Starting March 15, 2011 Applications Should Be Submitted Online:
https://www.nichd.nih.gov/cccert/default.aspx?ic=NIAAA

CONTENTS

Who Can Apply to NIAAA for a Certificate of Confidentiality
What is a Certificate of Confidentiality
Who May Apply for a Certificate
Limitations of a Certificate
To Whom May I Apply for a Certificate
How to Apply for a Certificate for an Alcohol Research Project
Informed Consent
Statutory Authority
Applicable Regulations
For Further Information
Frequently Asked Questions

Who Can Apply to NIAAA for a Certificate of Confidentiality?

NIAAA is now accepting applications for Certificates of Confidentiality for alcohol-specific projects. Even though your application is being submitted online, once we have reviewed it and you have made the necessary changes you will still be required to print the completed application, have it signed by the Institutional official, and send the signed original to:

Isabel Ellis, MSW 
Public Health Analyst 
National Institute on Alcohol Abuse and Alcoholism, NIH 
5635 Fishers Lane; Room 3111, MSC 9304 
Bethesda, Maryland  20892-0304 
(for Express Mail; UPS etc., use Rockville, MD  20852-1705) 
Tele. 301.443.8771       FAX 301.480-1726 
Email:  iellis@mail.nih.gov

PLEASE NOTE: Online applications must be completed in-full once initiated since the information cannot be saved.  The following Q&A Section and Application Section is provided to familiarize you with some of the questions we receive and the types of information you will need to provide to NIAAA.

What is a Certificate of Confidentiality?

A Certificate of Confidentiality authorizes withholding the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate. This authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of that research.

Persons so authorized may not, at any time, be compelled to provide the names or other identifying characteristics of the research subjects encompassed by the Certificate in any Federal, State, or local civil, criminal, administrative, legislative or other proceedings.

The Certificate must be in effect at the time of subject participation for the information to be protected. However, when this condition is met,  the information is protected permanently.  There are however unusual circumstances that could impair the effectiveness of the CoC.  For example, in circumstances where a subpoena is issued prior to issuance of the CoC, the investigator may be compelled to disclose information. In other words, an application for a CoC may not be protective until the certificate is actually issued.

Who May Apply for a Certificate of Confidentiality?

Any person engaged in research in which sensitive information is collected from human subjects (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality.

A separate application is required for each research project for which a Certificate is desired.

A certificate is generally issued to a research institution for a single project (not broad groups or classes of projects). However, for cooperative multi-site projects, a coordinating center or "lead" institution can apply for, and receive, a Certificate on behalf of all member institutions. The lead site must retain copies on file of IRB approvals from all participating multi-sites. The lead institution must assure that all participating institutions conform to the Application assurances and inform their subjects, appropriately, about the Certificate, its protections and the circumstances in which voluntary disclosures would be made.

Limitations of Certificate

The protection offered by a Certificate of Confidentiality is not absolute. A Certificate protects research subjects only from legally compelled disclosure of their identity. It does not restrict voluntary disclosures.

For example, a Certificate does not prevent researchers from voluntarily disclosing to appropriate authorities such matters as child abuse, a subject's threatened violence to self or others, or from reporting a communicable disease. However, if researchers intend to make such disclosures, this should be clearly stated in the informed consent form which research subjects are asked to sign.

In addition, a Certificate of Confidentiality does not authorize the person to whom it is issued to refuse to reveal the name or other identifying characteristics of a research subject if

  • the subject (or, if he or she is legally incompetent, his or her guardian) consents, in writing, to the disclosure of such information;
  • authorized personnel of the Department of Health and Human Services (DHHS) request such information for audit or program evaluation, or for investigation of DHHS grantees or contractors and their employees; or
  • release of such information is required by the Federal Food, Drug, and Cosmetic Act or regulations implementing that Act.

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To Whom May I Apply for a Certificate of Confidentiality?

If the research project for which you would like a Certificate is alcohol-related, you may apply to NIAAA (whether or not the project is Federally funded).

