Participants At Risk of Suicide

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Purpose and Applicability

This guidance is intended for investigators whose research may identify participants who are at risk of suicide. This includes research that focuses on suicide prevention, research that asks about suicidal ideation or intent even if it is not the focus of the research, situations when participants are screened out for suicidal ideation, as well as situations in which participants disclose unsolicited information about suicidality.

In most cases where the research may identify research participants who are at risk of suicide, the UW IRB requires researchers to develop a Suicide Risk Mitigation Plan. Identifying the Need for a Suicide Risk Mitigation Plan and Building a Suicide Risk Mitigation Plan provide guidance about when a Plan is required and what to include.

Context

When a Suicide Risk Mitigation Plan is required, HSD expects researchers to design an evidence-informed Plan and should be prepared, if requested, to provide the IRB with appropriate references and citations to support its design. For some research, if the research team does not have expertise in mental health research, it may be necessary to hire consultants or collaborate with experts in the field.

When reviewing Plans, the IRB must make decisions based on the information in this guidance and current scientific literature. Decisions should not be based on personal preference, clinical experience, previously approved studies, or strategies of “better safe, than sorry” (Hom et al., 2017). It is the IRB’s responsibility to assess whether the Plan has adequate empirical support and to consider the research team’s qualifications to implement it.

An appropriate Plan will depend heavily upon the participant population and study procedures. Researchers must also factor in the particulars of the research setting. For example, a Plan for a study taking place in Washington State may not be appropriate for the same study taking place in another U.S. state or in an international setting. HSD expects researchers to be familiar with local laws that apply to their research (e.g., mandatory reporting; involuntary commitment) and with relevant local context issues (e.g., different availability of resources and services by location). These local context issues can be described in the IRB Protocol section on “Non-UW Research Settings” or in the Risk Mitigation Plan itself.

For multi-institutional research, researchers may need to consult with the IRB/HRPP or other regulatory offices of relying institutions to confirm the acceptability of the Plan in regards to local laws and institutional policies.

This guidance was developed using peer-reviewed publications, NIMH and FDA guidance, and the approaches used by the IRBs at University of Kentucky, University of California, Berkeley, and Brown University. University of Washington faculty and IRB members with subject matter expertise also provided input on this guidance.

Responsibilities – Researcher vs Clinician

It is important to distinguish between the duties of a researcher versus a clinician. A clinician’s duty is to care and treat. Researchers have a duty to protect participants from research risks and to ensure risks are reasonable in relation to anticipated benefits. Thus, it is important to distinguish between risk mitigation strategies that are specific to the research-related risks versus resources that are being offered because of the expected underlying risk with which participants enter the study. In the context of identifying the potential of suicide risk in the course of a research study, the duty of the researcher is generally to serve as a gatekeeper who routinely takes appropriate actions to categorize risks and may do their best to connect the participant with appropriate services rather than providing those services. In an emergency, a research clinician may need to act as a provider until a hand-off can be completed, but in most cases, it is beyond the scope of the researcher’s responsibility to ensure participants connect with recommended resources (Hom et al., 2017).

An exception to this general rule is research where the expression of mental or physical harm to the participant or others may be directly study-related, such as a behavioral intervention that triggers an elevation in participant indicators of anxiety, depression, or thoughts of self-harm. In these situations, the research may have a more causal relationship with the risk and so the researcher has a more direct responsibility to ensure participants receive the appropriate services. Also consider, it may be that the study procedures/interventions are not risky and may in fact be decreasing the risk through the intervention, the validation and support offered by being in a study, resources offered, or more frequent monitoring.

More detailed information about the appropriate Level of Response and Connection to Services is discussed in the section of this guidance on Building a Suicide Risk Mitigation Plan.

