also be beneficial; (5) a description of how confidentiality of records will be maintained; (6) for treatment involving more than minimal risk, an explanation of the potential consequences resulting from participation in the research; (7) contact information for answering questions; and (8) a statement that the individual’s participation in the research must be voluntary, that refusal to participate will not result in a penalty or loss of benefits to which the individual is otherwise entitled, and that the individual may withdraw at any time.11 Additional information may also be required, depending on the specific nature of the research.12 The investigator must document that the person agreed to participate in the research project by obtaining the individual’s signature or the signature of an authorized representative.13

Institutional Assurances

Generally, the Common Rule requires that the departments or agencies applying the Common Rule obtain some form of written assurance from all research institutions engaging in covered research that the research complies with the regulations.14 If a research organization frequently conducts research supported by one of the signatory federal agencies, it may apply for a federal-wide assurance (FWA), a special kind of assurance process administered by the DHHS. The research organization seeking an FWA certifies that (1) all research will be performed in accordance with the ethical principles in the Belmont Report and (2) for any research that the organization conducts for which it receives any federal funds,15 certain procedures will be followed that ensure compliance with the Common Rule and any other applicable subparts the organization chooses to sign on to.

In lieu of requiring its own form of written assurance, a department or agency other than DHHS may accept the FWA.16 In that case, once the FWA is approved by the DHHS, it allows individual research proposals to be approved by the organization and its local IRB rather than by the individual federal department or agency that is funding the research, and any reports required are made both to the department or agency and the OHRP.17 Note that most organizations that conduct federally funded re search hold an FWA.

11

45 C.F.R. § 46.116(a).

12

45 C.F.R. § 46.116(b).

13

45 C.F.R. § 46.117.

14

45 C.F.R. § 46.103.

15

If the organization voluntarily extends its assurance to all research regardless of funding source, the organization’s certification extends to that research as well.

16

45 C.F.R. § 46.103(a).

17

45 C.F.R. § 103(a).



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