Understanding Potential Risks for Human Subjects Research

Understanding Potential Risks for Human Subjects Research

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As part of their ethical duty to participants, all researchers are required to properly identify, minimize, and disclose any potential harm or discomforts that may come to participants. These harms and discomforts are labeled as “risks,” and should be minimized, according to the beneficence principle of the Belmont Report. Any risks that may potentially befall participants must be disclosed in the informed consent, and participants should be given the choice of whether or not to participate in research. 

Additional risks may also be encountered in light of a catastrophic event (e.g., a natural disaster, epidemic, terrorist attack, pandemic, etc.). During these times, researchers with active protocols must review their study activities to identify and mitigate any new risk. For example, prior to the COVID-19 pandemic and depending on the topic, TC IRB typically considered in-person surveys with adults competent to consent as low risk. Under COVID-19 circumstances, however, studies with in-person components are now reviewed as higher risk, as person-to-person exposure is the most frequent route of transmission for infectious viruses. The IRB is required to assess the level of risk involved in a research study when making a determination for review requirements. Some items factoring into the IRB’s risk assessment include possible risk to a subject’s psychological wellbeing, or the risk to a subject if their confidentiality is compromised. The more risk involved in a study, the higher the level of review and the more human subject protections required by the IRB.

Examples of Potential Risks & Suggestions for Mitigation

Reviewing potential risks to participants requires a knowledge of various types of harm or discomfort that participants may encounter. The Teachers College research community is largely composed of behavioral and social researchers. The following examples and suggestions for minimizing risks are likely to be encountered in behavioral science research, though they may also extend to biomedical and other types of research as well. 

Loss of Time: Researchers are required to include the estimated time of each study activity and the total time of completion on the informed consent (parent permission or assent form). Researchers should: 

  • Estimate study completion time based on pilot tests.
  • Consider the reading level of participants (e.g., 3rd grade readers vs. post-secondary students) when calculating the time necessary to complete the study.
  • Reasonably overestimate times to account for participants that may take longer.
  • Prepare for potential time delays when using online software (e.g., Zoom) or introducing new activities.

    Traumatic Events: Recalling traumatic or distressing events can be uncomfortable, and in some cases, harmful to an individual. Traumatic events are defined as events that are shocking, scary, or dangerous (e.g., natural disasters, acts of violence, accidents, etc.). While it is not always possible to identify what types of questions may trigger participants, researchers should identify and disclose questions or activities pertaining to traumatic events. Researchers should: 

    • Disclose any topics, study activities, or questions that may be triggering in the informed consent. For example, if the study includes questions about a traumatic event (e.g., 9/11), provide a trigger warning such as “The next section will include questions that may be uncomfortable to you. This study is voluntary. You can choose to stop the study at any time or skip any question.” 
    • Monitor the participant during each study activity and after, if possible. While the participant may appear fine during a study, recalling traumatic events may lead to flashbacks, insomnia, trouble concentrating, or higher levels of anxiety, sadness, or anger for a prolonged period of time.
    • Provide participants with a list of community resources, or offer free counseling services (if appropriate), should the need arise.
    • Consider options such as recruiting a trained professional to be available to help debrief the participants if they start to experience symptoms of distress.

    Unwanted Stimuli: Exposure to unwanted or distressing stimuli during a study’s activities may bring harm and discomfort. Participants should not be exposed to distressing stimuli (e.g., pornography, smoking, suicide) without first providing their clear consent. Researchers should:

    • Know the risks associated with exposing participants to unwanted stimuli (e.g., increased sadness or irritability), and implement additional safeguards throughout their study, such as debriefing participants after the study activities are finished.
    • Refrain from exposing high-risk groups to unwanted stimuli. For example, study activities including heavy drinking or intoxication should screen out recovering substance users.  

    Labeling: Participants unfamiliar with clinical terminology may begin to identify with disorders or personalities outlined in study measures. For example, someone taking a scale labeled “Depression Scale” may begin to identify as having depression without receiving a clinical diagnosis. Researchers should:

    • Reduce participant confusion by appropriately and clearly naming scales or removing measure names altogether. 
    • Examine tiles of studies for potential bias and risk to participants.

    Environmental Stimuli: Environmental stimuli, such as the research location, building layout, lighting, or external noise, is not always considered in the research design. However, some stimuli may be triggering for participants, and should be eliminated, if possible. Researchers should:

    • Examine their research space for any environmental allergens or health issues, such as dust and flickering lights, prior to inviting participants.
    • Remain mindful of possible food allergies (e.g., nuts, shellfish, gluten) when serving snacks or refreshments.
    • Ensure that the space is safe, secure, hygienic, and, if applicable, private.
    • Review the CDC's detailed instructions on how to clean and disinfect workspaces, along with their list of EPA-approved disinfectants.

