Federally Funded Studies
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Quorum Review IRB provides review of publicly funded studies in the U.S. and Canada. In addition to the forms specific to U.S. federally funded studies, submission of standard protocol level and site level start-up forms and information is also required.
Please review our Federally Funded Research FAQ for a list of these additional submission requirements.
Required
F-015 - Federal Funding Addendum
This form, along with supporting documentation named within this form, is required to be completed and submitted along with the Central Study Questionnaire for any studies which are funded in whole or in part by the federal government of the United States.
As Indicated
F-034 - Institutional Authorization Agreement
Formal document by which an institution (typically, one with an FWA) waives local IRB jurisdiction of a particular study to Quorum Review IRB.
F-042 - Waiver of Documentation of Informed Consent Submission Form
This form is required if a Waiver of Documentation of Informed Consent will be necessary.
F-043 - Waiver or Alteration of Informed Consent Submission Form
This form is required if a Waiver or Alteration of Informed Consent will be necessary.
Guidance
G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.
Q. What is Quorum Review’s OHRP/FDA Registration Number? >>
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.
Q. What is required for Board review of a federally-funded study? >>
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/humansubjects/assurance/engage.htm. A copy of the FWA form may be downloaded from the following OHRP website: http://www.hhs.gov/ohrp/assurances/assurances_index.html#domestic. (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.)
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Q. What is Quorum Review’s Federal Wide Assurance (FWA) number? >>
An independent IRB does not need to obtain a separate 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. More information is available at http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.
Q. Do I need to draft a separate protocol, or will my grant work satisfy your submission 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.
Q. What is a Certificate of Confidentiality? >>
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).
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).
Q. Does Quorum Require a Certificate of Confidentiality? >>
No. Quorum does not require an investigator to apply for Certificate of Confidentiality.
Q. 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.
Q. Does a Certificate of Confidentiality apply to data collected in foreign countries? >>
The protection of a Certificate of Confidentiality applies only if the data is sent to and maintained in the U.S.
Q. What agencies issue Certificates of Confidentiality? >>
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.
Q. 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.
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.