Responding to Information About Suicidality When There is No Suicide Risk Mitigation Plan

If the likelihood of participants sharing information about suicidal thoughts or intent is low enough, it may not warrant developing a Plan (review framework table). Even if a study does not solicit information about this topic, participants may offer this information in survey or questionnaire responses, during interviews, or during other interactions with the research team. Depending on the information that is shared and whether the participant is identifiable, researchers may need to reach out to the participant to offer support or a referral or they may need to reach out to others in case of mandatory reporting requirements or information about an imminent threat to the participant. As a result of the disclosure, researchers and the IRB may identify the need to implement a Plan if information sharing of that kind is likely to occur again. When this occurs, researchers are encouraged to read the guidance below for information about how to respond. If further assistance is needed, contact the HSD Regulatory Affairs Team at hsdreprt@uw.edu.

Identifying the Need for a Suicide Risk Mitigation Plan

Whether a Suicide Risk Mitigation Plan is needed depends on the likelihood that information about suicidal thoughts, past or present, will be shared by the participants. It is helpful to think of likelihood in terms of the type of research being conducted. Use the table below to determine whether a Plan is needed and to identify the elements that the UW IRB will generally expect researchers to include. More detailed information about risk monitoring, assessment, and response elements to include in a Plan are described in Building a Suicide Risk Mitigation Plan.

Use this table to determine whether your study needs a Suicide Risk Mitigation Plan.

Type of Research	Is a Risk Mitigation Plan Required?	Which Elements Should the Risk Mitigation Plan Include?
Research in which information about suicidality is not anticipated but might be possible. Even when questions about suicide are not asked, there are certain types of research or particular research instruments that may increase the chances participants will share this information. For example, studies that administer quality of life or life satisfaction surveys that include open-ended responses may result in the participant sharing that they are experiencing suicidal thoughts or behavior. Research that includes populations who may be at elevated risk of suicide. Even when questions about suicide are not asked, consider whether the population you enroll may be at high risk (e.g., veterans, post-partum mothers).	A Plan should be considered. For these categories of research, the research team will decide whether to submit a Plan to the IRB. In most cases, the IRB will defer to researcher preference. However, the IRB may request a Plan if they deem it necessary in order for the study to meet the IRB Criteria for Approval. Even if it is unlikely that the Plan will be used often, having the Plan in place minimizes the potential for confusion and decisions made without an empirical basis if a potential risk to participants is identified (Hom et al., 2017).	In most cases, the Plan for this type of research will include: A description of the data, participants, and procedures to which the Plan applies. The frequency with which this data will be reviewed when there is no direct communication between researchers and participants. The process for informing the PI if study staff identify responses that indicate a participant may be experiencing suicidal thoughts or behaviors and how that process differs whether the data are collected remotely or in direct contact with the participant. The PI or some other qualified individual will reach out to the participant and use the Mental Health Resources sheet, or the study’s own resources list, to provide resources that are relevant for the participant and what they have shared. A description of steps that will be taken to educate research staff on the Suicide Risk Mitigation Plan. A description of the qualifications of the research staff who will be expected to implement the Plan. Review Building a Suicide Risk Mitigation Plan for other elements that may apply.
Research in which information about suicidal thoughts or behavior is used to screen participants out of a study. Sometimes researchers choose to exclude participants at risk of suicidal thoughts or behavior from their study. Before excluding this population from your study, review the section on Inclusion and Exclusion Criteria for additional discussion and considerations.	A plan is required.	In most cases, the Plan for this type of research will include: Providing a thoughtful explanation to participants as to the reason for their exclusion. The messaging may differ depending on whether the screening takes place remotely or in direct contact with the prospective participants. “Warm” language can be important when participants are taking a “cold” remote survey. Consider ways to include validation and empathy and reduce punitive responses to disclosing suicidal thoughts and behaviors. Developing a list of participant resources prior to initiating the research that are specific to the needs of the population. You can use or adapt HSD’s Mental Health Resources. Provide this list of resources to all participants regardless of whether they screen out of the study. The process for informing the PI if staff identify responses that indicate a participant may be experiencing suicidal thoughts or behaviors and how that process differs whether the data are collected remotely or in direct contact with the participant. The process by which the PI/other will assess the level and immediacy of the risk (remote vs in person) and whether a response, beyond providing resources, is required. A description of steps that will be taken to educate research staff on the Suicide Risk Mitigation Plan. A description of the qualifications of the research staff who will be expected to implement the Plan. Review Building a Suicide Risk Mitigation Plan for other elements that may apply.
Research in which information about suicidal thoughts or behavior is collected but is not a focus of the research. Many studies used standardized instruments (e.g., PHQ-9) to collect baseline mental health information that may include questions about suicidality.	A plan is required. When participant data will be collected anonymously, review Plans When the Participants Are Not Identifiable. Depending on the expertise of the research team, outside consultation may be needed to design an appropriate Plan and/or to respond to participant distress or crises that might arise during the research.	In most cases, the Plan for this type of research will include: Developing a list of participant resources prior to initiating the research that are specific to the needs of the population. You can use or adapt HSD’s Mental Health Resources. A description of the data that the Plan applies to, including thresholds that would trigger a response. A description of how often these data will be monitored when there is no direct communication between researchers and participants and whether collection of this information continues after screening/ baseline. The process for informing the PI or other qualified person when staff identify responses that indicate a participant may be experiencing suicidal ideation. This will differ depending on whether the data are being collected remotely or in person. The process by which the PI/other will assess the level and immediacy of the risk (remote vs in person). A description of the framework for determining how to respond and a list of response elements (remote vs in person). When a response is required, the process by which the PI/other will provide resources or other support (remote vs in person). A description of steps that will be taken to educate research staff on the Suicide Risk Mitigation Plan. A description of the qualifications of the research staff who will be expected to implement the Plan. Review Building a Suicide Risk Mitigation Plan for other elements that may apply.
Research in which suicidal thoughts and behavior is a focus of the research, but a suicide attempt or other suicidal behavior is unlikely.	A Plan is required. When participant data will be collected anonymously, review Plans When the Participants Are Not Identifiable.	For this type of research, the IRB will require a thorough Plan that includes many of the elements listed in Building a Suicide Risk Mitigation Plan. The research team must include members with appropriate expertise.
Research in which suicidal thoughts or behavior is a focus of the research, participants are at high risk, and a suicide attempt or other suicidal behavior is expected.	A Plan is required.	For this type of research, the IRB will require a thorough Plan that includes many of the elements listed in Building a Suicide Risk Mitigation Plan. The research team must include members with appropriate expertise.

