Occidental College Policy on Research Involving Human Subjects
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.
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 Title 45 Code of Federal Regulations, Part 46 (45 CFR46). A copy of the regulations is available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
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 human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Thus, the scope of “subject” is interpreted broadly. Even if the investigator is “just interviewing” people, human subjects are involved in the research.
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Risk is a possible harm to a human subject. It can be social, psychological, physiological, as well as physical. The investigator shall identify the possible risks for HSRRC review. HSRRC shall evaluate whether such risks may be beyond the minimal risk. Risks are an inevitable part of life. Minimal risk means that 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.
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. 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 considerations:
- Minors: subjects under the age of 18 require parental/ guardian consent.
- Mentally Disabled: subjects may or may not be capable of giving consent.
- Prisoners: subjects are severely limited since such subjects’ ability to voluntarily consent is limited by the nature of the environment they are in.
All student-initiated research must be submitted with a faculty supervisor. In the case that a student is to work on a faculty’s project that already has HSRRC approval, the faculty investigator shall submit an amendment to the HSRRC to name the student as a student investigator.
The faculty principal investigator or the faculty supervisor shall maintain all documents pertaining to each research project. These documents 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.
Any research project involving human subjects that is carried out without HSRRC approval is a noncompliance. The HSRRC cannot approve any project if the investigator has begun data collection prior to receipt of the HSRRC approval.
For HSRRC-approved research projects, any significant protocol deviation by an investigator, and a protocol change without prior HSRRC approval of an amendment are examples of noncompliance.
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.
revisions approved by Robert A Skotheim, President on January 30, 2009
- Human Subjects: firstname.lastname@example.org
- Non-Human Subjects: email@example.com
- Biosafety: firstname.lastname@example.org or email@example.com