mission unless one parent is deceased, unknown, incompetent, or not reason- ably available, or when only one parent has legal ission is to be obtained from par- ents, both parents must give their per- mission unless one parent is deceased, unknown, incompetent, or not reason- ably available, or when only one parent has legal responsibility for the care and custody of the child. (c) In addition to the provisions for waiver contained in § 46.116 of subpart A, if the IRB determines that a re- search protocol is designed for condi- tions or for a subject population for which parental or guardian permission is not a reasonable requirement to pro- tect the subjects (for example, ne- glected or abused children), it may waive the consent requirements in sub- part A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not incon- sistent with Federal, state or local law. The choice of an appropriate mecha- nism would depend upon the nature and purpose of the activities described in the protocol, the risk and antici- pated benefit to the research subjects, and their age, maturity, status, and condition. (d) Permission by parents or guard- ians shall be docu ctivities described in the protocol, the risk and antici- pated benefit to the research subjects, and their age, maturity, status, and condition. (d) Permission by parents or guard- ians shall be documented in accordance with and to the extent required by § 46.117 of subpart A. (e) When the IRB determines that as- sent is required, it shall also determine whether and how assent must be docu- mented. § 46.409 Wards. (a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under § 46.406 or § 46.407 only if such research is: (1) Related to their status as wards; or (2) Conducted in schools, camps, hos- pitals, institutions, or similar settings in which the majority of children in- volved as subjects are not wards. (b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advo- cate for each child who is a ward, in ad- dition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to ac ild as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the re- search and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian or- ganization. Subpart E—Registration of Institutional Review Boards SOURCE: 74 FR 2405, Jan. 15, 2009, unless otherwise noted. § 46.501 What IRBs must be registered? Each IRB that is designated by an in- stitution under an assurance of compli- ance approved for federalwide use by the Office for Human Research Protec- tions (OHRP) under § 46.103(a) and that reviews research involving human sub- jects conducted or supported by the De- partment of Health and Human Serv- ices (HHS) must be registered with HHS. An individual authorized to act on behalf of the institution or organi- zation operating the IRB must submit the registration information. § 46.502 What information must be pro- vided when registering an IRB? The following information mu half of the institution or organi- zation operating the IRB must submit the registration information. § 46.502 What information must be pro- vided when registering an IRB? The following information must be provided to HHS when registering an IRB: (a) The name, mailing address, and street address (if different from the mailing address) of the institution or organization operating the IRB(s); and the name, mailing address, phone num- ber, facsimile number, and electronic mail address of the senior officer or head official of that institution or or- ganization who is responsible for over- seeing activities performed by the IRB. 158 Dept. of Health and Human Services § 50.1 (b) The name, mailing address, phone number, facsimile number, and elec- tronic mail address of the contact per- son providing the registration informa- tion. (c) The name, if any, assigned to the IRB by the institution or organization, and the IRB’s mailing address, street address (if different from the mailing address), phone number, facsimile number, and electronic mail address. (d) The name, phone number, and electronic mail address of the IRB chairperson. (e)(1) The approximate numbers of: (i) All active protoc ), phone number, facsimile number, and electronic mail address. (d) The name, phone number, and electronic mail address of the IRB chairperson. (e)(1) The approximate numbers of: (i) All active protocols; and (ii) Active protocols conducted or supported by HHS. (2) For purpose of this regulation, an ‘‘active protocol’’ is any protocol for which the IRB conducted an initial re- view or a continuing review at a con- vened meeting or under an expedited review procedure during the preceding twelve months. (f) The approximate number of full- time equivalent positions devoted to the IRB’s administrative activities. § 46.503 When must an IRB be reg- istered? An IRB must be registered before it can be designated under an assurance approved for federalwide