FAQ - Conducting Research: Background Information

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Who approves research activities at GVSU?
         
The University through its departmental structures approves all research at GVSU. This includes bench science research, and research on human and animal subjects. For research involving human subjects, the University also requires approval from its Institutional Review Board (IRB), known at GVSU as the Human Research Review Committee (HRRC). The HRRC does not approve research activities: it certifies that proposed research activities are in compliance with Federal Regulations, University policies and procedures, and ethics standards pertaining to the protection of the rights, interests and welfare of human subjects’ research.

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What is a Federal Wide Assurance?              

GVSU has assured the federal government that all research conducted under GVSU authority will comply with federal regulations as specified under the Code of Federal Regulations and elsewhere. This assurance pertains to all requirements and procedures specified by all federal agencies and departments. That is why it is called a Federal Wide Assurance (FWA).

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OHRP guidance - engaged in research 

 

Who must have an FWA?           

Any individual or entity engaged in federally sponsored research involving human subjects must have an FWA or have the research activity reviewed and approved by an Institutional Review Board (IRB) at an institution that holds an FWA.  Researchers are not allowed to receive research grant funds directly from the federal government. The researcher’s employing institution receives the money and uses it to pay the costs of the research, including a percentage of the researcher’s salary. Every institution adds a percentage on top of the actual research costs for use of its institutional resources to support research activities, called indirect costs (ICs).  For example, if a researcher’s project costs (including her salary) total $100,000, and her institution’s indirect costs are 35%, then the grant is written for $135,000. The federal government limits the ICs percentage that it will pay, but state, private, and other granting agencies and foundations set different limits. 
The FWA document basically makes three separate assurances:

1. Our researchers know about the regulations to protect research participants;
2. All of our researchers will always follow the regulations;
3. If any researcher violates the regulations we will report it, take corrective action, and institute preventive measures so it does not happen again.

If an institution does not want federal funding for research, it does not need an FWA. If it does want to apply for federal grant funds and signs an FWA, it has several options to consider. These are best understood in response to specific questions.

a. How extensive are the assured protections? Every institution must agree to abide by Subpart A (the Common Rule). Subparts B (protections for pregnant women, fetuses & neonates), subpart C (protections for prisoners), and subpart D (protections for minors) are all optional to adopt.  Adding them requires checking up to three (3) boxes on the FWA form.

b. Is the assurance dependent upon the funding source for the research? The institution must indicate on the FWA document whether it assures compliance with federal regulations to all research, or only to federally funded research. It is a fourth box to check.

Note: The gold standard  (sometimes called the “moral high ground”) for assuring protections for research participants is referred to as “checking all the boxes”, i.e., including all 3 subparts and extending the protection assurance to all research regardless of funding, including no external funding.  GVSU has always checked all the boxes.

c. Does the FWA expire? The FWA is renewed every 3 years but the choices about the extent of protection assurance may be amended at any time.

d. Who is responsible for the institution’s assurances? Whoever signs the FWA on behalf of the institution is the accountable party if a complaint is received or a regulatory violation occurs. At GVSU the signatory official is the Provost.

e. Can the institution amend its FWA to get grant money? Yes, at any time. Some federal agencies and some private pharmaceutical companies require specific subpart assurances to receive their grant money. This may require filing a protocol specific amendment to the FWA if the relevant subparts were not initially included.  In addition, some federal agencies add additional rules to the regulations and require special amendments be signed to receive funding support for their projects. They also may require that additional training in participant protections be completed by the institutional official, chair of the HRRC, individual researchers, and possibly others. The US military does this and each branch has its own set of amendments and training requirements. An amendment to the FWA may only be made by the signatory official or their designee.

Updated: October 2009

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Page last modified September 14, 2010