CONFIDENTIALITY AND SAMHSA PARTICIPANT PROTECTION / HUMAN SUBJECTS

General Policy

All of the University of Florida’s (UF) research and evaluation activities are guided by the ethical principles contained in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and / or the ethical standards recognized by the funding source, in this case DHHS, federal statute 45 CFR 46. As such, all activities including human participants must be reviewed, revised if needed, and approved by the UF’s Institutional Review Board prior to the collection of any data. All studies must be approved at least annually with all interim changes to the data collection instruments or evaluation procedures requiring written approval before they occur. In addition, all principal investigators and all evaluation staff must undergo annual training or recertification in procedures and principles related to the protection of human participants to ensure that all are familiar with such and what is required in the event of an adverse incident. In compliance with the GFA, a Certificate of Confidentiality will be sought for this project.

  1. Protect Clients and Staff from Potential Risks
  • Identify and describe any foreseeable physical, medical, psychological, social, and legal risks or potential adverse effects as a result of the project itself or any data collection activity.

Risks due to the evaluation:

The foreseeable risks to participants, i.e., children, youth, and their foster, relative, or biological caregivers are the possibility of some psychological discomfort in answering questions contained in the surveys. This risk is no greater than risk from standard psychological assessment. The second risk to children, youth, and their caregivers is that of confidentiality.

No additional risks to staff are anticipated as a result of data collection.

  • Describe the procedures you will follow to minimize or protect participants against potential risks, including risks to confidentiality.

Risks due to the evaluation:

Risks of psychological discomfort - will be addressed by allowing participants to skip questions which make them uncomfortable, by taking breaks if needed, or terminating the interview.

Risks to confidentiality – as part of the informed consent process, participants will be informed in the consent form that the information they provide will not be shared with others in ways that they can be identified, except in instances in which they pose a danger to themselves or others or there is unreported child abuse.

All data sheets containing confidential information will be kept in locked filing cabinets. At the point of data entry into the National Evaluation system, an evaluation identification number will be assigned to each participant which is not based on personal identifiers, so that names and other identifying information are not maintained electronically. For follow-up purposes, a master list of participant names and evaluation identification numbers will be maintained in a separate locked filing cabinet. All reporting of data will be done in the aggregate.

  • Identify plans to provide guidance and assistance in the event there are adverse effects to participants.

Risks due to the evaluation:

In the case of an adverse event, emergency needs will be addressed by contacting 911. For urgent, but non-life threatening, events, the participant will be assisted in contacting their therapist or case manager for further support. All such events will be reported to the University of Florida’s Institutional Review Board.

  • Where appropriate, describe alternative treatments and procedures that may be beneficial to the participants. If you choose not to use these other beneficial treatments, provide the reasons for not using them.

Children, youth, and their caregivers who do not give consent or assent to participate in the evaluation will receive services without penalty.

  1. Fair Selection of Participants
  • Describe the population(s) for the proposed project.

The priority population to be served by the SAMSHA Expansion group consists of youth, ages 10-17 with a recent admission to emergency level psychiatric services. These youth will be residents of Clay, Duval, or Nassau counties in Northeast Florida. Sixty-six percent are anticipated to be Caucasian, 29% are expected to be African American, and five percent are from other racial and ethnic groups. In terms of gender, approximately 2/3s are expected to be male and 1/3 are expected to be female. Fourteen percent are expected to be Latino/a. The priority population includes foster children.

  • Explain the reasons for including groups of pregnant women, children, people with mental disabilities, people in institutions, prisoners, and individuals who are likely to be particularly vulnerable to HIV/AIDS.

Children and youth with serious emotional disturbance and their families are the population for this grant, consistent with GFA requirements. It is possible that this group will include pregnant women, persons with behavioral health disorders, or persons who may be vulnerable to HIV/AIDS. None of these health risk factors are the specific target of the proposed project. If these issues were identified, these people would be referred for appropriate treatment.

Incarcerated persons will not be a population for the proposed project.

  • Explain the reasons for including or excluding participants.

Children with or at risk of SEDand have experienced a recent emergency inpatient psychiatric placements, and their caregivers, are included because this is the population identified in the cooperative agreement. No participants will be excluded from participation in the evaluation because of their behavioral health issues, racial or ethnic background or socioeconomic status.

  • Explain how you will recruit and select participants. Identify who will select participants.

