Guidelines for Developing a Data and Safety Monitoring Plan: Appendix D

Sample of an Initial DSM plan for a Prevention Clinical Trial

Data and Safety Monitoring Plan (DSMP)
A Drug Abuse Prevention Intervention

PI: Sara Bellum
R21 DA11111-01

Drug Abuse Prevention Intervention Project is designed to develop and test a state-of-the- art multi-level intervention for youth at risk for substance use and related problems. The primary aims of the project are to: (1) develop an intervention for youth and families with risk factors for substance use and related problems, (2) evaluate implementation feasibility and initial efficacy of the intervention in a pilot study, (3) develop and refine measurement methods for assessing key mediational processes, and (4) test an integrative theoretical model that hypothesizes how youth, family, and community factors are linked to adjustment and substance use outcomes.

Participants will be drawn from 90 families with a focal middle school-aged youngster. In the pilot efficacy study, half of the families will be assigned randomly to receive the preventive intervention and half will serve as controls. The study also blocks on gender. All families will have the opportunity to participate in existing support programs available in the community.

At the conclusion of funding, we expect that the Project will pave the way for a comprehensive prevention research program that will evaluate intervention efficacy on a larger scale.

The following descriptions are included in this report:

  1. Potential adverse events resulting from participation
  2. Procedures to safeguard against those events
  3. Response procedures for adverse events
  4. Reporting procedures for adverse events
  5. Oversight

1. Potential adverse events resulting from participation

Adverse events identified as possible outcomes for all of our study subjects participating in the assessment:

  1. possible violation of confidentiality,
  2. possible discomfort due to assessment procedures,
  3. possible embarrassment in disclosing sensitive personal information,
  4. possible disclosure of information about intended physical harm to victims or abuse of children that would need to be reported to the child welfare agency and an investigation of the allegations(s) and further action, as indicated, that could ensue,
  5. possible dissatisfaction with the assessment procedures, and
  6. possible dissatisfaction with the intervention activities.

2. Procedures to safeguard against adverse events

All data collection protocols include a form on which research staff members record any problems with the data collection, concerns about the child or family, or unusual occurrences during the collection. These forms allow our research staff an opportunity to quickly review and respond to any possible concerns or adverse affects.

Informed Consent
All youngsters and their parents will be required to read and sign detailed assent/consent forms before participating in the study. Participants are advised of the voluntary nature of participation and of their right to withdraw from the project at any time and to require that information about themselves and their family be removed from data analysis. Each study family receives a verbal and written description of the study. Experienced research staff members are available at all points of the study process to answer questions and to explain assessment procedures, uses to which the data will be put, and confidentiality of data. As our population includes a significant number of Latino families, all project documents, including the consent/assent forms, will be available in both Spanish and English. If a staff member determines that a participant's reading skills are limited, all materials will be presented verbally—in Spanish or in English, as indicated—and questionnaires will be administered as an interview.

Confidentiality Safeguards
To ensure confidentiality, all information will be coded so that it cannot be associated with any individual. A master sheet, with individual names and their respective code numbers, will be kept in a locked file that can be accessed only under supervision of the Principal Investigator (PI). All data entered into the computerized database will be identifiable by subject code number only. All Center staff and volunteers sign confidentiality agreements. No one outside of The Center will have access to records identifying subjects' names at any time. The information gathered will be used only for scientific, educational, or instructional purposes.

Mandatory Reporting Safeguards
Procedures to prevent the violation of confidentiality in accordance with reporting requirements are limited by the mandatory nature of these requirements. Subjects are informed in the consent document that staff must report to authorities 1) physical injury to any child caused by other than accidental means, as required by ORS 419B.005 through 419B.040; and 2) information from a study participant which leads staff to believe a person is in imminent danger of physical harm. Staff will inform parents or guardians if, in the judgment of the professional staff, their child (under 18) is in imminent danger of trying to kill him/herself.

Staff Training Safeguards
Every employee or volunteer at The Center is required to participate in a mandatory, ongoing training program on human subject protection. Key personnel are required to complete a more extensive, three-part training/testing program, which focuses on the Belmont Report, NIH's online training course, and a video produced by NIH and the FDA.

Research staff receive training specific to each assessment tool. For assessments requiring home visits, new data collection staff members are paired with experienced staff members for the first 2 weeks.

All project staff meet on a weekly basis for ongoing training, monitoring of protocol, and problem solving. Questions regarding data collection are promptly referred to the PI.

Research and clinical staff are trained to identify events that would fall under mandatory reporting guidelines. These include physical injury to any child caused by other than accidental means or information from a study participant that leads staff to believe a person is in imminent danger of physical harm.

