Compliance

This page provides links to detailed information about required federal compliance issues related to:

  • Conflicts of Interest
  • Protection of Human Subjects through Institutional Review Boards
  • Research Misconduct

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.

Conflicts of Interest

A Conflict of Interest exists when a Sinclair employee participates in the selection, award or administration of a financial relationship or transaction with an external entity, and the employee, or a member of the employee’s immediate family, has a financial or other interest in, or would receive a tangible personal benefit from, such financial relationship or transaction with that entity.

Prior to submitting a proposal for a Federal award, Sinclair requires the Principal Investigator/Project Director and the Co-Principal Investigator/Co-Project Director to receive training on the Conflict of Interest for Federal Awards Policy. In addition, the Principal Investigator/Project Director and the Co-Principal Investigator/Co-Project Director must complete and sign the Financial Interests Report. Both requirements may be met by accessing the Conflict of Interest Policy.

Protection of Human Subjects

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?

Important Links
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:

IRB Training
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:

  • Unanticipated problems involving risks to subjects or others
  • Serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB.

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

Research Misconduct

Research Misconduct is fabrication, falsification or plagiarism in proposing, performing or reviewing research or reporting research results. Sinclair is responsible for the prevention and detection of research misconduct.

Prior to submitting a proposal for a Federal award, Sinclair requires the Principal Investigator/Project Director and the Co-Principal Investigator/Co-Project Director to receive training on the Research Misconduct Policy. In addition, the Principal Investigator/Project Director and the Co-Principal Investigator/Co-Project Director must complete and sign the Certification on the Research Misconduct Process. Both requirements may be met by accessing the Research Misconduct Policy and Training.