Bioethics & Research Regulation

The Role of State Law in Protecting Human Subjects of Public Health Research and Practice

Published Year: 
2003

Scott Burris, Lance Gable, Lesley Stone, & Zita Lazzarini, The Role of State Law in Protecting Human Subjects of Public Health Research and Practice, 31 J. L. Med. & Ethics 654 (2003).

SSRN
Article

Public Health Surveillance of Genetic Information: Ethical and Legal Responses to Social Risk

Published Year: 
2001

Scott Burris, Public Health Surveillance of Genetic Information: Ethical and Legal Responses to Social Risk, in GENETICS AND PUBLIC HEALTH: TRANSLATING ADVANCES IN HUMAN GENETICS INTO DISEASE PREVENTION AND HEALTH PROMOTION (M. Khoury ed., Oxford University Press 2000) (with L. Gostin & D. Tress).

Article

Genetic Screening from a Public Health Perspective: Three "Ethical" Principles

Published Year: 
2002

Scott Burris & Lawrence Gostin, Genetic Screening from a Public Health Perspective: Three "Ethical" Principles, in A COMPANION TO GENETHICS 455 (Justin Burley & John Harris, eds., Blackwell Publishing 2002).

Chapter

Population -- Based Surveillance and Research: The Role of State Law in Protecting Human Subjects of Public Health Research and Practice

Published Year: 
2003

Scott Burris, Lance Gable, Lesley Stone & Zita Lazzarini, Population -- Based Surveillance and Research: The Role of State Law in Protecting Human Subjects of Public Health Research and Practice (pt. 4), 31 J.L. MED. & ETHICS 654 (2003).

Article

Bioethics & Research Regulation

The Problem: 

Since the 1970’s, most U.S. research involving humans has been subject to a growing body of federal regulations (“the Common Rule”) that is intended to prevent harm and promote ethical research behavior. As a regulatory system, the Common Rule exhibits weaknesses in design and implementation. It:

  1. was adopted without a systematic effort to empirically assess the problem of harm to human research subjects;
  2. applies to multiple research disciplines without accounting for differences in the purposes, methods and risks of the research;
  3. deploys regulatory tools whose actual effectiveness in preventing human subject harm and abuse is unknown; and
  4. was implemented without new funding, and imposed largely unknown costs in money, lost research opportunities, researcher morale, and research efficacy.
Our Work: 

Our purpose was to redefine the issue of human subject protection as one of effective and efficient regulation. Without questioning the goal of safe and ethical research practices, we will focus policy and research attention on the question of how the current system works, and what alternative approaches might work better. We addressed three questions:

  1. What do we know about the problem of harm and abuse in research?
  2. What do we know about how institutional review boards operate, how the protective tools they use actually work, and the costs and benefits the system provides?
  3. What are the alternatives to our current approach?

Learn more by visiting our project site.

U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study

Published Year: 
2006

Scott Burris & Kathryn Moss, U.S. Health Researchers Review Their Ethics Review Boards: A Qualitative Study, 1 J. Empirical Res. Hum. Res. Ethics 39 (2006).

Article on SSRN
Article

Regulatory Paradox: A Review of Enforcement Letters Issued by the Office for Human Research Protection

Published Year: 
2007

Scott Burris & Jen Welsh, Regulatory Paradox: A Review of Enforcement Letters Issued by the Office for Human Research Protection, 101 Nw. U. L. Rev. 643 (2007).

Article on SSRN
Article

A Modest Proposal

Published Year: 
2009

Scott Burris & Corey Davis, A Modest Proposal, 9 Am. J. Bioethics W3 (2009).

Article

Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?

Published Year: 
2009

Scott Burris & Corey Davis, Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?, 9 Am. J. Bioethics 48 (2009).

Article on SSRN
Article

The Prisoner as Organ Donor

Published Year: 
2000

Mark Anderson, The Prisoner as Organ Donor, 50 Syracuse L. Rev. 951 (2000).

Article

 

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