Building a Suicide Risk Mitigation Plan

Researchers should first review the framework table to determine whether a Plan is needed. Use the SUPPLEMENT Suicide Risk Mitigation Plan to provide the IRB with the following information: 1) a description of the aspects of the study that require a Plan, including study procedures that are greater than minimal risk; 2) a description of the monitoring and risk assessment activities; 3) a description of the Plan for responding to identified risks; 4) a description of the research team qualifications, training and compliance monitoring activities; 5) consent specific considerations (e.g., participants must be informed of instances when confidentiality would need to be breached); and if requested by the IRB (6) supporting literature.

Plans When the Participants Are Not Identifiable

Considerations when developing Plans are different when the participants are not identifiable and cannot be contacted directly if they share information about mental health distress. Consider the type of data being collected and the study population to assess whether it is appropriate to collect those data when there will be no ability to contact participants. If the information solicited in the research instruments is particularly sensitive, detailed, and/or the participant population is vulnerable, it might increase the likelihood that the research may cause the participants distress to the point that the research team may have an ethical obligation to monitor the data and contact them. There will be many situations where collecting non-identifiable data is appropriate, even if the topics are sensitive, but it is something the research team should think carefully about.

Example: Participants who lived through childhood trauma will be asked about those experiences and whether they have suicidal thoughts in an anonymous online survey. The researcher and the IRB must carefully consider what the participants might experience as they are asked to revisit those past traumatic experiences and be asked about suicidal ideation with no opportunity for contact with the research team. Does simply providing a list of relevant treatment and other trauma support resources seem sufficient? If participants are likely to indicate an imminent risk of suicide, administering the survey anonymously may not be appropriate for ensuring participant safety and well-being.

