9-1: Institutional Review Board Policy – Procedures

The Santa Fe Community College Institutional Review Board (IRB) follows all federal regulations outlined in the Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects (45 CFR 46). In addition, the IRB will adhere to the following operational procedures.

1. The IRB consists of a chair and six members. The current membership list is available online.
2. The chair is appointed by the Vice President for Strategy and Organizational Effectiveness. The remaining six members are nominated by the chair and current members. New members are identified, invited and appointed by the chair.
3. The membership is comprised of a cross-section of faculty and staff with experience and expertise in their subject areas and one community member from outside the institution.
4. The membership reflects areas of expertise where typical research projects at SFCC are likely to occur.
5. View the complete federal guidelines for the composition of an IRB.
6. All members must complete the federal Human Subjects Training Course.
   1. The instructions for completing the course are online.
   2. Members must provide the chair with a copy of the certificate of completion and renew their certificate every three years.
   3. Meeting times are determined by members.
   4. Meetings will take place once a month on consistent days/weeks; e.g., the second Monday of the month.
   5. If there is no new business, the chair will cancel the scheduled meeting three days before it is to be held.
   6. The current meeting schedule is made public online.
7. Application and Review.
   1. The application and review process consists of two parts:
      1. Permission to do research in the SFCC community (discussed below), and
      2. Permissions for access to college-owned data (see Section E.e.).
   2. The standard application can be viewed here or by contacting the chair Valerie Nye at nye@sfcc.edu.
   3. Upon receipt of an application, the chair reviews for completeness. The chair may return an application to the applicant for clarification or additional information.
   4. When complete, the chair reviews the application and decides whether the research project qualifies for exempt, expedited or full review. Complete descriptions of project categories are available at the U.S. Office for Human Research Protection website.
   5. The chair forwards materials to the IRB members with their recommendation.
   6. IRB members email their agreement/disagreement with the recommendation to the chair. If the IRB differs by a majority with the decision of the chair, the members must meet.
   7. Human subjects training is required for all applicants regardless of standard, expedited or exempt status.
      1. Acceptable human subjects training is available online.
      2. SFCC also accepts CITI training.
      3. Proof of training completion must be attached to the IRB application.
      4. Training must be no more than one year old at the beginning of the research. If training becomes more than one year old during the research, new documentation of completion must be provided.
8. Deliberative Responsibilities.
   1. The IRB will discuss and reach a conclusion regarding the risk and ethics of the research proposal.
   2. The IRB does not consider the quality of the research design, academic merit or generalizability of the proposed research.
   3. The decision regarding the disposition of the proposal will be reached by consensus.
   4. The decision of the IRB is final.
9. Conclusion of the Process
   1. After IRB deliberation, or after a proposal is deemed exempt or expedited, the applicant will receive a letter from the IRB chair indicating the Project is:
      1. Exempt from IRB review,
      2. Expedited,
      3. Approved without changes,
      4. Approved provisionally pending changes required by the IRB, or
      5. Not approved.
   2. An approval letter will contain the start and end dates of the research. If the dates of the research change, the IRB must be notified in writing before the original project end date.
   3. The letter will indicate the next steps to be taken by the applicant; e.g., data approval from the Office of Planning and Institutional Effectiveness.
   4. No research may begin until the IRB application and deliberation process are complete.
   5. If the project is to include college-owned data, no research may begin without explicit approval from the Office of Planning and Institutional Effectiveness, regardless of IRB approval. Approval for data use must be obtained separately before data collection or analysis may begin.
   6. All records of IRB applications, meetings, and decisions will be kept by the IRB chair for three years.

Contact:          Valerie Nye, Library Director

505-428-1506, valerie.nye@sfcc.edu

Updated:         11/17/2022