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Copy of online submission made by CMF on 15 September 2009 to the General Medical Council drafts for consultation on Research guidance: Good practice in research and Consent to research

Published: 16th September 2009

Drafts may be viewed online:
Consent to research
Good practice in research.

Questions relating to Good practice in research

Principles of good research practice (paragraphs 1-27)

Question 1.

Do you think this section covers the most important principles that doctors must consider when they are involved in research?
Not sure.

Generally, excellent and comprehensive.

However, do paragraphs (9) and (19) say enough about pressures arising from the commercial interests of sponsors and causing publication bias? How accurate are abstracts as a reflection of the research? In other words, is there enough here on the ethics of publication?

The draft guidance aims to make clear that doctors must ensure that the safety, dignity and well-being of participants take precedence over the development of treatments and the furthering of knowledge. The guidance makes reference (in footnote 4 of paragraph 4) to the advice in the Declaration of Helsinki that placebo should only be used where there is no existing proven therapy.

Question 2.

Do you think that a reference to the advice in the Declaration of Helsinki on using placebo-controlled trials is sufficient?

Not sure.

This brief reference raises a whole raft of issues! eg There would never be any 'existing proven therapy' if somebody hadn't once done a placebo-controlled trial...

There needs to be a clearer explanation with reference to context.

Questions relating to Consent to research

Responsibility for seeking consent (paragraph 7)

The draft guidance aims to make clear that consent to participate in research can be sought by any member of a research team, as long as they meet the requirements set out in paragraph 7.

Question 3.

Do you think that this is a reasonable approach?

Yes.

But paragraph (7) needs to include the concepts of paragraphs (1)-(6) - especially competence in communication.

Sharing information with others involved in care (paragraph 9)

The draft guidance aims to make clear that where participants give consent doctors should share information with others involved in the care of participants, even when the research involves people who are not patients.

Question 4.

Do you think that this is a reasonable approach?

Not sure.

What happens if the patient does not give consent? And the research potentially affects 'their continuing care'? For patient safety reasons, should we be doing this research at all on patients who refuse to have GPs and other professional carers informed?

Research involving children and young people (paragraphs 10-12)

The principles in Consent to research apply to research involving children and young people but there are particular sensitivities and legal and other requirements when making decisions about involving children or young people in research. To avoid duplication, Consent to research signposts to the advice in 0-18 years: guidance for all doctors (2007) and more detailed guidance published by other organisations. Specific advice on some of the legal requirements for involving children and young people under 16 in clinical trials is set out in the legal annex.

Question 5.

Do you think that this is a reasonable approach to take?

Yes.

Research involving neonates (paragraphs 13-14)

The draft guidance sets out advice on seeking consent to involve neonates in research, including during an emergency. It acknowledges that it is often an emotional and difficult time for parents when treatment is available only as part of research and a decision is required quickly.

Question 6.

Do you agree with the guidance about seeking consent to involve neonates in research?

Not sure.

We found this confusing as written. Surely if the 'research' is only done when it 'is expected to benefit the child' it is treatment and not research? And surely the professionals will be totally occupied with treating in an 'emergency'?

Are we confusing research and treatment here?

Research involving adults without capacity (paragraphs 17-25)

Paragraphs 18 and 19 of the draft guidance set out the circumstances when people who lack capacity might be involved in research. It aims to take account of the complex legal framework that governs the involvement of people (over 16) who lack capacity in research.

Question 7.

Do you think that the guidance set out in paragraphs 18 and 19 about when people who lack capacity might be involved in research is clear?

Neutral.

Paragraph (18) is fine. In paragraph (19) break the long first sentence after the two criteria are stated. Make everything about risks a new sentence or sentences.

? Reference 'clinical trial' back to the footnote (2) on page 2.

General questions about the guidance

The following 9 questions relate to both pieces of draft supplementary guidance, Good practice in research and Consent to research.

Question 8.

Do you think the draft guidance contains the right level of detail?

Please give your answer for Good practice in research

About right.

Please give your answer for Consent to research

Too detailed.

No annexes were provided, so it was not possible to assess this fully. Even so, this seemed lengthy - eg paragraph 27

Question 9.

Do you think the guidance is clear?

Please give your answer for Good practice in research

Very clear.

Please give your answer for Consent to research

Clear- revisit paragraphs (19) and (27)

Question 10.

Do you think the guidance accurately reflects the law that applies to research in the UK where you live or work?

Please give your answer for Good practice in research

Yes.

Please give your answer for Consent to research

Yes.

Question 11.

Can you point to any other guidance documents, information or resources that would be useful to refer to in the guidance? These may include other guidance about, for example:
a) appropriate record retention periods in research;
b) involving children and young people in research; or
c) conducting clinical trials.

No.

Question 12.

Can you point to any important inconsistencies between the draft guidance and the guidance published by other relevant organisations? Other organisations may include, for example, the National Research Ethics Service, Medical Research Council, or the Royal College of Physicians.

Please give your answer for Good practice in research

No.

Please give your answer for Consent to research

No.

Question 13.

Can you identify any changes that would be needed in order to meet the standards set out in the guidance? (For example, in the recruitment of participants or any reporting or other system in place to protect research participants from harm).

Please give your answer for Good practice in research

No.

Please give your answer for Consent to research

No.

Question 14.

Do you think that applying the standards in this guidance will have an adverse impact on particular groups of people that might be involved in research? (For example, people living in care homes or other institutions or people with learning disabilities or mental illness).

Please give your answer for Good practice in research

No.

Please give your answer for Consent to research

No.

Question 15.

We would welcome any additional comments you may have on the draft guidance Good practice in research or Consent to research. These may include, for example:
a) How clearly Good practice in research and Consent to research link together.
b) Whether you think we have achieved the right balance between setting out the key principles that apply to research and referring to more detailed guidance elsewhere.

Felt 'Good Practice' had the right balance. Felt 'Consent' was too detailed and, in the few places indicated, unclear.

And lastly…

Question 16.

Do you have any comments on the consultation documents and/or process?

Yes.

Could not find any Annexes for the 'Consent' paper, which made comprehensive assessment difficult.

For further information:

Philippa Taylor (CMF Head of Public Policy) 020 7234 9664
Steven Fouch (CMF Head of Communications) 020 7234 9668

Media Enquiries:

Alistair Thompson on 07970 162 225

About CMF:

Christian Medical Fellowship (CMF) was founded in 1949 and is an interdenominational organisation with over 4,000 British doctor members in all branches of medicine. A registered charity, it is linked to about 65 similar bodies in other countries throughout the world.

CMF exists to unite Christian doctors to pursue the highest ethical standards in Christian and professional life and to increase faith in Christ and acceptance of his ethical teaching.

Christian Medical Fellowship:
uniting & equipping Christian doctors & nurses
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