Understanding Risk

When designing your study and writing your IRB application, you must consider how you will deal with risk to participants in terms of both magnitude and probability of harm.

Risk must:
1) be minimized through study procedures and design,
2) be reasonable compared to benefits expected for participating, and
3) be thoroughly explained (along with benefits) through the informed consent process.
Risk can be mitigated, so don’t shy away from discussing risks.
The IRB views risks contextualized within a risk-benefit analysis; they want to know that risks are minimized as much as possible and are in proportion to benefits. Seeing a list of risks on your application does not trigger an automatic bounceback from the IRB; you just need a plan. Contact GME Research Staff for support. When discussing risk in your IRB protocol, consider:

  1. Risk Factors
    Many factors are taken into account by the IRB when understanding risk:
    a. Study Procedures
    ■ What is happening to participants (what are the possible harms?)
    b. Person(s) Performing the Study Procedures
    ■ Who is performing research with participants (their experience, skill level, etc.)
    c. Study Setting
    ■ Where is the research happening (what privacy protections are in place? what equipment is at the facility?)
    d. Population
    ■ Will a vulnerable population be involved (and if so, how will
    participants be protected?)
  2. Vulnerable populations include participants
    a. under the age of 18
    b. who are prisoners
    c. with impaired decision-making capacity
  3. In some cases, vulnerable populations may include: those
    who are economically, socially, or educationally
    disadvantaged; people who are pregnant; or participants
    experiencing health disparities.
  4. Risk Type
    Think about risk broadly and do not assume your study carries “no risk” to participants. Pro Tip: Writing in the application that your study carries no risk to participants will almost guarantee a bounceback from the IRB; it signals that you haven’t thought through the participant perspective. At a minimum, research participants almost always risk losing privacy when joining a study. Risk can be physical but also:
    a. psychological (could the questions in your survey provoke traumatic memories for subjects?);
    b. social (if someone found out that a participant had participated in your study, could they be ostracized?);
    c. legal (consider participants such as undocumented populations – could there be legal ramifications for participating in your study?) or
    d. economic (could there be a loss of wages related to participating in your study?)
  5. Risk Mitigation
    Consider strategies relevant to mitigating the risk of participating in your study to minimize probability, severity, and duration of harm by:
    a. Making sure that the protocol is explicit and thorough about its study design and rationale while including information on previous related studies;
    b. Verifying that your Research Team has the experience and expertise it needs to complete the study with integrity;
    c. Projecting a sufficient sample size;
    d. Outlining strict inclusions/exclusion criteria;
    e. Collecting data from SOC procedures (when possible);
    f. Seeking signatures from LARs, as needed;
    g. Providing links to resources for participants before a need arises; and
    h. Adding to your protocol safety measures, as applicable, such as:
    ■ a Data Safety Monitoring Plan
    ■ training in obtaining informed consent and other research procedures
    ■ an IT security plan for protecting research data on work computers (including encryption and password protection)
    ■ obtaining a Certificate of Confidentiality
  6. Benefits
    Though you will not need to classify the benefits of your study in your IRB protocol, it may help to understand how the IRB thinks about benefits. Benefits can be thought of as direct (benefits from receiving a study intervention, such as a Watchman device undergoing clinical trials) or indirect (collateral or aspirational).
    a. Aspirational benefits benefit society and future patients as a result of the study; for example, the results of the Watchman trial lead to FDAapproval of the device, which becomes standard-of-care treatment worldwide.
    b. Collateral benefits are those gained from being in a study even if a participant does not get the intervention; for example, obtaining test results from labs not typically considered standard-of-care. Evidence outlining expected benefits may include such sources as past studies in animal models, past studies with smaller or slightly different populations, or a
    literature review.

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