Institutional Review Boards (IRBs) require that researchers identify and minimize potential participant risks and ensure that the benefits of the research outweigh those risks. Researchers conducting studies on emotionally charged, physically taxing, or distressing topics may need to develop safeguards based on characteristics identified among potential participants, especially those who might be particularly vulnerable to harm or discomfort. Examples of these safeguards include strategies for research staff to quickly respond to anticipated negative emotional reactions, physical discomfort, or distress in participants that arise during the course of the study. One such safeguard is a Research Participant Safety Plan. Safety plans are set protocols that ensure participant protection and are implemented when participants display distress or incur physical harm as a result of the research activities. Safety Plans anticipate possible risks to participants and seek to minimize harm. A researcher should tailor the Safety Plan to the specific population and study activity. Some key components of a Safety Plan may include: 

• Listing who will be contacted and when (e.g., 911, licensed clinician, child protective services, etc.).
• Identifying what conditions will trigger a Safety Plan (e.g., verbal or non-verbal expressions of distress) including the minimum threshold of response.
• Itemizing immediate and long-term triggers for implementing the Safety Plan and details regarding each step of the plan. 
• For example, an immediate plan might include “immediate referral and prompt the clinician to contact the participant.” Whereas a long-term Safety Plan may include specific details on a four-week follow-up and check-in with the participant. 
• Strategizing how best to communicate with the participant (e.g., in-person, phone, etc.) and what is an appropriate level of information-sharing depending on the context (while maintaining privacy and confidentiality standards). 
• Adapting the Safety Plan if the study procedures take place at various locations, (e.g., study lab, participant’s home, public setting), and what procedure to follow for each setting.
• Confirming how research staff are trained on the Safety Plan and monitoring their adherence to the plan.

Other examples of safeguards may include an eligibility screener which provides researchers with insights into the characteristics of their potential research population and can help identify individuals at high risk of adverse reactions. Research interviews with participants also provide real-time feedback for researchers to gauge whether they need to implement a  Safety Plan. A research interview can occur during a pilot study or main study. 

The process of developing an IRB protocol should inspire researchers to consider their personal assumptions about human subject protections in research as they develop a Safety Plan tailored to their population of interest. A “Research Participant Safety Plan” can be submitted as part of the initial IRB protocol submission, and then adjusted through a modification if the researcher learns new information on how best to protect study participants. If emotional distress, reflections on past traumatic experiences, or potential physical harm (e.g., skin irritation due to wearing a study device) are judged to be a risk, researchers must develop strategies to minimize them.

Considerations for a Research Participant Safety Plan 

When developing a “Research Participant Safety Plan,” researchers should consult relevant literature, field experts, colleagues, mentors, and other sources to develop context-relevant processes and procedures for field research. In their research protocol, researchers should:

1. Delineate a timely course of action in the event of a distressed participant or participant who encounters harm. This procedural document should be titled, “Safety Plan”;
2. Supplement research staff’s CITI training with content-specific training as relevant to the study project. Include information regarding how research staff will be trained on the Safety Plan and monitored for adherence to the Plan;
3. Onboard research staff who are equipped to handle psychological distress or who can respond to potential physical discomfort;
4. Consistently monitor participant’s mental, emotional, and physical status through observations, check-ins, or self-report assessments;
5. Provide opportunities to pause the study, take a break, or reschedule the study activity during stressful data collection procedures;
6. Clearly delineate a communication chain in the event of a distressed participant. Itemize who will be contacted (e.g. licensed clinician, primary researcher, 911, etc.) and how they will be contacted (phone, text, email, etc.). Confirm that all research staff know who is available and how to contact them in the event of an emergency prior to engaging in any research activities;
7. Provide relevant information on available psychological, health, or social services to all participants;
8. Debrief the study participant on relevant study content, resources, or next steps. 

Guidelines around Safety Plans for Research Participants

Each Safety Plan should be tailored to the researcher’s potential participants based on expert feedback and contextual knowledge. The following guidelines are intended for researchers to adapt to their own field research:

1. Define the purpose of a “Research Participant Safety Plan” based on the well-being of study participants who may experience significant distress, and may be at risk of harming themselves or others.
1. Establish the purpose of the Safety Plan for the present study to ensure the safety of all study participants as an important part of human subjects research. 
2. Take, for example, a research study interviewing participants about their mental health. If the participant discloses elevated levels of current suicidal ideation, suicidal plans, or suicidal behaviors, or they spontaneously express a threat to themselves or others, the research team should be prepared to take immediate steps to protect the well-being of the participant through evaluation by a licensed clinician.
2. Describe when a Safety Plan should be implemented in a research protocol. Include the research procedures involved, as related to the study topic and activities.
1. Following the previous example, the research team should explain to participants that the Safety Plan will be implemented if the participant discloses a risk of harm to self or others.
3. Incorporate assessment tools (e.g., assessment of suicidality) to measure for elevated risk. For example, one questionnaire that commonly requires a Safety Plan is the Patient Health Questionnaire-9 (PHQ-9). For studies targeting populations at high risk for self-injury, researchers can consider these items in a Safety Plan:
1. Identify the questions and responses that would trigger the Safety Plan. If the investigator is administering a measure like the PHQ-9, identify the minimum threshold of response/scoring that would set the Safety Plan into motion. Another example is in cases where researchers assess an individual who is likely to fall or has imbalanced mobility (e.g., individuals with Parkinson’s). For these cases, a Safety Plan can itemize ways to mitigate risk and responses to follow if an adverse event should occur.
2. Describe the timeline for implementing the Safety Plan and details regarding the steps of the plan. The timeline should always include “immediate under specified conditions” and/or “referral and prompt clinician contact with the participant” with study-specific details.
3. Detail how the researcher(s) will communicate the next steps to the at-risk participant.
4. If study procedures take place at various locations, (e.g., study lab, public place, refugee camp, hospital setting, etc.), describe the procedures that will be followed for each setting.
5. Describe the timeframe and plan for follow-up with and monitoring of a participant after an incident or emergency.
6. Include a resource/referral list for at-risk participants and describe when the list will be provided to study participants. 

Remember, an IRB administrator reviews each IRB protocol submission on a case-by-case basis within the study context, time frame, setting, and population of interest parameters. A “Research Participant Safety Plan” is reviewed as part of the protocol submission. No one protocol is exactly the same, as each research study is constrained within its own time and place. Researchers can work closely with their IRB reviewers to find ethical solutions and improve participant protection.

— Myra Luna-Lucero, Ed.D.