Evaluation for the Unevaluated:
Program Evaluation 102

Supplements

SAMHSA CONFIDENTIALITY CERTIFICATE (CC) INFORMATION (updated 12/16/99)

APPLICATION INSTRUCTIONS (for General Information, please see page 3):

The principal investigator (PI) of the research project (e.g., of the evaluation segment of a demonstration) applies for a Confidentiality Certificate. We suggest that the PI apply for his/her CC after the project is entirely planned and the final consent form is written. She/he would have to apply again if the consent form or anything else substantial changed, since by signing the application, he/she is legally affirming that description of the study. That is, the consent form and protocol in the actual study have to be as presented in the application. Please let Dorita Sewell know by a call or e-mail if you need your certificate very quickly--that is, if you're about to recruit participants in the next week or two--and please don't hesitate to call with questions or status checks. Applications are filed by PI name, so please identify your application by PI name in any communications about your application.

An example of an application is attached to these instructions. An example of consent-form text related to the Confidentiality Certificate is in these instructions. We try to comply with the regulations perfectly in case your Certificate faces a legal challenge.

A CC application is a letter from the principal investigator to SAMHSA (to Dorita Sewell, Ph.D., SAMHSA OPPC, 12C-26, 5600 Fishers Lane, Rockville, MD 20857 301-443-7023; FAX 301-594-6159. E-mail dsewell@samhsa.gov). The LETTER MUST PROVIDE the following (as required in the regulations--it may save time to respond very literally and exactly):

a) Name & address of person primarily responsible for the conduct of the research [the principal investigator], and of the sponsor or institution with which that person is affiliated

Name and contract or grant ID number of the project

Documentation of institutional approval in the form of a copy of or reference to a valid Institutional Review Board (IRB) approval (revisions made to meet CC regulations [regs] also may require IRB approval) if IRB approval is required, or other documentation of institutional approval

b) Location of the research project and description of the facilities available for conducting the research, including the name and address of any hospital, institution, or other facility to be used in connection with the research

c) Names, addresses, and summaries of the scientific or other appropriate training and experience--of all personnel having major responsibilities in the research project, and the training and experience requirements for major positions not yet filled

d) An outline or summary of the research protocol, including a clear and concise statement of the rationale and purpose of the research project and the general research methods to be used (Generally, these should include criteria and procedures for subject selection, study variables, procedures for data collection and analysis, any treatment/intervention provided, and informed consent procedure. Subject selection and informed consent procedures are especially important.)

e) Start date and estimated end date (CC will expire then) for the project

f) Specific request (e.g., "I request authority to withhold..."), signed by the individual primarily responsible for the conduct of the research, for authority to withhold the names and other identifying characteristics of program participants, and the reasons supporting that request

g) through k) are assurances that each application must provide. The application might say: "As principal investigator, I assure you of the following:

g) that my colleagues and I will comply with all the requirements of 45 CFR 46, "Protection of Human Subjects" [IRB regs]

h) that the CC will not be presented as endorsement of the research by the Secretary, DHHS, or used to coerce or pressure subjects to participate

i) that the Certificate 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 Certificate 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

  1. Under any of the following conditions, the CC does NOT authorize any person to refuse to reveal identifying information concerning research subjects:
    1. If the subject (or guardian) consents in writing to disclosure of identifying information
    2. If release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regs thereunder (21 CFR)
    3. If authorized DHHS personnel request identifying information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors
  2. The Certificate does not prevent voluntary disclosure of identifying information
  3. The Certificate does not represent an endorsement of the research by the Secretary, DHHS

k) that all research subjects entering the study after termination of the Certificate will be told the protections do not apply to them

We ask for all these assurances. Only those that are relevant to your project, however, have to be reflected in your consent forms or other information you give to project participants.

The application letter must be complete and provide all of the information requested. The following documents should be attached to the letter:

1. A copy of the original grant application or research protocol (not necessary if the project is described well in the application)

2. Documentation of IRB review and approval of procedures for the protection of human subjects if IRB approval is required. The IRB must have an SPA or MPA from the Office for Protection from Research Risks.

3. Sample consent forms

GENERAL INFORMATION ABOUT CONFIDENTIALITY CERTIFICATES

The Substance Abuse and Mental Health Services Administration (SAMHSA) has responsibility for issuing Confidentiality Certificates for projects it sponsors. This document is intended to help project directors develop their requests for Confidentiality Certificates. It is based on the Federal regulations for implementing the authorizing legislation regarding Confidentiality Certificates: 42 CFR 2a.

