FDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable not only for medicinal products but for medical devices too. In this summery are some of the main points that everyone setting up clinical trials should pay attention to:

1.Advertising materials

FDA consider advertising materials as part of the consent process and expect them to be consistent with the information in the informed consent. It is important to mention that they include also online advertising in their guidance. They mention that advertising information should be limited to determining patients’ interest and potential eligibility. If you are planning a clinical trial and have a web site, where you intend to promote the study, you need to take this into consideration.

2. Consent discussion

There is a special stress on discussing the informed consent and making sure that patients actually understand what the research is about. This could be confirmed by asking the patient questions to assess if they understood what was explained to them.

3. Coercion and undue influence

While in the past was very common to see in protocols statements that company’s employees and their relatives are excluded from participating in a clinical trial funded by the company, FDA have made an important clarification that patients should understand that their participation is voluntary. There are no requirements to exclude company’s employees or their relatives from the study.

4. Risks, benefits, and discomforts

The guidance clearly states that it is prohibited to claim safety or efficacy of investigational drugs or medical devices which are not approved on the market. FDA are also against statements in the consent form such as ‘FDA has given permission for the clinical investigation to proceed’ or ‘FDA has approved the clinical investigation’ because it could affect patients’ decision to participate. This is a very good point as it could be seen as endorsement.

FDA recommends including information on data protection and what the risks are. Also, they advise to consider information that could cause discomfort to patients – for example, claustrophobia-like symptoms during an MRI.

5. Travel expenses reimbursement

FDA have clearly stated that they don’t consider reimbursing patients’ expenses for travelling as coercive or influence. They have left it open to the IRBs to decide based on the specific study if the reimbursement is fair and appropriate.

6. Informed consent length

FDA is against lengthy informed consents and recommend finding ways of simplifying them by diagrams or adding details of the procedures in addendum to the consent. They also recommend the focus to be on risks and benefits of the study instead of details. This is another important point in times when the informed consent tends to grow longer and longer.

7. Alternative treatments

FDA recommends that if new information becomes available about alternative treatments this may need to be updated in the informed consent. They also recommend providing information on risks and benefits of such alternative treatments; however, this information does not need to be in the informed consent.

8. Confidentiality

While FDA expects to see statement that FDA can inspect the study, they are against suggestions that they need patient’s permission to have access to medical records used for the clinical trial.

9. Use of electronic signatures in informed consent

FDA clarified that it is permitted to use electronic signatures in the informed consent as long as they are compliant with the regulatory requirements. They also open the door for alternative consent methods by clarifying they are happy to be consulted. However, FDA specified that oral consent over the phone which is documented in the source data is not acceptable method unless it is a study with minimal risk and no procedure involved. In cases where patient is infectious and electronic signature cannot be obtained a photo of the signed consent is acceptable to be retained.

10. Sponsor personnel

If sponsor personal will present during a procedure or follow up done to the patient, this information should be included in the consent form.

11. Paediatric patients

In case of clinical investigations conducted in wards involving children there should be an advocate who is qualified by education and experience to support the child. This person should not be connected to the sponsor or clinical centre conducting the study.

12. Patients who do not speak English

FDA states that not speaking English should not be a reason for patients to be excluded from clinical trial and that all factors should be considered before deciding to exclude such patients.

The guidance provides very useful insights on how to accommodate patients who don’t speak English, vulnerable patients and those who may lose capacity as a result of their disease.       

You can find more information here

Author: Olga Peycheva

Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe. 

Published on 16 Aug 2023