Human Research Protections in Demographic

Research and the Social Sciences

Participant Notebooks

Table of Contents

I.    General Materials

•          Agenda
•          Ethical Standards of ASA

II.  Ethical Guidance and Federal Regulations in Human Subjects Protection 

•          Presentation: Overview of Ethical Underpinnings of Human Research Protections and Federal Regulations ¨C George Pospisil
•          The Belmont Report
•          Declaration of Helsinki
•          The Nuremberg Code
•          Code of Federal Regulations
•          Human Subject Regulations Decision Charts
•          Expedited Review Categories

III.  Key Concepts in Human Research Protections

•          Presentation: Key Concepts in Human Research Protections - Sally Hillsman
  •         Informed Consent Checklist
  •         Tips on Informed Consent
  •         Sample Informed Consent Form
  •         Methods for Conveying Consent
  •         Issues in Risk and Harm: Recommendations of the National Human Research Protections Advisory Committee
  •         Summary of Types of Harm and Ameliorative Measures
  •         Issues in Confidentiality: Recommendations of the National Human Research Protections Advisory Committee

IV.   Emerging Issues in Human Research Protections

•          Presentation: HIPAA and Research -  Linda Adair
•          Presentation: Third Parties in Research -  Virginia Cain

V.  Human Research Protections in Demographic Research

•          Presentation: Issues in International Research  -  Linda Adair
•          Presentation: Surveys ¨C Cross-sectional and Longitudinal - Sally Hillsman
•          Presentation: Use of Extant Data - Virginia Cain
  •         Inter-University Consortium for Political and Social Research (ICPSR), University of Michigan
  •         University of Wisconsin

VI.  The IRB Process and the Role of Review

•          Presentation: Oversight of Social and Behavioral Research - George Pospisil

VII. Overview and Discussion of Issues in a Demographic Study

•          Presentation: Ethical Issues related to the National Longitudinal Survey of Adolescent Health (Add Health) - Linda Adair

VIII.  Selected Readings

•          Issues in Accessing and Sharing Confidential Survey and Social Science Data, V. A. deWolf
•          Informed Consent and Survey Response: A Summary of the Empirical Literature, E. Singer
•          Confidentiality Assurances and Response: A Quantitative Review of the Experimental Literature, E. Singer, D. R. Von Thurn, & E. R. Miller
•          Ethical Challenges in Community-Based Research, P. A. Marshall & C. Rotimi
•          Searching for "Research Involving Human Subjects," I. A. Pritchard
•          Presidential Address: Informed Consent and Confidentiality in Survey Research, S. Presser
•          The Institutional Review Board: Its Origins, Purpose, Function, and Future, C. R. McCarthy
•          Executive Summary: Responsible Research: A Systems Approach to Protecting Research Participants, Institute of Medicine, National Academy of Sciences