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Risks and potential benefits

Robert Hood

08/22/2008 10:47 am

Help for researchers: Risks and potential benefits

Information about Application Questions

Sample Answers and Examples

General Information A regulatory criterion for approval of research is that risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
  • Investigators should provide information about risks and potential benefits so the IRB can determine whether research satisfies this criterion.
  • The investigator should explain the likelihood and magnitude of harms and benefits, and the importance of the knowledge reasonably expected to result.
  • The investigator should explain the range of harms, if any, including physical, social, economic, psychological, and legal harm.
  • The investigator should also explain the range of benefits. Benefits can take the form of therapy, education, information, resources or empowerment. Benefits can be directed at participants or their community.
Required Determinations by the IRB Information the investigator can provide the IRB to satisfy regulatory requirements:
  • Risks to participants are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose participants to risk.
  • Risks to participants are minimized, when appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
  • Risks to participants are reasonable in relationship to the potential benefits, if any, to participants, and the importance of the knowledge that may be expected to result.
Physical risk Information the investigator can provide the IRB to satisfy regulatory requirements:
  • Are there any other treatment options for these patients?
  • Does the proposed research option pose fewer side effects?
  • Does the proposed research reduce the number or kind of risks compared with standard of care?
  • Will participants experience any physical ailments as a result of being in the study?
  • Is it possible reduce the probability or magnitude of harm?
  • Example: an HIV study might indicate the extent to which participants have other treatment options; whether the investigational drug might have fewer side effects and indicate other drugs against which the comparison is made; whether there is risk of physical ailments (liver problems, lipodystrophy etc) and whether it is possible to reduce the possibility or magnitude of harm (for example by monitoring patients with frequent clinical visits)
  • At continuing review, investigators should describe whether risks or benefits have changed, and whether there have been changes to strategies to minimize risks.
Psychological risks Information the investigator can provide the IRB to satisfy regulatory requirements:
  • Will participation in research result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, or hallucination resulting from drugs, feelings of stress, guilt, and loss of self-esteem)?
  • Example: Research on anti-tuberculosis medications may cause mood changes; investigators can mitigate this through counseling and monitoring.
  • Example: Research on emergency responders after public health emergencies such as natural disasters or terrorism might involve participants with post-traumatic stress; the investigator might minimize this risk by providing counseling services or referring participants to counseling.
  • At continuing review, investigators should describe whether risks or benefits have changed, and whether there have been changes to strategies to minimize risks.
Legal risks Information the investigator can provide the IRB to satisfy regulatory requirements:
  • Will participating in the study put people at risk of prosecution or mandatory reporting?
  • Example: Research on sexually transmitted diseases or HIV may require reporting to health department officials; investigators should explain why reporting is required under state law
  • Example: In research on injection drug users and HIV, the data collected can be subject to discovery for prosecution; investigators could minimize this risk by not collecting identifiers or obtaining a Certificate of Confidentiality.
  • At continuing review, investigators should describe whether risks or benefits have changed, and whether there have been changes to strategies to minimize risks.
Economic risks Information the investigator can provide the IRB to satisfy regulatory requirements:
  • Are participants exposed to increased costs by participating in the study?
  • Example: Additional clinical visits may increase transportation costs; investigators might provide transportation reimbursement.
  • At continuing review, investigators should describe whether risks or benefits have changed, and whether there have been changes to strategies to minimize risks.
Social risks Information the investigator can provide the IRB to satisfy regulatory requirements:
  • What steps has the researcher taken to minimize the chance that participants will be victims of social stigma or shunned or ostracized?
  • Example: In 1993 an outbreak of hantavirus infection in the Four Corners area (where the borders of four states--Arizona, New Mexico, Utah, and Colorado--meet) of the United States was initially referred to by reporters as a Navajo disease, which led to severe fear, stigmatization, and discrimination of Native Americans in the region. Investigators should be cognizant how research findings might result in stigma.
  • Example: Research on stigmatizing conditions, such as mental illness, or populations who may be subjects to stigma, such as migrant workers or sexual minorities, may require investigators to take precautions so research does not increase stigma.
  • At continuing review, investigators should describe whether risks or benefits have changed, and whether there have been changes to strategies to minimize risks.
Accreditation Element Standard II-4, Element II.4.A: The Research Review Unit has and follows written policies and procedures for identifying and analyzing potential sources of risk and measures to minimize risk, including physical, psychological, social, legal, or economic risks. The analysis of risk includes a determination that the risks to participants are reasonable in relation to potential benefits to participants and to society.
Regulations 45 CFR §46.111(a)(1), 45 CFR §46.111(a)(2), 21 CFR §56.111(a)(1), 21 CFR §56.111(a)(2)
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