sented by the following question—“What protections would a potential participant want in place before and after he or she has consented to be a part of a study?” Based on testimony from research participants and their families (Cohen, 2001; Gonsalvez, 2001; Pedrazzani, 2001; Terry, 2001; Wayne, 2001) and the committee members’ own experiences as research participants, investigators, and research administrators, the committee believes that the goals of an effective program are to ensure that

  • Participant welfare is of central concern to the investigator(s) and staff and that researchers take steps to minimize the level of harm to which participants may be exposed and treat participants with respect and dignity throughout the study.

  • The investigator(s) who designed the study, those who will collect the data, and others who interact with participants are appropriately trained and well qualified to conduct research with humans and to perform all study procedures.

  • The investigator(s) who designed the study, those who will collect the data, and those who oversee the research have no financial or other conflicts of interest that could bias the study or negatively affect participant care, and unavoidable potential for conflict has been disclosed to participants before enrollment and adequately managed throughout the study.

  • The proposed study has been reviewed by neutral scientific experts to ensure that the question(s) asked are important; that the protocol is feasible, well designed, and likely to result in an answer(s) to the research question(s); that the risks have been minimized and do not outweigh the benefits (even if the participants will not directly benefit); and that participants are given all the information necessary to make an informed decision1 about participation in language they can understand.

  • An advocate or friend can help explain the details of the study to participants if necessary or desired.

  • Participants understand that they are free to refuse to participate or to withdraw from the study without fear of retribution or loss of benefits to which they are otherwise entitled.

  • The investigator(s) or a central coordinator will monitor the progress of longitudinal studies, and if new information pertinent to the protocol becomes available during the study that might be important to participants, the research team will share it with participants and adjust their individual involvement as appropriate (similarly, if the risks are greater than first believed or if the intervention is found to be successful earlier than predicted, the study might be stopped by the central coordinator).

1  

Such information should include mention of any major controversy within the research community involving the protocol’s methods.



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