Suicidal Ideation and/or Behavior in Research Protocols

Background Information

Some studies submitted to the UCSF IRB include the use of questionnaires which elicit information about suicidal ideation and/or behavior (SIB). Though empirical research demonstrates that asking questions related to SIB does not increase suicidal risk, research studies which inquire about SIB, or conduct research in an environment where such disclosure from participants may be likely, require additional monitoring of participants’ responses.

This guidance provides a general framework to direct research teams through the ethical and regulatory questions common within these types of research designs. Investigators are encouraged to adapt this guidance as it applies to their individual research protocols, providing justification of questions that assess SIB and a plan to protect participants when inclusion of SIB questions are appropriate. The UCSF IRB will evaluate whether adequate rationale, safety plans, and qualifications of the research team members to implement the plan have appropriately been established.

IRB Application

Justification or Rationale for inclusion of SIB related measures:

Suitable provisions for assessing and handling risks of SIB will depend on the nature of the research. Protocols may range from a clinical study which focuses on major depressive disorders and history of suicide attempts to a study design where SIB are somewhat less likely. For example, a measure that screens for or directly assesses SIB may be included to gather information about a low-risk/non-vulnerable population. Additionally, the environment where the research is taking place also may impact disclosure and is important to consider. For example, an on-line survey may require a different risk management plan than an in-person comprehensive interview about past trauma experience.

Researchers should first consider whether inclusion of measures that elicit information about SIB is necessary to answer the research questions. If inquiring about SIB is important and/or the study is focused on SIB, then the following information related to the application and consent process are relevant. However, if this is not the case, there are several alternate measures of depression which may be more appropriate to utilize. Researchers should review the evidence-based literature about the various types of assessments available when determining best options. Please see the Depression Assessment Instruments detailed on the American Psychological Association website for more information.

Identification, Assessment and Safety Plan:

If the investigators determine that SIB related measures need to be included, they should provide a rationale in the IRB application as to why the measures are necessary and describe the methods which may identify SIB in research participants. This should be explained under Study Purpose/Design, Subject Population, Risks/Discomforts, and/or other sections as appropriate.

If such measures are being used, the IRB requires study teams to present a detailed risk mitigation plan, which may include, but not be limited to, consideration of the following questions:

  • Who within the study team has the relevant clinical expertise to review these responses?
  • How quickly are measures with these questions being reviewed?
  • Can responses be tied to the individual?
  • What is the step-by-step guide being used in these scenarios, who is notified and when?
  • How will the participant’s safety be prioritized?

Within this framework, researchers who administer questionnaires or conduct interviews with research participants to gather information about SIB must have a comprehensive plan for when a participant reports SIB.

Research teams must closely review their interview guides/questionnaires to identify whether any questions may elicit an admission of SIB. Each study protocol will require an individualized risk mitigation plan (for instance, an online questionnaire will require a different approach than an in-person interview with proximity to the emergency department).

1. If participants’ responses will be assessed and can be linked to the individual:

  • The application/protocol must explain how the investigators will assess level and immediacy of risk (e.g. in person/by phone, types of questions, persons who will conduct the assessment). Timing of response review must also be discussed. If investigators propose to wait longer than a 24-hour period to review individually identifiable responses to SIB-related questions, this must be justified within the application/protocol.
  • A detailed safety plan must be provided in the application/protocol.
  • Qualifications of the PI (lead investigator), as well as training information for any study team members who may be involved in such assessment and/or implementation of the safety plan must be described.

2. If participants’ responses will NOT be individually identified:

  • The explanation should include why the investigators believe such individually identifiable assessment is not necessary (risk-wise) or feasible (e.g. online survey programmed to collect anonymous responses would not allow for ‘real-time’ assessment of participants’ answers or follow-up if concerns were to be identified.)

If participants are not at high risk for SIB and will not be asked questions about intent, plan, and/or means to commit suicide, this should be specified in the explanation that there is no individual identification of/safety plan for participant responses.

Regardless of the above, provisions should be made to offer resource referral information in all studies that involve assessment of SIB. The consent form should warn participants what types of SIB related questions they can expect to be asked, whether or not there will be individual feedback, and refer to a resource referral sheet that will be offered (at a minimum).

