How to Consent a Research Subject

The biggest and most important issue of clinical research is the protection of subjects' rights and welfare. This includes a patient’s right to review the clinical trial information and decide without coercion or intimidation to become a research subject. The best person to consent a subject is the principal investigator. The principal investigator has the medical training and knowledge to be able to answer all of the patient’s questions and alleviate any concerns. However, the Principal Investigator may delegate this task to the Sub-investigator and the Clinical Research Coordinator. Regardless of who is conducting the informed consent process, the subjects must be given all information described in the regulations and the Declaration of Helsinki. Read on to see a good practice for consenting patients into clinical research.

Difficulty: Moderately Challenging

Instructions

Things You'll Need:

• Basic knowledge of Good Clinical Practices.
• Basic knowledge of The Declaration of Helsinki.
• Clinical Research Site
• Clinical Trial
• Patients

1. 

   Explain the clinical protocol to the patient ensuring they are aware of all protocol requirements, what they are expected to do and how often they are expected to visit the research center. Answer all of their questions. If you do not know the answers, tell the patient you do not know and make every effort to find out. Most likely, other patients will have the same question, too.

2. 

   Tell the subjects that clinical trials are experimental and that they have the right to refuse to participate. They should also be told that they can withdraw at anytime with no explanation if they wish.

3. Provide the patient with a copy of the Institutional Review Board (i.e. ethics committee) approved Informed Consent Form. The Informed Consent Form must be in the language the patient is comfortable speaking. If you have patients who speak Russian, Spanish and Portugese, you need three Informed Consent Forms, one in each language with the same information previously approved by the Institutional Review Board.

4. 

   Allow the patient time to read the Informed Consent form and then review the Informed Consent Form with the patient. Again, allow the patient time to ask questions and provide all answers truthfully and to the best of your ability.

5. 

   Encourage the patient to take the Informed Consent Form home and think about the clinical trial overnight. If they still want to participate the next day, then move forward. Tell the patient not to sign the Informed Consent Form until they return to the Clinical Research Center, per Good Clinical Practices.

6. 

   When patient return after at least 24 hours, consent the patient. Ensure the patient signs and date the Informed consent in your presence. If applicable, sign and date the form after the patient.

7. If a witness is required, ensure someone not affiliated with the clinical trial (another hospital employee or the patient’s relative) is present during the consenting process.

8. 

   Document in the source notes that the subject voluntarily consented to participate in the clinical trial.

Tips & Warnings

• Once a patient is consented into clinical research they are known as “subjects”.
• If the patient seem confused, disoriented or unable to understand what you are saying, stop the consenting process and note the patient as a screen failure.
• Never coerce or try to persuade a patient to join a clinical trial. Just give them the facts, and let them decide.
• Failure to properly consent research subjects could lead to serious consequences including the data being eliminated from the NDA process.

Resources

• FDA Website
• Protection of Human Subjects (Title 21 CFR Part 50)
• The Declaration of Helsinki

[3-Point]

on 7/2/2008 Interesting article. Great research.

[Desula]

on 6/29/2008 This is very interesting. Thank you.

[mattlee]

on 6/29/2008 sounds like you work in this field, interesting article

[vikki9]

on 6/28/2008 Interesting.

[purrfect1969]

on 6/28/2008 Interesting.