[Federal Register Volume 60, Number 246 (Friday, December 22, 1995)]
[Proposed Rules]
[Pages 66530-66531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31154]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50 and 312

[Docket No. 95N-0359]


Protection of Human Subjects; Informed Consent

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its current informed consent regulations to require that the written 
consent form signed by the subject or the subject's legally authorized 
representative, be dated by the subject or the subject's legally 
authorized representative at the time consent is given. FDA is 
proposing this requirement because the agency has had problems on 
occasion verifying that informed consent was obtained from a research 
subject prior to participation in a study because the consent document 
was not dated. The agency believes that by explicitly requiring that 
the consent form be dated at the time it is signed, the agency will be 
able to help ensure that informed consent was, in fact, obtained prior 
to entry into the study as required by FDA regulations. FDA is also 
proposing to amend its regulation on case histories to clarify what 
adequate case histories include.
DATES: Written comments by March 21, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Glen D. Drew, Office of Health Affairs 
(HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION:

I. Description of the Proposed Rule

    Except as provided in FDA regulations, no investigator may involve 
a human being as a subject in research covered by part 50 (21 CFR part 
50) unless the investigator has obtained the legally effective informed 
consent of the subject or the subject's legally authorized 
representative. Section 50.20 requires the investigator to seek 
informed consent only under circumstances that provide the prospective 
subject or the representative sufficient opportunity to consider 
whether or not to participate and that 

[[Page 66531]]
minimize the possibility of coercion or undue influence. In past audits 
of clinical investigations, FDA has had problems on occasion verifying 
that consent was obtained prior to participation in the study because a 
number of the consent documents were not dated. By explicitly requiring 
that the consent form be dated at the time it is signed, the agency 
will be able to help ensure that informed consent was obtained prior to 
entry into the study and will be able to verify that the investigator 
has fulfilled his or her obligation. Thus, FDA is proposing to amend 
Sec. 50.27(a) to explicitly require that the consent form be dated by 
the subject or the subject's legally authorized representative at the 
time that it is signed.

II. Request for Comments

    Interested persons may, on or before March 21, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This rule simply adds a requirement that consent 
forms be dated at the time that they are signed in order to permit the 
agency to verify that informed consent is obtained prior to an 
individual's entry into a research study. Because the majority of 
consent forms are currently dated at the time that they are signed, the 
agency certifies that the proposed rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.

V. Clarifying Amendments

    Along with this proposal to require that consent forms be dated at 
the time they are signed, FDA believes that a number of related changes 
to the regulations for human drugs and biologics are warranted. FDA is 
proposing to revise Sec. 312.53(c)(1)(vi)(d) (21 CFR 
312.53(c)(1)(vi)(d)) to expressly recognize that the informed consent 
referred to be in accordance with 21 CFR part 50 and that institutional 
review board review and approval referred to be in accordance with 21 
CFR part 56. Also, FDA is proposing to revise Sec. 312.62(b) (21 CFR 
312.62(b)) to clarify that adequate case history records include the 
case report forms and supporting data, including, for example, signed 
and dated consent forms and medical records.

List of Subjects

21 CFR Part 50

    Human research subjects, Informed consent, Prisoners, Reporting and 
recordkeeping requirements, Safety.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 50 and 312 be amended as follows:

PART 50--PROTECTION OF HUMAN SUBJECTS

    1. The authority citation for 21 CFR part 50 continues to read as 
follows:

    Authority: Secs. 201, 406, 408, 409, 502, 503, 505, 506, 507, 
510, 513-516, 518-520, 701, 721, 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 356, 
357, 360, 360c-360f, 360h-360j, 371, 379e, 381); secs. 215, 301, 
351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241, 
262, 263b-263n).

    2. Section 50.27 is amended by revising paragraph (a) to read as 
follows:


Sec. 50.27  Documentation of informed consent.

    (a) Except as provided in Sec. 56.109(c), informed consent shall be 
documented by the use of a written consent form approved by the IRB and 
signed and dated by the subject or the subject's legally authorized 
representative at the time of consent. A copy shall be given to the 
person signing the form.
* * * * *

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION-

    3. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 
352, 353, 355, 356, 357, 371); sec. 351 of the Public Health Service 
Act (42 U.S.C. 262).

    4. Section 312.53 is amended by revising paragraph (c)(1)(vi)(d) to 
read as follows:


Sec. 312.53  Selecting investigators and monitors.

* * * * *
    (c) * * *
    (1) * * *
    (vi) * * *
    (d) Will inform any patients, or any persons used as controls, that 
the drugs are being used for investigational purposes and will ensure 
that the requirements relating to obtaining informed consent (21 CFR 
part 50) and institutional review board review and approval (21 CFR 
part 56) are met;
* * * * *
    5. Section 312.62 is amended by revising paragraph (b) to read as 
follows:


Sec. 312.62  Investigator recordkeeping and record retention.

* * * * *
    (b) Case histories. An investigator is required to prepare and 
maintain adequate and accurate case histories that record all 
observations and other data pertinent to the investigation on each 
individual treated with the investigational drug or employed as a 
control in the investigation. Case histories include the case report 
forms and supporting data including, for example, signed and dated 
consent forms and medical records.
* * * * *

    Dated: December 12, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31154 Filed 12-21-95; 8:45 am]
BILLING CODE 4160-01-F