Human Subjects Research
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Committee for Human Subjects Research
The following is a summary of the general ethical guidelines (as described in the Belmont report: Ethical principles and guidelines for the protection of human subjects of research, 1979) that underlie federal ethical regulations and guidelines.
- Respect for persons. Researchers must recognize the personal dignity and autonomy of individuals. Each participant must be given an informed consent form that contains the information about the purpose of the study and study procedures, as well as the voluntary nature of participation.
- Beneficence. Researchers are obligated to protect people from harm by maximizing anticipated benefits and minimizing possible risks of harm, ensuring a favorable balance between the two. Risks may include physical harm, psychological harm, harm to one's reputation or employment status, and financial harm.
- Justice. Researchers must fairly distribute the benefits and burdens of research. That is, participants should be fairly selected with respect to membership in social, racial, or ethnic groups. For example, participants cannot be selected only because they are favored or disliked by a researcher. A researcher may be required to defend a decision about why a particular class of participants was chosen.
The above general guidelines underlie the following specific guidelines (translated from pages 5–7 of Ethical principles in the conduct of research with human participants; American Psychological Association, 1982), which will be considered by the CHSR when reviewing all research proposals. See also the guidelines for informed consent and debriefing.
- Obtain informed consent. To make an informed decision about participating in the study, participants must be informed of the following:
- The purpose and design of the study;
- Any risks (physical or psychological/emotional), expected duration, or other factors that might affect their decision to participate;
- The procedures involved in the experiment;
- Any possible benefits of participating;
- That they can withdraw from the study at any time without consequences;
- Whom they can contact if they have questions/concerns about the study.
Research involving infants, juveniles, individuals with impairments, or detained individuals must include special safeguarding procedures (see the informed consent guidelines).
- Minimize risks and maximize benefits to research participants. Avoid using procedures that may cause stress or harm to the participant. If the risk to the participant is greater than the benefits of the experiment, the study will not be approved.
- Do not coerce participants. Researchers should realize that they are often in a position of authority or influence over participants who may be their students, employees or clients. This relationship must not be allowed to coerce the participants to take part in, or remain in, an investigation. Therefore, people should not be forced to participate in a study (e.g., college students made to participate for classes; employees asked to take surveys).
- Maintain privacy. Results must be kept anonymous and confidential.
- Anonymity. Individual data from an experiment should not be linked with participants' names; therefore, research ID numbers should be used to identify participants' data. In cases where identification of individual participants is necessary for the purposes of the study (e.g., medical information, diagnoses, treatment options), only the Principal Investigator should be able to match the data with the associated participant.
- Confidentiality. Anything learned about a research participant is held in strictest confidence. The researchers
- Must keep data in a controlled situation (e.g., locked file cabinet),
- Must minimize the number of people who see or handle the data,
- Must not discuss a participant and his/her data (e.g., personal information, performance, answers) with anyone who is not a collaborator on the same project.
- Avoid deception. Participants should be completely and fully informed about the nature of the research project before participating. In some situations (e.g., study of social phenomena), mild deception may be necessary to ensure the participants act naturally.
- Debriefing. Immediately after the experimental session is over, participants should be informed about the actual purpose of the study. Researchers should explain any deception that occurred. After the completion of the study, researchers should send a letter or some type of summary information to all participants to relay the study results.