Recommendation

Research Organization

Sponsors

Research ERBsa

Investigators

Research Participants

Accreditation Programs

Relevant Regulationsb

7.3 Groups addressing bioterrorism response mechanisms and research should pay special attention to the protection of research participants.

X

X

X

X

 

NOTE: Within the table, entities with a primary responsibility for the implementation of committee recommendations are indicated by an X. In several instances, other elements within an HRPPP may possess a secondary role in the systemic implementation of the recommendation (e.g., the Research ERB); however, to preserve the clarity of the table, only primary relationships are indicated. Likewise, while the pursuit of a recommended action may be facilitated by a government organization, this indirect role is not represented within the table.Some recommendations are contained within both tables due to their multistep nature or substantial overlapping responsibility.

a In accordance with Recommendation 3.1, Research Ethics Review Board (Research ERB) is used to designate the traditional IRB panel.

b The relevant regulations are provided for reference. Unless otherwise noted, the committe recommendations can be implemented without further promulgation or revision of regulations. In some instances, the development of guidance documents directed at specific issues may be useful to facilitate the recommended action.

c If it is determined through the evaluation of the suggested demonstration programs covering lost income due to temporary or permanent disability resulting from research harm that a federal insurance program is the appropriate solution to broad implementation of this responsibility, Congressional intervention could be required (see Chapter 6).



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