Redesigning Consent for Health and Medical Research

This article was originally published by ARDC: 23 July 2024
The launch of a new, simplified participant information and consent form (PICF) template is set to improve how participants engage with health and medical research studies nationwide.
The recent launch of a simplified template for a participant information and consent form (PICF) will change how participants engage with health and medical research in Australia.

Health research, including clinical trials, requires PICFs to give prospective participants information to decide whether they want to participate in the study. This includes information about the requirements, risks, and benefits associated with the trial, and how trial data will be managed and shared. Considering the global shift towards the sharing of clinical trial data, obtaining participant consent to share data is critical to ensure transparency and respect autonomy. However, most of the sector uses PICF templates created over a decade ago that are often long, complex, and difficult to understand.

CT:IQ (Clinical Trials: Impact & Quality), with support from the ARDC, has redesigned the PICF to create a simpler, shorter, and more engaging PICF template as part of their InFORMed Project. The new participant-centric template was designed with input from over 700 survey respondents, including consumers, researchers, contract research organisations and human research ethics committees.

A key output of the InFORMed Project is the simplified PICF template that researchers can freely access and modify to help potential participants make better-informed decisions about research participation and future sharing of their research data. The template is accompanied by a comprehensive user guide for researchers.

“Making sure people understand the way their data will be handled when they participate in research is paramount – it allows them to make informed decisions, and empowers researchers to work consistently with the wishes of their participants,” said Dr Kristan Kang, Program Manager for the Health Studies Australian National Data Asset (HeSANDA) at the ARDC.

New PICF template makes health research consent more accessible

Fleur O’Hare, a clinician-researcher at the Centre for Eye Research Australia, was involved in the beta-testing phase of the InFORMed Project. In her clinical practice, Fleur frequently engages with people with low vision and blindness and understands the importance of providing information in various formats to improve accessibility.

“Starting with an easy-to-read information sheet is a great first step in providing accessible information. This is why I use the CT:IQ InFORMed template as a starting point.”

Fleur said that her decision to use the PICF template was influenced by it being shorter and having more accessible language, considering that around 44% of Australians have low health literacy. Fleur’s research will expand the existing resources, providing the template in an enlarged and digitally accessible format to encourage more inclusive and equitable consent practices.

“The uptake and acceptance of the template by more research and healthcare organisations will mean national endorsement and a new standard set,” said Fleur.

State government support of CT:IQ’s InFORMed project

The template has garnered support from state governments, including in South Australia and New South Wales, highlighting its potential to inform standards nationally. James Cokayne, head of Research Ethics and Governance in the NSW Ministry of Health, said that the PICF template and user guide fill an important gap in replacing the existing templates with more consumer-focused materials.

“CT:IQ has broken down consent into its component parts to create a practical, next-generation template that encourages researchers to think about the design, audience and language of the consent form.”

“It’s a groundbreaking way of thinking about how participant consent is presented in human research, ensuring that it is both meaningful and informative.”

He commended CT:IQ on the co-design process used to create these materials.

“To take in the views of so many stakeholders is a difficult thing to get right, but CT:IQ has done it really well.”

The consent form is being piloted by the Western Sydney Local Health District Human Research Ethics Committee. The committee, and researchers who have used the template, agree it is a vastly improved and user friendly document.

Simon Windsor, Manager of Research Governance and Ethics in SA Health’s Southern Adelaide Local Health Network (SALHN) is also positive about the new approach.

“If you’ve got a 30-page document, it’s a genuine barrier to being involved in clinical trials and health research. This project will have a beneficial impact on the community through better communication, which is crucial to healthcare in the modern era.”

SALHN incorporated a barcode in the PICF template, allowing the consent forms to be readily scanned into participants’ electronic medical records.

“We were the first site in Australia to use the PICF template during beta-testing. We deployed the template at SALHN as one of the early adopters,” said Simon.

The ARDC, through its HeSANDA initiative, which is improving access to health research data, partnered with CT:IQ to develop the Data Sharing Statement for the InFORMed Project. HeSANDA is part of the ARDC’s People Research Data Commons, which is providing national-scale data infrastructure for health research.

“Sharing research data has tremendous potential to improve the science we do, our investment into research, and ultimately the outcomes of health consumers,” said Kristan. “Partnering with CT:IQ on the InFORMed project has been a key piece in ARDC’s work to modernise our research system and to make the most of the valuable contributions made to clinical trials by health consumers.”

Following its success in the beta-testing phase, the next step of the InFORMed Project will be to seek endorsement from the National Health and Medical Research Council to replace the existing PICF templates. Simplifying PICFs is a promising shift towards more accessible, participant-friendly approaches in health and medical research, reducing barriers to informed consent.

Learn more about the InFORMed Project PICF template and user guide.

Watch CT:IQ’s webinar on Redesigning Consent to Research: Putting Patients and Participants at the Centre.

The ARDC is enabled by the National Collaborative Research Infrastructure Strategy (NCRIS) to support national digital research infrastructure for Australian researchers.