Assessing and Minimizing Risk in Human Research
Assessing and minimizing risk in human research is crucial for ensuring the safety and well-being of participants. Researchers must understand the various types of risks that participants may face. These include physical, psychological, social, legal, and economic risks. The probability and magnitude of harm or injury can vary from minimal to significant. Researchers are responsible for assessing these risks and implementing procedures to minimize them.
The Office for Human Research Protections (OHRP) provides helpful resources on minimizing risk in human research, including a video training module. OHRP is the U.S. Department of Health and Human Services (HHS) office responsible for protecting the rights, welfare, and well-being of human subjects involved in research. OHRP provides guidance, develops educational materials, conducts regulatory oversight, and advises on ethical and regulatory issues in biomedical and behavioral research.
Concept of Minimal Risk
When assessing risk, it is important to keep in mind the concept of minimal risk. Federal regulations define minimal risk as research where 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. It is important to consider all categories or types of risks. This includes those that may apply to groups of individuals, such as vulnerable populations.
Evaluating Risks for human subjects
When evaluating risks, it is crucial to consider the perspective of the participant and the potential for subjective experiences of harm. This is particularly important in social, behavioral, and educational research. In this field, risks may be more difficult to quantify objectively. Additionally, it is important to recognize that risks may be minimal for certain individuals or groups. However, risks can be greater than minimal for others, depending on the circumstances of the study and the effect on vulnerable populations.
Minimizing Risk for human subjects
There are several key steps that researchers can take to minimize risk:
- Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research.
- Use procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.
- Assemble a research team with sufficient expertise and experience to conduct the research.
- Develop inclusion/exclusion criteria that will enroll only the desired population of interest.
Other strategies for minimizing risk include:
- Collecting data from standard-of-care or methodologically appropriate procedures to avoid unnecessary risk.
- Providing a thorough debriefing following the completion of studies involving an element of deception.
- Incorporating adequate safeguards into the research design, such as an appropriate data and safety monitoring plan and the presence of trained personnel who can respond to emergencies.
- Storing data in such a way that it is impossible to connect research data directly to the individuals from whom or about the data pertains.
Permissions and Waivers
It is important to obtain necessary permissions and waivers, such as:
- HIPAA Authorization or a waiver
- FERPA Permission or an exception
- A signature from the Legally Authorized Representative (LAR) for potential adult participants with diminished decision-making capacity
Obtaining a Certificate of Confidentiality (CoC) can also provide protection against compelled (legal demand) disclosure of identifying information about individuals enrolled in sensitive biomedical, behavioral, clinical, or other research.
Conclusion
Assessing and minimizing risk in human research is a complex and multifaceted process. Assessment requires careful consideration of various types of risks and vulnerabilities. Researchers must prioritize the safety and well-being of participants and implement procedures to minimize risk and ensure ethical and responsible research practices. By following these guidelines and incorporating best practices for minimizing risk, researchers can help to ensure the success and integrity of their research while protecting the safety and well-being of all participants involved. Our team obtains annual certification to OHRP’s training module.
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