Everyone has the legal and ethical right to decide what happens to their own bodies. Sometimes, however, an informed decision cannot be properly made if the options available to them are poorly understood or ill-explained. Gaps in knowledge between the informer and informee only serve to exacerbate this problem. The consequences of this can be far-reaching when considered in a medical context, and with respect to good clinical practice (GCP), as choices made can have a bearing on one’s overall quality of life.
Anyone involved in the informed consent process of a clinical trial knows that accuracy and clarity are key when communicating study information with (potential) participants. Study staff are required to provide accurate information and answer any questions a participant may have. However, understanding of information can be compromised due to factors of time, communication medium (text, online, phone, in person), and various personal circumstances of the participant in question. Thus, when communicating with participants, it is imperative to find both the right format and the right words to use when discussing clinical trials with “the public”.
One promising solution is the National Participant Information & Consent Form (PICF). It is in ongoing development by a number of medical and clinical trial specialists from Australia’s research community and driven by Bellberry Limited (Australia’s largest group of Human Research Ethics Committees). The National PICF aims to provide nationally agreed-upon standard templates for communicating with all types of participants interested in medical research. This includes participants unable to give consent, and parents and guardians of participants.
On the official website, it is stated that the National PICF was designed to treat patients with respect and facilitate mutual understanding with the study staff. The significant body of text that is provided offers general clinical trial information and instructions on how best to present study-specific information within its framework. It aims to comply with these four guidelines and requirements regarding participation in clinical trials:
- National Statement on Ethical Conduct in Human Research (2007)
- Australian Code for the Responsible Conduct of Research (2007)
- Good Clinical Practice – CPMP/ICH/135/95
- Code of Federal Regulations, 50.25 – CFR – Title 21
The National PICF is free for researchers to use. The current version can be downloaded here. It is divided into three separate parts (A, B, and C) for sites to edit and distribute to potential participants as part of the informed consent process:
- Part A is a six page document containing general information about the clinical trials process. Due to its general nature, it is provided as a pdf and cannot be edited. It covers the following topics:
- What a clinical trial is
- Trial staff
- Usage of collected information
- Informed consent
- The withdrawal process
- Sample questions to ask at any time before or during the trial (involvement, risks, reimbursement, and post-trial issues)
- Part B is a six page editable word document regarding specific information about the study. Text is colour coded, providing paragraphs written for participants, general instructions on what should be written in a section, and replaceable text with details about the study. This is provided in the form of 20 questions and answers covering:
- Condition and treatment(s)
- Study flow and administration
- Tests administered
- Risks and benefits
- Part C is a one page editable consent form in word document form, most of which is standard text. There is a small table where study contact details can be entered. There is also a place for both participant and a doctor or senior researcher to sign.
You can find a detailed user guide on the National PICF website detailing how to use the templates here. Templates are reviewed annually and updated as required, with more to be added in the future (such as interventional, biospecimen, registry, behavioural, and social science studies). It is important to note that these templates are considered to be the minimum amount of information that is provided to participants. Any extra study or sub-study information should also be provided as necessary.
With the inception of the National PICF in early May 2016 it is apparent that now, there is no need to reinvent the wheel for each new study when it comes to informed consent. In a multicentre study, having to create a different PICF for each site duplicates work and requires a significant amount of time. The adoption of the National PICF would mean that a single template would be developed, and could be used at each Site rather than determining the requirements of each Site individually.
Furthermore, adopting the National PICF could speed the ethics review process, as the template ensures that all necessary information is incorporated in a patient-centric manner. Ethics committees that become familiar with the National PICF, by understanding the format of the PICF, the function of each section, and the study-specific text that needs to be reviewed, saving time during ethics review for sites using this form. Again, this is invaluable in multicentre studies, as a standard PICF could be reviewed just once for all sites, saving time.
Study start-up times have been a key focus for the Australian Government, aiming to streamline the ethics review process nationally. The National PICF is a helpful framework that ensures Australia is still one of the best places to run clinical research. Datapharm Australia is proud to be one of the first CROs to adopt and support the National PICF when needed. If you would like to know more about how we have implemented it, and how we can help you get your study up and running faster, get in touch with us today!