Table 3.
Examples of research where consent is difficult to obtain
| Type of research | Possible alternatives to standard informed consent in these types of research |
|---|---|
| Emergency care research, e.g. | Waived consent: The US Department of Health and Human Services has issued guidance on conditions necessary for the waiver of informed consent in emergency care situations (Ref. 29) |
| (1) Patients in pain and distressed. Intervention required immediately. No time for consideration (Ref. 27) | Obtaining consent post hoc, e.g. patient can withdraw permission to use blood or tissue sample when informed of study after recovery |
| (2) Patient has blood or tissue sample taken on admission when unable to consent (Ref. 28) | Prior consent/assent from community from which subjects will be drawn, or from specific individuals within that group (Ref. 30) |
| Epidemiological research using patient records or databases, e.g. use of records of cancer patients to investigate relationship between outcome and NHS care (Ref. 31) | Community assent: General information about possible use of data given to members of the group from which the participants will be drawn (e.g. patients in a primary care practice, patients on a cancer registry). Individuals have an opportunity to refuse (Ref. 29) |
| Cluster randomized trials, e.g. RCT of practice based intervention to improve care of asthmatic and diabetic patients (Ref. 32) | Consent from `guardian' of the cluster or `cluster representation mechanism' (e.g. CEO of acute hospital or managing partner in a primary care practice) or local community reps (Ref. 33) |
| Assent from all individuals in clusters without prior knowledge of the interventions (Ref. 34) | |
| Future research on tissue samples or genetic material obtained as part of clinical care | Open ended consent: Participants are informed of the broad parameters of possible future research on their samples but do not consent to specific research projects (Ref. 35) |
| Zelen studies, where the control group is unaware of the intervention, e.g. RCT to assess effectiveness of outreach programmes post discharge for patients admitted with CVA (Ref. 36) | Modified consent: Participants are informed that there is an additional research question about which they cannot be informed as it would affect the results, but they will be informed about it at the end of the study. Therefore participants consent to not having full information at enrolment (Ref. 37) |
| Ethnographic studies, e.g. a study exploring the course of substance abuse in people with severe mental illness (Ref. 38) | Evolving consent: The ESRC Research Ethics Framework provides guidance on consent in participatory social science research. In this context, consent to participate is seen as an ongoing process, and is continually open to revision and question. `Highly formalized or bureaucratic forms of consent' are avoided in favour of `fostering relationships in which ongoing ethical regard for participants is to be sustained (Ref. 39) |
RCT, Randomized clinical trial; NHS, National Health Service; CEO, Chief Executive Officer; CVA, cerebrovascular accident