Confidentiality Certificates (CCs) are issued under the authority vested in the Secretary, DHHS, by section 301(d) of the Public Health Service Act, 42 U.S.C. ยง241(d), as amended. A CC authorizes "persons engaged in research on mental health, including research on the use and effect of alcohol and other psychoactive drugs, to protect the privacy of individuals who are the subject of such research by withholding from all persons not directly connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals." In other words, a CC protects researchers from having to comply with things like subpoenas and court orders. SAMHSA works to protect participants in its projects and SAMHSA's issuance of Confidentiality Certificates incorporates this aim. CC's were tested successfully in a Supreme Court case soon after they were enacted.

If an IRB grants approval contingent only on the project's having a CC, then SAMHSA can proceed as if the project had IRB approval. A CC applies to research, and does not cover services or services components. CCs do not apply to research requiring an Investigational New Drug exemption or to research related to law enforcement activities within the purview of 502(c) of Controlled Substances Act and 21 CFR 1316.21. A CC applies to one project; separate application is required for each project.

CONSENT FORMS

A consent form that leads to genuine and realistic informed consent is a key element of adequate participant protection. A consent form should truly inform readers, in language they understand. In some cases, consent forms should be read out loud. If there will be questions about drug use, mental health or substance abuse treatment, sexual activity, or any other sensitive issue, this should be explicit in the consent form. If risks are discussed, the risk of confidentiality breach must be mentioned for participants to consider. Many consent forms follow this statement of confidentiality risk with information about how confidentiality is being protected, to reassure prospective participants.

Consent forms should not, however, over-promise the degree of protection or be vague or misleading. For example, stating that "participant information will be kept in strictest confidence" is vague and false since DHHS can audit and you may be reporting child abuse. "Only researchers will have access to your data" is similarly false. SAMHSA has had to turn down many consent forms with statements like these.

Better than such general (and false) statements is to tell people about the specific steps that have been taken to protect participants' confidentiality, such as training staff to keep information private, keeping the code file locked or encrypted, and getting a CC. Thanks to a policy change, SAMHSA now allows statements on the order of, "Information you give us will be kept private to the extent permitted by law, but SAMHSA still does not pass consent forms with false statements.

SAMHSA CC projects' consent forms (or other pre-consent information forms) must have 1) CC information required by the regulations and mentioned in the assurances, and 2) information related to requirements that are based on department and agency requirements. HHS and SAMHSA require researchers to report communicable diseases (if they are testing for them; most SAMHSA projects do not do this), and SAMHSA requires reporting of child abuse as legally required by States. We also ask researchers to take appropriate steps, including reporting confidential information, if they discover that there is danger that someone will harm him/herself or others. Researchers must notify participants (usually in consent forms) in advance about any reporting they will do. Another way to put this is, DHHS CCs do not protect information about communicable diseases in projects that routinely seek this information in States that require reporting, and SAMHSA CCs do not protect information about evidence of child abuse or imminent harm to self or others where States require reporting. If imminent harm or child abuse might be discovered in the research setting, researchers should establish a reporting policy that conforms with State law, to deal with this. Participants must be told in advance (in consent forms or information sheets) that this information may or will be reported, if that is the case.

The laws about reporting child abuse and other information differ from State to State. For example, it may be illegal for some researchers to volunteer information about child abuse, or it may be illegal for some researchers not to report child abuse in your State. Please make sure your child-abuse and other statements are consistent with applicable laws.

Consent forms may leave out what is not germane. For example, if a project does not fall within the purview of the FDC Act, then SAMHSA doe not require consent forms to include information about the CC limitation regarding the FDC Act, even though you will have signed all the assurances, including the one about including it.

Consent forms differ, but the following is an example of consent-form language about CCs that was approved as suitable for some projects:

To help keep information about you confidential, we have obtained a Confidentiality Certificate from the Department of Health and Human Services (DHHS). This Certificate does not imply that the Secretary, DHHS, approves or disapproves of the project. The Confidentiality Certificate will protect the investigators from being forced, even under a court order or subpoena, to release any research data in which you are identified. This protection is not absolute, however. For example, it does not apply to disclosure of medical information in cases of medical necessity, reporting if you are likely to harm yourself or others, or reporting child abuse under State law. Also, because this research is sponsored by SAMHSA, staff from that and other DHHS agencies may review records that identify you.