When the research includes asking participants about suicidal thoughts or behavior:

• Always provide participants with a resource sheet that is specific to the topics covered and the participant population. Resources should be provided to all participants, regardless of their responses to surveys or questionnaires, although you might provide different resources depending on survey responses. Review HSD’s Mental Health Resources.
• Always tell participants in the consent form, and remind them before they begin the research procedures, that researchers will not be able to identify and contact them after reviewing their responses.
• Depending on the sensitivity of the questions and vulnerability of the participants, consider inserting “check-ins” in the instrument, (e.g., “Are you okay with us continuing the interview/survey?”)

Risk Monitoring, Assessment, and Response

Monitoring and Assessing Risk

Whether the research will collect direct or indirect information about suicidality, the sensitivity of the information, and the vulnerability of the participant population will all factor into which of the elements listed below should be included in the Plan.

Elements to Consider for a Suicide Risk Monitoring and Assessment Plan:

(Hom et al., 2017; NIMH)

• Identify the questions and measures that may indicate a participant is experiencing suicidal thoughts or behavior.
• Identify the suicide risk assessment frameworks that will be used (e.g., Bergman & Silverman, 2014; Linehan, Comtois & Ward-Cieselski, 2012).
• Describe the frequency of monitoring, if assessed after screening/baseline.
• Identify the study staff (or other individuals) who will assess the immediacy of the risk.
• Identify the study staff (or other individuals) who will make the clinical assessment, when applicable.
• Determine cut-offs or indicators of when the research team will provide resources, will recommend clinical action or will otherwise intervene with the participant.
• For suicide-focused research, consider having a clinician “on-call” for crises or to help make an assessment.
• Consider whether the Plan should be different depending on the participant group. For example, a control group may have less opportunity for receiving monitoring and assessment than an intervention group. The research team should consider whether additional points of contact would be appropriate to ensure adequate monitoring for the control group.
• For clinical trials of drugs that include prospective assessment of the occurrence of treatment-emergent suicidal ideation and behavior, review this draft FDA guidance.
• Special considerations for remote surveys. When research procedures are conducted remotely and there is no direct communication between the researchers and participants, automated strategies may need to be developed for monitoring indicators of the need for clinical action or other intervention (e.g., text alerts to PI or automated referral of participant to crisis line) and determinations need to be made about who receives the notifications (study staff, clinician, participant).

Assessing Suicidality

A strong body of research indicates that asking questions about suicide does not increase the risk of suicide. Additionally, a report of past or even recent suicidal ideation is not enough to indicate an imminent threat of self-harm. If a participant expresses suicidal ideation in combination with intent, plan, and/or means then there may be risk of imminent threat. Determining whether clinical action is needed, and if so, what the appropriate action is, depends on the level of risk and the identification of: risk factors, such as a history of attempts, current elevated intent, current Plans and preparation; protective factors, such as social support and reasons for living; and access to lethal means, such as firearms or medications (Hom et al., 2017). This assessment must be made by a qualified professional.

Responding to Risk

Elements to consider for a Suicide Risk Mitigation Plan. Depending on the study specifics, some or all of these elements may be appropriate to include in the Plan
(Hom et al., 2017; NIMH).

