Basic Ethical Principles
By law, the IRB can only grant approval to projects that satisfy certain requirements. Researchers who anticipate evaluation on these requirements and attend to them in their applications will encounter markedly fewer problems during the IRB approval process. The requirements for approval (as paraphrased from the Code of Federal Regulations), include the following:
- Risks to participants are minimized. This is the first and foremost concern in the review of application by the IRB. What potential risks, stresses, or discomforts (if any) will be incurred by participation in this project? Have the researchers taken steps in the design or procedures of the study to reduce the possibility of these risks or discomforts?
- Risks to participants are reasonable in relation to anticipated benefits. Do the benefits, if any, to be derived from this research outweigh the risks posed by this research to the participants? In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research. The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of participants is equitable. In making this assessment, the IRB should take into account the purposes of the research, and the setting in which the research will be conducted. The IRB should be especially cognizant of the special problems of research involving vulnerable populations, such as children, and people who are in prison, pregnant, mentally disabled, or economically or educationally disadvantaged.
- Informed consent is secured from participants. Participants must be fully informed of the risks and benefits of participation in the research and of their basic rights in participating (e.g., withdrawal without penalty). All of the appropriate aspects of informed consent must be included; if not, the omissions must have been adequately justified (see [link to Studies Involving Deception button]). If audio or video taping is part of the research procedure the participants must be given the option of not being taped or having taping stopped at any time. A copy of the informed consent form must be given to the person signing the form (see here).
- Adequate provisions are in place for monitoring data to ensure the safety of participants. When appropriate, the research plan must make adequate provision for monitoring the data collected to ensure the safety of participants. This includes the monitoring of data in the case that individual participants are identified as being at risk for medical or psychological problems.
- Adequate provisions are in place to protect the privacy of participants and maintain confidentiality of the data. To what degree are participants' responses protected with respect to confidentiality and anonymity? Will participants' names be associated with their data? Who will have access to materials (e.g., data files, audio recordings or videotapes) through which participants might be identified? Will response sheets be kept in a safe place? What are the plans for disposition of materials through which participants might be identified when the study is finished?
- Appropriate additional safeguards are in place for participants who are especially vulnerable. Have adequate additional provisions been made to protect the rights of those participants who might be especially vulnerable to coercion or undue influence? Are there any circumstances in the proposed research under which participants might feel coerced to participate?
- Participants are debriefed. In most cases, once participants have completed their participation in the study, they should be informed of the full purpose of the research, including the research hypotheses, and should be given the opportunity to ask questions of the researchers. Debriefing is especially important in studies involving deception, and extra steps are involved in the debriefing in deception research (see here).
