3 - uob - setting up research in the nhs: practical and ethical considerations

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Heather Draper [email protected] For whose benefit is information provided? Reflections on our unfolding electronic text

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Page 1: 3 - UoB - Setting up research in the NHS: practical and ethical considerations

Heather [email protected]

For whose benefit is information provided? Reflections on our unfolding electronic text

Page 2: 3 - UoB - Setting up research in the NHS: practical and ethical considerations

Structure of session• Briefly present some of the results related to

two studies using this type of information sheet.

• Findings used as a spring board to a general discussion about participant information i.e. What happens if participants have a clear choice about what to read and chose not to read (much); why is information provided, who are we trying to protect, why and against what?

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The problem• Potential research participants need

information on which to base their decision• The amount of information ‘required’ seems

to be increasing• Researchers have expressed concerns that the

length of PIS is a deterrent to research– (and in ways that may be biasing recruitment)

• No empirical data about the sorts of things participants want to be told about

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Acknowledgements• Doctoral Researchers: Eva Antoniou and Helen Kirkby• Collaborators/doctoral supervisors: Dr Melanie Calvert, Professor Sue

Wilson, and Professor Maurice Zeegers

• Funding: HK and MC are funded by the MRC Midland Hub for Trials Methodology Research (Grant ID G0800808).

• The second study would not have been possible without the help of Professor Richard McManus and the Bp-Eth research team, especially Raman Kaur

• Ralph Ramah (Chief Executive of the Discount Web Design), John Couperthwaite and Christopher Withers for help with website programming

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Results of 2 studies to date:

• 1st used in web-based questionnaire survey (results published Antoniou et al 2011)

• 2nd systematic review (published Kirkby et al) + embedded alongside standard information sheet in ‘low risk’ clinical trial (Kirkby et al 2013)

• Will only present limited results on what participants most accessed

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Antoniou et al• See Antoniou, E., Draper, H., Reed, K., Burls, A., Southwood, T. R., Zeegers, M.

(2011) An empirical study on the preferred size of the participant information sheet in research. Journal of Medical Ethics 37(9); 557-562

• 552 participants recruited to web-based survey between July 2008 – November 2009

• Recruited via twins groups so did not require NRES review – was reviewed by the University of Birmingham Research Ethics Committee

• 77% accessed Level 1, 12%, level 2 6% level 3

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IISN= 552

Level1 n(%)

Levels1-2 n(%)

Levels1-3 n(%)

What is our research about? 446 (80) 78 (18) 53 (12)

Why are we doing this research? 425 (76) 50 (12) 27 (6)

Why have you been invited to take part?

419 (75) 41 (10) 23 (5)

What would we would like you to do? 462 (82) 53 (11) 32 (7)

Who will see the information collected?

427 (76) 43 (10) 12 (3)

What will happen to the information collected?

390 (70) 39 (9) 22 (6)

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• Vast majority did not access level 2 information

• Yet 20% wanted more information (only 6% clicked though to the final level)

• 4% said they did not click on + signs (whereas we know this was 18%)

• 34% said information they read did not influence decision to participate.

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Kirkby, Calvert and Draper• See Kirkby HM, Calvert M, McManus RJ, Draper H (2013) Informing

Potential Participants about Research: Observational Study with an Embedded Randomized Controlled Trial. PLoS ONE 8(10): e76435. doi:10.1371/journal.pone.0076435

• Embedded in Blood Pressure Monitoring in Different Ethnic Groups (Bp-Eth)– PI: Professor Richard McManus

• Three components– Overall study to assess feasibility of electronic information– RCT of PDF vs. IIS in terms of recruitment outcome– Observational study

• Data collected 5th Feb-12th Dec 2011

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Participants in each group

Information Provision nIIS 44PDF 42No PIS 106Paper PIS 870

This group expressed willingness to enrol without attempting to access ANY information

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Information accessed by potential research participants using IIS

Accessing any information type

No levels 18/4441%

Only needed Level 1 18/4441%

Needed Level 2 4/449%

Needed Level 3 4/449%

Also accessed external Information

4/449%

Total time spent reading: Median(IQR)

57 seconds(0; 195)

UK NRES approved level of information – i.e. Identical to paper version

Had information, chose not to access any

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Accessed and stayed long enough to have read Level 1 Level 2 Level 3

