OHRC IORG0006767; FWA00017017
Committee members effective January 21, 2019 are as follows:
- Robert Baker
- Jennifer Fredricks (ex-officio)
- Joshua Hart (Chair)
- Claire Hughes (external member)
- Zoe Oxley
- Timothy Stablein
- D. Catherine Walker
If you are interested in conducting research using human participants, please follow these steps. Note that these steps must be followed regardless of the location of the project or the method of recruiting participants.
1. Are you conducting research? Through the Office for Human Research Protections (OHRP), the United States Department of Health and Human Services, 45 CFR 46.102(l), defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” If you plan to apply your findings to a broader population, or hope that others will do so, and/or if it is possible that you will tell others, either in meetings or in print, about your findings, your project qualifies as research. Note: “Scholarly and Journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) including the collection and use of information, that focus directly on the specific individuals about whom the information is collected” are NOT considered research by this definition.
2. Is your research exempt from review? If you are conducting research, please see here (§46.104) to determine if it is exempt from HSRC review. Of particular note: survey research, interviews, observation of public behavior, and “benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording” are exempt IF the subject agrees, in advance, to the intervention and information collection, AND (A) the subject’s information is anonymous, or (B) there is no risk to the subject if the subject’s information becomes public. (Exception: The HSRC’s policy is to review any research involving children.) If your research is exempt from review, please complete and submit the Statement of Exemption found below. Such research projects will not receive formal approval and can be conducted upon acknowledgment from the HSRC chair that the statement of exemption has been received. In some cases, more information will be requested so that the HSRC can conduct a limited review. You may still wish to use our sample informed consent form. If you have any questions about whether your research is exempt, please email the HSRC chair (firstname.lastname@example.org).
3. If your research is not exempt from review, complete the Application to Engage in Research Involving Human Subjects found below. Please ensure that you answer all the questions and attach all applicable appendices. Print and deliver in person or via campus mail to Prof. Joshua Hart, Chair of the Human Subjects Review Committee, Psychology Department. Emailed, hand-printed, or unsigned applications will be returned unreviewed.
4. You will receive notice about the status of your application from the Chair via email. You may not begin data collection of any kind until you have received an approval from the Chair.
5. If, after receiving approval, you wish to make changes to your methods, you must seek approval for those revised methods.
Here are the pertinent forms:
- Application to Engage in Research Involving Human Subjects: This form should be submitted for research approval.
- Statement of Exemption: This form should be submitted for research projects that are exempt from review.
- Renewal form: This form should be submitted to extend a previously granted one-year approval.
- Sample Informed Consent Form: Nearly all proposals will require this form to be submitted as an appendix.
- Parental Informed Consent Form: This is used when parents will provide consent for their underage children to participate.
- Application to Make Changes: If your proposal was approved but you'd like to make changes to the design, use this form.
The following links should also be helpful to researchers who plan to conduct research with human subjects.
1. Guidelines for Faculty and Students Engaged in Human Subjects: This is an overview of the philosophy behind and regulations pertaining to the review of research involving human subjects at Union College.
2. Code of Federal Regulations, Title 45, Department of Health and Human Services (DHHS), Part 46, Protection of Human Subjects.
3. Definitions of human subject and research (From Code of Federal Regulations, Title 45).
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research
(1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or
(2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record).
4. Official Website of the Office of Human Research Protection.
5. The Nuremberg Code. Developed for the Nuremberg Military Tribunal, it set standards for judging the human experimentation conducted by the Nazis. The Code includes many of the basic principles governing the ethical conduct of research involving human subjects.
6. The Belmont Report, which was written by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. Those principles are, respect for persons, beneficence, and justice. They are now accepted as the basic requirements for the ethical conduct of research involving human subjects.