Reducing Study and Participant Risks
Human Research Protections Program
Researchers and Advisors
WWU researchers conduct mostly minimal risk social, behavioral, educational, and biobehavioral research. While assessing risk for these types of studies can sometimes seem ambiguous, main areas to consider are privacy, confidentiality, and study activities. This page will help you better understand how to identify various types of risks that study participants could encounter and ways to mitigate or reduce these risks.
The Risk Assessment Checklist below identifies common risks in social-behavioral-educational research. Biobehavioral and biomedical projects also could involve these risks, as well as physical risks from activities or procedures. Studies with higher risks require more protections for participants, especially vulnerable ones.
Answering YES to one or more of the questions below indicates a risk you'll need to describe thoughtfully in your protocol, along with ways to reduce the risk(s). Keep in mind some situations might not represent a risk for your specific population, depending on what might be a “normal, everyday experience” for them. If you're uncertain how to mitigate or reduce risks, contact the HRPP for guidance.
- For pedagogical research, are you using or evaluating instructional strategies or assessment procedures that are not common or that will occur outside an established or commonly accepted educational setting?
- Are you focusing on topics participants might consider sensitive or personal (intimate relationships; ethical, religious, political beliefs; health history or behaviors)? (BUT note that these topics involve less risk if the participant does not consider them sensitive and wishes to speak openly about them.)
- Could the data you collect reasonably place participants at risk of criminal or civil liability or damage their financial standing, employability, or reputation if someone outside the research team saw their responses?
- Could any procedures or discussion of topics create higher stress or anxiety for participants than what they might encounter in their everyday life? For example, are you asking participants to recall traumatic or distressing events? (Again, this question is contextual: some participants might normally encounter such experiences in their daily lives, whereas the same might be unusual for other participants.)
- Could participants reasonably consider any of the materials you use or present as offensive, threatening, or degrading? (Assess context: what might be “yes” for some might not be for others.)
- Could participants experience physical injury or discomfort, including physical exertion beyond normal activity (for that person or population)?
- Will you manipulate an individual’s normal physiological requirements, such as nutrition, sleep, sensory comfort, etc.?
- Will you alter psychological and social variables in a way that negatively impact participants, such as inducing stress, creating isolation, impacting self-esteem?
- Could a power dynamic exist between you and participants (e.g., you are their instructor, supervisor, etc.) that might influence them to participate or to respond in a certain way?
- Do you plan to access protected information such as health care, legal, or educational records?
- Do you intend to collect and/or remove any participant fluids or tissue?
- Will you video record or photograph participants individually or in a group setting?
- Could the timing or location of your study heighten risk? (Certain topics could be more sensitive at different times or in different cultures.)
You can try, but it’s rare to eliminate every risk: that’s why the consent process is so important. If you clearly and honestly explain possible risks to potential participants, they have the choice whether to take those risks.
Allowing adult participants with full cognitive capacity to make their own choices helps show the Belmont Report principle of respect. (Minors and other vulnerable populations still have the choice whether to participate, but usually guardians/parents/legal representatives need to be involved in the decision-making process.)
Remember to focus on reasonably occurring risks. You don’t want to assume the worst-possible scenarios, but neither do you want to underestimate a possible risk. To determine what’s “reasonable,” consider the likelihood and the magnitude of each risk. A risk could pose significant harm but be extremely unlikely to occur. On the other hand, a risk might be very likely to occur but unlikely to cause harm. Accurate assessment of reasonable risks can help you better explain them to potential participants.
What are some ways to mitigate or reduce participant risks?
Recruitment materials should be clear about the nature and purpose of the study. Don’t mislead or leave out information (unless the study involves approved deception techniques).
Provide clear inclusion and exclusion criteria. For studies involving physical activity, recommend caution to people with preexisting health conditions and/or conduct screening to remove them from the participant pool, if appropriate.
Don't collect more information than necessary for your study objectives, whether direct identifiers (name, phone number) or indirect (demographics, etc.). Participants might be uncomfortable disclosing information about income, health habits, sexual activities, illegal substance use, etc., so the consent needs to identify which types of information you will request. You also need to clarify whether they must provide such information for the study. You can’t state that “participation is voluntary” or “you may skip any question” if you require any responses.