More information about adequate informed consent forms and other aspects of participant protection can be found in the regs published by the Office for Protection from Research Risks (OPRR) (301-496-8101)under the title "Protection of Human Subjects."

AMENDMENTS/EXTENSIONS OF SAMHSA CCs

CC protection is permanent for information on those who participate in a covered study while the CC is in effect. CC protections do not extend to a research project that changes significantly from its description in the original CC application, or to new participants in a project whose CC has expired. An amended application or application for extension must be made and approved if protection under the CC is to continue in force.

To extend a CC, the principal investigator in whose name the original CC was issued sends a signed request for an extension, with the new expiration date requested, the justification for the extension, a copy of the current IRB approval, and a statement that the project has not changed in any significant way since the original CC was issued. That is, the primary staff, consent form, scope and direction, instruments, and other significant features must be the same as when the certificate was issued. If there have been changes, a full new application must be submitted. A copy of the original CC should accompany the request.

An Example of a SAMHSA Confidentiality Certificate (CC) Application:

Dorita Sewell, Ph.D.
SAMHSA OPPC
12C-26, 5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Sewell,

I am writing to request a confidentiality certificate for the project described below.

a) Principal investigator's name and address:

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."

b) Location and description of study sites:

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 University Research Institute. The project sites are as follows: [Please give names and addresses of any hospital, institution, or other facility to be used in connection with the research. If their nature isn't obvious, please also give a brief description.]

c) Information about investigator(s):

[Resumes or brief summaries, including names and addresses, of the scientific or other appropriate training and experience--of all personnel having major responsibilities in the research project, and the training and experience requirements for major positions not yet filled. At least the PI's resume or summary should be attached or included.]

d) An outline or summary of the research protocol:

[This should be a half-page or shorter clear, concise statement of the purpose of the research project and the general research methods to be used. Generally, this should include criteria and procedures for subject selection, study variables, procedures for data collection and analysis, any treatment/intervention provided, and informed consent procedure. Subject selection and informed consent procedures are especially important.

In addition, please include a paragraph summarizing the purpose of the research and the other key characteristics in one or two paragraphs, such as the following:]

The purpose of the study is to evaluate the effectiveness of ... and .... by comparing their outcomes over a period of .... years. We will use a quasi-experimental research design and will conduct baseline and three follow-up interviews. We will also use information from .... The following outcome categories will be studied: ..... A total of 300 adult clients and 200 of their children are expected to participate. Some of the data will be used in a wider cross-site study.

e) Start date and estimated end date (CC will expire at end date) for the project:

The project began 10/1/97 and will end 9/30/2000. We expect to begin recruiting participants by 12/1/97, pending finalization of our cross-site instruments, receipt of the CC, and final IRB approval. [Knowing when your CC must be done helps me plan the work on it.]

f) Signed specific request with reasons:

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 [reasons you want authority to protect your participants should very briefly be summarized here. This should include how the Certificate will benefit participants in your project.]

____[signature]__________

John Doe, Ph.D.

g) - k) Assurances:

I assure you of the following:

g) that my colleagues and I will comply with all the requirements of 45 CFR 46, "Protection of Human Subjects;

h) that the CC will not be presented as endorsement of the research by the Secretary, DHHS, or used to coerce or pressure subjects to participate;

i) that the Certificate 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 Certificate 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

  1. Under any of the following conditions, the CC does NOT authorize any person to refuse to reveal identifying information concerning research subjects:
    1. If the subject (or guardian) consents in writing to disclosure of identifying information
    2. If release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regs thereunder (21 CFR)
    3. If authorized DHHS personnel request identifying information for audit or program evaluation of a research project funded by DHHS or for investigation of DHHS grantees or contractors
  2. The Certificate does not prevent voluntary disclosure of identifying information
  3. The Certificate does not represent an endorsement of the research by the Secretary, DHHS;

k) that all research subjects entering the study after termination of the Certificate will be told the protections do not apply to them.

[We ask for all these assurances. Only those that are relevant to your project, however, must be reflected in the content of consent forms or other information given to project participants.]

I include copies of the notice of final approval from all IRBs that must approve our project and of every consent form that will be used in the project.

Sincerely yours,

John Doe, Ph.D.
Principal Investigator

Enclosures

<< Previous Page