If the research project for which you would like a Certificate is not alcohol-related, you may apply to the appropriate Institute of the National Institutes of Health (whether or not the project is Federally funded).

If you are uncertain to which Institute you should apply for a Certificate of Confidentiality, contact:

Olga Boikess, J.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 8253
Bethesda, Maryland 20892
ob4k@nih.gov

How to Apply for a Certificate for an Alcohol or Alcohol-Related Research Project

To apply for a Certificate of Confidentiality for alcohol-related research, please direct a request on institution letterhead  containing the information listed below to:

Isabel Ellis, MSW 
Public Health Analyst 
National Institute on Alcohol Abuse and Alcoholism, NIH 
5635 Fishers Lane; Room 3111, MSC 9304 
Bethesda, Maryland  20892-0304 
(for Express Mail; UPS etc., use Rockville, MD  20852-1705) 
Tele. 301.443.8771       FAX 301.480-1726 
Email:  iellis@mail.nih.gov

IMPORTANT:  Once you initiate the online submission process, it must be completed, since the incomplete application cannot be saved https://www.nichd.nih.gov/health/clinicalresearch/cccert/default.aspx?ic=NIAAA.  The following information is provided to familiarize you with the information required for the electronic submission.  

1. Name and address of applicant research institution. This is the institution with which the applicant is affiliated and the recipient of grant support for the research, if there is any.

2. Sites where the research will be conducted and a brief description of the facilities available for the conduct of the research. Please indicate if this is a multi-site project. The lead site of a multi-site project should apply for a single Certificate to protect participants enrolled at all sites. However, lead multi-site applicants must list each participating unit, its address, and project director. If any new sites are added after the certificate is issued, the lead site should provide NIH with an updated list and the cover letter should include a statement by the lead site that IRB approval has been given at the new site and that the lead site is maintaining a copy of that approval (see item 5(b) below.)

3. Title of the research project. If the project title on the IRB form (see item 5 below) is different from the title given here, the applicant must document that the IRB approval pertains to this project.

4. Source and number of the supporting grant, if applicable (e.g., NIMH, NIH, 1 R01 MH 12345-01; ABC Foundation, Grant No. 123). If the NIH funds the project, please provide the name and telephone number of the Project Officer at the funding IC. If there is no support, type "None."

5(a). Requirement - A Certificate of Confidentiality will not be issued to an applicant conducting research involving human subjects unless the project has IRB approval. The approving IRB must be in compliance with applicable Federal requirements. If the applicant institution is receiving DHHS funding for research involving human subjects, an OHRP-approved IRB for that institution must approve the project for which a Certificate of Confidentiality is sought. For additional information on OHRP and IRB assurances, see http://www.hhs.gov/ohrp/

If the applicant institution does not receive DHHS funding for this research involving human subjects but has an IRB that complies with the requirements for IRBs imposed by another Federal agency, that IRB must approve the research. If the applicant institution does not have an IRB, the project should be reviewed by an IRB in accordance with 45 CFR Part 46.

5(b). Documentation of IRB approval: Attach letter or form signed by an authorized IRB representative. Approval must be current and unconditional, or conditioned only upon the issuance of a Certificate of Confidentiality and documented by a letter or form signed by an authorized IRB representative. If this is a multi-site project, the lead site must maintain a copy of the IRB approval from each site, which must be made available to the NIH upon request.

5(c). Documentation of IRB qualifications: For all projects, submit the IRB  assurance number assigned by OHRP or other documentation that the IRB complies with the applicable Federal regulations governing research involving human subjects. If this is a multi-site project, the lead site must maintain the OHRP assurance number for the reviewing IRB at each site, which must be made available to the NIH upon request.

6. Name, title, mailing and email addresses, telephone and fax numbers of the Applicant as well as name and title of other key personnel. Also include a brief summary of the scientific training of the Applicant and key personnel. If this is a multi-site project, information from the lead site should be submitted to the NIH. The lead site must collect and maintain information for each site and make it available to the NIH upon request.