Clearly explain confidentiality measures: who will have access to identifiable data, how it will be stored, retained, and so forth. If applicable, explain any situations where you reasonably might need to break confidentiality.
Do not promise confidentiality in group settings because you can’t control what others might disclose beyond the study. Instead, say that you will ask all participants to respect one another’s confidentiality but cannot guarantee it.
Consider whether you should obtain a Certificate of Confidentiality (CoC) for studies involving highly sensitive information. A CoC protects you and others with access to research records from disclosing identifiable participant data information in legal proceedings.
Determine a clear plan for deidentifying or destroying data after a set time, which you should indicate in your consent form.
For minor risks such as mental fatigue, embarrassment, slight emotional or physical discomfort, frustration, physical fatigue, you can state “This study should not involve any risks other than those you might encounter in daily life. But …” and then indicate the possible risk, such as “you could feel embarrassed or frustrated,” or “your arm might feel tired,” etc.
Even with minor risks, monitor ongoing activities for signs of reluctance or distress from participants, and remind them that they can stop at any time.
If participants will or might recall traumatic or distressing events, or if they will be exposed to upsetting stimuli (e.g., explicit sexual material, suicidality, alcohol/drug use, smoking), provide additional checks during the study. For example, on a survey, include an additional warning about upcoming questions and remind participants that they can skip questions, pause the activity, or stop the study at any time. Or after obtaining initial written consent, re-obtain oral consent (if feasible) right before exposing participants to more sensitive materials.
Consider whether using clinical terminology or scale or measure names (e.g., “Depression Scale”) could confuse or bias participants, or whether it could increase risk by leading an undiagnosed participant to inappropriately self-diagnose.
If you will have a resource support list, provide it as a matter of course to all participants vs. offering “as needed.” (You could miss whether someone is in distress, or some individuals might feel self-conscious about taking them otherwise.) For studies involving high potential for psychological distress, consider asking a trained professional (e.g., school counselor) to be available for participants.
If feasible, follow up with participants after study activities, because recalling traumatic events or experiencing distressing stimuli could generate subsequent challenges with anxiety, depression, sleeping difficulty, etc.
Consider whether you should screen out individuals with negative experiences related to study questions: for example, if your study involves alcohol or drug use, screen out those with substance use disorders unless you’re specifically recruiting from that population (similarly, screen out those who have previously attempted suicide if your study could trigger distress and you aren’t intentionally recruiting from that population).
Indicate any exclusion criteria on your recruitment materials and in the consent form. Explain all activities in the consent form that could result in physical discomfort and disclose any reasonable health risks.
Ask about any underlying health conditions through screening procedures. Evaluate a participant’s current health and ability to complete study activities (e.g., able to run for 10 minutes at a slow pace). Monitor participants for fatigue or distress throughout study activities.
For research involving higher physical exertion or risks, follow up with participants after the study activities to check on their health and comfort level.
Evaluate the physical location of data collection. Consider whether lighting, noise, space constraints, or other factors could be triggering or distressing for participants. Be aware of hygienic factors such as excessive dust, restroom availability for individuals of all gender identifications, access to drinking fountains, safe lighting if the study takes place at night, etc. Follow CDC instructions on disinfecting spaces, when relevant.
For studies involving sensitive information, conduct activities in private, safe, and secure locations.
If you plan to provide food or snacks, avoid unsafe foods to accommodate participants with possible allergies or sensitivities (e.g., gluten, nuts, shellfish, etc.).
While you should always handle and store data carefully as a matter of best practice, you need to provide higher protections for more sensitive data. Carefully read Data Security and Storage for guidance.
In addition to evaluating potential risks, you should also have a plan in case a problem (expected or not) arises. To better understand how to handle these situations, as well as possible reporting requirements, read the HRPP Unanticipated Problem/Adverse Event Reporting Policy.
If an extreme unexpected event happens (e.g., natural disaster, violent situation, epidemic), you might need to quickly pause your ongoing study to develop additional protections for participants. In these unusual cases, please contact the HRPP for guidance as soon as possible.