8.11 Community involvement and ethics of research
Clinical research is only possible because people agree to be participants.
Independently of their role in the study, people need to be treated ethically. This is why there are research guidelines about the safety of participants.
This section includes:
- Participant information and informed consent.
- Study safety and reducing the risk of harm.
- Access to study drugs after the research ends.
- Equipoise: justifying the need for each study.
- Conflict of interest and transparency.
Participant information and informed consent
The Declaration of Helsinki was developed to focus on the safety and rights of participants in research studies. It includes the need for people to understand the study before they consent to join.
One part of informed consent is having clear information about the study so people can decide whether or not to join.
This information should use simple non-technical language so a participant can decide whether this is something they want to be involved with. Written information should also be in a participant first language. It can also be supported by discussions with their doctor or researcher.
Community advocates should be involved in writing and approving this material.
People need to understand the risks and benefits of a study.
This is why study participants need to sign an ‘informed consent’ form before entering a study. In theory, it should mean that every participant understands the risk and benefits of the study, and voluntarily agrees to take part in the research.
In practice, informed consent forms can be difficult to understand, and many participants sign if their doctor recommends joining.
All participants can withdraw their informed consent at any time, without this affecting their future care.
Study safety and reducing the risk of harm
Research guidelines include that participants should not knowingly be harmed as part of any study.
- This involves all participants receiving at least the minimum standard of care when the study is designed. It should also involve adapting the study to reflect any changes in the standard of care while the study is running.
- This means that a study may need to be discontinued early if one arm is found to be much better than another.
- It also means results from other research have an impact on the current trial.
- Studies should have pre-planned reviews of the results (either blinded or unblinded). This should ideally by independent experts who are not connected with running the study. This group is called a DSMB (Data and Safety Monitoring Board) or an Independent Data Monitoring Committee (IDMC). Ideally, community advocates should also be included in following the conduct and early results from a trial, and included in trial steering committees and at investigator meetings.
- The US Tuskegee Study is a famous and shocking example of a study that actively harmed both participants and their families.
- In the early days of ART, some studies of HIV drugs continued arms with only two ARVs after we knew that three drugs were needed.
- New approaches have been developed to study potential PrEP drugs because oral PrEP means that placebo studies are no longer ethical.
Access to study drugs after the research ends
Guidelines for ethical research include that new treatments, if approved, should be available in the countries where the studies were run.
Patients taking part in a study should be able to benefit afterwards from the results of a study.
- This is to prevent low-cost trials being run in low-income countries that are then only available in high-income countries.
- If approved, new drugs need to then be available at an affordable prices.
Equipoise: justifying the need for each study
Research guidelines include that a study should answer a relevant medical question.
- This includes making sure that new studies are only approved if the answer to the research question is not already known.
- With randomised studies, it involves making sure at the start that each group in the study has the potential to be the best option.
- Equipoise is a word that means experts are divided on the research question: that all the study arms could potentially be best.
- Studies need to be approved by an ethics committee linked to the research centre. An ethics committee for an HIV drug therefore needs to understand the current standard of HIV care.
Conflict of interest and transparency
Nearly everyone connected to a research study will have different reasons that they are involved. Very few people will be completely independent.
Some of these will be practical. For example, a participant might need a better treatment or for a researcher it is part of their job.
If researchers have additional financial links to a study, these need to be declared.
This is so there is transparency about anything that could affect the safety of a study.
Last updated: 1 January 2023.