9-1: Institutional Review Board – Policy

Policy Overview

This policy establishes the responsibilities of the Santa Fe Community College (SFCC or College) Institutional Review Board (IRB) to oversee the protection of human subjects involved in any research through or at the institution. This policy also outlines the process required by those seeking to conduct research on human subjects at SFCC.

Scope and Applicability

This policy applies to all persons or entities, internal or external to SFCC, seeking access to SFCC for the purpose of conducting research on human subjects. This encompasses all SFCC campuses and locations, all existing or desired SFCC data, and all population segments of the SFCC community.

Policy Statement

SFCC is committed to the principle of research as a necessary component of the pursuit and expansion of generalizable human knowledge. SFCC supports research on campus as well as the use of existing SFCC data. In keeping with federal regulations and guidelines, SFCC is committed to conducting systematic review of all requests for access to the College or to existing College data for the purpose of research. Further, SFCC is committed to the protection of all human subjects throughout the research process, particularly subjects from vulnerable groups as defined by the U.S. Department of Health and Human Services Office of Human Research Protection.

Definitions

1. Exempt review means the activities present no risk to human subjects and do not require review by the IRB. The IRB Chair makes this determination based on federal guidelines.
2. Expedited Review means a streamlined review process, and is reserved for research activities that present no more than minimal risk to human subjects. The review shall involve at least one IRB member and the Chair.
3. Generalizable Knowledge as defined in US code 45 CFR 46 and the Belmont Report, means knowledge used to draw general conclusions, inform policy, or apply findings beyond a single individual or program, often through publications or presentations.
4. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data or private information through intervention or interaction with the individual.
5. Institutional Review Board (IRB) is an appropriately constituted group or committee that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights, safety and welfare of humans participating as subjects in the research. In accordance with the U.S. Food and Drug Administration regulations, the IRBhas the authority to approve, require modifications in (to secure approval), or disapprove research. The board reviews all research involving human subjects to ensure that it is conducted in accordance with all federal, institutional, and ethical guidelines.
6. IRB Approval means that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.
7. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
8. Researcher means any person conducting research as defined above.
9. SFCC Community is defined as all those who are physically on campus, are working or studying remotely, and/or who possess an SFCC email address.
10. Vulnerable Populations include, but are not limited to, pregnant women, children, cognitively impaired persons, prisoners, some veterans and educationally disadvantaged individuals (S. code 45 CFR 46).

Policy Process

1. The IRB consists of a chair and six members. The chair is appointed by the Vice President for Strategy and Organizational Effectiveness. The chair is responsible for recruiting the members of the IRB according to guidelines provided in the US Code 45, Part 46; e.g., a mix of genders, scientific interests, and professions. One member is appointed from outside the institution.
2. All researchers will conduct their projects in accordance with federal and state regulations, institutional policies, and ethical best practices within their field.
3. All researchers, including, but not limited to SFCC employees, students and outside researchers, will obtain approval from the IRB prior to beginning any research involving human subjects, adhere to the procedures set out by the IRB, and submit to periodic monitoring. No research may be approved retroactively.
4. Researchers may not make the determination of whether or not a research project requires IRB approval.
5. Educational research, such as that proposed and conducted at SFCC, often falls into a category of “expedited review.” SFCC will follow the regulations for expedited review as long as the proposed research is set within the guidelines provided by the U.S. Office for Human Research Protection and does not involve research with any vulnerable population.
6. The IRB will make decisions regarding the risk to human subjects engendered by the research and will oversee the research to ensure adherence to federal standards. The IRB bases its decisions on these three categories, as defined by the Office of Human Research Protection:
   1. Research project: May have some level of risk involved or involve vulnerable groups. Requires full review by entire IRB.
   2. Expedited research project: SFCC uses the Office of Human Research Protection definition of expedited research, which indicates there is a minimum level of risk, the identities of participants are protected, the research may involve existing data, and that no vulnerable groups are involved. Approval requires review by the IRB Chair and at least one board member.
   3. Exempt research project: SFCC uses the U.S. Office for Human Research Protection definition of exempt research (Section 46.101(b).), which indicates there is no discernible risk to participants, that participant identities are protected or that only unidentifiable aggregate data is used, there is no involvement of vulnerable groups, and that research is often conducted in educational settings involving normal educational practices. Approval may be made by the Chair.
   4. SFCC uses the Office of Human Research decision charts for determining eligibility for exemption or expedition.
7. Class projects designed to familiarize students with research practices and methods are exempt from IRB review if they meet the following criteria:
   1. The project or assignment is developed solely for educational use and is supervised by the course instructor.
   2. The project or assignment presents no more than minimal risk to respondents,
   3. The project or assignment is not intended to develop or contribute to generalizable knowledge and will be viewed only in a classroom context. Results of the research will not be published electronically or by other means.
   4. The student does not collect data from any protected group.
   5. Data is collected in such a manner that the respondents’ identities are protected.
   6. The faculty member who is supervising the class project has a current IRB training certificate.
8. The rules for IRB approval apply to survey research as well, whether the survey research is considered a full-review research project, an expedited project, or an exempt project (SFCC Policy 9-2 Surveys on Campus).
9. Approval of a research project by the IRB does not imply permission to conduct research at SFCC. Access to SFCC for the purpose of research is negotiated separately with the Office of Planning and Institutional Effectiveness for all approved research projects, including surveys.
10. Any member of the SFCC community conducting research independent of the College may not represent the work as being associated with the College.
11. The IRB’s approval or disapproval of research proposals is final. The IRB decision may not be overturned by any other entity of the College, including the President or the Office of Planning and Institutional Effectiveness.
12. No IRB member will be subject to retribution, retaliation or reprisal from any person because of a good faith finding reached while serving on the Board.
13. Failure to comply with the decision of the IRB may result in termination of the research project or termination of a professional relationship between the researcher/funding entity and SFCC.
14. Any SFCC employee or student who is found to be out of compliance with a ruling of the IRB may be subject to corrective and/or disciplinary action (SFCC Policy 4-2 Employee Corrective Action and Disciplinary Action or SFCC Policy 2-2 Student Corrective Action and Disciplinary Action).
15. The IRB is not responsible for the academic quality of the research.

Statement of Accountability and Responsibility

The President, through the Vice President for Strategy and Organizational Effectiveness and the Office of Planning and Institutional Effectiveness, shall be responsible for enforcing institutional research policies and procedures. The Office of Planning and Institutional Effectiveness shall work with the different departments and offices to comply with this policy and to develop procedures that will enforce this policy regarding awareness, prevention and remediation.

Authority

U.S. Office of Human Research Protection
U.S. code 45 CFR 46
Code of Federal Regulations Title 21
SFCC Policy 2-1 Student Code of Conduct
SFCC Policy 2-2 Student Corrective Action and Disciplinary Action
SFCC Policy 4-1 Workplace Ethics and Code of Conduct
SFCC Policy 4-2 Employee Corrective Action and Disciplinary Action
SFCC Policy 9-2 Surveys on Campus

Approval

SFCC Governing Board approved: 8/23/2017

Associated Procedures

• Institutional Review Board Policy – Procedures