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Responsible Research: A Systems Approach to Protecting Research Participants
Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, Editors, Committee on Assessing the System for Protecting Human Research Participants

Responsible Research.The protection of individuals who volunteer to participate in research is essential to the ethical conduct of human research. In response to mounting concerns about the well-being of research participants and the ability of current approaches to ensure their protection, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of the national system for providing research participant protection. The resulting analysis emphasizes the responsibilities and functions of human research participant protection programs (HRPPPs), providing substantive descriptions of the activities intrinsic to a robust protection program. In its work, the committee suggests a systems approach to providing protection, offers several broad recommendations for reform, and proposes practical suggestions to improve the oversight of human research at the institutional level.

A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948

Moral Science - Protecting Participants in Human Subjects ResearchMoral Science Protection Participants in Human Subjects Research Report
The Presidential Commission for the Study of Bioethical Issues recently issued a report, Moral Science – Protecting Participants in Human Subjects Research. One of the Commission’s recommendations was that the government “improve accountability through public access.” Specifically, the report stated, “To enhance public access to basic information about federal government-funded human subjects research, each department or agency that supports human subjects research should make publicly available a core set of data elements for their research programs – title, investigator, location, and funding – through their own systems or a trans-agency system…(page 53).... “For example, the Department of Energy’s Human Subjects Research Database provides a wide range of protocol-level information about Department of Energy-supported human subjects research, including funding for and number of subjects involved in specific studies.” (page 50)

DOE maintains, in a publicly available database, information on non-exempt research projects funded by DOE, conducted in DOE facilities, performed by DOE personnel, or involving information on DOE or DOE contractor personnel. Project information is obtained annually from a questionnaire completed on-line by principal investigators conducting work for DOE. Data are available from 1995 through 2011.

The database was an invaluable tool in responding to the request from the Presidential Bioethics Commission for more detailed information on DOE human subjects research projects. The Oak Ridge Institute for Science and Education (ORISE) maintains this database for DOE, which can be found at: http://www.orau.gov/hsrdreport/.

DoD Issued 'Instruction' for Adherence to Ethical Standards in DoD-Supported Research
The Department of Defense reissued a directive describing the duties and responsibilities of investigators conducting DoD-funded human subjects research as an "instruction," a type of document that provides details on how to implement agency policy. The instruction follows the Common Rule, and references it as well as the Belmont Report, but also contains provisions applicable only to DoD research. Among them are "unique" limitations on waivers of informed consent and "additional protections for confidentiality." The instruction is effective from the date of publication.

Best Practices for Reviewing Classified Human Subject Research (HSR) at DOE Sites
This document describes the specific considerations that are unique to classified human subject research (HSR) at DOE sites. It provides guidance for everyone engaged in such research, and is a living document. Check back periodically to make sure you have the current version.

DOE Requirements for Protecting Personally Identifiable Information (PII)
Links to resources and checklists pertaining to PII at DOE sites.

Web Sites of Interest
A list of Web sites related to human subjects research.

International Issues
Links to sites that discuss international issues of importance.

Genome Research Resources
Links to resources for both the DOE genome research program as well as the national genome research program.

Meetings and Conferences
Links to sites that list meetings, conferences, and other educational opportunities specific to human subjects research offered by various organizations.

Workers as Research Subjects: A Vulnerable Population
by Susan L. Rose, PhD and Charles E. Pietri, BA (J Occup Environ Med. 2002; 44:801-805)
Workers should be considered as a vulnerable human subjects research population since they require special protections. The Code of Federal Regulations “Common Rule for the Protection of Human Subjects In Research” does not offer adequate definition of this Issue. Currently there is no formal ethical framework that addresses the unique vulnerability of workers (or former workers) who participate in research studies. This article addresses this concern and Is based on a larger report published by the U.S. Department of Energy. Further, even though workers may be study subjects for legitimate political, social, and scientific reasons, meritorious science and adherence to the Common Rule must be the expectation.

Content reviewed: February 6, 2014