This page provides:
Links to policies and procedures about compliance issues that relate to publically-funded grant projects
Detailed information and forms related to the Protection of Human Subjects through Sinclair’s Institutional Review Board
Noncompliance in these areas can result in losing future grant funds, or worse, having to pay back funds that have already been spent. Noncompliance with human subject regulations may result in journals not publishing articles related to your project.
The following policies and procedures pertain to all federal grants. Most of these policies also pertain to grant-funded activities from non-federal sources, such as all public state/local funding and most private funding.
The 16 policies are listed below for easy access by Principal Investigators (PIs), Project Directors, Project Managers, and Administrative Assistants who assist with budgeting activities. In addition to the policies listed below, PIs must also be knowledgeable about purchasing policies found on Sinclair’s Purchasing Office website and travel policies found on Sinclair’s Accounting Office website.
The first five policies below are pertinent during the proposal development stage, before the grant is awarded (also called the pre-award stage) as well as during the project implementation stage (also called post-award stage).
All institutions applying for federal funds must have Institutional Review Boards (IRBs) with clearly defined policies and procedures to ensure that grant-funded research activities protect human subjects. Principal investigators submitting proposals involving research and human subjects must complete required forms and submit the project for IRB review prior to submission. The information in this section is divided into three areas:
IRBs must adhere to federal regulations found in the Code of Federal Regulations (Title 45 Part 46, Protection of Human Subjects). Learning about these regulations begins with some basic definitions: Is my project considered research? Does my project involve human subjects? Does my project involve only minimal risk? Why is risk level important? According to federal regulations, principal investigators have an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
Informed consent helps assure that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. Consent forms tell subjects they are free to withdraw from participation at any time, as well as convey other critical information; see informed consent guidelines.
Get Help Making Decisions
The Office for Human Research Protections of the Department of Health & Human Services provides a decision tree to help you decide: Does my research activity have to be reviewed by the IRB? Can the review go through the expedited process? Can informed consent be waived?
The online version of the Code of Federal Regulations (45 CFR Part 46) is user-friendly and allows you to search for particular topics.
Another indispensable online resource is the Department of Health and Human Services, Office for Human Research Protections website. The National Science Foundation, and 16 other federal agencies, adhere to federal regulations called the Common Rule for the Protection of Human Subjects (45 CFR Part 690).
Sinclair Charter and Operating Procedures contain Sinclair’s written guidelines that operationalize federal IRB requirements.
Research Review Forms
The Sinclair Grants Team will help Sinclair principal investigators decide which type of review to request from the IRB. There are four categories of review:
Federal regulations require IRB committee member training. IRB members can follow this link to complete training at the time of their appointments. IRB members must then submit a training verification form to the IRB chair indicating they have completed human subjects training.
Other Sources of IRB Training and Information:
It is Sinclair’s IRB policy that Sinclair employees report to the Chair of the IRB any of the following upon knowledge of such:
The Sinclair Grants Development office acknowledges the assistance of these institutions that allowed us to adapt and adopt their IRB forms and policies: Bridgewater State College, Academic Affairs, Grants and Sponsored Projects; Indiana University - Purdue University, Indianapolis Research and Sponsored Programs; University of Massachusetts Lowell, Office of Institutional Compliance; Wright State University, Research & Sponsored Programs; Youngstown State University, Grants & Sponsored Programs