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- Informed Consent (35)
- Assurance Process (25)
- Research with Children (22)
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- Investigator Responsibilities (12)
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- 45 CFR 46 (7)
- Exempt Research Determination (3)
Results: 1 - 20 of 25
| Q | What assurance ofcompliance process for human subject protection is accepted by the Office for Human Research Protections (OHRP) and other Federal agencies? |
|---|---|
| A | HHS human subject protection regulations and policies require that any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to OHRP. More >> |
| Q | What is an assurance of compliance with human subject protection regulations? |
| A | An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. More >> |
| Q | When does a research institution need to be covered by an assurance of compliance with human subjects research protections? |
| A | All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). More >> |
| Q | When is an institution considered to be “engaged in research”? |
| A | In general, an institution is considered to be engaged in human subjects research when its employees or agents:
(1) obtain data about living individuals for research purposes through intervention or interaction with them,
(2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102; or
(3) obtain the informed consent of human subjects. More >> |
| Q | What is a Federalwide Assurance (FWA)? |
| A | The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. More >> |
| Q | What research does the Federalwide Assurance (FWA) cover? |
| A | The FWA covers all non-exempt human subjects research at the submitting institution that is HHS-conducted or -supported or funded by any other federal department or agency that has adopted the Common Rule and relies upon the FWA. More >> |
| Q | What time period does the Federalwide Assurance (FWA) cover and when does it have to be updated? |
| A | The Federalwide Assurance (FWA) is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA. More >> |
| Q | What are the key features of the Federalwide Assurance (FWA)? |
| A | The key features of the Federalwide Assurance (FWA) are the following:
a) The identifying information for the institution filing the FWA, the Human Protections Administrator (or a reliable point of contact) at the institution, and the institutional official signing the FWA;
b) A list of the institution’s legal components that operate under different names that will be covered by the FWA and the city and state or country where the component is located. More >> |
| Q | Do international institutions have a separate FWA form or Terms of Assurance? |
| A | No. More >> |
| Q | Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46? |
| A | OHRP is sometimes asked whether, if an international institution selects a procedural standard under the FWA that has less stringent requirements than 45 CFR part 46, the institution may disregard the more stringent requirements of 45 CFR part 46. More >> |
| Q | Are there options other than the Federalwide Assurance (FWA) for obtaining an assurance of compliance to conduct HHS-supported or -conducted research? |
| A | No. More >> |
| Q | Who is covered by a Federalwide Assurance (FWA)? |
| A | Employees and agents of the institution holding an approved FWA are covered whenever they are involved in the conduct of research covered by the FWA. More >> |
| Q | What are the procedures for submitting a Federalwide Assurance (FWA)? |
| A | Institutions must submit all FWAs (including new submissions, updates, and renewals) electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability submit electronically. If an institution believes it lacks the ability to submit its FWA electronically, please contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/assurances/contact/index.html) and explain why the institution cannot submit its FWA electronically.
The FWA application will only be considered complete by OHRP when it is completed in its entirety, signed by the Signatory Official, and dated. More >> |
| Q | Who may sign as the Signatory Official on a Federalwide Assurance (FWA)? |
| A | The FWA Signatory Official should be a high-level institutional official who has the authority to represent the institution named in the Federalwide Assurance (FWA), as well as all the institutional components listed in the FWA. More >> |
| Q | Where can I find the instructions and forms for submitting a Federalwide Assurance (FWA)? |
| A | Links to the instructions and the forms for submitting an FWA may be found on the OHRP website at http://www.hhs.gov/ohrp/assurances/forms/index.html. More >> |
| Q | Who can I contact with questions about submitting a Federalwide Assurance (FWA)? |
| A | If you have questions about submitting an FWA, you should contact the Assurance Coordinator assigned to your state or international region (see the OHRP website at http://www.hhs.gov/ohrp/assurances/status/contact/index.html). More >> |
| Q | How can I track the Office for Human Research Protection's (OHRP) receipt of my Federalwide Assurance (FWA) submission? |
| A | You may track the receipt of an FWA on the Office for Human Research Protections website at http://ohrp.cit.nih.gov/search/. More >> |
| Q | How will I know when my institution’s Federalwide Assurance (FWA) is approved? |
| A | With electronic submission of your institution’s Federalwide Assurance (FWA), which is required unless your institution lacks the ability to submit its FWA electronically, the Signatory Official, Human Protections Administrator, and the individual who submitted the FWA will receive an automatically generated email when OHRP approves the FWA. A copy of the approved FWA will be attached to that email. |
| Q | How will the Office for Human Research Protections (OHRP) respond to queries from an FWA institution about human subjects research conducted or supported by a non-HHS department or agency? |
| A | When the Office for Human Research Protections (OHRP) receives a request from an FWA institution for guidance regarding implementation of the Common Rule for human subjects research conducted or supported by another department or agency that has adopted the Common Rule, OHRP will direct the requestor to contact appropriate officials at the other department or agency. More >> |
| Q | When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)? |
| A | If human subjects research conducted or supported by a non-HHS Common Rule department or agency involves collaborating institutions that do not hold an FWA or other applicable OHRP-approved assurance of compliance for federalwide use, OHRP does not require the collaborating institutions to obtain FWAs, but an FWA may be required by the non-HHS department or agency conducting or supporting the human subjects research. More >> |
Results: 1 - 20 of 25
