How to understand the privacy and confidentiality impacts of participation in clinical research

What can I do to ensure that I understand the consequences of participation in clinical research from a privacy and confidentiality perspective?

You should take steps to ensure that you understand the benefits and risks of participating in research from a privacy and confidentiality perspective. Whether it’s conducted by your healthcare provider or any other research program, institutions tend to treat the process of your consent as a regulatory compliance exercise or a one-off discussion. However, thanks to work by patient advocates and other groups, there is a concerted push towards adopting better models of patient engagement including through ‘dynamic consent’. You might also want to ensure that the research aims do not conflict with your moral or other values.

You can use the following framework (informed by the recommendations of the Clinical Trials Transformation Initiative) to evaluate if the research institute conducting the trial is adopting ethical processes to ensure that your consent is well informed:

  • Ongoing and interactive conversation: Do the researchers treat the process of obtaining your consent as an ongoing and interactive communication? Ideally, the researchers should not simply administer a consent form at the beginning of the trial with limited to no engagement afterwards.
  • Customized consent: Have the researchers taken care to customize the consent process to the particular needs of the patient group you are part of?
  • Communication and responsiveness: Are the people taking your consent able to effectively communicate information specific to your trial? Are they responsive to the needs of your patient group?
  • Discussion tools and interactive techniques: Do the researchers employ discussion tools and interactive techniques to ensure that your consent is well informed? Some factors you might consider are whether the researchers respond well to your education level, health literacy, disabilities, and other factors that may impact your ability to provide consent. Do they explain in plain language important considerations in a clinical trial such as purpose and duration, compensation for injury, and conditions for withdrawal? Do they explain in plain language what steps they are taking to protect your data and what de-identification techniques they employ while sharing your data?

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