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Compliance

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.

Policies and Procedures

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).

  1. Mandatory Disclosures—All employees, whose work is funded by a public entity, must be knowledgeable about which incidents, events, and other matters that should be disclosed, and how to disclose it.
  2. Subrecipient Assessment and Monitoring—PIs need this information if they want to work with partner organizations. This policy also explains how the PI can determine if the partner is a subrecipient or a contractor, how a risk assessment is done prior to selecting a partner, and how to monitor a subrecipient’s performance on the project after it is funded.
  3. Conflicts of Interest—All employees, who want to perform activities that are charged to a public entity, must complete training to understand what constitutes a conflict of interest to determine if they have any financial relationships or transactions that would be considered a conflict of interest. The link connects to the actual training as well as the policy.
  4. Research Misconduct—Concerns about research misconduct begins during the proposal development stage for projects that contain research. PIs must complete training to understand what constitutes research misconduct to detect and prevent it.
  5. Selection of External Evaluators— PIs who work with an external evaluator need this information while they are developing their projects if they seek an external evaluator’s assistance in designing the project evaluation plan.

Policies pertaining primarily to project implementation (post-award activities)

  1. Records Retention—As soon as a project begins, a PI who is knowledgeable about the type of records to be kept and the length of time to retain them, will get their programs off to a good start.
  2. Funds Availability and Allowability—PIs must know how to access and use their grant funds to ensure that the costs incurred and charged against public awards are allowable, allocable and reasonable.
  3. Financial and Performance Reporting—Principal Investigators are responsible for the preparation and submission of performance reports, and work closely with Sinclair’s Grants Accountant in the preparation of financial reports.
  4. Time and Effort Reporting—All employees, who perform activities that are charged to a public entity, must complete documentation that certifies, after-the-fact, that the time charged to the grant is consistent with the effort that was contributed.
  5. Matching Funds—If a project requires matching funds, PIs are responsible for documenting the types and amounts of match contributions.
  6. Participant Support Costs—PIs have responsibilities in this area, and must know who is eligible to receive participant support.
  7. Budget Entries—This policy contains useful information for PIs when revisions are needed to the project budget.
  8. Journal Entries—This describes the procedures to be taken if a Principal Investigator determines the need to make a cost transfer in the project budget.  
  9. Protected Personally Identifiable Information—PIs need to safeguard personally identifiable and sensitive data related to their projects.
  10. Federally-funded Equipment—This policy address the PI’s maintenance and disposition responsibilities regarding equipment purchased with federal funds.
  11. Award Closeout—This policy addresses specific procedures for PIs to implement to ensure timely and complete closeout of financial transactions, as well as submission of reports related to the award.

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 Source 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