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Certificate of Confidentiality Guidance.doc
Certificate of Confidentiality Guidance.doc
Certificate of Confidentiality Guidance.doc
Certificate of Confidentiality Guidance.doc
Certificate of Confidentiality Guidance.doc
Certificate of Confidentiality Guidance.doc
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Certificate of Confidentiality Guidance.doc

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  • 1. Guidance for Certificates of Confidentiality (COC) When conducting human subject research that involves sensitive identifiable information, the IRB may ask a researcher to apply for a Certificate of Confidentiality (COC) for the project. Certificates of Confidentiality are granted by the Department of Health and Human Services (DHHS) Institutes or Centers, and they are intended to prevent researchers from being compelled to release research information (thereby protecting the participating subjects’ privacy). Information about COC’s can be accessed at the NIH website called the “Certificate of Confidentiality Kiosk. http://grants2.nih.gov/grants/policy/coc/ The NIH also has a section of the kiosk for Frequently Asked Questions http://grants2.nih.gov/grants/policy/coc/faqs.htm which contains a wealth of information about the Certificates and the process, and you are strongly encouraged to read it. The information presented in this guidance is only a general summary of information. This guidance will provide information on:  The purpose of COC  What is meant by “identifying characteristics”  What is meant by “sensitive information”  Examples of research projects that are eligible for a COC  How research may be affected  Time considerations in the COC application process  Deciding to which Institute or Center to apply  Instructions for preparing your COC application:  Instructions for preparing the consent document to accompany the COC application  Instructions for submitting the application to the IRB and DHHS Institute/Center  COC approval periods and renewals  How making changes in the research may affect your COC  Whom to contact if you need more information Purpose of a COC A COC assists researchers in protecting the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. What is meant by “identifying characteristics”? Identifying characteristics include things such as: o name; o address; o social security or other identifying number; o fingerprints, voiceprints, photographs; o genetic information or tissue samples; or o any other item or combination of data about a research participant which could reasonably lead, directly or indirectly by reference to other information, identifying a research subject. What is meant by “sensitive information” According to the NIH website, sensitive information includes (but is not limited to): o information relating to sexual attitudes, preferences, or practices such as sodomy, incest, sexual orientation, or sexual activity of minors; o information relating to the use of alcohol, drugs, or other addictive products; o information pertaining to criminal, illegal or controversial conduct; o information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination; o information pertaining to an individual's psychological well-being or mental health; and v 8/07
  • 2. o genetic information or tissue samples. Examples of research projects that are eligible for a COC: Examples of research are eligible for a Certificate are: research on HIV, AIDS, and other STDs; studies that collect information on sexual attitudes, preferences, or practices; studies on the use of alcohol, drugs, or other addictive products; studies that collect information on illegal conduct; studies that gather information that if released could be damaging to a participant's financial standing, employability, or reputation within the community; research involving information that might lead to social stigmatization or discrimination if it were disclosed; research on participants' psychological well being or mental health; genetic studies, including those that collect and store biological samples for future use; research on behavioral interventions and epidemiologic studies. Examples of genetic research projects that may need a COC: Not all studies involving genetic testing will require a COC. Generally, the IRB may request the investigator to apply for a COC when there is a reasonable likelihood during the time frame of the study that the genetic results would reveal a susceptibility to a disease or drug interaction, or for studies where there might be information learned that would not otherwise have been recorded in the subject’s medical record. For example, if testing is related to an already known diagnosis obtaining a COC would not generally be required; however, if any of the following apply obtaining a COC may be requested: o unaffected family members are being tested or the test is intended to diagnose or characterize risk of developing a disease in subjects who have not already been diagnosed; o characterizing risks of developing a disease in subjects who have not already been diagnosed; or o there is a reasonably likelihood that the results of the tests could demonstrate a condition that would be harmful or stigmatizing to the research subject if released. How research may be affected The IRB will allow most research projects that involve sensitive identifiable information to begin (or continue) prior to having an approved Certificate of Confidentiality on file at the IRB, provided that evidence of the submission to DHHS is submitted to the IRB (see instructions in “Submitting the Application” below). A few kinds of research may be deemed too sensitive to proceed without an approved COC in place. In those rare cases, the IRB may require receipt of the approved Certificate before allowing the research to begin. If you receive a document that states that receipt of an approved COC is required in order for the IRB to issue final approval, please contact the IRB for further instructions. Otherwise, please follow the instructions as listed below. Time Considerations in the COC application process DHHS suggests that applications for Certificates should be submitted at least three months prior to the date on which enrollment of research subjects is expected to begin. Since IRB approval (or approval pending receipt of the COC) is required before submitting the application, this means that submitting to the IRB as early as possible to begin the review process is recommended. Deciding to which Institute or Center to apply 1. If your research involves an IND (Investigational New Drug application) then you must apply to the FDA for your Certificate of Confidentiality. If it does not involve an IND, and is sponsored by an Institute or Center, you must apply to your sponsoring Institute for your Certificate. v 8/07
