Protecting and promoting the interests of patients and the public in health research1

Patients, the Public, and Research

Information for patients and members of the public who want to promote better research for better health care. Read more

a slide set to help those reviewing research make fair, shared and consistent decisions.

This section of TTi has been created to help patients and members of the public who wish to promote better research for better health care. These include people helping to prioritise and design research to test treatments; those invited to participate in tests of treatments; and patient and public groups helping to improve tests of treatments and their impact in health care.

In this section there is information for:

i. People helping to decide what uncertainties should be addressed in research

ii. People helping to design research to test treatments

iii. People helping to review proposed research

iv. Patients and others invited to take part in research

v. People helping to prepare reports of research

vi. People helping to distribute reports of research

vii. People helping to ensure research results are considered in health care

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Reviewing proposed research

Questions we should consider

i. Why do we have research review and what are its purposes?

ii. What are the difficulties for review?

iii. What are our key initiatives in research review?

iv. What is the role of our Research Ethics Committees?

v. What is fair review?

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Why do we have research review and what are its purposes?History (IC / HD)

Balance between benefits and harms

Public perspective (AH)

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What are the difficulties for review?What are the challenges to fair review? HD

Where are the disagreements? RaSS

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What are our key initiatives in research review?HRA view and initiatives JW

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What is the role of our Research Ethics Committees?Roles and responsibilities of RECs

Personal views RB DL

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What is fair review?

What is a fair test of a treatment test?

How do we test a treatment test?

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A fair test of a treatment test1. Is independent, balanced yet inclusive.

2. Is reasoned.

3. Is founded on an understanding of the project, its method and context.

4. Accommodates good research practice.

5. Accommodates guidance.

6. Accommodates evidence.

7. Is consistent.

8. Is proportionate and pragmatic.

9. Is itself open to review.

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Fair review accommodates good research practice.

An introductory sketch of good research practice: questions to start with.

What is the research question and is it of clinical or scientific relevance?

Is the project building on what is known already?

Can the method answer the research question?

Are the research team suitably equipped to complete the study fairly?

Has the research incorporated views of patients and participants?

Are participants fairly recruited with justifiable inclusion and exclusion?

Have participants been offered a fair choice? (Informed consent)?

Have consequences (benefits/harms) been fairly evaluated and minimised?

Is personal data handled appropriately (confidentiality)?

Once the study is finished will participants receive appropriate care?

Will the project be registered and results be in the public domain?

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Fair review accommodates expertise and guidance (i/ii)

Here we seek expertise inside or outside the REC to help us.

(i) What expert (peer or scientific) review is available?“Bad science is bad ethics” and it’s clear from past research experience that appropriate scientific review could have made a significant contribution to participant safety.

(ii) What expertise is available in committee?Evidence is that on many occasions, the REC satisfies itself of the study’s science by considering the material presented and using expertise within the committee.It’s when the science might be considered a “deal breaker” or internal expertise is lacking that members need to turn to external advice.

Fair review accommodates expertise and guidance (ii/ii)

(iii) What other guidance have experts provided?

Here we turn to expert opinion and professional guidance. International bodies such as the World Health Organisation, the World Medical Association and the Council of Europe have gathered scientific experts, philosophers, public and service users and we should be able to use their judgements. In the United Kingdom, the Medical Research Council, the Wellcome Foundation and the Nuffield Foundation have done likewise.

However their application may not be straightforward. Articles or documents from these bodies have varying authority, hence uncertain ranking and are occasionally inconsistent. For some, provenance is not always “robust”.

Also they may not match the specific purpose of an REC. Publications also may not be able to accommodate all the details of a specific research project. Their conclusions or recommendations may not therefore be appropriate.

However if RECs go against guidance we ask them to explain why they did so.

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Fair review accommodates evidence

Here we use published evidence (e.g. interviews and surveys) about the acceptability (to the public or patients) of an aspect of the research proposal. If ethical research is that which society would accept, committee members need to reflect society‘s views. In the modern era, in parallel with the rise of evidence based medicine, some have described this as “Evidence Based Research Ethics”.

