Academic research spurs advancements in medicine, anthropology, engineering and the sciences. But, progress requires significant monetary investments.
The federal government is one of the best sources for research funding. In fiscal year 2015, the estimated total award amount of federally funded research was more than five billion dollars.
To win funds and remain compliant, educational institutions need to not only meet federal grant reporting requirements, but also specific research requirements.
Unless research meets one of the six exemptions outlined in section 46.101(b) of 45 CFR 46, it is required to meet human subject requirements to obtain grant funding. These can vary based on funding agency; see the Health and Human Services (HHS) website for a breakdown of agencies and related resources.
Generally speaking, however, non-exempt research involving human subjects requires the submission of supplemental information in the Human Subjects Section of the grant application. This includes human subject involvement and consent plans, justification for inclusion, potential risks and procedures to minimize, and benefits and acquired knowledge in relation to risks.
For clinical trials, a data- and safety-monitoring plan must also be provided that outlines monitoring and adverse effects reporting procedures. And the trial must be registered at www.ClicnicalTrials.gov.
If funded, the following documentation is required: federal-wide assurance (FWA) via the Office of Human Research Protections (OHRP), institutional review board (IRB) approval, and verification that key personnel in the design and execution of the study underwent human subject education.
Similarly, grantees also face additional requirements for the use of live vertebrae research animals. Justification for use of the animals (including the particular species, number selected, sex and ages) and details on how animals will be treated humanely must be outlined in the grant application.
In addition, the grantee must commit to compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals by submitting a written assurance with the Office of Laboratory Animal Welfare (OLAW) and obtaining approval from their local Institutional Animal Care and Use Committee (IACUC).
Conflict of Interest
To ensure research objectivity, requirements are also set forth around conflict of interest. Grantees must post publicly a Financial Conflict of Interest policy that can be referenced in their grant application. Then, ongoing, they are required to disclose significant financial interests (SFIs) of key personnel to the awarding agency.
For more research compliance best practices, download our ebook, Grant Seeking and Grant Management in Education.
What compliance challenges have you faced? Share in the comments below.
Image Source: National Eye Institute