INFORMED CONSENT FORM (ICF)

INFORMED CONSENT FORM (ICF)

Introduction:

•     Informed consent process is the voluntary confirmation of a subject to participate in a clinical trial after being informed about all the relevant information necessary for the participation of the subjects in the clinical trials.

•     It is documented by means of written, signed and dated Informed consent form.

In brief ICF means:

• Informed - Having full knowledge and understanding of clinical trail process.

• Consent   - Decision of an individual to voluntarily accept and participate in the trail.

• Process    - It’s a continuous, ongoing consent for the trail.

Who, to whom, what and how ICF should be explained?

• WHO             - Investigator/person assigned by investigator?

• TO WHOM   - Subject/subject’s LAR.

• WHAT           - About the key aspects of the trail.

• HOW             - Using non-technical and understandable language.

ICF approval:

For documenting and acquiring ICF, the investigator should:

• Adhere to the regulatory requirements.

• Adhere to Good clinical practices (GCP) and also to all the ethical principles that have their origin in the Declaration of Helsinki.

• Have written approval from IRB/IEC to be provided to subjects.

Signature on ICF:

• Both the Investigator and the subject/subject's Legally acceptable representative should sign and date the written ICF.

• Even though trail is conducted with the consent of legally acceptable representative, the participated subject should know about the trail to the extent compatible with his/her understanding and if capable subject should sign and date the written ICF.

• When the subject and subject's LAR is illiterate, then the impartial witness will sign and date the ICF.

• Impartial witness is an independent person who is not associated with the clinical trail or the subject. He will read and explain the ICF and attests that the information was accurately explained and apparently understood by the subject and that informed consent was given freely to the subjects.

Process of Informed consent form: 

1. Informed consent process is an ethical, legal, and mandatory process for the clinical trail.

2. Investigator or a person involved in informed consent discussion should educate the subject about the key aspects of the trail.

3. Then the investigator should provide relevant time for the subject to inquire about the trail details whether to participate or not.

4. After the subject voluntarily accepts to participate in the research then he/she will sign and date the ICF along with Investigator.

Copies of ICF:

• After signing the consent, copies of ICF will be present with both the investigator and the subject.

• During the trail, subject/LAR should receive copy of ICF if any new information related to the clinical trail of the subject is available.

Revision of ICF:

1. Whenever new information becomes available about the subject consent, ICF should be revised and must have approval from IRB/IEC.

2. Then the subject/LAR should be informed about this information that is relevant for the subject to continue to participate in the trail.

3. Documentation should be done for this communicated details.

Main contents/elements in the ICF:

• Research details: Describes about the title of research, ultimate purpose of trail, alternative treatment/procedures, probability of assigning the treatments, duration of trail, approximate number of subjects involved in the trail etc.

• Risks and benefits: All the trail related risks and potential benefits should be explained.

• Alternatives: Alternative treatment or procedures that are available for the trail should be discussed.

• Confidentiality: All the records relevant to the subject information should be kept confidential. Without violating the subject’s confidentiality direct access to the subject’s medical records will be given to monitor, auditor, IRB/IEC and the regulatory authorities for verifying the trail data.

• Compensation: Available treatments in trail injury and the compensation to the subject should be explained.

• Contacts: It explains the participant to contact a person for knowing more information regarding the trail and trail related injury.

• Voluntariness: No one should force or influence the subject to participate in the trail and the subject’s participation should be voluntary.

• Clinical trial withdrawal: The clinical trial subject can withdraw from the trail at any time without loss of expenses or penalty.

Non-therapeutic trails:

1. Non-therapeutic trails should be conducted only if subject have personally given consent with signed and dated ICF.

2. The conduct of non-therapeutic trails in subjects with consent of LAR only if:

• Trail is not prohibited by law.

• Risks and negative impact on subject’s well being is low.

• Subject cannot give consent personally.

• And inclusion of such subjects requires approval from IRB/IEC.

Emergency situations:

• In emergency situations, prior consent of subject is not possible. If subject’s legally acceptable representative is available, then consent of LAR is requested.

• If LAR is unavailable, then the investigator should follow the measures that are described in the protocol or opinion from IRB/IEC.

• As early as possible, this information should be explained to subject/LAR.

References:

• https://www.ich.org/page/efficacy-guidelines

• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent#language

• https://research-compliance.umich.edu/informed-consent-guidelines

V.Chandana

B.Pharmacy

Clinosol Student ID: 283/1021.