Behavioral Research

Plans for responding to unexpected suicidality

A plan to ensure that timely and appropriate follow-up of research participants who are at increased risk for potential suicide must be included in the research protocol, including a plan to train study staff in implementation of the safety protocol. The following questions and items should be addressed in the research protocol

1. When will questionnaires with questions about suicide be obtained, and by whom?
2. How soon after the questionnaires are administered will participant responses be reviewed and by whom?
3. If, based on the questionnaires or other study procedures a participant is suspected of having suicidal intent, how will the PI be notified?
4. Describe the plan for responding to potentially suicidal participants and for determining which subjects to direct towards appropriate mental health resources.

Participants at Higher Risk for Suicide

Some groups of research participants, such as adolescents who have made a suicidal attempt, or depressed mothers, are at higher risk for suicide. A number of human subjects considerations apply to research with these highly vulnerable individuals, including recruitment that avoids coercion in recruitment and obtaining informed consent, participants' expectations and assumptions regarding the research, offering of alternative treatments, and clarifying the limits of confidentiality.

Plans for the high risk suicide subject

Investigators contemplating conducting a study that will intentionally target subjects at higher risk of suicide should first consult NIMH's webpage Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers. This page has extensive advice, references to key literature and links to other resources.

The protocol should clearly distinguish between the risks of the proposed study interventions and measures and the prospective risks faced by the subject population being studied. For a review and discussion of these issues, see:

• King, C.A., & Kramer, A.C.: Intervention research with youths at elevated risk for suicide: Meeting the ethical and regulatory challenges of informed consent and assent. Suicide and Life-Threatening Behavior, 38:486-97, 2008

As with participants with unexpected suicide risk, once the research team learns of immediate suicide risk, the team is then obligated to make timely and appropriate efforts to assure participant safety.

1. When will information about suicide be obtained, and by whom?
2. How will participant responses be reviewed and when?
3. If a participant is suspected of having suicidal intent, how will the PI be notified, and how will the participant be directed towards securing appropriate mental health resources?
4. If a participant seems unwilling/unable to secure mental health resources on his/her own behalf, how will the research team see that the necessary level of support is in place for that participant?

Adverse Event Reporting in Behavioral Research

Adverse event reporting in research on suicide or depressed individuals should be tailored to the individual study. If the study involves individuals with a high risk of suicide, then a suicide would not be unexpected. In a study with healthy adolescents, the event would be unexpected, and therefore potentially reportable. Either way, for a suicide or suicide attempt to be reportable, this would have to be at least possibly related to the study intervention procedures. In most circumstances, this would not be the case. For more detailed guidance on adverse event reporting, see: Reportable Events page and IRB SOP 408.

Model Plan for Implementing Suicide Risk Management in a Clinical Research Protocol

This plan was developed for a particular protocol and may not provide appropriate guidance for all protocols involving measures that evaluate suicidal thinking. However, it is included as a guide to inform the development of a suitable plan for other protocols.

Suicide Safety Plan: The XXX Study After the CBCL, FIRST and BDI-II have been completed, and before the caregiver leaves the session, check the following items/scores:

• CBCL: #91 ("talks of killing oneself"); if endorsed as "sometimes" or "often" true, implement plan for CHILD.
• If FIRST items referring to suicide or domestic violence are endorsed, ask caregiver if this is about them personally or someone else in the family. If about them personally, after all measures are completed, implement plan for CAREGIVER.
• BDI-II #9 (suicidal thoughts); #14 (worthlessness); if positively endorsed, implement plan for CAREGIVER.
• Total the score for the BDI-II; if >20, implement plan for CAREGIVER.

Note: CHILD and CAREGIVER plans are to be implemented at the end of the assessment session.

CHILD Plan Ask caregiver for more details about child's talking of killing him/herself.

• When did this occur?
• Under what circumstances?
• How often has the child spoken of killing him/herself?
• Does the child have access to a way to harm him/herself?
• Notify Dr. Mental Health Provider (C: xxx-xxx-xxxx/P: xxxxx) or Dr. Principal Investigator (C: xxx-xxx-xxxx/P: xxxxx) about findings from the CHILD PLAN to determine next steps.

CAREGIVER Plan Ask caregiver for more details about his/her thoughts of harming self and/or feelings of worthlessness.

• How often have they felt this way?
• When did this start?
• What's going on in his/her life right now? Is the caregiver engaged in counseling or other therapy for depression?
• If yes, elicit more information about this.
• Does the caregiver have a way to harm him/herself?
• Does the caregiver have a plan to harm him/herself?
• Notify Dr. Mental Health Provider (C: xxx-xxx-xxxx/P: xxxxx) or Dr. Principal Investigator (C: xxx-xxx-xxxx/P: xxxxx) about findings from the CHILD PLAN to determine next steps.

