Treatment training manual

8.11 Community involvement in research

Clearly, studies need patients. But patients are real people, not just the subjects of research.

Any clinical study should follow guidelines to ensure that the trial is ethical:

People are willing to be part of the research and consent to this.

This is why non-technical information about any study has to be available for discussions with doctors and researchers AND as written material in a patients’ first language. Community advocates should be involved in writing and approving this material.

People understand the risks and benefits of a study.

This is why every patient needs to sign an ‘informed consent’ form before entering a study. In theory, it should mean that every patient 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 patients are happy to sign whatever their doctor recommends.

Informed consent can be withdrawn by a patient at any time, and this should not affect his or her future health care

Patients are not knowingly harmed as part of the research.

  • This involves all patients receiving at least the minimum standard of care when the trial is designed, and that the trial is changed to reflect any changes in the standard of care over the duration of the study.
  • This means that a study may need to be discontinued early if one arm is found to be much better than another.
  • This mean that a study design is changed or amended if results from other research have an impact on the current trial.
  • Studies should have pre-planned reviews of study results (either blinded or unblinded), preferably by independent experts who are not connected with running the study. This group is called the DSMB (Data and Safety Monitoring Board).These are reasons why patient advocates need to 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 an especially shocking example of a study that actively harmed both participants and their families.

Patients taking part in a study will be able to benefit from the results of a study.

  • For example, a company can not save money by running cheaper trials in poor countries without ensuring that the drug will made available at an affordable cost for people in these countries afterwards

A study answers a relevant medical question.

  • This includes making sure that new studies are not designed, for which we already know the answer.
  • With randomised studies, it involves making sure at the start that each group in the study has the potential to be the best option. The study should have been approved by an ethics committee linked to that research centre.People in the ethics committee should understand the current standard of HIV care.

Last updated: 21 July 2009.