• Develop a list of participant resources prior to initiating the research that are nuanced and feasible for the participants’ needs. Review Mental Health Resources for a list that is maintained by HSD. All participants should receive the study resource list regardless of whether they have indicated they are in need. Crisis resources should be provided in multiple modalities (phone, text, chat) and should be specific to the population (e.g., children, active-duty military, post-partum mothers).
• If resources or other study instruments note that participants can contact the study team for help, be clear about what that means. If help is limited to providing participants with assistance in using the resources provided, and not an offer to intervene or provide care, make that clear.
• Consider including mood check-ins throughout the instrument. This can include asking the participant whether they want to continue and reminding them that they can stop at any time. Also consider adding a debrief at the end to check in on the participant. When available, provide information about how to contact a member of the study team or other clinical staff for help and provide a link to the resource list.
• When remote surveys are administered, consider programming them to provide resources differently based on participant responses.
• When the research is conducted in a clinical setting, consider whether clinicians are immediately available for a direct connection to care.
• If participants are known to be at high risk for self-harm and there is a high risk that a rescue will be needed, consider how the participant population may react if the Plan suggests connecting them with services or calling the police for a welfare check. Participants may refuse a connection with a mental health care provider. Calling the police to a participant’s home may escalate a situation rather than protect them from self-harm. For remote procedures, be sure to collect current location and phone number before beginning the research procedures.
• If symptoms worsen to the point that the participant should be withdrawn and/or transferred to clinical care (when feasible), precautions should be taken to manage conflicts of interest at the outset of the study. One way to do this is to identify the criteria for withdrawal in the study protocol. Alternatively, an independent monitor or IRB Chair could make the determination and the responsibility for making that determination is described in the DSMP or DSMB charter. Situations under which participants may be withdrawn, and the process for withdrawal must be described in the consent process and form.
• Researchers studying suicide must understand applicable state and country laws regarding involuntary hospitalization and the ways in which those laws might interact with the research. In Washington State RCW 71.34.530 (provision of adolescent outpatient mental health care) and RCW 71.34.500 and RCW71.34.510 (provision of adolescent inpatient mental health care) may be relevant. This information should be described in the IRB Protocol question asking about local context.
• When the study population includes children or adults with fluctuating consent capacity, be clear in the protocol and the consent process and form about which risk response situations may cause the research team to break confidentiality and contact a caregiver.

Level of Response

It is vital that the response proposed in the Plan be appropriate to the potential risk of physical harm or mental distress. On one hand, a participant who reports a low indicator of suicidal thoughts or behavior is not likely to need an extensive response involving a direct and immediate connection with care. In fact, an unnecessarily high level of response may create an undue burden for the participant (Hom et al, 2017). While this situation still requires appropriate assessment from a qualified team member, the intervention Plan should align with the risk level. However, if a participant indicates an imminent risk of suicide, the research team must be prepared to implement a clear Plan for providing the participant with a connection to someone who is qualified to provide therapeutic assistance, whether that person is a member of the research team or not. Note that the participant may refuse the connection, and the Risk Mitigation Plan should describe what the research team will do in that situation, usually including crisis response.

Connection to Services

Access to mental healthcare professionals and services may be difficult to obtain during periods when staffing is low and need is high (e.g., during and after the COVID-19 pandemic). While it may be ideal to create a Plan that directs research staff to connect a participant directly to a mental health professional, it may be unlikely that they are able to follow through with providing participants with immediate connection to services. In these circumstances, it may be more feasible to provide thoughtful and targeted resources for the participant. It is also important to consider that even when connection to care is feasible, participants may refuse those services.

Research Setting

The resources in the research setting will influence the Risk Mitigation Plan. For example, the Plan is likely to be different if the research is taking place in a hospital or clinic versus in a university lab, the participant’s home, or virtually. Researchers working in clinical settings should investigate whether they can leverage existing clinical resources for responding to a participant in crisis. In these situations, it is important to clearly identify how coordination between research staff and the clinical care team will occur when the need for a response is identified.

Consider cultural context if the research is taking place internationally or within groups that may have different cultural norms, support structures, etc. Be sure the research team has appropriate cultural competency or consults with someone who does while designing the Suicide Risk Mitigation Plan in these situations.

Research Ream Qualifications, Training, and Compliance Monitoring

Appropriate Expertise

When the research is focused on suicide, it is vital that the research team include individuals with appropriate expertise to develop the Plan and, if needed, respond to participant distress or crisis. When suicide is not the focus of the research, the research team may need to consult with a subject matter expert, or they may be able to design a Risk Mitigation Plan on their own using this guidance and the SUPPLEMENT Suicide Risk Mitigation Plan.