  • 3. 2. If your project is not funded by a National Institute or Center, you may still apply for a COC from the Institute or Center that handles the related area of scientific research. For instance, if you are to conduct a project in which you will collect lung specimens for a repository, you would send your COC application to the National Heart, Lung, and Blood Institute (NHLBI). If there is no Institute or Center that has an area similar to your research area, you may submit your application to the central COC resources at the DHHS—the NIMH. Their contact information is listed in #3. 3. If you have any doubt about where to send your application, contact the COC Central Resource representatives at the NIMH, and ask which Institute or Center is appropriate place to send the application. The list of COC representatives at each Institute and Center is available on their website at http://grants2.nih.gov/grants/policy/coc/contacts.htm. If you need further assistance, contact the IRB. Instructions for preparing your COC application: The COC “application” is not an actual form provided to you; it is simply a letter you write on Institutional letterhead that contains the following information: 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 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, 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 6 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 center. 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. 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/assurances/assurances_index.html . 5(b). Documentation of IRB approval: Attach a copy of your IRB approval letter signed by an authorized IRB representative. Approval must be current and unconditional, or conditioned only upon the issuance of a Certificate of Confidentiality. 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 for the IRB that reviewed the project the assurance number assigned by OHRP or 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 Federal Wide Assurance (“FWA”) number for the reviewing IRB at each site, which must be made available to the NIH upon request. v 8/07
  • 4. UT Southwestern’s FWA Number is 00005087 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, only information from the lead site should be submitted to the NIH. However, the lead site must collect and maintain this 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. NOTE: 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, 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.) If significant changes are made to the informed consent form, 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 indicate that it has 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. v 8/07
  • 5. 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://grants.nih.gov/grants/policy/coc/cd_policy.htm . 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 J. Gregory Fitz, M.D. Executive Vice President for Academic Affairs and Provost Dean, UT Southwestern Medical School Instructions for preparing the consent document to accompany the COC application: 1. For the consent form, do NOT use the suggested consent language provided on the Certificate of Confidentiality Kiosk website. Please use the standard UT Southwestern language outlined in the Consent Form Template. Submitting the application to the IRB and the DHHS Institute/Center: 1. After preparing your COC application, place a cover memo on it that indicates that it is a COC application that is being submitted for the signature of the Institutional Official. Submit the memo, the application form (signed by the PI), and copies of the consent document(s) to the IRB office. After reviewing the application, the IRB will forward it to the Institutional Official for signature. If you haven’t received it previously, the IRB will also release your project approval at this point. Only if your project is of such a sensitive nature that the IRB requires that you receive your COC prior to starting will you receive an approval letter conditioned on the receipt of the COC and not have any consent forms released to you at this time. v 8/07
  • 6. 2. The IRB will notify you when the application has been signed. 3. Include a copy of the signed IRB approval letter that is printed on IRB letterhead. If the IRB office did not generate a signed letter for you previously (not all projects receive signed letters), contact the IRB to have one created for you prior to sending in your application. 4. Send your completed COC application packet to the appropriate DHHS Institute or Center address. 5. Once you receive your approved Certificate, or notification that the COC was denied, please submit a copy of the approved certificate or denial letter to the IRB office. COC approval periods, renewals, and changes In your COC application, you will be asked to indicate the beginning date and expected end date of the project. The Certificate you receive 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. NOTE: 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 the DHHS Institute/Center issuing the certificate at least three months prior to the Certificate's expiration. It must include an explanation of the reasons for requesting an extension (e.g., new subjects continue to be enrolled in the project), a revised estimate of the date for completion of the project, documentation of the Institutional Review Board's most recent approval for the project, and a copy of the consent form which should include language explaining the Certificate's protections, specify any voluntary disclosures, and clearly state any other limitations. If your request is approved, an amended Certificate will be issued. How making changes in the research may affect your COC If a significant change in your research project is proposed after a Certificate is issued, you must inform the Certificate Coordinator of the Institute issuing the certificate 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 the NIH Institute issuing the certificate 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 prospective termination of the original Certificate. Any termination of a Certificate of Confidentiality is operative only with respect to the identifying characteristics of individuals who began their participation as research subjects after the effective date of such termination. Whom to contact if you need more information • UT Southwestern’s IRB (214) 648-3060 • Certificate Coordinators at the various Centers and Institutes. They are all listed on the NIH’s COC Kiosk website at http://grants2.nih.gov/grants/policy/coc/contacts.htm . v 8/07

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