use by OHRP under § 46.103(a). IRB registration be- comes effective when reviewed and ac- cepted by OHRP. The registration will be effective for 3 years. § 46.504 How must an IRB be reg- istered? through Each IRB must be registered elec- tronically http:// ohrp.cit.nih.gov/efile unless an institu- tion or organization lacks the ability to register its IRB(s) electronically. If an institution or organization lacks the ability to register a ically http:// ohrp.cit.nih.gov/efile unless an institu- tion or organization lacks the ability to register its IRB(s) electronically. If an institution or organization lacks the ability to register an IRB elec- tronically, it must send its IRB reg- istration information in writing to OHRP. § 46.505 When must IRB registration information be renewed or up- dated? (a) Each IRB must renew its registra- tion every 3 years. (b) The registration information for an IRB must be updated within 90 days after changes occur regarding the con- tact person who provided the IRB reg- istration information or the IRB chair- person. The updated registration infor- mation must be submitted in accord- ance with § 46.504. (c) Any renewal or update that is submitted to, and accepted by, OHRP begins a new 3-year effective period. (d) An institution’s or organization’s decision to disband a registered IRB which it is operating also must be re- ported to OHRP in writing within 30 days after permanent cessation of the IRB’s review of HHS-conducted or -sup- ported research. PART 50—U.S. EXCHANGE VISITOR PROGRAM—REQUEST FOR WAIV- ER OF THE TWO-YEAR FOREIGN RESIDENCE REQUIREMENT Sec. 50.1 Authority. 50.2 Excha of the IRB’s review of HHS-conducted or -sup- ported research. PART 50—U.S. EXCHANGE VISITOR PROGRAM—REQUEST FOR WAIV- ER OF THE TWO-YEAR FOREIGN RESIDENCE REQUIREMENT Sec. 50.1 Authority. 50.2 Exchange Visitor Waiver Review Board. 50.3 Policy. 50.4 Waivers for research. 50.5 Waivers for the delivery of health care service. 50.6 Procedures for submission of applica- tion to HHS. 50.7 Personal hardship, persecution and visa extension considerations. 50.8 Compliance. AUTHORITY: 75 Stat. 527 (22 U.S.C. 2451 et seq.); 84 Stat. 116 (8 U.S.C. 1182(e)). SOURCE: 49 FR 9900, Mar. 16, 1984, unless otherwise noted. § 50.1 Authority. Under the authority of Mutual Edu- cational and Cultural Exchange Act of 1961 (75 Stat. 527) and the Immigration and Nationality Act as amended (84 Stat. 116), the Department of Health and Human Services is an ‘‘interested United States Government agency’’ with the authority to request the De- partment of State to recommend to the Attorney General waiver of the two- year foreign residence requirement for Exchange Visitors under the Mutual Educational and Cultural Exchange Program. HHS eligibility requirement criteria for waivers are in addition to and independent year foreign residence requirement for Exchange Visitors under the Mutual Educational and Cultural Exchange Program. HHS eligibility requirement criteria for waivers are in addition to and independent of the existing waiver and visa criteria established by the Im- migration and Naturalization Service (INS), the Department of State, and 159 § 50.2 45 CFR Subtitle A (10–1–24 Edition) the Department of Labor. The waiver regulations described in this part do not relieve alien physicians seeking a waiver of the 2-year foreign residence requirement from complying with the terms and conditions imposed on their admission to the United States. [67 FR 77695, Dec. 19, 2002] § 50.2 Exchange Visitor Waiver Review Board. (a) Establishment. The Exchange Vis- itor Waiver Review Board is estab- lished to carry out the Department’s responsibilities under the Exchange Visitor Program. (b) Functions. The Exchange Visitor Waiver Review Board is responsible for making thorough and equitable evalua- tions of applications submitted by in- stitutions, acting on behalf of Ex- change Visitors, to HHS for a favorable recommendation to the Department of State that the two-year foreign resi- dence requirement f applications submitted by in- stitutions, acting on behalf of Ex- change Visitors, to HHS for a favorable recommendation to the Department of State that the two-year foreign resi- dence requirement for Exchange Visi- tors under the Exchange Visitor Pro- gram be waived. (c) Membership. The Exchange Visitor Waiver Review Board consists of no fewer than three members and two al- ternates, of whom no fewer than three will consider any particular applica- tion. The Director of the Office of Glob- al Health Affairs, Office of the Sec- retary, is an ex officio member of the Board and serves as its Chairman. The Director may designate a staff member of the Office of the Secretary to serve as member and Chairman of the Board in the Director’s absence. The Assist- ant Secretary for Health appoints two regularly assigned members and two