Reshaping the review of consent so we might improve participant choice
Bibliographic Data
| ID | 21787665 |
|---|---|
| Authors | Hugh Davies (0000-0003-3060-166X, Science Oxford, corresponding author) |
| Year | 2022 |
| Volume | 18 |
| Issue | 1 |
| Pages | 3-12 |
| Publication date | 2022-01-01 |
| Peer Reviewed | Yes |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Research Ethics (JOURNAL) |
| Journal identifiers | ISSN: 1747-0161 • E-ISSN: 2047-6094 |
| Publisher | SAGE Publications (PUBLISHER • US) |
| DOI | 10.1177/17470161211043703 |
| OpenAlex | W3200988775 |
| Language | EN |
| Citations received | 3 |
| References cited | 14 |
Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps: Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues. Step 2: Explaining all the details of the study using the detailed Participant Information Sheet. Step 3: After a gap, if necessary, reviewing and checking understanding. Step 4: Reaching agreement and recording consent. These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations
Alternative medicine · Engineering ethics · Informed consent · Political science · Public relations · Research ethics · Biomedical Ethics and Regulation · Computer Science · Engineering · Ethics in Clinical Research · Ethics in medical practice · Law · Medicine · Psychology
Reshaping consent so we might improve participant choice (II) – helping people decide
Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process
UK Research Ethics Committee’s review of the global first Sars-CoV-2 human infection challenge studies
Interventions to Improve Research Participants' Understanding in Informed Consent for Research
Quality of informed consent in cancer clinical trials
Communicating Risks and Benefits in Informed Consent for Research
It's not just what you say, it's also how you say it
Do informed consent documents for cancer trials do what they should? A study of manifest and latent functions
| Unique citing works | 3 |
|---|---|
| Citations per year | 1 |
| Citation span | 2023 - 2024 (2) |
| Citation velocity | recent |
| Highly cited | No |
| Citation types | Neutral: 3 |