7. Beginning date and expected end date of the project. The Certificate will state the date upon which it becomes effective and the date upon which it expires. A Certificate of Confidentiality protects all information identifiable to any individual who participates as a research subject (i.e., about whom the investigator maintains identifying information) during any time the Certificate is in effect. The protection afforded by the Certificate is permanent. If this project is not completed by the expiration date, the Applicant must submit a written request for an extension three months prior to the expiration date. Any such request must include a brief description of the reason for the extension, documentation of the most recent IRB approval, and the expected date for completion of the research project.

8. Concise description of project aims and research methods (1-2 paragraphs, omit background). This section should include a brief description of procedures for the collection and storage of identifying information as well as the number of subjects to be included in the study, the source from which they will be recruited, and a description of the study population (e.g., gender, age, race, etc.) If significant changes are made to the project aims or methods during the course of the study, the Applicant should contact the Certificate Coordinator who issued the Certificate. That person will determine if the Certificate can be modified or if the Applicant will need to submit an amended application.

9. A description of means used to protect subjects' identities (i.e., subjects are coded by numbers not names, linking information is kept in locked files, identifiers will be destroyed when the study is completed, etc.)

10. Reasons for requesting a Certificate of Confidentiality (e.g., will collect sensitive information, identifying information on subjects, etc.) Include brief description of sensitive and identifying information to be collected.

11. Informed consent forms for human subjects from each study site, as approved by the IRB (attach copy). The informed consent form must include a description of the protections and limitations of the Certificate of Confidentiality, including the circumstances in which the investigators plan to disclose voluntarily identifying information about research participants (e.g., child abuse, harm to self or others, etc.) Sample language is provided below. If significant changes are made to the informed consent at anytime after issuance of the certificate, the Applicant should contact the Certificate Coordinator who issued the Certificate and submit a copy of the revised consent form. If this is a multi-site project, the lead site must maintain on file a copy of the consent form as approved by the IRB from each site, which will be made available to the NIH upon request.

12. Research not funded by NIH in which drugs will be administered to human subjects must provide the following additional information:

  • Identification of drugs to be administered;
  • Description of methods for administration of these drugs, including a statement of dosages;
  • Evidence that individuals who will receive the drugs are authorized to do so under applicable Federal and State law.

13. All research in which a controlled drug or drugs will be administered must submit a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.

14. If the research project is testing for reportable communicable diseases, the applicant must submit information relating to its compliance with State reporting laws as specified in the August 9, 1991 memorandum from the Assistant Secretary for Health ( http://grants2.nih.gov/grants/policy/coc/cd_policy.htm).

NOTE: NIAAA requires that the Assurances be printed on your institution's letterhead and the inked original signed by you and the Institutional Official along with the complete mailing address and contact information.

Assurances

The following assurances are required and the following information should be inserted verbatim into the Certificate application letter. Both the PI and the Institutional Official must sign this letter:

This institution agrees to use the Certificate of Confidentiality to protect against the compelled disclosure of personally identifiable information and to support and defend the authority of the Certificate against legal challenges.
 

The institution and personnel involved in the conduct of the research will comply with the applicable Federal regulation for the protection of human subjects or, if no such Federal regulation is otherwise applicable, they will comply with 45 CFR Part 46.

This Certificate of Confidentiality will not be represented as an endorsement of the project by the DHHS or NIH or used to coerce individuals to participate in the research project.

All subjects will be informed that a Certificate has been issued, and they will be given a description of the protection provided by the Certificate.

Any research participant entering the project after expiration or termination of the Certificate will be informed that the protection afforded by the Certificate does not apply to them.