Training and Compliance Monitoring

The IRB expects researchers to provide a robust description of their Plan for training and monitoring compliance for the research staff (or other individuals) who will be responsible for implementing the Plan, particularly for studies that ask about and/or are focused on suicide. This includes ensuring that staff know procedures for escalation to the PI, on-call clinician, direct connection to resources, and all steps identified in the Plan. It should also include the specifics of how compliance will be monitored and who is responsible for the monitoring. The description of training may include information about what will be provided at study start-up as well as any regular refresher training.

Suicide-Focused Research

Researchers studying suicidal ideation must maintain competence in evidence-based suicide risk assessment and management. Some examples of training and monitoring activities include: reading scientific papers; requiring a minimum number of shadowing or observation experiences prior to seeing participants; watching training videos with mock participant interactions; administering an annual evaluation of competence in risk assessment and emergency referral procedures using role play; conduct of routine reviews and/or ratings of proficiency in risk assessment and management techniques using audiotapes, videotapes, or observation by a clinical supervisor (Hom et al., 2017).

Other Considerations

Inclusion and Exclusion Criteria

When developing inclusion and exclusion criteria, researchers should carefully consider the purpose of the research and the scientific question. This is particularly important when the study may offer significant benefit to the individual participant or the participant population. For example, if individuals experiencing suicidal thoughts are routinely excluded from clinical interventions for depression, they are also excluded from the potential benefits of the development of evidence-based understanding, services, care, and interventions to treat depression (FDA 2018). However, there may be some situations where it does make sense to exclude particular groups and the research team should be prepared to justify their exclusion to the IRB. Risk screening tools should be carefully selected and when individuals screen out of the study, the research team should provide them with resources.

Example: A study is recruiting for an app-based mental health intervention for identifying and treating depression. The study population may include individuals who are experiencing suicidal ideation. Researchers need to develop a Suicide Risk Mitigation Plan that includes steps for responding should a participant express an imminent risk of self-harm. If the research team does not include mental health expertise, the researchers must determine whether there is some other means of obtaining the required expertise and/or resources (e.g., hire an on-call clinician; recruit a collaborator) or whether they should screen out participants who are at high risk of suicide. As part of this calculation, the researchers think carefully about the potential benefits that this health intervention could provide to individuals experiencing suicidal ideation.

Confidentiality

The collection of sensitive information about suicidal behavior and mental health requires thoughtful consideration of confidentiality concerns prior to beginning the study. The Suicide Risk Mitigation Plan, state mandatory reporting requirements, and/or inclusion of minors may trigger the need to share a participant’s confidential research data with particular people or organizations outside of the research team in order to protect the participant or to comply with local law. When there is a reasonable likelihood that confidentiality may need to be breached for these or other reasons, participants must be informed of this possibility as part of the consent/assent process and form.

Information sharing in response to imminent threat of suicide. Some research may have Plans that include procedures for a warm transfer to a clinician or crisis line. Rarely, a Plan may include procedures for requesting an evaluation for involuntary hospitalization by an emergency department. When the research involves children, parents may need to be notified if their child is at risk. When a Plan anticipates information sharing of this kind, it must be disclosed during the consent process and in the consent form (Hom et al., 2017; NIMH).

Post-Study Support

Researchers should think prospectively about the participant experience at the end of their participation. For certain studies, it may be important to ensure participants have what they need to stay safe such as clinical resources, counseling services, or crisis line information. This assures participants that they have not been “abandoned” and have a linkage to care, if needed. For some research, it may be useful to invite participants to take part in follow-up assessments and/or to review their vital records for continued outcome data. For suicide-focused research, consider ahead of time whether the family will be contacted or be provided with resources if the participant dies during their participation in the research. (NIMH).

Designing Consent

The importance of informed consent is emphasized throughout this guidance. Researchers should review the main Consent guidance and the guidance on Designing the Consent Process for general information about consent. The sections, Consent Overview, Protected and Vulnerable Populations, and Diminished or Fluctuating Consent Capacity may be relevant when a suicide Risk Mitigation Plan is required. Several other consent issues particular to suicide research are discussed below.

