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