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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:

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Confidentiality, Participant Protection, Human Subjects

Mary Phillips, M.A.

Kenneth M. Coll, Ph.D.

Brenda Freeman, Ph.D.


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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


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Such Involvement will include

  • Descriptions of Plans for:

    • Data Collection

    • Data Management and Analysis

    • Data Reporting

    • Existing Approach to the collection of data


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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)


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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)


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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


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Continued- Inclusion of Children

  • Informed consent is needed from both the youth (if at an age of understanding) and the caregiver(s)

  • SEE EXAMPLE


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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


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Existing Approach to the Collection of Data

  • Description of Current Management Information System


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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


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