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

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  • Confidentiality, Participant Protection, Human SubjectsMary Phillips, M.A.Kenneth M. Coll, Ph.D.Brenda Freeman, Ph.D.

  • Part of Section D of the NOFA: Evaluation and DataApplicants 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 AnalysisData ReportingExisting Approach to the collection of data

  • Data CollectionConfidentiality and Participant Protection (of Human Subjects) through:Informed consent from the Participant, including:Purpose and backgroundProcedures for collecting the dataDescription of risks/discomfortsBenefitsCostsPaymentsQuestions Voluntary consent (signed)Participant Bill of Rights (Safety Monitoring Plan)

  • Data Management and AnalysisConfidentiality and Participant Protection (of Human Subjects) throughData entry person(s) signs a confidentiality statementWorks from a secure location and computerTrains in HIPPA guidelinesEnters data without identifying information (e.g, names, other identifications)

  • ContinuedConfidentiality and Participant Protection (of Human Subjects) throughSecurely storing raw data in a locked file cabinet for a specified period of time then shredded

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

  • Data ReportingTo Whom?Key informants (e.g., families, community leaders and members, service providers)How often?MonthlyQuarterlySemi-annuallyIn what formats, venues?e.g., Radio, newspaper, executive summaries, newsletters

  • Existing Approach to the Collection of DataDescription of Current Management Information System

  • Data Collection Instruments/Interview Protocols?See examplesReliability and validity of evaluation methods and instruments in terms of gender/age/culture of the target populationCommunity based-committee in development stageFocus groupsPiloting


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