The JSOCI will be the a single point of access for information on the services being provided through this grant, however, partner agencies such as Mental Health Resource Center, Partnership for Child Health, Baptist Healthcare, and LSF Health Systems will provide support to youth and their families through this grant in Clay, Duval, and Nassau counties. All families who are eligible to participate in grant funded services, will be asked to participate in the national evaluation and asked to provide their informed consent. Project staff will be trained by evaluation staff to administer informed consent to willing caregivers. If families agree to participate, contact information, consent forms and demographic and diagnostic information, currently captured on the Enrollment and Demographic Information Form (ORC Macro International, 2004), will be forwarded to the evaluation team.

Caregivers will be asked to provide their informed consent so that they can be interviewed about their child and their family life. Youth will be asked for their assent to be interviewed. In the case of dependent children and youth, permission from the legal guardian will be obtained. If the participant agrees to be part of the study, they will have the consent form reviewed for them and will be asked to sign it. A copy of the signed consent form will be provided to the participant and a copy of the signed consent(s) will be forwarded to the evaluation team to be kept with the completed protocols. At the start of each data collection interview, informed consent will be reviewed with participants and they will be asked for their continued verbal permission to participate.

  1. Absence of Coercion
  • Explain if participation in the project is voluntary or required. Identify possible reasons why participation is required, for example, court orders requiring people to participate in a program.

Participation in the proposed study is completely voluntary and participants will be able to terminate their participation at any time during data collection or between data collection waves.

  • If you plan to compensate participants, state how participants will be awarded incentives (e.g., money, gifts, etc.).

Participant payment amounts were selected such that they show respect for the time the participants give, but not large enough to be considered coercive. Participants will be paid at the completion of each data collection interval. Payments to caregivers and youth will be made at baseline, six months, 12 months, 18 months, 24 months, 30 months and 36 months. Incentives will not exceed $20 at any data collection point.

  • State how volunteer participants will be told that they may receive services intervention even if they do not participate in or complete the data collection component of the project.

Participants will be reminded at each data collection point and will receive a copy of informed consent documents which indicate that receipt of services now or in the future is not affected by participation in the evaluation.

  1. Data Collection
  • Identify from whom you will collect data (e.g., from participants themselves, family members, teachers, others). Describe the data collection procedures and specify the sources for obtaining data (e.g., school records, interviews, psychological assessments, questionnaires, observation, or other sources). Where data are to be collected through observational techniques, questionnaires, interviews, or other direct means, describe the data collection setting.

The National Evaluation requires that data be collected from parents/caregivers who and from youth. Since the population includes children who may be in the child welfare system, caregivers may include natural parents, foster parents or residential facility staff members, relative caregivers, and/or adoptive parents. All eligible families and youth in the Longitudinal Child and Family Outcome Study will be interviewed in person at intake and every 6 months, up to 36 months, for a total of seven interviews. The interview protocols will include all the measures specified by the National Evaluation. Interviews will take placein whatever setting is most comfortable for the participants, typically in their homes.

  • Identify what type of specimens (e.g., urine, blood) will be used, if any. State if the material will be used just for evaluation or if other use(s) will be made. Also, if needed, describe how the material will be monitored to ensure the safety of participants.

Not applicable.

  • Provide in Attachment 2, “Data Collection Instruments/Interview Protocols,” copies of all available data collection instruments and interview protocols that you plan to use.

The data collection forms are included in Attachment 2.

  1. Privacy and Confidentiality
  • Explainhow you will ensure privacy and confidentiality. Include who will collect data and how it will be collected.

Cross-sectional data collection- the web-based data entry procedures used by the National Evaluation contractor assign a unique study identification number that is not related to personally identifying information. This number is assigned at the point of data entry and no identifiers are maintained electronically.

Outcome study – For caregivers and youth who agree to participate in the longitudinal outcome study, the number assigned through the web-based system will be used for all electronically maintained data. For follow-up purposes, a master list of these identification numbers and contact information will be maintained in locked filing cabinets at all times when not in active use.