This, as with the others, has its limitations. While such articles and reports can capture broad views across society and paint the background, appraising and assimilating the evidence presents problems. The research base is limited, of uncertain quality, and the results depend on methodology. The method is also time consuming. What is needed is a workable assessment of the hierarchy of the source of evidence that might allow us to weigh competing papers and methods that can assess their quality and validity.

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Fair review is pragmatic

There’s no such thing as a perfect research project! Any project will be limited by available resources. RECs have a role in promoting research and shouldn't place unrealistic burden on researchers. This, however, is NOT a licence for unethical research. These issues should be discussed with the research team.

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Fair review of research should be independent, inclusive yet balanced.

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Fair review of research should be reasoned.

We must be prepared to justify our opinions, to explain how we have reached our position. Debate and ultimately consensus depends on this and later adjudication of an REC’s decision requires exploration of reasons. Otherwise we sink to the pantomime argument “Oh yes I will” against “Oh no you won’t”.

If we are to understand research ethics and develop consistent and justifiable review we need to know not only what standards we would expect of ethical research but also where they come from.

The key question that we always need to ask ourselves is:

“On what did I base my judgment, decision, view or opinion?”

The “8 Questions” or 8 “Es” might help.

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Fair review of research should be founded on an understanding of the project, method and context.

It’s important to recognise that factual errors are VERY likely to lead to ethical errors (and unnecessary argument) and the chair should ensure the committee shares the same (factual) view of the research project. This is one key purpose of the first part of REC deliberations, before the researcher attends.

An understanding of the context will also help the REC understand any constraints the researcher may be working under.

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Fair review of research is consistent

That RECs should have consistent processes would seem difficult to contradict. This is the role of the Health Research Authority and REC officers. Consistent reasoning and decisions are a more difficult consideration. Certain parts of research review are matters of fact and we might reasonably expect consistency. Others are finer judgements and we might reasonably expect members to reach different conclusions. Some inconsistency may be justifiable.The burden however, if we meet inconsistency, is to justify it. Is it clear that

the judgement is made on a sound factual basis.

the different decision is ethically relevant - it morally matters.

reasons have been clearly elucidated and discussed.

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Fair review of research should itself be open to review

Natural justice requires us to be accountable for our decisions. Members’ individual views should be open to examination (and challenge). The RECs’ views should be open for the researchers to comment and any final opinion should be open to appeal.

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Process• Understand your purpose(s)• Help the chair and coordinator do their jobs• Have a methodLogic and Meaning • Don’t contradict yourself• Agree and follow definitions within committeeValues • Be consistentDiscourse• Only say what you believe, don’t “game” or “bargain”• Allow all who have an interest to speak• Allow all who have an interest to question • Allow all who have an interest to express their views 

The REC debate: A deeper (philosophical) analysisLittle (Journal of Medical Ethics 1999 255 259) lays out a theoretical structure for discourse following the philosopher Jurgen Habermas (Moral consciousness and communicative action. Cambridge Polity press).

Quadrant 1Working in committee

What we ask you to do in committee

What we ask you NOT to do

Attack people personally Keep to the idea rather than the person.

Agree with everything The purpose of the meeting is to look at the application from different points of view.

Be inconsistent/changing the subject without explanation It helps the chair and coordinator who have to write minutes if items are addressed and resolved in turn.

Chat  Impose your views on others

Criticize (in a hostile manner) Best done in private, and comment on the idea not the person!

Display anger

Display superiority/domination

Make a long-winded contribution Write down key points and stick to them. You’re more likely to be “heard”

Back to key pointers for the new REC member

To read the studies Commitment

To try to understand the context of the research

Critical appraisal and imagination,

To consider all involved Empathy and respect

To identify and work out any ethical problems in the research

Clarity of thought

To express opinions and judgments Clarity of thought and expression

To identify, understand, and accommodate others’ opinions

Listening, respect and humility

To accept and weigh up arguments to make a decision

Respect and humility

To accommodate disagreement but if necessary stand firm

Humility and confidence

To identify and question your own convictions and values

Insight

What we ask you to do What we ask of you

How do we test a treatment test?

1 The processes (will have to be suitable for international audience) 2 Link to proposed model HD

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