Any time a researcher engages human subjects in research, some risk exists. It is never the case that no risk exists to participants in research. If you cannot foresee any risks in your research, please state that the risks to participants are "minimal."
The Institutional Review Board reviews each protocol to determine if the risks to subjects are minimized. The IRB carefully reviews the research proposal to ensure procedures that are consistent with sound research design are used and that they do not expose subjects to unnecessary risks.
Though the Brandeis IRB encourages freedom in research design, it does consider the research plan, including the research design and methodology, to determine that there are no flaws that would place subjects at unnecessary risk.
It is important to note that research can and will contain risks, but the risks should be fully detailed in the research protocol with a description of how these risks will be managed.
Since most of the research submitted to the Brandeis IRB is social and behavioral in nature, the following considerations will be especially helpful when writing a protocol and describing the risks involved. As always, investigators should think carefully about their research, as other risks may also be applicable to it. Some common risks are:
The potential for participants to experience stress, anxiety, guilt or trauma that can result in genuine psychological harm.
The risk of criminal or civil liability or other risks that can result in serious social harms, such as damage to financial standing, employability, insurability or reputation; stigmatization; and damage to social relationships.
The risk of individually identifiable private information that you have collected being leaked, resulting in a breach of confidentiality that could harm subjects.
The IRB also considers the qualifications and experience of the research team. Investigators should possess the professional and academic qualifications and experience, along with the resources to conduct the research and to protect the rights and welfare of subjects.