Patients support a broader use of their biological material and health data

The study was led by the Norwegian Institute of Public Health (FHI), which examined the views of patient representatives from Norwegian healthcare institutions.

“With a general consent model, patients can agree that their biological material and health data may be used for any medical and health-related research approved by an ethics committee. This would allow researchers to use the material across various research projects and fields,” says lead author Rebecca Bruu Carver from FHI.

Current consent procedure is limited

The existing practice of “broad consent” allows researchers to use biological material such as tissue, blood, and urine samples, as well as health data, for “specific, broadly defined research purposes.” Examples include research areas such as cancer or heart disease.

“Even though broad consent can be used for ‘broadly defined purposes,’ it must still be limited to specified objectives within a defined research field or area. In practice, this means that researchers must obtain new consent every time they start a project in a different research field. Studies from other countries with similar practices show that this may hinder research progress,” Carver explains.

Patients Support a More General Consent Model

The study invited all members of patient advisory boards and committees in Norwegian healthcare institutions to participate in a survey about consent models. A total of 157 respondents participated, corresponding to a response rate of 40%.

Patient representatives were asked about their views on allowing a more general consent model, meaning that researchers could use biological material collected in the healthcare system for various projects across medical and health disciplines.

Key Findings

• Most patient representatives (66.2%) support a general consent model for the use of biological material and health data in medical research, without limitation to specific diseases or research purposes. 21% support the current broad consent model.
• The majority (63.7%) believe that surplus diagnostic material, such as tissue samples from surgical procedures, should also be used for general medical research purposes.
• The main reason for this support is that patients wish to contribute to medical research and help future patients.
• More than half (57%) still want to be informed that their biological material and health data may be used for medical research in general, and they wish to have the option to opt out.
• Most respondents (65%) believe that biological material should be stored for research purposes without time restrictions.

Patients Want to Be Informed

The findings in this study align with several other studies indicating that patients are positive about having their biological material and health data better utilized to advance medical research.

However, the study also highlights that patients prioritize being informed:

“For this to work in Norway, patients must be adequately informed that their biological material and health data may be used for future research. It must also be easy to opt out, and all new research projects must, of course, be approved by the regional ethics committees (REK),” Carver states.

“The patient representatives in this study also expressed a desire to access information about which studies their data are used for, preferably via the digital platform helsenorge.no. Therefore, it is crucial that new consent models allow for this.”

Carver believes that further research should explore how a more general consent model can be implemented with appropriate information and security procedures.

A limitation of this study was that it did not directly survey patients; instead, the respondents were members of user advisory committees, most of whom were women over the age of 60. Additionally, the sample size was relatively small, although the response rate was high.

“Nevertheless, we hope this study will be considered in the revision of the Norwegian Health Research Act, which is currently being reviewed in Norway,” Carver says.

About Biobank Norway

Biobank Norway is a research infrastructure for biobanks, funded by the Research Council of Norway. The Norwegian Institute of Public Health is one of several Norwegian partners involved. This study included participation from FHI, Oslo University Hospital, St. Olavs Hospital HF, and NTNU.

Reference

The study has been published in the journal Biopreservation and Biobanking:

Toward a More General Consent for the Use of Patients’ Biological Material and Health Information for Medical Research—The Patient Perspective.  https://doi.org/10.1089/bio.2024.0078