  • Describe:
  • How you will use data collection instruments.
  • Data collection instruments will be used to provide descriptive information on children, youth and families served and for the analysis of outcomes.
  • Where data will be stored.
  • No identifying information will be stored electronically. Personally identifying information will be maintained in locked filing cabinets when not in active use.
  • Who will or will not have access to information.
  • Per UF IRB policy, only persons identified to the IRB as members of the evaluation team and who have completed human subjects training are allowed access to identified data. Representatives of the UF IRB, the federal Department of Health and Human Services, and the Florida Department of Health may also inspect identifiable information for compliance purposes.
  • How the identity of participants will be kept private, for example, through the use of a coding system on data records, limiting access to records, or storing identifiers separately from data.
  • All of these methods are used to protect participant confidentiality. Code numbers will be used for all electronically maintained data. These identifiers are completely unrelated to personal identifiers. Access to records is limited to authorized individuals who have completed approved human subjects protections training. Contact information for caregivers and youth enrolled in the outcome study will be maintained in a locked filing cabinet when not in active use.
  1. Adequate Consent Procedures
  • List what information will be given to people who participate in the project. Include the type and purpose of their participation. Identify the data that will be collected, how the data will be used and how you will keep the data private.

All federally required elements are provided to participants in oral and written form. Federal law requires that participants be provided with the purpose of the study, the amount of time required for participation, whether there will be remuneration for their participation, the risks and benefits of the study, how their information will be protected and the circumstances under which information would be disclosed (i.e., mandated reporting), the voluntary nature of participation, and who they should contact about the study or their rights as a research participant.

  • Explain how you will get consent for youth, the elderly, people with limited reading skills, and people who do not use English as their first language.

It is recognized by the evaluation team that families receiving services may have limited literacy in English or in their native tongues. To address linguistic differences, all consent forms will be available in Spanish as well as English. To ensure that families understand, consent forms will be written in the simplest possible language, at the 8th grade level or lower, and will be read with the participant. The person obtaining the consent will ask the participant to repeat the key elements of the consent to ensure they understand the study as well as their rights as a research participant.

All consent forms will be approved by the UF IRB. Potential participants will have the opportunity to have any questions they have answered to their satisfaction prior to signing the consent form. A copy of the signed form will be provided to the participant so that questions that arise after signing can be answered by the evaluation team or by the Institutional Review Boards.

  • Indicate if you will obtain informed consent from participants or assent from minors along with consent from their parents or legal guardians. Describe how the consent will be documented.

Informed consent and witnessed assent will be obtained from caregivers and youth, respectively. Caregivers will sign their consent forms, and both youth and caregivers will sign youth assent forms. The person obtaining consent will also sign consent forms. All participants will receive copies of the signed forms at the time they provide consent.

  • Include, as appropriate, sample consent forms that provide for: (1) informed consent for participation in service intervention; (2) informed consent for participation in the data collection component of the project; and (3) informed consent for the exchange (releasing or requesting) of confidential information. The sample forms must be included in Attachment 3, “Sample Consent Forms”, of your application. If needed, give English translations.
  • A sample consent form for the evaluation is contained in Attachment 3.

NOTE: Never imply that the participant waives or appears to waive any legal rights, may not end involvement with the project, or releases your project or its agents from liability for negligence.

  • Describe if separate consents will be obtained for different stages or parts of the project. For example, will they be needed for bothparticipant protection in treatment intervention and for the collectionand useof data?
  • Separate consents will be required for treatment and participation in the evaluation. For the evaluation a single consent form will be used. At each data collection point, the consent form will be reviewed with the participant and their continued participation will be orally requested.
  • Additionally, if other consents (e.g., consents to release information to others or gather information from others)will be used in your project, provide a description of the consents. Will individuals who do not consent to having individually identifiable data collected for evaluation purposes be allowed to participate in the project?
  • There are no other consent forms.
  1. Risk/Benefit Discussion

Discuss why the risks are reasonable compared to expected benefits and importance of the knowledge from the project.

The risks to participants are real but small. In general, risks are related to participation and receipt of services, rather than the evaluation. As noted earlier, potential evaluation participants will be assured that there will be no loss of current or future services if they choose not to participate in the evaluation. There are no anticipated physical or medical risks anticipated due to participation in this evaluation. The proposed study likely meets minimal risk criteria, in that it is no more intrusive than standard psychological assessment procedures. It should be noted that data collectors are required to report if a participant is thought to be a danger to him/her self or others or if there is suspected active child abuse occurring. This information will be contained in consent forms and shared with the participant prior to their signing any consent forms.

Participants will be informed that there are no expected benefits that they will receive from participation in the study, although it is hoped that our study will inform us about how to better serve families in the child welfare system that have a child with serious emotional disturbance.