Regardless of the outcome of an assessment for suicidality, give an Information Card to the caregiver. Then, after the session, complete the Suicidality Response Log to detail steps taken to ensure safety, including notification of the PI.

Research in Schools

Research conducted in schools, or involving information provided from school personnel such as teachers, is governed by additional research regulations in addition to those of the Common Rule. These regulations are known as the Family Educational Rights and Privacy Act, or FERPA, also known as the Buckley Amendment or HIPAA for schools. The FERPA regulations govern the release of student records, in either de-identified or identified forms, to organizations outside the schools. This includes research conducted by outside organizations such as CHOP.

What do schools require?

The requirement for school district approval is typically waived when the investigator is recruiting a very limited number of children from a particular school (or district) and a large number of schools throughout the Delaware Valley are participating.

Regardless of the type of high level administrative approval necessary to conduct research in schools (within the Philadelphia SD or in other districts, charter schools, or private schools), it is essential that the building principal provide written authorization for the investigator to contact a professional within the school for the purposes of involving that individual in the study. The principal has the right to pass this responsibility on to his or her supervisor (e.g., the superintendent). When there are a large number of schools anticipated or the exact schools that need to be approached isn't known at the time of protocol submission to the IRB, it becomes the investigator's responsibility to determine the requirements for authorization from each school during the study conduct. The protocol and application should specify how the investigator will execute and document this process during the study.

Research where schools are peripherally involved

Some research is not conducted in schools but information from the school or a professional in a school is needed as a component of the research. The consent form (or a signed letter authorizing release of information) should provide sufficient documentation for the school to release information to CHOP.

Since the research doesn't involve recruitment of subjects from the school but simply requires information from school professionals about subjects of the research recruited outside of the school, the requirements for school permission may be more flexible (e.g., may not require district IRB approval).

How can investigators obtain the cooperation of the school?

Principals and teachers are more likely to offer their approval if they are provided with:

• a letter introducing and briefly summarizing the study, including the procedures to take place in the school; and
• evidence that the parent has consented to the child's participation in the form of either:
  • a copy of the signed parental consent form; and/or
  • a letter signed by the parent indicating that the parent offers consent for the school to participate in the study.

Is the teacher a subject of the research or are they a third party?

The nature of the information gathered about the teacher will determine whether the teacher is a "third party" or a subject of the research. The teacher does not become a subject of the research until the investigator obtains information about the teacher that is both private and individually identifiable. Identifiable means readily identifiable, not possibly or potentially identifiable. If the teacher does not meet the definition of a research subject, then they are simply a third party who is providing information about the subject.

This means that if the teacher is completing questionnaires and surveys about a student, the teacher is not a research subject and there is no requirement for their informed consent or documentation of consent. The act of completion of the questionnaires, surveys, or other materials about the research subject/student is sufficient evidence that they have agreed to participate as a third party.

What type of information should be included in the application or protocol?

The CHOP IRB assumes that those conducting research in schools will have completed CITI training for research in schools, and will be informed about FERPA. Other issues that should be addressed include:

• Plans to obtain information from teachers about individual students should be in accord with FERPA and with local educational research approval practices. This requirement will usually be met by having the informed consent document specify what information is being released by the school. The parent's signature on the consent form should provide sufficient documentation of their consent for the release of the information.
• If research is to be conducted within schools within the Philadelphia School District, a letter of approval from the Research Review Committee is required before CHOP approval will be finalized.
• If research is to be conducted within schools outside the Philadelphia School District, written permission for the conduct of the research must be presented to the CHOP IRB for full study approval.
• The research protocol must describe the process for how study personnel will contact school personnel for research participation, e.g., the school principal, prior to contacting teachers to invite research participation.
  • The principal should approve the researchers' request to contact the teacher and a plan developed for how the approval will be documented.
• The role of the teacher or other school professional in the research should be clearly presented.
  • If the teacher is acting as a third party in the research, there is no requirement for the teacher to provide informed consent or to document consent.
  • If in addition to collecting information about a student the researcher is also collecting private, personally identifiable information about the teacher, then the teacher's formal written consent must be obtained prior to participation unless the IRB waives the requirement for documentation.

Additional Requirements for Research Supported by the Department of Education:

• All instructional material - including teachers' manuals, films, tapes, or other supplementary instructional material - which will be used in connection with any research or experimentation program or project must be available for inspection by the parents or guardians of the children engaged in such research.
• Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.
• Children are persons in enrolled in research not above the elementary or secondary education level who have not reached the age of majority as determined under state law.