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Confidentiality, Participant Protection, Human Subjects

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

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

  2. 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

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

  4. 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)

  5. 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)

  6. 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

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

  8. 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

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

  10. 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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