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# Template for an Application Letter for a Certificate of Confidentiality (CC)

**Principal investigators (PIs)/lead evaluators (LEs) must submit a cover letter as part of their official request for a certificate of confidentiality (CC). The cover letter must provide the following information in the indicated order. SAMHSA asks PIs/LEs to state all of the Federal-wide Assurances (FWAs) in the cover letter, but only those that are relevant to the project must be reflected in the consent forms or other information that is given to project participants.**

**Month****XX**, 20**XX**Ms. Janet HeekinSAMHSA CC CoordinatorSAMHSAFishers LaneRoom 15E21BRockville, MD  20857

Dear Ms. Heekin:

*“I am writing to request a certificate of confidentiality (CC) for the project described below.”*

a) **Include the name, address, email, and phone number of the person primarily responsible for conducting the evaluation and of the sponsor or institution with which that person is affiliated. Also, include the name and contract or grant ID number of the project.**

*“John Doe, Ph.D., Director of Studies, Services Research Institute, Suite 400, 3300 Dupont Avenue, Fremont, MD  20999. I can be reached at 301-123-4567 (voice), 301-123-8910 (fax), jdoe@SRI.org.*

*My study is CSAT grant no. TI01234, “Evaluation of Project HEALTH.”  Our project officer at SAMHSA is Ken Ncadi.”*

b) **Include the location of the study site for the services, follow-up interviews, and where the data will be collected, housed, and analyzed. Describe the facilities available for the evaluation. Also, explain the treatment or services to be provided, including the name and address of any hospital, institution, or other facility to be used in connection with the project. The cooperating agencies are also covered by the CC and should be identified in the application.**

*“The study sites are residential substance abuse treatment facilities in three Oklahoma counties.  Treatment will be provided and all interviews will be conducted at these sites. Data analysis is housed at the Services Research Institute. The project sites are as follows:”*

c) **Provide summaries of the scientific or other appropriate training and experience of all personnel having major responsibilities in the evaluation project. Also, include the training and experience requirements for major positions not yet filled. A resume, curriculum vitae, or bio sketch will suffice.**

d) **Outline or summarize the evaluation protocols and include a concise statement of the rationale and purpose of the evaluation project and the general methods to be used. Ideally, these should include summaries of criteria and procedures for subject selection, study variables, procedures for data collection and analysis, any treatment/intervention provided, and the informed consent procedure. Also, include the number of participants per year for the number of years of the grant period.**

*“The purpose of the study is to evaluate the effectiveness of...and...by comparing their outcomes over a period of...years. Using a pre/post research design, the researchers will conduct baseline and three follow-up interviews, at three, six, and 12 months after discharge. We will also use information from... and administer urine tests. A total of 200 adult clients and their children are expected to participate annually for a total of XXX over the X-year grant. Some of the data will be used in a cross-site study.”*

3.  “My project has the following plans for” **[briefly describe the plans for handling the following]**

a) Reporting suspected child abuse or neglect: [Example, *“We plan to report to local authorities.”*]

b) Reporting communicable diseases we test for: [Example, *“We plan to report to state public health officers,”* or *“We are not testing for a communicable disease.”]*

c) Reporting harm to self or others: [Example, *“We plan to report to participant’s physician.”]*

d) Dealing with pregnant substance abusers: [Example, *“We plan to test for pregnancy and to provide counseling or referral to local substance abuse treatment providers or physicians as appropriate.”*] 

e) Other reporting we plan to do:

e) **Include the start date and estimated end date of the project:**

*“The project began on 10/1/2005 and will end on 9/30/2010. We expect to begin recruiting participants by 12/1/05, and we will/will not wait until our CC is in place.”***[The CC coverage is effective from the start date to the estimated end date of the project. However, once the PI/LE has a CC in place, it covers anyone who is in the study for the entire study, including the time before they received the CC. Coverage extends to those who did not participate but signed up. If the PI/LE recruit before the CC protection begins, information obtained from participants before the CC date will be protected.]**

f) **Include a specific request**(Example:*****“I request authority to withhold...”*)**, signed by the individual primarily responsible for conducting the evaluation for authority to withhold names and other identifying characteristics of program participants. Briefly summarize the reasons for wanting authority to protect the participants and include how the CC will benefit participants in the project.**

*“I request authority to withhold the names and other identifying characteristics of the participants in my study, “Evaluation of Project HEALTH.” My reasons for this request are that I am collecting sensitive substance abuse and mental health data, and the CC will protect my participants’ privacy and help me recruit participants.”*

*“____ [signature] __________*

*John Doe, Ph.D., PI*

*____ [signature] _______*

*Institutional Official”***[The authorized institutional official is the individual named by the applicant organization who is authorized to act for that organization. This person assumes on behalf of the institution the obligation imposed by the FWAs as well as those imposed by the federal law, regulations, and requirements and other conditions that may apply to grant applications and awards.]**

g) - k)**FWAs that applicants must provide. The application might say:***“As principal investigator or lead evaluator, I assure you of the following:*

g) *that my colleagues and I will comply with all the requirements of Protection of Human Subjects, 45 CFR 46 and its standards for informed consent*

h) *that the CC will not be presented as an endorsement of the research by the Secretary, Department of Health and Human Services (HHS), or used to coerce or pressure subjects to participate*

i) *that the CC will be used by all those covered by it, to refuse to disclose identifying characteristics of research subjects in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings to compel disclosure of the identifying characteristics of research subjects*

j) *that all research participants under the CC will be informed that:*

1) *A CC has been issued*

2) *The persons authorized by the CC to protect the identity of research subjects may not be compelled to identify research subjects in any civil, criminal, administrative, legislative, or other proceedings, whether state, federal, or local”***Limitations (from Protection of Identity – Research Subject, Contents of Application; in General, 42 CFR Part 2a.4)**

3) *“Under any of the following conditions, the CC does NOT authorize any person to refuse to reveal identifying information concerning the research subjects:*

i. *If the subject (or guardian) consents in writing to disclosure of identifying information*

ii. *If release is required by the Food, Drug, and Cosmetic Act, 21 U.S.C. 301 or regulation thereunder (21 CFR)*

iii. *If authorized HHS personnel request identifying information for audit or program evaluation of a research project funded by HHS or for investigation of HHS grantees or contractors*

4) *The CC does not prevent voluntary disclosure of identifying information*

5) *The CC does not represent an endorsement of the research by the HHS Secretary*

k) *That all research subjects entering the study after termination of the CC will be told the protections do not apply to them.”*

**[SAMHSA asks for many FWAs but only those that are relevant to the project must be reflected in the consent forms or other information given to project participants.]**

*“I included copies of the notice of final approval from all IRBs***[or the only IRB]***that must approve our project and of every***[or the only]***consent form that will be used in the project.*

*The FWA Number***[s]***on file with the Office for Human Research Protections for these IRBs is***[are]***as follows:*

· *Services Research Institute (applicant)--FWA000000012*

· *Health Services, Inc. (study site)--FWA00000034*

*I understand that if this project is not completed by the expiration date I can request an extension of the CC***[preferably prior to the expiration date]***by sending SAMHSA my reasons for the extension, a copy of the most recent IRB approval, the new expiration date, copies of current consent forms, a copy of the original CC, and a statement that the project has not changed in any significant way since the original CC was issued.*

*I understand that if the project changes in any significant way (if there are modifications to the consent form, protocols, key personnel, or other significant elements of the project), regulations require me to notify SAMHSA of the changes before the changes are implemented.”*

Sincerely yours,

John Doe, Ph.D.Principal Investigator