alternates to consider applications concerning health, biomedical re- search, and related fields. The Chair- man may request the heads of oper- ating divisions of the Department to appoint additional members to con- sider applications in other fields of in- terest to the Department. The Board may obtain expert advisory opinions from other sources. The Board m f the Department to appoint additional members to con- sider applications in other fields of in- terest to the Department. The Board may obtain expert advisory opinions from other sources. The Board may es- tablish a workgroup from the operating divisions of the Department to consider applications for waivers based on the need for the delivery of health care services to underserved populations. [49 FR 9900, Mar. 16, 1984, as amended at 67 FR 77695, Dec. 19, 2002] § 50.3 Policy. (a) Policy for waivers. The Department of Health and Human Services endorses the philosophy that Exchange Visitors are committed to return home for at least two years after completing their program. This requirement was im- posed to prevent the Program from be- coming a stepping stone to immigra- tion and to ensure that Exchange Visi- tors make available to their home countries their new knowledge and skills obtained in the United States. The Department will request waivers for the delivery of health care service to carry out the Department’s mission to increase access to care for the na- tion’s most medically underserved in- dividuals. However, in keeping with the philosophy of the Program, the Ex- change V e to carry out the Department’s mission to increase access to care for the na- tion’s most medically underserved in- dividuals. However, in keeping with the philosophy of the Program, the Ex- change Visitor Waiver Review Board may determine the appropriate num- bers and geographic areas for waivers for the delivery of health care service. (b) Criteria for waivers. The Exchange Visitor Waiver Review Board carefully applies stringent and restrictive cri- teria to its consideration of requests that it support waivers for Exchange Visitors. Each application is evaluated individually based on the facts avail- able. (c) Waiver for members of Exchange Visitor’s family. Where a decision is made to request a waiver for an Ex- change Visitor, a waiver will also be re- quested for the spouse and children, if any, if they have J–2 visa status. When both members of a married couple are Exchange Visitors in their own right (i.e., each has J–1 visa status), separate applications must be submitted for each of them. [67 FR 77696, Dec. 19, 2002] § 50.4 Waivers for research. In determining whether to request a waiver for an Exchange Visitor en- gaged in the conduct of research, the Board considers th each of them. [67 FR 77696, Dec. 19, 2002] § 50.4 Waivers for research. In determining whether to request a waiver for an Exchange Visitor en- gaged in the conduct of research, the Board considers the following key fac- tors: (a) The program or activity at the applicant institution or organization in 160 Dept. of Health and Human Services § 50.5 which the Exchange Visitor is em- ployed must be of high priority and of national or international significance in an area of interest to the Depart- ment. (b) The Exchange Visitor must be needed as an integral part of the pro- gram or activity, or of an essential component thereof, so that loss of his/ her services would necessitate dis- continuance of the program, or a major phase of it. Specific evidence must be provided on how the loss or unavail- ability of the individual’s services would adversely affect the initiation, continuance, completion, or success of the program or activity. The applicant organization/institution must clearly demonstrate that a suitable replace- ment for the Exchange Visitor cannot be found through recruitment or any other means. The Board will not re- quest a waiver when the principal prob- lem appears to be onstrate that a suitable replace- ment for the Exchange Visitor cannot be found through recruitment or any other means. The Board will not re- quest a waiver when the principal prob- lem appears to be one of administra- tive, budgetary, or program inconven- ience to the institution or other em- ployer. (c) The Exchange Visitor must pos- sess outstanding qualifications, train- ing and experience well beyond the usually expected accomplishments at the graduate, postgraduate, and resi- dency levels, and must clearly dem- onstrate the capability to make origi- nal and significant contributions to the program. The Board will not request a waiver simply because an individual has specialized training or experience or is occupying a senior staff position in a university, hospital, or other insti- tution. [67 FR 77696, Dec. 19, 2002] § 50.5 Waivers for the delivery of health care service. In determining whether to request a