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Are risks to subjects minimized?

Robert Hood

03/06/2008 01:57 pm

Help for IRB Committee Members: Determining Risks to Subjects are Minimized

Belmont principle Beneficence
Where to start: initial application Check protocol description and summary section
Where to start: continuing review application Check summary question B, C, D, G
Required Determination Are risks to subjects minimized (consider physical, psychological, legal, economic, and social risks) by using procedures consistent with sound research design and do not unnecessarily expose subjects to risk? Are risks to subjects minimized (consider physical, psychological, legal, economic, and social risks) by using procedures already being performed on participants for diagnostic or treatment purposes?
General considerations The IRB must:
  1. identify the risks associated with the research, as distinguished from the risks of therapies the subjects would receive even if not participating in research;
  2. determine that the risks will be minimized to the extent possible (see below for points to consider for various dimensions of risk);
  3. identify the probable benefits to be derived from the research;
  4. determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained;
  5. assure that potential subjects will be provided with an accurate and fair description of the risks or discomforts and the anticipated benefits;
  6. determine intervals of periodic review, and, where appropriate, determine that adequate provisions are in place for monitoring the data collected
General considerations when identifying and assessing risks:
  • Are the researcher's competent in the area being studied?
  • Do the researchers serve a dual role that may compromise safety?
  • What are the researcher's strategies to minimize or mitigate risks? For example, is there appropriate monitoring?
OHRP Guidebook, Chapter 3
Physical risk
  • 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?
Psychological risks
  • 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)?
Legal risks
  • Will participating in the study put people at risk of prosecution or mandatory reporting?
Economic risks
  • Are participants exposed to increased costs by participating in the study?
Social risks
  • What steps has the researcher taken to minimize the chance that participants will be victims of social stigma or shunned or ostracized?
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); 21 CFR §56.111(a)(1)
Guidance No specific guidance
OHRP Guidebook Chapter 3: Basic IRB Review

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