The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review.

• When drafting the Research Plan, follow the format and use the section headings (i.e. A – I) provided below, refer to the bulleted items for section content.
• For each section, this guidance includes a description of why the information is important for IRB review (in italics).

G. Potential Research Risks or Discomforts to Participants

In order to approve the research, the IRB must consider the risks posed to participants by the research and any efforts to mitigate those risks. The IRB needs to determine that the risks have been both minimized and are reasonable in relation to the anticipated benefits to participants as well as to the importance of the knowledge that may be gained. The IRB will also consider whether the informed consent process provides potential participants with an accurate and fair description of the risks or discomforts.

• Describe any reasonably foreseeable risks of harm or discomforts for individuals and/or groups that may result from participation in the research. While risks associated with participation may not be expected, most protocols carry some risk. Consider the following:

  • Information risks (e.g., loss of privacy and/or breach of confidentiality).

  • Psychological or emotional risks (e.g., fear, stress, confusion, guilt, loss of self-esteem, depression, triggering of past emotional experiences).

  • Social risks (e.g., social stigma, chance of being ostracized or shunned), economic risks (e.g., change in employment or insurability).

  • Physical risks or harms (e.g., fatigue, pain or discomfort, potential for injury, illness or disease, or death, side effects and contraindications of drugs or substances used in the research).

  • Legal risks (e.g., risk of prosecution, mandatory reporting).

  • Genetic privacy risk (e.g., stigmatization, self-stigmatization, limits to insurance coverage or employability, misattributed paternity, etc.).

• For each identified risk, explain all of the following:

  • Likelihood of the risk occurring.

  • Magnitude of the effects the risk would have should they occur.

  • How the risk will be minimized.

  • How the risk will be disclosed in the informed consent process.

• If the protocol involves treatment or intervention, describe the “standard of care” and describe how the risks of the research treatments or interventions compare.

• When appropriate, describe any provisions for data and safety monitoring for the progress of the research and the safety of the participants.

  •  If there is a separate Data and Safety Monitoring Plan (DSMP), state this and attach.

  • If there is an established Data and Safety Monitoring Board/Committee (DSMB/C) to monitor the progress of the research and the safety of participants, clearly indicate this. The frequency and operations of the DSMB/C should be covered in the DSMP.