waiver for an Exchange Visitor to de- liver health care service, the Board will consider information from and co- ordinate with State Departments of Public Health (or the equivalent), other ‘‘interested government agen- cies’’ which request waivers, and other relevant ag ard will consider information from and co- ordinate with State Departments of Public Health (or the equivalent), other ‘‘interested government agen- cies’’ which request waivers, and other relevant agencies. The Board requires the following criteria for requests for waivers for the delivery of health care service: (a) The Exchange Visitor must sub- mit a statement that he or she does not have pending and will not submit any other ‘‘interested government agency’’ waiver request while HHS processes the waiver request being sub- mitted. (b) Waivers are limited to primary care physicians and general psychia- trists who have completed their pri- mary care or psychiatric residency training programs no more than12 months before the date of commence- ment of employment under the con- tract described in subparagraph (d). This 12-month eligibility limitation is to ensure that the physicians’ primary care training is current and they are not engaged in subspecialty training. This HHS eligibility requirement re- lates only to eligibility for an HHS waiver request and does not relieve physicians of the responsibility to maintain lawful status. Alien physi- cians are strongly encouraged to begin requirement re- lates only to eligibility for an HHS waiver request and does not relieve physicians of the responsibility to maintain lawful status. Alien physi- cians are strongly encouraged to begin the waiver process as early as they pos- sibly can while still in the residency training program. Early filing of the waiver request by the alien physician, coupled with timely processing of the request by the relevant government agencies, will facilitate the timely completion of the waiver process before the authorized J–1 admission expires, and the physician’s subsequent applica- tion for change of nonimmigrant status from J–1 to H–1B. (c) Primary care physicians are de- fined as: physicians practicing general internal medicine, pediatrics, family practice or obstetrics/gynecology will- ing to work in a primary care Health Professional Shortage Area (HPSA) or Medically Underserved Area or Popu- lation (MUA/P); and general psychia- trists who are willing to work in a Mental Health HPSA. Note: these HHS eligibility criteria for waivers are in addition to and independent of the ex- isting waiver and visa criteria estab- lished by the Immigration and Natu- ralization Service (INS), the Note: these HHS eligibility criteria for waivers are in addition to and independent of the ex- isting waiver and visa criteria estab- lished by the Immigration and Natu- ralization Service (INS), the Depart- ment of State, and the Department of Labor. (d) The Exchange Visitor must have entered a contract with the applicant employer. This contract must: (1) Require the Exchange Visitor to provide primary medical care in a fa- cility physically located in an HHS- designated primary care HPSA or 161 § 50.6 45 CFR Subtitle A (10–1–24 Edition) MUA/P, or general psychiatric care in a Mental Health HPSA. (2) Require the Exchange Visitor to complete a term of employment of not less than three years providing pri- mary care health services for not less than 40 hours per week. (3) Require the Exchange Visitor to: (i) Be licensed by the State where he or she will practice; (ii) Have completed a residency in one of the following specialties: family practice, general pediatrics, obstetrics/ gynecology, general internal medicine, or general psychiatry; and (iii) Be either board certified or board eligible in the relevant primary care discipline. (4) Be terminable only for cause until completion ogy, general internal medicine, or general psychiatry; and (iii) Be either board certified or board eligible in the relevant primary care discipline. (4) Be terminable only for cause until completion of the three-year commit- ment, except that, with the agreement of the alien physician, the employer may assign the contract to another eli- gible employer with the prior approval of HHS and compliance with all appli- cable INS and Department of Labor re- quirements. Prior to approving an as- signment of the contract, HHS will re- view and consider the health care needs of the alien physician’s current and proposed new locations, as well as the reasons for the request. (5) Not contain a restrictive covenant or non-compete clause which prevents or discourages the physician from con- tinuing to practice in any HHS-des- ignated primary care HPSA or MUA/P or Mental Health HPSA after the pe- riod of obligation under the contract has expired. (6) Provide that any amendment to the contract complies with all applica- ble