When more Information means less Informed Consent

We've all seen them. Participant information sheets that run to several pages, accompanied by consent forms containing multiple statements, declarations and signatures.

And often, for very good reasons.

Researchers want to make sure participants are properly informed. Ethics committees want assurance that important information has been communicated. Organisations have their own requirements, and templates have a habit of growing over time as new considerations are added. Case and point, the AI World we find ourselves in.

The result can be a considerable amount of information for someone to work through before they have even begun participating in the research. But it raises an interesting question:

At what point does providing more information stop supporting informed consent and start making it harder to achieve?

It's worth considering because, in our efforts to demonstrate ethical rigour, we may inadvertently create processes that are more burdensome for participants than they need to be.

More information doesn't necessarily mean better consent

A participant information sheet (or PIS) should help someone understand what they're being asked to participate in, what the risks and potential benefits are, how their information will be used, and what choices they have.

It isn't supposed to be a miniature research protocol, a legal disclaimer (though there may be an element of this) or a demonstration of how thoroughly the researcher has considered every possible ethical issue.

And yet, there is a tendency to assume that more information, more statements and more signatures equate to better consent.

Research on informed consent has consistently identified challenges with readability, comprehension and information overload. Providing extensive information doesn't necessarily mean people will read, understand or engage with it.

There is also a question of proportionality.

Interestingly, this isn't simply a matter of preference. NEAC's National Ethical Standards explicitly state that participant information sheets should not contain excessive information, and that their primary purpose is to inform participants rather than protect researchers or sponsors (section 7.19). The Standards also emphasise that information should be proportionate to the risks of participation and appropriate to participants' circumstances.

In other words, proportionality applies not only to the research itself, but also to the information we ask participants to navigate.

If someone is participating in a one-hour interview about their professional experiences, should the process of reading information and completing consent documentation constitute a significant portion of their participation burden?

On the opposite side of this, that doesn't mean every PIS should be incredibly short. Complex or higher-risk research may genuinely require more detailed explanations. A clinical trial will always require more consideration in terms of informed consent than an ‘innocuous’ anonymous survey on whether we prefer Jazz apples to Granny Smith.

But the amount of information should reflect what participants need to make an informed decision, not how much information we can provide.

Informed consent isn't the same as documented consent

This is an important distinction.

Informed consent concerns whether someone understands the research and voluntarily agrees to participate. Documented consent concerns how that agreement is recorded.

A signed form provides evidence that someone agreed to participate. It doesn't necessarily demonstrate that they understood what they were agreeing to.

Equally, informed consent doesn't always require a signature. Depending on the research and applicable requirements, verbal, electronic or other approaches may be entirely appropriate.

For example, a researcher conducting a low-risk interview might explain the research, invite questions, check understanding and record verbal agreement before beginning. There is a common myth which circulates in research ethics that verbal consent is somehow not a viable form of consent. However, this is a meaningful consent process without requiring participants to initial multiple statements across several pages.

Documentation matters, but we shouldn't confuse having a record of consent with having achieved informed consent.

So what makes a good PIS?

Rather than starting with a template (though we do have one on our website!) and trying to fill every section, we would encourage researchers to consider five questions.

1. Have I written this for the participant?

Use plain language. Explain what participation actually involves, rather than reproducing the detail of your research protocol. Someone unfamiliar with the project should be able to understand what they're being asked to do. My general rule: if you provided this to a family member with no context, could they understand what they are being asked to do?

2. Is the important information easy to find?

Participants should be able to identify the purpose of the research, what participation involves, reasonably foreseeable risks, how their information will be used, their choices around withdrawal, and who they can contact with questions or concerns.

3. Does everything here need to be here?

Consider whether each section helps someone make an informed decision. If information is included simply because it has always appeared in the template, ask whether it is necessary or could be communicated more clearly. I love a bit of a flowchart or a table.

4. Is the format appropriate for the people involved?

Written information isn't the only way to communicate. Verbal explanations, videos, audio recordings, translations and visual materials may be more accessible or appropriate. Cultural context matters too. Standard written consent processes may not always align with tikanga Māori or the relational ways in which decisions are made within particular communities.

Participants should still have access to the information they need (perhaps using a standard PIS), but how that information is communicated can be much more flexible.

5. Does the process support understanding, not just agreement?

Make room for questions and clarification. Consider how participants will have the opportunity to understand the research and make a decision without pressure.

A well-designed conversation may achieve more than several pages of declarations.

Protecting participants, or protecting the process?

Research ethics rightly places considerable emphasis on informed consent. But perhaps we need to pay just as much attention to the experience of giving that consent, and whether the processes we design genuinely work for the people expected to navigate them.

Lengthy or complex information sheets can also create accessibility barriers, potentially discouraging participation and affecting whose experiences are represented in research.

The answer isn't to provide less information than participants need. It's to think more carefully about what information matters, how we communicate it, and whether our processes are proportionate to the research.

A good participant information sheet isn't the one that contains the most information. It's the one that helps people understand what they're agreeing to.

And that's the question we should be asking more often when we review them.