CPHS Update

Defining the Changing Waiver of Consent Written by: Catherine Beebe

Obtaining Informed Consent is the ethical portal into a research study.  It is the outcome of the Belmont Report which enunciated the principle of respect for all persons.  However, how can emergency medicine conduct research when there is no possible means for obtaining the consent, informed or not?  For years, IRBs have been redefining the informed consent to allow for all possible exceptions, such as children, prisoners, and people with diminished understanding.  They deserve to be included in the research study population, but they also deserve proper protection.  Therefore, the ethical question of handling informed consent in the event of an emergency has been a difficult one.

In 1994, The Committee for the Protection of Human Subjects (CPHS) met with representatives of the NIH and FDA to discuss the need for a waiver of consent in one of the UTHSC-H trials.  The result was the first allowance for such a waiver, provided that four stipulations were met: the patient must be in a life-threatening situation, the patient might receive a direct benefit from the treatment, no treatment would be denied that would otherwise have been done, and public disclosure and community consultation would be carried out. The following year, the FDA issued regulations for research in an emergency situation, however the definition of public disclosure and community consultation remained vague and without explanation.  Despite the expanding definition offered in the guidances issued by the OHRP and FDA, public disclosure and community consultation remained unclear.  CPHS is one of the IRB's currently leading in defining and carrying out the ambiguous stipulations given by the FDA in order to use waiver of consent in a research protocol.

The idea for consulting the community is to get feedback from those outside the medical profession who may be affected by the study.  If the study were to be pediatric or geriatric, the study community would be easier to focus on and recruit in a conversation, but what if the study is trauma with research subjects being any age possible and physically unable to give consent?  This is the problem that one study at UTHSC-H experienced when identifying the community.  Who are the people that would make up the community?  The answer is everyone, provided that they are diverse in everything including race, age, and socioeconomic background.  Depending on the potential risk involved in the study, the CPHS sets a number of community consultations that must be met to determine the public opinion.  A typical meeting involves a member of the IRB and the PI meeting with community members who responded to advertised meeting regarding study patients' rights.  After noting the diversity and how many people attend, there is a discussion of the study and need for a waiver of consent in the event of an emergency.  Afterward, an optional 3 question pop quiz is handed out for assessing understanding.  The IRB representative and PI report the outcome to CPHS in order for the protocol to be approved.

Paula Knudson, a veteran member of the creation and progression of the CPHS, was involved in the beginnings of the waiver of consent with Congress in 1994 and has been involved in defining community consultation and public disclosure.  "The FDA has not yet come up with an adequate description of community consultation and public disclosure, but the CPHS is a leading IRB in defining and informing the community on the issues.  We have to be very blunt in explaining that a waiver of consent is a direct denial of autonomy of a research subject.  They lose their rights.  Despite these bleak discussions, the outcome of the consultations is one of approval.  There is drama in this, and the community responds to that favorably."

There have been 6 studies at UTHSC-H in the past which have required community consultation.  There are none currently.  To find out more about how to set up community consultations, consult CPHS.  To read more about the definition of community consultation by the medical research world, read the December 12 article from JAMA entitled, “Aiding Emergency Research”.