Participants Information & Consent Form (PICF) Medical Writing

What is a Participants Information & Consent Form (PICF)?

In line with Good Clinical Practice and the Declaration of Helsinki, participation by individuals in medical research must be voluntary. It is the Investigator’s responsibility to ensure that research participants are adequately informed, to enable the provision of informed consent. The Participant Information and Consent Form (PICF) is a key component to enabling this communication process.

The PICF is used to explain the purpose of the research, what participants will be required to do, the time commitment required and any potential risks and benefits.  

In some cases, it will be necessary to have the PICF translated into a language other than English depending on the target audience, or to provide access to an interpreter for the participant during the informed consent process.

What information should be included in a Participant Information and Consent Form?

Information to include in the PICF includes (but is not limited to) the purpose of the research, the expected length of time for participation, a description of all the procedures that will be completed during enrollment on the clinical trial, information about all experimental procedures that will be completed during the clinical trial, risks and benefits, who to contact for questions and/or complaints and how to withdraw from the study.

As outlined in NHMRC guidance, the language should be readily understandable by the participant in plain English (Grade 8 reading level or below) and include Australian spelling. It should be clear and concise and in a format that assists with comprehension.

When should a PICF be Updated?

An updated PICF is required and should be completed when new information becomes available. The new information may have also required a Protocol and/or Investigator Brochure update and in this instance the PICF can be updated and submitted to the chosen HREC at the same time as other essential documents. For example, this could include new information concerning risks and/or potential benefits as the study has progressed.

Obatica PICF Medical Writing Services 

The Obatica medical writing team has created many Participant Information and Consent Form (PICF) that has gone passed many inspections. We can provide a cost efficient, fast, and high quality PICF medical writing services to support your study. We have experienced in developing master PICF, country PICF, and also site PICF. Having many experience in the running of clinical trials from start till end, we are familiar with the common issues with PICF that can be costly to the sponsor. 

A Participant Information and Consent Form (PICF) may need to be further customized to meet specific requirements as requested by the reviewing institution Human Research Ethics Committees. For example, the reviewing institution may have preferred language or standard wording/clauses that are required to be included.

Once the PICF has received HREC approval, it may need to be updated with site specific information. Depending on the local institution – this may be completed by site staff. Obatica is also able to assist with these updates.

Resources:

Declaration of Helsinki – https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

ICH-GCP Guidelines (INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2)) – https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

NHMRC Templates – https://www.nhmrc.gov.au/research-policy/ethics/ethical-issues-and-resources

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