Federally Funded Studies: FAQs
Quorum Review IRB is registered with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and with the Food and Drug Administration (FDA) with registration number IRB 00003226.
Prior to the Board’s review of federally-funded research, the following documentation must be submitted in addition to other required material for review of new protocol submissions:
- A completed Federal Funding Addendum (available on our website).
- A complete copy of the applicable grant application or other funding application. (The grant application or other funding applications typically does not need to be reviewed by Quorum Review IRB for a non-awardee institution involved in a multi-site research project).
- A copy of the federal contract (if available).
- A valid Federal Wide Assurance (FWA) number. A Federal Wide Assurance (FWA) must be filed for each legal entity engaged in the federally funded study as required by 45 CFR § 46.103 and in accordance with the following OHRP guidance: “Engagement of institutions in Research”http://www.hhs.gov/ohrp/policy/engage08.html. You can submit the FWA form electronically on the OHRP website. For more information visit: http://www.hhs.gov/ohrp/assurances/assurances/file/index.html. (Please contact the applicable agency if using a different assurance process other than a FWA).
- A completed IRB Authorization Agreement (IAA). (Quorum Review IRB will accept any standard IAA form. You may obtain Quorum’s template IAA from our website).
Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.
An independent IRB does not need to obtain a separate Federal Wide Assurance (FWA). It is generally accepted that the IRB is not actively engaged in the research nor is it a direct recipient of federal funds. Consequently, the IRB can be considered a sub-contractor and as such should be listed on the Sponsor’s FWA form as the IRB of record.
To designate Quorum as an IRB of Record on the FWA, simply include “Quorum Review IRB” and Quorum’s IRB registration number IRB00003226 on the FWA.
For more information on Federal Wide Assurances, visit the U.S. Department of Health and Human Services website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html. Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.
Quorum asks that you submit a finalized version of the protocol that is separate from the grant. It is recommended that you review the Quorum Handbook for information on Board expectations for protocols to be considered for review. This information is available in Appendix A of Quorum’s Handbook, protocol Contents.
A Certificate of Confidentiality is a document that federal agencies issue to investigators to protect the privacy and welfare of subjects by preventing the release of protected health information and other sensitive information regarding subjects who are participating in a research study. Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. An investigator should consider obtaining a Certificate of Confidentiality for IRB-approved research when he or she collects information from or about a subject that is identifiable and sensitive (i.e., could lead to discrimination, social stigmatization, legal prosecution, damage to their financial standing, employability, insurability, or reputation).
Even if a Certificate of Confidentiality is issued, research investigators should be aware that federal, state, or local law may require that licensed health care providers and/or certain other individuals report identifiable information regarding subjects involved in research if they have reasonable cause to suspect issues such as child abuse, a possible threat to self or others, or reportable communicable disease. Other disclosures may also be required by federal, state, or local law. For example, Certificates of Confidentiality do not authorize researchers to refuse to disclose information regarding a subject if such disclosure is required by federal law (e.g., required disclosures as set forth in the Food, Drug, and Cosmetic Act or if federal agency requests information for auditing or program evaluation purposes).
No. Quorum does not require an investigator to apply for Certificate of Confidentiality.
How is the Certificate of Confidentiality different from a confidentiality agreement between a research investigator and an institution?
An institution may enter into confidentiality agreements between its research investigators and the institution’s IRB so that investigators can access records without a subject’s written consent or authorization. Such agreements vary, but they usually describe the investigator’s obligations and responsibilities regarding the confidentiality and use of those records.
The protection of a Certificate of Confidentiality applies only if the data is sent to and maintained in the U.S.
A number of federal agencies issue Certificates of Confidentiality, including the Food and Drug Administration (FDA). For a list of other Department of Health and Human Services (HHS) agencies that issue the Certificate, see http://www.hhs.gov/about/index.html#agencies. Information related to NIH-funded research and Certificates of Confidentiality can be found at http://grants.nih.gov/grants/policy/coc/faqs.htm.
What information should be included in the consent form if a Certificate of Confidentiality is issued?
Participants must be informed in the informed consent document regarding the limitations and protections of the Certificate of Confidentiality. Please notify Quorum Review IRB if you have requested or will be requesting a Certificate of Confidentiality. Also note that if a Certificate of Confidentiality is obtained after the study has commenced, the consent form will need to be revised in order to inform subjects about the Certificate, including its limitation and protections.
Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.