Consent in special circumstances
Consent departs from the ordinary case when the participant cannot consent before enrolment and when consent cannot be taken face to face. One view holds that informed consent is waning in US research.
Consent in an emergency
In the emergency department, research staff support physicians in obtaining the patient's informed consent to a trial, which must be written, dated and signed. Good clinical practice allows a trial only if the participant has had the chance, in a prior interview with the investigator, to understand its objectives, risks and inconveniences and is able to give informed consent, or a legal representative gives it where the patient cannot.
Obtaining consent in an emergency department is nearly always problematic. The time available to recruit participants is often far tighter than in standard trials. Patients are frequently sedated or unconscious, as in cardiac arrest, or, when conscious, stressed and highly dependent on the medical team, and a legal representative is rarely present.
The Exception From Informed Consent (EFIC) has been used successfully to enrol participants into pre-hospital and emergency department research when neither the patient nor a legal representative is available. It allows enrolment without prior consent when these criteria are met:
- the situation is life-threatening
- available treatments are unproven or unsatisfactory
- participation in the research holds out the prospect of direct benefit to the participants
- the clinical investigation could not practicably be carried out without the exception, and the Office of Human Research Protections must allow its use
Even when consent is waived before enrolment, notification must be made and consent obtained from the patient or legally authorised representative as soon as possible.
Consent taken at a distance
During the COVID-19 pandemic, technology offered alternative methods of consent where it could not be taken face to face, and documentation of the consent was emphasised. Consent could be given in many ways, verbally by telephone or by video with some email confirmation, and this varied from country to country. Electronic consent (e-consent) has been implemented since.
In the UK, the Health Research Authority has published joint guidance with the Medicines and Healthcare products Regulatory Agency (MHRA) on eConsent.
The argument that consent is eroding
One view holds that informed consent is waning in US research: two laws have passed that formally allow research to be conducted legally without people's permission or even their knowledge, and many enterprises are burgeoning. In that view, the erosion runs through these cases:
- The Department of Defense obtained a waiver to force 8.9 million ground troops bound for the Persian Gulf to be inoculated with experimental anthrax vaccines (1990–2005).
- Poor Black women in North Carolina were forced into racialised nonconsensual drug studies (1994).
- New York City law enforcement officials helped researchers coerce Black parents into enrolling their sons, without consent, in a study seeking a genetic propensity for violence (1994–1995).
- A modification of the federal regulations (21 CFR 50.24) permitted investigators to conduct research with trauma victims without their knowledge or consent (1996).
- In a national trial run by Northfield Laboratories, ambulance crews randomly gave the blood substitute PolyHeme to unconscious victims of car accidents, shootings and cardiac arrests (2003).
- The Resuscitation Outcomes Consortium set out to recruit 21,000 people in the United States and Canada to test experimental drugs and devices for severe injury and cardiac arrest without consent.
In the same view, informed consent is being slowly and insidiously taken off the table in American medical research, the law is allowing it to be dispensed with, and the pandemic is, not surprisingly, escalating the tendency. Little attention is paid to it, and people simply do not know. The fear is that, unless a stance is taken and it is examined ethically to decide whether this is how medicine and science should be conducted in the United States, people will not realise it until it is too late, until informed consent has been lost.
The hope is that other medical writers will find the erosion worth looking into, and it may need a groundswell of attention. At the least, the hope is that people will think about it and whether it is worth their time.