Data Safeguards
Access to Center buildings is restricted. Reception staff members supervise public entrances during normal operating hours. All space accessible to the public is separated from research offices by locked, coded doors. All staff entrances are secured with locked, coded doors. Staff entry codes are changed regularly.

The Center computing system is protected from outside access by a two-tiered firewall system: the Linux Server running Netfilter is backed-up by the Windows Server running Microsoft Internet Security and Acceleration Server (ISA). The Netfilter and ISA firewall software allows us to define rules that block any attempt to compromise the system. Both servers maintain logs and generate reports of access attempts, which are reviewed by the Network Administrator.

During the analysis of the data, all identifying information with the exception of the subject identification number is removed from the data. No information about the identities of study participants will be published or presented at conferences.

Discomfort with Assessment Procedures or Disclosure Safeguards
During the course of participation in the research, a participant may have questions about the assessment procedure. An project staff member or therapist will be available to answer questions. Should a participant feel embarrassed or uncomfortable asking questions of an project staff member or therapist, a professional in the community will be available on a consultant basis to act as an advocate for families. The professional will not be hired by the project but will be available to handle problems encountered as a result of this project.

To prevent discomfort or embarrassment, staff undergoes considerable training in building rapport and skillful interviewing. Higher-level research staff members are available to answer questions subjects may have about the assessment. Subjects are informed prior to the assessment that they may choose to skip any question or procedure they find uncomfortable. If any individual becomes overly distressed or distraught during the family assessment and/or interaction task, the assessment will be stopped immediately and an staff clinician will talk privately with the affected individual(s). Appropriate referrals will be made, as needed.

Dissatisfaction Safeguards
Participants will be encouraged to discuss with the project PI or interventionists any possible dissatisfaction with the intervention or assessment activities. Referrals to alternative community services will be made at the family's request or when it appears to be appropriate.

3. Response procedures for adverse events

Discomfort with disclosure
During initial training, staff members are coached by a staff licensed clinical psychologist to respond to embarrassment or discomfort in an appropriate and compassionate manner. If a subject participant experiences any other adverse reaction to the assessment, a staff licensed psychologist is available to assess and refer the subject to appropriate community mental or physical health providers. At the time of assessment, a community services resource list is available to all participants to take home with them and use in the event of a later adverse reaction for which they wish to seek help. Participants will also be encouraged to contact the project PI and other project staff in the event of a later adverse reaction and will receive specific written (in the form of a project description and PI's contact business card) and verbal instructions during the project consent procedures about how to do so, if needed.

Mandatory reporting
One serious adversity a subject may encounter is the possibility that staff must report to authorities the instances of physical abuse, neglect or threat of physical harm among participants to themselves or others. To anticipate these concerns, the project has established procedures and guidelines to respond to risk disclosures and crisis situations among subject families. Assessment staff will be trained to recognize risks or crises that require immediate reporting response. Four types of situations require special procedures:

  1. Suicide thoughts or attempts
    Two types of risks will be addressed in the project: (a) ideation or the presentation of thoughts or interest in suicide, and (b) action, which includes both thoughts of suicide as well as the presence of a plan and means to accomplish a suicide act.
    Assessment staff: As the participant completes the instruments, staff will be required to review identified instruments and items for response values that indicate concern. Based on the response values, staff will be required to review disclosure information with the PI and, if deemed necessary, conduct follow-up inquiry with the participant to further determine level of risk. If the participant is determined to present immediate risk of suicidal action, a clinical psychologist on the project will be engaged to develop a safety plan with the client and to make indicated referrals. If the disclosure is the result of one of the written assessment items in the project, the psychologist will contact the family by telephone. If the disclosure occurs during an on-site session, the staff member will follow through with an in-person interview to clarify the presence of suicidal risk or develop a plan of action. In the most extreme cases of risk, the psychologist then assumes follow-up responsibility for the plan of action with the family.
    Intervention Staff: During treatment sessions, interventionists are trained and required to identify suicidal risks in both the domains of ideation and action. In either situation, interventionists will be required to engage the clinical psychologist on the project to verify the presence of individual risk in the case.
  2. Abuse
    Child abuse concerns may arise from any or a combination of the following sources: (a) the parent or child verbally indicates that abuse has occurred or is occurring, (b) the parent or child answers one or more assessment questionnaire items suggesting the possibility of abuse, (c) the child is observed being treated abusively during an assessment or intervention session, (d) the child is observed with bodily injury (e.g. bruises, burns, black-eyes) whose origin appears to differ from the explanation given of the injury.
    Assessment staff: At any time during the assessment, if any of the above information lead staff to suspect abuse or neglect of children, steps are outlined for staff to obtain additional information and contact the project psychologist. Based on the information, the psychologist will advise staff regarding communication to the family, appropriate further inquiry, follow-up, and reporting.
    Intervention staff: At any time during intervention, if any of the above indicators of abuse lead staff to suspect abuse or neglect of children, the project's clinical psychologist is notified to review the information and determine next steps. If abuse is indicated, the project psychologist will develop a safety plan with the parents that may include a participatory report of abuse to protective services on behalf of the children and parents.
  3. Threat of danger to others
    The threat of danger to others includes disclosure of potential physical harm by a participant to others, including members of the participant's family or other individuals in the community.
    Assessment staff: At any time during the assessment, if any information derived through assessment lead staff to suspect a participant poses a threat of harm to others, steps are outlined for staff to obtain additional information and contact the project psychologist.
    Intervention staff: At any time during the intervention, if participants disclose information suggesting the threat of harm to others, the project's clinical psychologist is notified to review the information and determine next steps.
  4. Family crisis
    Family crisis involves a range of situations that threaten the ability of subjects to provide essential supports for their children. As part of our clinical practice, the project has developed guidelines for responding to family crisis within the scope of our project objectives that focus on parenting training skills and practice. Crisis situations that are appropriate for the project to cover include: problem behaviors of a child or siblings that have escalated, parent confusion in problem-solving new responses of their child to the curriculum, and disagreements between parents regarding curriculum implementation with children. Additional situations requiring clinical response in events not directly related to curriculum include domestic violence or marital crisis, mental health symptoms of parents or children such as depression and mania, and family environmental changes such as unemployment or homelessness.
    Assessment Staff. Assessors will be trained to recognize signs of family crisis and to consult with a clinical psychologist involved in the project. Together they will determine the best response to the family's needs, including referral, if so indicated.
    Intervention staff: Participants in the project will have emergency numbers to call if there is a crisis situation involving the parent's use of the curriculum tools that may have resulted in a problem situation that escalates, such as a major temper tantrum or violence to others in the household. Lead interventionists will be the first person parents attempt to reach, with the PI designated to back-up these needs.

In all situations that are referred to a psychologist, the written report is kept in a participant's confidential file for future reference.

4. Reporting procedures for adverse events

The anticipated potential adversity inherent in assessment is limited to those situations described above and is addressed by the timely intervention of a licensed clinical psychologist skilled in risk assessment and mandatory reporting requirements.

As a part of the ongoing statistical analyses conducted to evaluate the effectiveness of the intervention trial, the intervention and control groups will be routinely compared on several dimensions, including the occurrence of the type of adverse events described above. With any significant group difference, the relevant covariates will be thoroughly examined in order to understand more completely the relationship between the variables of interest and potential effects of the intervention. The results of our analyses, including the occurrence of adverse events, will be reported both to our IRB and to NIDA through annual progress reports. We will also report adverse events to others, as directed by our IRB or NIDA Program Official.

Reporting Procedure for Serious Unanticipated Adverse Events
In the event of an unanticipated serious adverse event, the project PI will ensure that these events are reported to the NIDA Program Official within 24 hours by phone, fax, and/or email and will submit a written report to the Program Official no more than two days later. The project staff will also utilize the following reporting procedures:

  1. When the grant staff and/or PI becomes aware of a serious adverse event, reporting requirements must be implemented in a timely manner.
  2. PI completes a Center "Adverse Event Reporting Form" and submits the form to the Human Subjects Officer at the Center.
  3. The Human Subjects officer immediately distributes the form to the following individuals or groups as required: Center Administrator, Center Management Committee, and Center IRB Officials.
  4. The Human Subjects Officer will convene an expedited meeting of the IRB either on site or via telephone. The IRB, with the input of the PI will review the study protocol and determine what further action to take based on the best interests of the participants and of the research.

5. Oversight

The Center Administration is responsible for the general oversight for all grant activities and will inform the grants about changes and requirements for the DSMP. Each intervention grant will have a yearly review of its DSMP by the Center IRB during the regular continuing review process, outlining the following points:

  • Reassessment of the risks and benefits to study participants
  • Participant recruitment, accrual, and retention
  • Data quality and confidentiality
  • Consideration of external scientific or therapeutic developments with impact on the safety of participants or the ethics of the study
  • Review any adverse events

The Center Administration will update the general DSMP procedures as needed.