Confidentiality, Participant Protection, Human Subjects Mary Phillips, M.A. Kenneth M. Coll, Ph.D. Brenda Freeman, Ph.D.

Part of Section D of the NOFA : Evaluation and Data “Applicants must document their ability to collect and report required data”, including: –Evidence of involving community key informants (e.g., families, leaders) in the process

Such Involvement will include Descriptions of Plans for: –Data Collection –Data Management and Analysis –Data Reporting –Existing Approach to the collection of data

Data Collection Confidentiality and Participant Protection (of Human Subjects) through: –Informed consent from the Participant, including: Purpose and background Procedures for collecting the data Description of risks/discomforts Benefits Costs Payments Questions Voluntary consent (signed) Participant Bill of Rights (Safety Monitoring Plan)

Data Management and Analysis Confidentiality and Participant Protection (of Human Subjects) through –Data entry person(s) signs a confidentiality statement –Works from a secure location and computer –Trains in HIPPA guidelines –Enters data without identifying information (e.g, names, other identifications)

Continued Confidentiality and Participant Protection (of Human Subjects) through –Securely storing raw data in a locked file cabinet for a specified period of time then shredded

Continued- Inclusion of Children Informed consent is needed from both the youth (if at an age of understanding) and the caregiver(s) SEE EXAMPLE

Data Reporting To Whom? –Key informants (e.g., families, community leaders and members, service providers) How often? –Monthly –Quarterly –Semi-annually In what formats, venues? –e.g., Radio, newspaper, executive summaries, newsletters

Existing Approach to the Collection of Data Description of Current Management Information System

Data Collection Instruments/Interview Protocols? See examples Reliability and validity of evaluation methods and instruments in terms of gender/age/culture of the target population –Community based-committee in development stage –Focus groups –Piloting