Waiver of Consent in Emergency Medical Research

New regulations from the U.S. Food and Drug Administration and the Office of Protection from Research Risks (OPRR) provide an opportunity for researchers to conduct research in emergency medicine in limited circumstances without obtaining informed consent from subjects. The regulations outline the situations in which the Human Subjects Review Committee may waive consent to participate in research. Researchers wishing to request a waiver of consent in emergency medicine research must document the following to the Committee in their Human Subjects Review Committee application:

1. The potential subjects are in a life-threatening situation in which available interventions are unproven or unsatisfactory, and that clinical trials are necessary to determine the safety and effectiveness of interventions
2. Obtaining prospective consent from most potential subjects is not feasible because:
   1. Most of the subjects will not be able to consent to take part in the study because of their medical condition; and
   2. The study intervention must be administered before consent from most of the subjects' legally authorized representatives is feasible, and
   3. Eligible subjects cannot be identified prospectively.
3. Subjects may benefit from the research because:
1. Subjects are facing a life-threatening situation that necessitates the intervention;
2. Appropriate animal and preclinical studies support the potential of the intervention to provide direct benefit to subjects; and
3. The risks associated with the intervention are reasonable in light of what is known about the subject's medical condition, the risks and benefits of standard treatment, and the risks and benefits of the proposed intervention.
4. The research could not practicably be carried out without the waiver. Researchers must document either that it is not possible to obtained consent from most subjects or their legally authorized representatives, or that limiting enrollment to subjects from or for whom consent can be obtained may bias the study results significantly.
5. The researchers have defined the therapeutic window of time scientifically and are committed to obtaining consent from the subject's legally authorized representative within that window. The researchers must provide a summary of efforts made to contact the subject's authorized legal guardian to the Human Subjects Review Committee at the time of continuing review. Researchers must attempt to obtain consent in the following order:
1. in-person informed consent from the subject;
2. in-person consent from the subject's legally authorized representative or next of kin;
3. telephone or facsimile consent from the subject's legally authorized representative or next of kin;
4. waiver of consent.
6. The researchers must develop informed consent procedures they will implement when it is possible to obtain consent -- either initially or if the subject becomes competent to provide consent during the study. The Committee will review and approve these procedures and forms.
7. The researcher must document for the Committee's review the following additional protections of the rights and welfare of subjects:
   1. Consultation, including presentation and discussion of and documentation of responses to the protocol, with representatives of the communities in which the study will be conducted and from which the subjects will be drawn; *
   2. Public disclosure to the communities in which the research will be conducted and from which the subjects will be drawn of plans for the study, and its risks and benefits;
   3. Public disclosure of the results of the study after completion;
   4. Establishment of an independent data monitoring committee for the study; and
   5. Procedures are in place to inform each subject, or the subject's legally authorized representative of the subject's inclusion in the study, of the details of the study, of the information contained in the consent form, and that either may decide to discontinue participation at any time.

The Human Subjects Division will retain records for at least three years after the completion of the research.

If the Human Subjects Review Committee declines to approve a requested waiver, it must document its findings and report promptly to the researcher and to the sponsor of the research. The research sponsor, in turn, must report this information to FDA and to the sponsor's researchers who are asked to participate in this or a substantially similar trial.

This rule does not apply to protocols involving populations and procedures that are specially protected by law. These include prisoners, fetuses, pregnant women, or in-vitro fertilization procedures.

The Human Subjects Division may also, in conjunction with the Office of Research and other appropriate units of the university, conduct educational and communication outreach efforts to communities and populations from which subjects for such research may be drawn. The purpose of these efforts is to both learning from the community about their research-related concerns and to provide information as requested.

Acceptable mechanisms of consultation with the communities in which the study will be conducted and from which the subjects will be drawn include, but are not limited to, the following:

1. Consultation with associations, support groups, and other agencies representing people who have survived the conditions and treatments by presentation, question and answer sessions, focus groups, and surveys;
2. Consultation with associations, groups, and agencies representing the communities in which the studies will be conducted by presentation, question and answer sessions, focus groups, and surveys. The groups may include, for example, neighborhood associations and councils, city councils, parent- teacher groups, community advisory boards, church and civic groups specific to the institution and community;
3. Community representation on the Human Subjects Review Committee specifically from survivor groups or from communities in which the studies will be conducted.
4. Development of a community advisory board specific to the proposed study.
   

Acceptable mechanisms of notification (pre- and post- study) of the communities in which the study will be conducted and from which the subjects will be drawn include, but are not limited to, the following:

1. Public meetings;
2. Press releases;
3. Presentations before interested and affected agencies, groups, or organizations.