Page 199 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent procedures for emergency interventional TBI & stroke research
despite diligent good-faith efforts by the researchers. It is particularly practiced in North America and Ethiopia, and described as valid in the Declaration of Helsinki 2 and in the International Ethical Guidelines for Health-related Research Involving Humans. 4 In an effort to improve the progress in emergency research involving patients unable to provide informed consent, the US American Food and Drugs Administration (FDA) published guidelines in 1996, describing the exception from informed consent requirements for emergency research and the waiver of informed consent (appendix p 21). Since the guidelines, exception from informed consent has been available for use in emergency research for US FDA regulated products and waiver of informed consent for non-FDA regulated products.
With this alternative, a study can start without patient or proxy informed consent before intervention. Relevant information on study participation and use of data should be communicated to patients or proxies at the earliest opportunity. Refusal of study continuation or use of already obtained data should always be respected. The exception from informed consent procedure could be necessary when patients are exposed to continued and prolonged study activities while obtaining patient or proxy informed consent before intervention is not possible. The participant remains in the study by default.
Community consultation or public disclosure are specifically required to support
the use of exception from informed consent or waiver of informed consent and aim
to protect the rights and welfare of study participants. 62 In community consultation, 9 representatives from general communities (geographic community) or from the
population at risk for the condition (condition-oriented community) are recruited. It
aims to involve and engage community members with research initiatives by using
public fora, community groups, or face-to-face and telephone surveys. Public disclosure
involves notifying the community in advance that patients will be enrolled in a study in
an emergency situation without patient or proxy informed consent before intervention.
After the study, results will be communicated to participants and the public. It remains
unclear whether patients, proxies, health-care providers, administrators, or a general
population should be considered to be the community.63 Although some reports are
positive and participants satisfied, 64,65 community consultation and public disclosure
are also challenging, time consuming, and costly. 66,67
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