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HRA publishes new proportionate consent guidance

Published on 31 January 2017

The HRA is encouraging researchers to take a more proportionate approach to the process of seeking consent for participation in research.

Researchers have an ethical and legal obligation to make sure that people volunteering for research projects have the information they need to help them decide whether they wish to take part or not.

This new guidance complements the existing HRA online guidance for consent and participant information sheets. It further reinforces our view that people who volunteer to take part in research should be provided with succinct, relevant, user-friendly information in a proportionate manner that better promotes genuinely informed consent and facilitates the conduct of ethical research. The document also includes new guidance on how consent might be sought in pragmatic trials in way that is proportionate to the low levels of risk involved in such research.

Seeking informed consent properly respects a person’s right to determine what happens to them.

However, the procedures for seeking that consent can sometimes be applied too rigidly and with too little appreciation of the risks, benefits and values that are at stake in connection with different kinds of research. This can lead to the use of excessively lengthy and complex participant information sheets which can inhibit, rather than promote, participant understanding and genuinely informed consent.

Clive Collett, HRA Ethics Guidance and Strategy Manager, said: “Different types of research involve different balances of benefits and risks, and for some research participants there may not be much difference from the standard care they may expect to receive if they were not taking part.

“Our guidance encourages researchers to take a proportionate approach to seeking consent, so that they can avoid presenting detailed and lengthy information which can deter and confuse potential participants.

“The HRA has long-recognised the importance of a proportionate approach in both the regulation and the conduct of research. We hope this latest document will support researchers to simplify the consent process for people taking part in vital and safe health research which benefits us all.”

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