Federal statutes, regulations and HHS policy. (7) Be consistent with all applicable Federal statutes, regulations and HHS policy. (e) The facility or practice spon- soring the es with all applica- ble Federal statutes, regulations and HHS policy. (7) Be consistent with all applicable Federal statutes, regulations and HHS policy. (e) The facility or practice spon- soring the physician: (1) Must provide health services to individuals without discriminating against them because either they are unable to pay for those services or pay- ment for those health services will be made under Medicare or Medicaid. (2) May charge no more than the usual and customary rate prevailing in the geographic area in which the serv- ices are provided. (3) Must provide care on a sliding fee scale for persons at or below 200 per- cent of poverty income level. Persons with third-party insurance may be charged the full fee for service. (4) Must post a notice in a con- spicuous location in the patient wait- ing area at the practice site to notify patients of the charges for service as required in this paragraph. (5) Must provide evidence that the applicant facility made unsuccessful efforts to recruit a physician who is a United States physician for the posi- tion to be filled by the Exchange Vis- itor. (6) Must provide a statement by the head of the facility to confirm the fa- cili orts to recruit a physician who is a United States physician for the posi- tion to be filled by the Exchange Vis- itor. (6) Must provide a statement by the head of the facility to confirm the fa- cility is located in a specific, des- ignated HPSA or MUA/P, and that it provides medical care to Medicaid and Medicare eligible patients and to the uninsured indigent. (f) The employer and the alien physi- cian must submit information to the Secretary at the times and in the man- ner that the Secretary may reasonably require. [67 FR 77696, Dec. 19, 2002] § 50.6 Procedures for submission of ap- plication to HHS. (a) The Exchange Visitor Waiver Re- view Board will review applications submitted by private or non-federal in- stitutions, organizations, or agencies or by a component agency of HHS. The Board will not accept applications sub- mitted by Exchange Visitors or, unless under extenuating and exceptional cir- cumstances, other U.S. Government Agencies. (b) Applications, instruction sheets and information are available from the Executive Secretary, Exchange Visitor Waiver Review Board. An authorized official of the applicant institution (educational institution, hospital, lab- oratory, c nd information are available from the Executive Secretary, Exchange Visitor Waiver Review Board. An authorized official of the applicant institution (educational institution, hospital, lab- oratory, corporation, etc.) must sign the completed application. The appli- cant institution must send the com- pleted application to the address indi- cated on the instruction sheet. [67 FR 77697, Dec. 19, 2002] 162 Dept. of Health and Human Services § 51.3 § 50.7 Personal hardship, persecution § 51.1 Purpose. and visa extension considerations. (a) It is not within the Department’s jurisdiction to consider applications for waiver based on: (1) Exceptional hardship to the ex- change visitor’s American or legally resident alien spouse or child; or (2) The alien’s unwillingness to re- turn to the country of his/her nation- ality or last residence on the grounds that he/she or family members would be subject to persecution on account of race, religion or political opinion. (b) Likewise, this Department is not responsible for considering requests to extend visas. (c) Inquiries concerning the above should be directed to the District Of- fice of the Immigration and Natu- ralization Service which has j is not responsible for considering requests to extend visas. (c) Inquiries concerning the above should be directed to the District Of- fice of the Immigration and Natu- ralization Service which has jurisdic- tion over the exchange visitor’s place of residence in the United States. [49 FR 9900, Mar. 16, 1984. Redesignated at 67 FR 77696, Dec. 19, 2002] § 50.8 Compliance. If an alien physician acquires H–1B nonimmigrant status following ap- proval by the INS of a request for waiv- er, then he or she becomes subject not only to the terms and conditions of the waiver, but also the terms and condi- tions of the H–1B nonimmigrant status. Failure to comply with those condi- tions will make that physician subject to removal from the United States by the INS. [67 FR 77697, Dec. 19, 2002] PART 51—CRITERIA FOR EVALU- ATING COMPREHENSIVE PLAN TO REDUCE RELIANCE ON ALIEN PHYSICIANS Sec. 51.1 Purpose. 51.2 Application. 51.3 Who is eligible to apply? 