GA-15 Human Subjects Research Compliance

In This Section

Purpose
To ensure that college staff, faculty and students affected by a research project can be certain that the research project is sound and does not violate any college policy or federal regulations pertaining to human subjects research.

Scope

  1. Individuals affiliated with Green River Community College including faculty, staff and students wishing to conduct a research project involving human subjects; or
  2. individuals not affiliated with the college, but wishing to conduct research at Green River using faculty, staff, students or college records as part of that research.

Definitions 
Human subjects review: A process for evaluating a research project to determine the following:

  1. Whether and to what degree it poses potential risks to either the subjects of the research in the form of physical, psychological, social or some other kind of harm; and
  2. the college itself in the forms of lawsuits, wasted resources, a diminished image or some other kind of harm.

Policy 
Any individual affiliated with Green River College including faculty, staff and students wishing to conduct a research project involving human subjects or an individual not affiliated with the college, but wishing to conduct research involving Green River employees, students or college records must comply with Green River’s human subjects review procedures as specified below.

All research proposals must be submitted in writing to the Office of Planning and Research. The proposal should include contact information for the principal investigator and a brief summary of the rationale for the study, the methodology to be used, the expected outcomes and a copy of the consent form(s) that will be used for the study. Principal investigators may click on this link to access an Application for Human Subjects Research and a Consent Form Template.

  1. Each proposal will be initially reviewed by the Institutional Review Board (IRB) chairperson and/or a reviewer(s) appointed by the chairperson to decide if the proposal is exempt or if it requires an expedited or full review. The reviewer(s) will notify the principal investigator in writing about this initial review decision within 10 business days. With this notification, the reviewer(s) may also request additional information that is needed to complete the proposal review. All final decisions for approval or denial will be based on the criteria in section 46.111 of the Code of Federal Regulations, Title 45, Part 46 
    1. Exempt proposals are exempted from IRB review as outlined in section 46.101 of the Code of Federal Regulations, Title 45, Part 46. When a proposal is determined to be exempt, the reviewer(s) will notify the principal investigator in writing that the proposed research may be conducted without IRB review.
    2. Expedited proposals do not require a full IRB review as outlined in section 46.110 of the Code of Federal Regulations, Title 45, Part 46. When a proposal is determined to be expedited, the proposal will be reviewed by the IRB chairperson and/or a reviewer(s) appointed by the chairperson. If the proposal is accepted, the full IRB will be notified of the decision and the reviewer(s) will notify the principal investigator in writing that the proposal has been approved. If the reviewer determines that the proposal should not be approved, the proposal will then be submitted for a full IRB review.
    3. Full review proposals require a full IRB review as outlined in section 46.108 of the Code of Federal Regulations, Title 45, Part 46. IRB meetings will be scheduled as needed. A majority of the IRB will need to be present to review a proposal requiring full IRB review, and a majority of the present IRB members will need to vote in favor of a proposal for it to be approved. If the proposal is approved, the reviewer(s) will notify the principal investigator in writing that the proposal has been approved. If the proposal is not approved, the reviewer(s) will notify the principal investigator in writing and include the reasons for not approving. A revised proposal may be submitted for reconsideration.
  2. If a research proposal has the potential of impacting a faculty member or a faculty member’s classroom in any way, the IRB chairperson and/or appointed reviewer(s) will also confer with the Dean and faculty member before making a decision. 
  3. Proposals that involve the collection of human subjects’ information for a period of longer than one year will need to be resubmitted to the Office of Research and Planning annually. These resubmissions will follow a process similar to the initial review. As part of its decision for approval, the IRB may request that a proposal be resubmitted more than annually, in which case the principal investigator will be notified as part of the initial approval notification.
  4. Principal investigators will need to notify the IRB with any substantial changes to research activity. These changes will be reviewed through a process similar to the initial proposal review. Changes should not be made to research activity without IRB approval except when necessary to eliminate apparent immediate hazards to the subject. Principal investigators may contact the Office of Institutional Effectiveness with questions about whether a proposed change will require IRB review. To help avoid unapproved changes, the Office of Institutional Effectiveness will contact principal investigators every three to six months to ask about the progress of approved research proposals. As part of its decision for approval, the IRB may require that a principal investigator be contacted more often than every three to six months or that sources other than the principal investigator also be contacted to verify that no substantial changes have occurred since previous IRB review, in which case the principal investigator will be notified as part of the initial approval notification.
  5. Principal investigators will need to notify the IRB if there are any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with human subjects’ research policy or the requirements of the IRB. When such concerns occur, the IRB will notify appropriate college officials, and may decide to suspend or terminate IRB approval, in which case the principal investigator will be notified in writing.
  6. The Office of Planning and Research will maintain records of submitted proposals, related documents, correspondence with principal investigators, and notifications of decisions for at least three years after completion of the research. The Office of Planning and Research will also be responsible for maintaining records of IRB membership that is consistent with section 46.107 of the Code of Federal Regulations, Title 45, Part 46, and for notifying the institution of IRB decisions.

Specific Authority 
Code of Federal Regulations, Title 45 Part 46

Law Implemented
1981, most recently revised 1991


History of Policy or Procedure
Draft: October 14, 2004
Adopted: January 6, 2006
Revised: July 11, 2013
Reviewed by: Devin Dupree, Chris Johnson
Contact: Chris Johnson, Executive Director of Institutional Effectiveness, ext. 2684
President’s Staff Sponsor: Chris Johnson, Executive Director of Institutional Effectiveness, ext. 2684