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Responsible Research: A Systems Approach to Protecting Research Participants (2002)
Institute of Medicine (IOM)

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. "Executive Summary." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.

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Responsible Research: A Systems Approach to Protecting Research Participants

TABLE ES.2 Recommendations That Can Be Implemented in the Absence of Direct Government Action

Recommendation

Research Organization

Sponsors

Research ERBsa

Investigators

Research Participants

Accreditation Programs

Relevant Regulationsb

2.2 Establish a pervasive culture of research excellence that includes clear lines of authority and responsibility for participant protection.

X

X

 

2.3 Provide the necessary financial support to meet the obligation to ensure HRPPPs have adequate resources.

X

X

 

45 CFR

46.103(a)(b)

2.4 Ensure that investigators, IRB members, and other individuals substantively involved in human participant research are adequately educated to perform their respective duties.

X

X

 

X

45 CFR

46.107(a)

and

46.111(a)(1)

2.5 Foster communication with the general public and research participants to assure that the protection process is open and accessible to all interested parties.

X

X

 

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