    Minor Emotional Risk: Typical common, but minor, risks include mental fatigue, embarrassment, discomfort, or frustration. Researchers should:

    • Review their study activities from the perspective of the participant in order to determine if these emotions might be encountered. For example, a 5-minute survey on personal food preferences is unlikely to cause frustration. However, a study activity in which participants must solve complex mathematical equations in front of peers may cause embarrassment or frustration. 
    • Always disclose any anticipated distressing emotions in the consent form.

    Participant Relationships: Putting strain on participants’ relationships (e.g., causing a fight between a dating couple) will likely cause harm or discomfort to a participant. Researchers should: 

    • Disclose study activities in the consent form that may cause relationship distress.
    • Distinguish between study activities that may cause relationship distress  (e.g., this study will examine household spending habits between partners) from unintentional relationship distress perpetuated in error by the researcher. In the latter’s case, the researcher should gauge the situation and take steps to ensure respect, participant autonomy, and care.

    Exercise & Repetitive Movements: Studies involving exercise or movement have an inherent risk of physical injury to the participants. Researchers should:

    • Disclose all activities at the beginning of the study that may cause physical discomfort.
    • Evaluate or discuss the participants’ physical health and ability based on the study activity (e.g., able to lift 20 pounds without assistance).
    • Gauge the health of the participant to engage in the activities. For example, does the participant have any underlying health conditions that might impact their ability to participate? (e.g., a study requiring intense cardio exertion might want to screen for asthmatic participants).
    • Disclose health risks on the consent form.

    Personal Information: Asking questions about private information such as income, health habits, illegal substance use, etc. may be distressing for participants. Inclusion of these types of questions should be clearly justified to the IRB. Researchers should:

    • Clarify confidentiality policies.
    • Disclose what identifiers may be disclosed, or are at risk of disclosure (e.g., during focus group sessions, researchers cannot guarantee confidentiality).
    • Review Certificates of Confidentiality (CoC) for human subjects, if applicable.

    Viral Illnesses, Spreads, or Pandemics: With the COVID-19 pandemic, person-to-person contact is the most frequent route of viral transmission. Researchers with in-person components in their study must evaluate study activities for points of contact. Exposure is at its highest when people are within approximately 6 feet of one another, and in close contact for 15 minutes or more. Shared spaces, equipment, and surfaces (e.g., office keyboards, writing utensils, etc.) can also be contaminated. To reduce the risk of infection, researchers should:

    • Implement routine hygiene practices and encourage participants to do so during the study, if necessary.
      • Wash hands with soap and water for 20 seconds. If soap and water are not available, use a hand sanitizer that contains at least 60% alcohol.
      • Avoid touching one’s face.
      • Use face coverings when around other people.
      • Cover coughs and sneezes.
      • Throw used tissues in the trash.
    • Practice social distancing, if possible.
    • Clean and disinfect high-touch surfaces daily. This may include tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
    • Restrict in-person interactions to ventilated areas, or outside when possible.
    • Remain vigilant about taking the steps that reduce exposure.

      Requirements for Mitigating Research Risks

      When assessing risk and benefits in a study, the IRB can support researchers in determining if a risk is justifiable or should be removed. Generally, risks to participants must be minimized, and any risks in the study should be reasonable when compared to the benefits of the study. 

      The IRB also requires that each individual participant provides their informed consent. All consent must be documented and available for review if requested. If a participant is unable to provide their consent (e.g., a minor), their guardian must provide consent, and the participant’s assent should be sought. If a participant is likely to be vulnerable to coercion (e.g., prisoners, cognitively impaired persons, etc.), additional safeguards must be outlined in the IRB application. Additionally, researchers must justify the rationale for conducting their study with vulnerable populations as opposed to general populations (e.g., the study provides an intervention which fills a need for that specific population). For sample consent and application language, please visit our TC IRB Submission Document Templates & Samples guide.

      In the informed consent, the privacy and confidentiality of the participants must be appropriately documented. TC IRB recommends that all data be de-identified prior to the start of analysis. Finally, the research plan must make provisions for the secure collection and monitoring of data (visit our Data Sharing, Requests, & Encryption for more information). TC IRB has worked closely with TC Information Technologies (IT) to support researchers working remotely with limited resources and technological capabilities. TC IT should be consulted as the first point of contact if data cannot be secured to the standards outlined in the data security plan.

      For COVID-19 related information, risks, and preparation please visit here.

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