As part of their ethical responsibility to participants, all researchers have an obligation to properly identify, reduce, and disclose any potential harm or discomfort that may occur during their studies. These potential harms and discomforts are referred to as “risks” and should be minimized according to the principles of beneficence in the Belmont Report. It is crucial to disclose these risks in the informed consent process, allowing participants to make an informed decision about their participation.
In addition to the inherent risks, catastrophic events such as natural disasters, epidemics, terrorist attacks, and pandemics can introduce additional risks. Researchers must review their study protocols during these times to identify and mitigate any new risks. For instance, before the COVID-19 pandemic, in-person surveys with consenting adults were generally considered low risk. However, due to the risk of person-to-person transmission, studies involving in-person components are now regarded as higher risk. The level of risk is assessed by the IRB (Institutional Review Board) which determines the review requirements and necessary human subject protections based on the level of risk involved.
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Examples of Potential Risks & Suggestions for Mitigation
In order to assess potential risks to participants effectively, researchers need to be aware of various types of harm or discomfort that participants may encounter. The Teachers College research community primarily consists of behavioral and social researchers. The following examples and suggestions for risk mitigation are particularly relevant to behavioral science research, but may also apply to other types of research.
Loss of Time
Researchers must provide accurate estimates of the time required for each study activity and the overall time commitment on the informed consent form. To ensure appropriate estimation, researchers should consider factors such as pilot tests, participants’ reading levels, and potential delays when using online software or introducing new activities.
Traumatic Events
Recalling traumatic or distressing events during a study can lead to discomfort or harm. Researchers should identify and disclose any questions or activities related to traumatic events in the informed consent form. They should also closely monitor participants during and after the study to ensure their well-being. Providing a list of community resources or offering counseling services can be helpful if participants experience distress.
Unwanted Stimuli
Exposure to unwanted or distressing stimuli during study activities can cause harm and discomfort. Researchers should obtain clear consent before exposing participants to potentially distressing stimuli. They should also implement safeguards, such as debriefing participants after the study activities, and avoid exposing high-risk groups to certain stimuli.
Labeling
Participants who are not familiar with clinical terminology may inaccurately identify with disorders or traits mentioned in the study measures. To avoid confusion, researchers should appropriately name scales or remove measure names altogether. They should also examine study titles for potential bias and risks to participants.
Environmental Stimuli
Environmental factors, such as the research location, lighting, or external noise, can trigger discomfort for participants. Researchers should carefully evaluate their research space for potential allergens or health issues, ensure the safety and hygiene of the environment, and consider food allergies when providing refreshments.
Minor Emotional Risk
Common minor risks in research include mental fatigue, embarrassment, discomfort, or frustration. Researchers should review their study activities from the participant’s perspective to determine if any of these emotions are likely to be encountered. It is important to disclose potential distressing emotions in the consent form.
Participant Relationships
Study activities that put strain on participants’ relationships can cause harm or discomfort. Researchers should disclose any study activities that may cause relationship distress and distinguish intentional relationship distress from unintentional distress caused by the researcher’s error. In cases of unintentional distress, researchers should ensure respect, participant autonomy, and care.
Exercise & Repetitive Movements
Studies involving exercise or repetitive movements carry an inherent risk of physical injury. Researchers should disclose all potential physical discomforts at the beginning of the study. They should also evaluate participants’ physical health and abilities and consider any underlying health conditions that might impact their ability to participate.
Personal Information
Asking questions about private information, such as income, health habits, or illegal substance use, may cause distress for participants. Researchers should clearly justify the inclusion of these questions to the IRB and clarify confidentiality policies. They should also review Certificates of Confidentiality (CoC) for human subjects, if applicable.
Viral Illnesses, Spreads, or Pandemics
In the context of the COVID-19 pandemic, person-to-person contact poses a significant risk of viral transmission. Researchers with in-person study components must evaluate their activities to minimize contact. Routine hygiene practices such as handwashing, avoiding face-touching, and using face coverings should be encouraged. Social distancing, regular cleaning and disinfection, and conducting in-person interactions in well-ventilated areas or outdoors are also important measures to reduce the risk of infection.
Requirements for Mitigating Research Risks
When evaluating the risks and benefits of a study, the IRB assists researchers in determining whether a risk is justifiable or should be eliminated. Minimizing risks to participants is a fundamental requirement, and the risks involved in the study should be reasonable compared to the potential benefits. Informed consent from each individual participant is essential, and consent documentation should be readily available for review. If a participant is unable to provide consent, their guardian must provide consent, while the participant’s assent should also be sought. Safeguards should be in place for vulnerable populations to prevent coercion. Researchers must also justify why they are studying vulnerable populations instead of general populations, focusing on the specific needs of those populations.
Privacy and confidentiality of participants must be appropriately addressed and documented in the informed consent process. The de-identification of data prior to analysis is strongly recommended. Researchers should plan for secure data collection and monitoring, adhering to data security standards. For resources and templates related to TC IRB consent and application language, please visit the TC IRB Submission Document Templates & Samples guide.
For any COVID-19-related information, risks, and preparation, please refer to the provided link.
Remember, it is crucial to prioritize the well-being and safety of participants throughout the research process to ensure the integrity and credibility of the study.