Confidentiality Concerns

As is noted above in the section describing confidentiality, when there is a reasonable likelihood that confidentiality may need to be breached for any reason, participants must be informed of this possibility as part of the consent process and form. More information and example language can be found in the guidance on Designing the Consent Process.

Consent Considerations for Research With Minors

Conducting suicide research when the participants are children requires that researchers consider what level of involvement parents or guardians will have in the research. This includes ensuring a clear understanding of the laws dictating age of majority in the jurisdiction(s) in which the research will take place. For example, Washington State law defines some exceptions to the standard age of majority for minors to provide legally effective consent when seeking inpatient or outpatient mental health care and inpatient or outpatient chemical dependency or substance abuse programs. It is possible that these types of exceptions might also apply to research consent. The guidance on Human Subjects Regulations lists these Washington State exceptions. If parental permission has been waived for a study, researchers should try to anticipate situations when participant confidentiality might be broken if the child is at risk and parents must be informed about their participation in the study. If this is a reasonably foreseeable possibility, participants must be informed about it during the assent process. The consent guidance section on Protected and Vulnerable Populations provides more information about parental permission and assent.

Fluctuating Consent Capacity

For participants who are in the midst of, or coming out of, a mental health crisis, researchers may need to design a consent process that assesses and, potentially, re-assesses their capacity to consent on their own behalf. Design the consent process as an interactive, collaborative, and ongoing process during which participants are encouraged to ask questions throughout their participation (Hom et al., 2017). Review the consent guidance section on Fluctuating Consent Capacity for more information.

Suicide-Focused Research

For research where suicide is the focus, the consent process and form should inform participants that participation in the study does not protect against future suicidal behavior (NIMH). For studies focused on suicidal behavior but that do not offer treatment as part of the study, the consent materials should make this very clear.

Post-Study Consent Considerations

Researchers should consider proactively obtaining consent to: (Hom et al., 2017; NIMH)

• Obtain contact info for emergency contacts and permission to contact them in case of imminent suicide risk.
• Contact participants after the study is complete to extend the post-study contact period or for future recruitment.
• Include consent language allowing access to individual-level data from state or national death records when participant death is an outcome (e.g., when studying populations at high risk of suicide).

Related Materials

GUIDANCE Human Subjects Regulations
INFORMATION SHEET Mental Health Resources
SUPPLEMENT Suicide Risk Mitigation Plan
WEBPAGE Consent Guidance
WEBPAGE Designing Consent Guidance

References

• Food and Drug Administration, Major Depressive Disorder: Developing Drugs for Treatment – Guidance for Industry June 2018
• Food and Drug Administration, Guidance for Industry – Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials August 2012
• National Institute of Mental Health, Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers
• National Institute of Mental Health, Guidance on Risk-Based Monitoring
• Brown University Human Research Protections Program, Appendix F: Mental Health Safety Plan
• University of California, Berkeley Human Research Protections Program, Suicidal Ideation in Protocols
• University of Kentucky Office of Research Integrity, Suicide Ideation or Behavior Among Research Participants, Guidance for Investigators and IRB Members
• Hom, MA., Podlogar, MC., Stanley, IH., Joiner, TE. Ethical Issues and Practical Challenges in Suicide Research Crisis 38(2): 107-114 2017
• Linehan, Comtois, Ward-Cieselski, Assessing and Managing Risk With Suicidal Individuals Cognitive and Behavioral Practice 19(2): 218-232 2012
• Silverman & Berman, Suicide risk assessment and risk formulation part I: a focus on suicide ideation in assessing suicide risk Suicide and Life-Threatening Behavior 44(4): 420-431 2014
• Strauss, D, Fisher, C., Marquez McKetchnie, S. “Studying Suicide and Subjects at Risk for Suicide – Identifying and Minimizing Risk to Promote Necessary Research”. [conference presentation] Public Responsibility in Medicine & Research, AER, Boston, MA. 2019

Version Table

Open the accordion below for version changes to this guidance.

Keywords: Risks/benefits; Vulnerable populations