Informed consent: Process and Procedure
Unit IV Clinical trials Pharmaceutical Regulatory Science Notes
Introduction to Informed consent (IC)
Informed consent (IC) is an ongoing process of communication and mutual understanding between a patient and investigator which is then demonstrated by the patient’s voluntary agreement to enter a clinical trial.
In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s) and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki.
Capacity to Give Informed Consent:
Before the informed consent process can begin, the potential participant must be deemed capable of understanding his or her actions and making a reasoned decision.
If the person lacks the capacity because he or she is a minor, is ill, or for any other reason, special provisions must apply (such as; a life-threatening emergency), or the person may not be included in the study.
A person who has a court-appointed legal guardian or who has been determined by a court to be legally incompetent cannot sign an Informed Consent Form even if he or she has the capacity to make a decision.
Disclosure of all Relevant Information:
The research team must disclose all relevant information about the study to the potential participant. The information disclosed must be sufficient to enable the potential participant to make an informed reasoned decision about whether to participate.
This information generally includes:
- The purpose of the study.
- The nature of the procedure or intervention that is being studied.
- Reasonable alternatives for participation in the study.
- The potential risks and benefits as well as the uncertainties of study participation.
- The participants obligations for the duration of the study.
Comprehension by the Participant:
The potential participant must understand the information disclosed to him or her about the research study.
The participant is free to ask questions to the study team as well as take additional time to make a decision regarding participation.
The research team must be able to evaluate the potential participant’s ability to understand what his or her participation in the study would involve.
Voluntary Agreement by the Participant:
The participant must agree to participate in the research study.
His or her agreement must be voluntary and free from coercion or undue influence.
The written informed consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative and by the person who conducted the informed consent discussion.
Right to Withdraw:
The participant must be informed that he or she has a right to withdraw from the study at any time and for any reason, without penalty or loss of benefits that he or she would otherwise be entitled to receive.
The research team or principal investigator may terminate participation in a study if it is in the best interest of the participant.
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