Â鶹ƵµÀ Policy on Research Involving Human Subjects
I. POLICY STATEMENT.
Pursuant to federal regulations and College policy, all research involving human subjects must be reviewed and approved by the College’s Human Subjects Research Review Committee.
II. APPLICABILITY.
This policy applies to all research involving human subjects conducted by any member of the College community.
III. DEFINITIONS.
Human Subject - A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual (e.g. “just interviewing" people) or (2) identifiable private information. This term should be interpreted broadly.
Minimal Risk - A risk where the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Minors - Subjects under the age of 18.
Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Examples of human subject research may include: experiments, interviews, surveys or questionnaires either on paper or electronic, observational studies, filming, and the collection and use of archival data.
Risk - A possible harm to a human subject. Researchers often conceive of risk as potential physical harm or discomfort. However, risk can also be social, psychological, physiological, as well as physical. Investigators should consider ways to minimize all forms of risk associated with their research.
IV. POLICY.
In accordance with the College’s Federal Wide Assurance (FWA) maintained with the Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP), all research involving human subjects conducted by or under the auspices of Occidental College will be performed in accordance with (45 CFR 46).
As mandated, the College designates and impanels the Human Subjects Research Review Committee (HSRRC) to protect the rights and welfare of human research subjects. The Research Compliance Officer is also appointed to oversee the three Institutional Review Boards on campus: Human Subjects Research Review Committee (HSRRC), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC), as well as to support the investigators in their compliance.
A. HSRRC Review
All research involving human subjects must be reviewed and approved by the HSRRC. As part of this process, the investigator must identify the possible risks for HSRRC review. HSRRC shall evaluate whether such risks may be beyond the minimal risk.
See more about the review process on the IRB’s Human Subjects Page.
B. Informed Consent
Potential research subjects must be given all available information that might reasonably be expected for their voluntary participation in the research. Investigators need to help them to understand fully the nature of the study being conducted, and the research risks and benefits associated with it, so that they can make an informed decision on participation. This information should be provided in a culturally appropriate manner and in language understandable to the subject or his/her authorized representative. Academic jargon and highly formal language should be avoided. The general recommendation is that informed consent forms be written at an eighth-grade reading level or lower, especially for studies targeting the general public.
ln addition, the informed consent materials should be free of any language that appears to be coercive, to waive any of the subject’s legal rights, or to release the investigator and/or sponsor from liability for negligence.
Certain groups of human subjects require special consent considerations:
- Minors: require parental/ guardian consent.
- Mentally Disabled: subjects may or may not be capable of giving consent.
- Prisoners: availability as human research subjects is severely limited because their ability to give voluntary consent is limited by the nature of their incarceration.
C. Student Projects
All student-initiated research must be conducted under the supervision of a faculty member. Student research proposals must be submitted to the HSRRC by the faculty supervisor on behalf of the student. If a student will work on a faculty member’s project that already has HSRRC approval, the faculty investigator shall submit an amendment to the HSRRC to name the student as a research assistant.
D. Record Maintenance
The faculty principal investigator or the faculty supervisor shall maintain all documents pertaining to each research project. These documents, including all signed consent forms, and the signed consent forms must be kept for a minimum of three (3) years following termination of the study, and made available for internal reviews and external audits as necessary.
E. Noncompliance
Any research project involving human subjects that is carried out without HSRRC approval is noncompliant. Retroactive approval is not possible. All projects must receive HSRRC approval prior to recruitment and data collection.
For HSRRC-approved research projects, examples of noncompliance include any significant deviation from the approved protocol (e.g. materials, procedures, researchers, participant groups) without prior approval of an amendment submitted to the HSRRC and failure to report any unanticipated problems involving risk to subjects or others.
All incidences of noncompliance shall be promptly reported to the Research Compliance Officer, and to the Dean of the College for possible referral to the Secretary of the Department of Health and Human Services and for other actions as necessary.
V. POLICY HISTORY.
Responsible Officer(s): HSRRC Chair
Last Revised Date: June 12, 2024
VI. RELATED POLICIES AND RESOURCES.