Also, a check-in with the participants (e.g., asking whether they wish to continue, whether they wish to be immediately connected to the referral information) may be required at several points throughout SIB related assessments.

Sample Safety Plan

Here is an example of a safety response plan. You may use it as a guide when creating your own safety plan, editing it as appropriate for your study.

Screening Documents and Consent Form:

The UCSF IRB has determined that questions regarding SIB may not be included in participant pool screening forms, or in other screening related processes which take place prior to informed consent. When such questions are used, they must be included within the main application/protocol, with appropriate justification and other related elements as described above.

If responses will not be individually assessed (e.g. such as for an online study), the consent form should clearly convey this, along with a note of resource referral information. For example:

Your responses will not be individually identified, so we will not be providing you with personal feedback or referrals based on any of your answers. If you are worried about your mood, please refer to the attached resource referral information sheet. [Or, where SIB is more likely, If you have been thinking about death or suicide, we encourage you to contact the National Suicide and Crisis Lifeline by dialing 988 (US residents only).]

If responses will be individually assessed (e.g. such as for in-person or identifiable online studies) the consent form should explain what the options are should the person become uncomfortable or upset during the study procedures, including reference or resource referral information and/or in-person referral.

Confidentiality Limitations: If applicable (e.g. if the participant can be individually identified and there is a safety plan in place) the Confidentiality discussion should explain limitations related to assessment, and potential reporting, of SIB.

Resources

UCSF-Related

Online and Phone or Text Resources:

  • 988 Suicide and Crisis Lifeline, a three-digit dialing code that routes callers to the National
  • Suicide Prevention Lifeline, and available Twenty-four hours a day, seven days a week. Individuals also have the option to text if they prefer, and can send any message to 988 to be connected with a crisis counselor.
  • The 988 Lifeline also offers Spanish call, text, and chat services. When texting 988 in Spanish, individuals will be asked to type Ayuda to connect with a Spanish-speaking counselor.
  • www.suicidepreventionlifeline.org

FAQ

Is this guidance applicable to all studies, or just studies specifically focused on mental health?

This guidance is applicable to all studies that directly assess and/or include measures that gather information about SIB.

Why is the IRB asking for a risk mitigation plan? Is it OK to just simply follow the local clinic’s procedures?

Appropriate suicide risk assessment and management plans are essential in reducing the likelihood of a completed suicide.  The Belmont Report’s principal of beneficence requires researchers to maximize potential benefits to participants and minimize possible harms to them. Therefore, research studies which inquire about SIB, or conduct research in an environment where such disclosure from participants may be likely, require additional monitoring of participants’ responses. Respecting local customs/clinic procedures are important. A robust risk mitigation plan and suitable provisions for assessing and handling risks of SIB will depend on the nature of the research.

What information should be included in my study application for my SIB risk mitigation plan?

Researchers should first consider whether inclusion of measures that elicit information about SIB is necessary to answer the research questions. It may be that the researchers can still collect necessary data about mental health without directly assessing SIB.  If SIB related measures need to be included, then the risk mitigation plan should be tailored to the specific project and take into consideration some of the following:

  • Is SIB directly or indirectly assessed (e.g. planned use of the PHQ-9 vs. Open- ended question about depression in general);
  • Can responses be connected to the individual (anonymous online survey, vs. Identifiable surveys collected in a focus group, vs. In-person interview)
    • If researchers will know the identity of participants (e.g. identifiable online survey or interviews), then referral alone is insufficient as a way of protecting the participant and more may be needed related to assessment and potential reporting of SIB. Please note that international studies should follow local guidelines and best practices for international research.
    • If the researchers do not know the identity of the participants the consent form should clearly convey this and referral to *988 and/or other online resources may be appropriate. Please note that international studies should refer participants to their national, local resources
  • Study population (e.g. high-risk and/or vulnerable populations)
  • Qualifications of the study team to directly assess SIB responses (e.g. licensed psychiatrists, counselors, social workers, etc.);
  • Resources available (online referrals vs. In-person; and training/oversight of the study team).
  • The plan must be tailored to each specific study
Can you provide an example of an acceptable plan?

There have been some excellent plans provided in recent IRB applications. 

 

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