_____________________________      __________________________

Signature of Principal Investigator         Signature of Institutional Official

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Informed Consent

If you decide to take part in this research study, you will be required to give us information about your [chose these or other words that are appropriate: substance use/genetic information/criminal behavior]. We have (applied for/obtained a) Certificate of Confidentiality (CoC) issued by the National Institutes of Health (NIH).  The CoC is issued to protect the investigators on this study from being forced to tell people that are not connected with this study about your participation in this study, even under a subpoena. The protection offered by the CoC does not stop us from voluntarily reporting information about suspected or known sexual, physical, or other abuse of a child or older person, or threats of violence to self or others. If any  member of the research team is given such information, he or she will make a report to the appropriate authorities. This protection will not apply until we have obtained the CoC, which may take a few weeks.

Even when a CoC is in place, you and your family members must still continue to actively protect your own privacy. If you voluntarily give your written consent for an insurer, employer, or lawyer to receive information about your participation in the research, then we may not use the CoC to withhold this information.

Also, because this research is sponsored by NIAAA, staff from that and other DHHS agencies may review records that identify you only for audit or program evaluation.  The can't report anything that would harm the research subjects.  This Certificate, however, does not imply that the Secretary, DHHS, approves or disapproves of the project.

Statutory Authority

Section 301(d) of the Public Health Service Act (42 USC 241(d)) permits the Secretary of Health and Human Services to authorize persons engaged in biomedical, behavioral, clinical or other research (including research on the use and effect of alcohol) to protect the privacy of individuals who are the subjects of that research.

Persons authorized by the Secretary to protect the privacy of research subjects may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify them by name or other identifying characteristic. 

Applicable Regulations

Issuance of Certificates of Confidentiality for alcohol-related research is governed by regulations set forth at 42 CFR Part 2a.

A research project for which a Certificate of Confidentiality is issued may also be subject to special rules on confidentiality of alcohol and drug abuse patient records which restrict voluntary disclosures of information from covered patient records (42 CFR Part 2).  

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For Further Information

  • On Certificates of Confidentiality for alcohol-related research:

    Isabel Ellis, MSW 
    Public Health Analyst 
    National Institute on Alcohol Abuse & Alcoholism, NIH 
    5635 Fishers Lane; Room 3111, MSC 9304 
    Bethesda, Maryland  20892-0304 
    (for Express Mail; UPS etc., use 
    Rockville, MD  20852-1705) 
    Tele. 301.443.8771       FAX 301.480-1726 
    email:  iellis@mail.nih.gov

  • On Certificates of Confidentiality for alcohol-related research requiring an Investigational New Drug (IND) exemption from the Food and Drug Administration:

Julie Unger
Division of Scientific Investigations
Center for Drug Evaluation and Research
Food and Drug Administration
301-827-1685 
ungerj@cder.fda.gov  

  • On Certificates of Confidentiality for research on drug abuse:

    Kate Bent, R.N., Ph.D., C.N.S.
    National Institute on Drug Abuse
    6001 Executive Boulevard
    Room 4241, MSC 8401
    Bethesda, Maryland 20892-8401
    bentkn@nida.nih.gov

  • On Certificates of Confidentiality for research on other topics:

Olga Boikess, J.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 8253
Bethesda, Maryland 20892
ob4k@nih.gov

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Frequently Asked Questions

(1) Who may apply for a Certificate of Confidentiality?

Any person engaged in research in which sensitive information is gathered from human subjects (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality.

A separate application is required for each research project for which a Certificate is desired.

A certificate is generally issued to a research institution for a single project (not broad groups or classes of projects). However, for cooperative multi-site projects, a coordinating center or "lead" institution can apply for, and receive, a Certificate on behalf of all member institutions. The lead institution must provide documentation of IRB approval of all the research projects and all of the IRB approved consent forms containing appropriate language about the protections and limitations of the Certificate of Confidentiality.

(2) What is meant by "sensitive information?"

Sensitive information includes (but is not limited to)

  • information relating to sexual attitudes, preferences, or practices;
  • information relating to the use of alcohol, drugs, or other addictive products;
  • information pertaining to illegal conduct;
  • information that, if released, could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
  • information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
  • information pertaining to an individual's psychological well-being or mental health; and
  • genetic information or tissue samples.

