Confidentiality, Participant Protection, Human Subjects

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

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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)

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)

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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