Committee for Human Subjects Research

Research Reviewed by the Committee

The committee strongly encourages that all research projects involving human subjects conducted by Hastings College faculty, staff, or students be reviewed and approved before the research is initiated. The purpose of the review is to ensure that human subjects are protected in a manner consistent with federal regulations, so that

1. Risks to subjects are minimized relative to benefits
2. Selection of subjects is equitable
3. Informed consent is sought and properly obtained
4. Privacy and safety rights of subjects are protected and confidentiality is maintained.

Although this review is voluntary from the point of view of the College, it may be required by other entities. For example, research supported by federal funds is required by law to be reviewed, and many academic disciplines require review of research as part of their codes of ethics. On the other hand, we do not expect to review research conducted for the sole purpose of monitoring and improving the performance of the College or one of its constituent parts (i.e., for administrative purposes), such as student evaluations of teaching. Projects that reuse existing data without collecting any new data do not need to be reviewed.

Note: If there is any doubt about whether a particular project should be reviewed, we encourage the researchers to consult the chair of the CHSR for advice.

Classroom Projects

Studies conducted by students as part of a classroom assignment, independent study, or senior project often qualify as research and may place their subjects at risk, and are thus encouraged to be reviewed like any other research. However, not all such studies are true research, nor do they all place their subjects at risk, so the Committee offers guidelines to help instructors determine whether they should submit class projects for review.

Definitions

Full definitions of all relevant terms may be found under Title 45 of the Code of Federal Regulations, Part 46, Section 102 (45 CFR 46.102, which can be viewed at the Web site of the Office of Human Subjects Research [OHSR], http://ohsr.od.nih.gov/guidelines/45cfr46.html). Here we summarize a few of the most important definitions.

• Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Normally, in order to contribute to generalizable knowledge, it is required that the information gathered be published, presented, or distributed in a public forum.
• Human subject means a living individual about whom an investigator conducting research obtains

1. Data through intervention or interaction with the person, or
2. Identifiable private information.

• Risk means the possibility of harm to a person's physical, psychological, or financial well-being; reputation; or employment status. This includes the possibility of stress, discomfort, harassment, invasion of privacy, or threatening the person's dignity. It is not limited to harm suffered during participation in a research activity, but also includes harm suffered afterwards as a result of that participation.
• 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.
• Vulnerable population is not defined precisely by the Office of Human Subjects Research; however, the Office does list the following examples of such populations: children, prisoners, pregnant women, handicapped or mentally disabled persons, and economically or educationally disadvantaged persons.