(3) What is the effect of a Certificate?

A Certificate of Confidentiality authorizes withholding the names and other identifying characteristics of individuals who participate as subjects in the research project specified in the Certificate while that Certificate is in effect. This authorization applies to all persons who, in the performance of their duties in connection with the research project, have access to information which would identify the subjects of that research.

Persons so authorized may not, at any time, be compelled to identify the research subjects encompassed by the Certificate in any Federal, State, or local civil, criminal, administrative, legislative or other proceedings.

Subjects who participate in the specified research project during any time the Certificate is in effect are protected permanently.

Certificates protect against involuntary disclosure; however, information may be voluntarily released under certain circumstances. For example, research subjects may disclose or consent to the disclosure of information (including research information) in their medical records to an insurer, and researchers may not use the Certificate to refuse disclosure under this circumstance. In addition, researchers are expected to make arrangements with local and state authorities to satisfy communicable disease reporting requirements, and subjects should be informed of this possibility in the informed consent document. Moreover, Certificates do not authorize researchers to refuse to disclose information about subjects if authorized DHHS personnel request such information for an audit or program evaluation or if such information is required by the Federal Food, Drug and Cosmetics Act.

(4) What is meant by "identifying characteristic?"

Identifying characteristics include:

  • name,
  • address,
  • any identifying number,
  • fingerprints,
  • voiceprints,
  • photographs,
  • genetic information or tissue samples,

or any other item or combination of data about a research subject which could reasonably lead, directly or indirectly by reference to other information, to identification of that research subject.

(5) To whom should I apply for a Certificate of Confidentiality?

If the research project for which you would like a Certificate is alcohol-related, you may apply to NIAAA (whether or not the project is Federally funded).

If the research project for which you would like a Certificate is not alcohol-related, you may apply to the appropriate Institute of the National Institutes of Health (whether or not the project is Federally funded).

(6) What if I am not sure to which NIH Institute I should apply?

If you are uncertain to which Institute you should apply for a Certificate of Confidentiality, contact:

Olga Boikess, J.D.
National Institute of Mental Health
6001 Executive Boulevard, Room 8253
Bethesda, Maryland 20892
ob4k@nih.gov

(7) May I apply for a Certificate if my research project is not funded by the Federal government?

Yes. A Certificate of Confidentiality can be awarded whether or not a research project is Federally funded.

(8) When should I apply for a Certificate?

Ordinarily, an application for a Certificate of Confidentiality is submitted after a research project is approved by the Institutional Review Board (IRB) responsible for its review (because IRB approval is a condition for issuance of a Certificate).

Applications for Certificates should be submitted at least three months prior to the date on which enrollment of research subjects is expected to begin.

Certificates for research projects funded by NIAAA are not issued until funding has been awarded.

(9) What if there is a significant change in my research project after a Certificate is issued?

If a significant change in your research project is proposed after a Certificate is issued, you must inform NIAAA by submitting an amended application for a Certificate of Confidentiality (in the same form and manner as your original application for a Certificate).

Significant changes include:

  • major changes in the scope or direction of the research protocol,
  • changes in personnel having major responsibilities in the project, or
  • changes in the drugs to be administered (if any) and the persons who will administer them.

Amended applications will be reviewed by NIAAA and either approved or disapproved. If an amended application is approved, an amended Certificate of Confidentiality will be issued. If an amended application is disapproved, you will be notified that adoption of the proposed significant change(s) will result in cancellation of the original Certificate.

(10) What if my research project extends beyond the expiration date on the Certificate?

If you determine that the research project for which you have received a Certificate of Confidentiality will extend beyond the expiration date on the Certificate, you may submit a written request for extension of the date. This request should be submitted to NIAAA at least three months prior to the Certificate's expiration. It must include a justification for the requested extension (e.g., new subjects continue to be enrolled in the project), a revised estimate of the date for completion of the project, and documentation of the Institutional Review Board's most recent approval for the project. If your request is approved, an amended Certificate will be issued.

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