51.4 How will the plans be evaluated? AUTHORITY: Sec. 212, Immigration and Na- tionality Act, Pub. L. 82–114, as amended by Pub. L. 97–116, 95 Stat. 1611 (8 U.S.C. 1182(j)(2)(A)). SOURCE: 48 FR 2539, Jan. 20, 1983, unless otherwise noted. The purpos Sec. 212, Immigration and Na- tionality Act, Pub. L. 82–114, as amended by Pub. L. 97–116, 95 Stat. 1611 (8 U.S.C. 1182(j)(2)(A)). SOURCE: 48 FR 2539, Jan. 20, 1983, unless otherwise noted. The purpose of this regulation is to establish criteria for review and eval- uation of the comprehensive plans of Graduate Medical Education Programs to reduce reliance on alien physicians, as required by the Immigration and Nationality Act Amendments of 1981, Pub. L. 97–116, for the waiver of certain requirements for exchange visitors who are coming to the United States to par- ticipate in programs of graduate med- ical education or training. § 51.2 Application. Materials covering procedures for ap- plying for substantial disruption waiv- ers (including the comprehensive plan) may be obtained from the Educational Commission for Foreign Medical Grad- uates, 3624 Market Street, Philadel- phia, Pennsylvania 19104. EXPLANATORY NOTE: The Department of State entered into an agreement with the Educational Commission for Foreign Medical Graduates in 1971 whereby the latter was des- ignated the authority to administer the issuance of the Form IAP–66 in all cases in- volving the admission, certification, Commission for Foreign Medical Graduates in 1971 whereby the latter was des- ignated the authority to administer the issuance of the Form IAP–66 in all cases in- volving the admission, certification, transfer or extension of stay for foreign physicians in exchange visitor status who are receiving graduate medical education or training. The Commission was further designated the au- thority (FEDERAL REGISTER, Volume 44, No. 59, March 26, 1979), to process waiver requests under the ‘‘substantial disruption’’ provision of Pub. L. 94–484, as amended, within criteria to be provided by the United States Informa- tion Agency on advice from the Department of Health and Human Services (formerly De- partment of Health, Education, and Welfare). § 51.3 Who is eligible to apply? Sponsors which had alien physicians in their exchange visitor programs on January 10, 1978, are eligible to apply. For purposes of this regulation, the term ‘‘program’’ relates to a graduate medical education program having an exchange visitor program for physi- cians participating in graduate medical education or training. An ‘‘exchange visitor program’’ is a program of a sponsor, designed to promote inter- change of p an exchange visitor program for physi- cians participating in graduate medical education or training. An ‘‘exchange visitor program’’ is a program of a sponsor, designed to promote inter- change of persons, knowledge and skills, and the interchange of develop- ments in the field of education, the arts and sciences, and is concerned 163 § 51.4 45 CFR Subtitle A (10–1–24 Edition) with one or more categories of partici- pants to promote mutual under- standing between the people of the United States and the people of other countries. § 51.4 How will the plans be evaluated? After consultation with the Federal Substantial Disruption Waiver Board (seven Federal representatives charged with the responsibility of reviewing substantial disruption waiver applica- tions), the Secretary of Health and Human Services will make rec- ommendations to the Director, United States Information Agency, for the purpose of granting waivers. The Sec- retary will consider the following fac- tors in determining whether or not a plan is satisfactory: (a) The extent of the specific prob- lems that the program or institution anticipates without a waiver, includ- ing, for example, (1) Curtailment of services cur whether or not a plan is satisfactory: (a) The extent of the specific prob- lems that the program or institution anticipates without a waiver, includ- ing, for example, (1) Curtailment of services currently provided, (2) Downgrading of medical care cur- rently being provided, (3) Reduction in the number of inpa- tients and outpatients receiving care, (4) Inadequate medical coverage for population served, or (5) Inadequate supervision of junior residents. (b) The adequacy of the alternative resources and methods (including use of physician assistants (as defined in 42 CFR 57.802), nurse practitioners (as de- fined in 42 CFR 57.2402), and other non- physician providers) that have been considered and have been and will be applied to reduce such disruption in the delivery of health services, espe- cially in primary medical care man- power shortage areas, as established under section 332 of the Public Health Service Act, and for medicaid patients. This may include, for example: (1) Greater reliance on fully licensed physicians, and on physician assist- ants, nurse practitioners and other non-physician personnel in an ex- panded role in the delivery of health care, such as admission pati