Accessed ANY (i.e. not ALL) information at this level

26/4459%

8/4418%

4/449%

Purpose 17/4439%

3/447%

1/442%

Have to take part 6/4414%

0/44 0/44

Why chosen 18/4441%

4/449%

1/442%

Expenses 22/4450%

5/4411%

1/442%

What will happen 13/4430%

0/44 0/44

Risks 22/4450%

7/4416%

2/445%

Benefits 20/4446%

3/447%

1/442.3%

Problems 16/4436%

1/442%

0/44

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Accessed and stayed long enough to have read

Level 1 Level 2 Level 3

Confidentiality 10/4423%

1/442%

0/44

Don’t want to carry on 6/4414%

0/44 0/44

GP 14/4432%

3/447%

1/442%

Samples 15/4434%

n/a

Genetics tests 10/4423%

n/a

Results 11/4425%

1/442%

1/442%

Organising and funding 10/4423%

3/447%

2/445%

Reviewed study 11/4426%

2/445%

2/445%

Further information and contact 4/449%

n/a

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UnderstandingN Mean score *(95%

CI)IIS 41 11.0

(10.3; 11.7)PDF-PIS 26 11.2

(10.0; 10.9)No PIS 37 11.1

(10.3; 11.8)Paper PIS 165 10.4

(10.0; 10.9)

* Mean score = the mean correct answers on the understanding questionnaire, out of a possible of 15

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SatisfactionIIS PDF-PIS No PIS Paper PIS

Wanted more information 1/403%

2/248%

1/363%

28/13920%

Would not have taken part without reading the PIS

17/4043%

9/2438%

17/3647%

73/13753%

Information was interesting but did not influence participation decision

16/4040%

9/2438%

17/3647%

73/13753%

Skimmed the information 14/4035%

4/2417%

4/3611%

18/13713%

Prefer electronic information 18/4045%

12/2450%

1/3628%

14/13710%

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• Fewer people than we anticipated provided an email address in the parent study.

• 59% of people in the ‘No PIS’ group took active step towards participation in parent study.

• 41% of IIS participants chose to read nothing before taking active step towards participation in parent study.

• For those who wanted some information, the most basic information seems mostly (41%) to have been sufficient for the purpose of deciding.

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Observations • UK REC reviewed level of information

– Satisfied 1/10th participants– Undersupplied 1/10th

– Oversupplied 4/5ths • Participants happy with information received

– Even those who chose to access nothing• People did not accurately recall/honestly report how much

information they accessed.• People may say they want more even if they do not access

what is actually available.

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Questions for discussion1. To what extent should participants be allowed to choose NOT

to read ANY information before expressing an interest in participation?

– How can we ‘force’ participants to read the information if we think they shouldn’t be allowed to choose?

– How influential to your views is the nature/kind of the research?– What information, if any, MUST participants know? Who says?– Might people decide for reasons that have nothing to do with

information – e.g. trust

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2. Electronic recruitment means that we may know what information people have/have not accessed. We might suspect that people do not read a paper PIS but we may know that they have not read electronic information.

– Does knowing for sure make an ethical difference? (Why?)– Should we assume that people are not reading the paper PIS? – What changes, if any in practice, should follow?

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3. Arguably, our data suggest that greater emphasis should be placed on the consent interview than on the written information (PIS)

– Should RECs actually be reviewing scripts for consent interviews rather than the PIS?

– Who should decide, and on what basis, what information should be imparted in the consent interview?

– What replaces the consent interview in e-trials?

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4. Would PIs, RECs, governance/sponsors permit the piloting or use of IIS in ‘riskier’ studies e.g.– Intervention carries risk of harm– Studies involving patients who have serious

conditions– Complex trials– Patient group more vulnerable (e.g. Impaired

capacity or lacking capacity) What safe guards would be required?

– (In the second study ALL actual participants had conventional consent interview)

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5. As currently written (i.e. level and depth of information) is the PIS geared more to protecting researchers than facilitating participant understanding?

6. Do electronic medium provide greater opportunities for flexible, meaningful information provision (i.e. Ethical review assesses risks, brief information that can be expanded on in a consent interview designed to protect participants from unknowingly taking risks, IIS available for participants to consult as and when needed)

7. Should we be developing non-text-based media?

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Current Bp-Eth PIS

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PIS based on access patterns + international requirements

• Introduction– Aim of study – Advice to read

information

Declaration of Helsinki required◦ Affiliations◦ Voluntary

participation◦ Withdraw consent◦ Funding body

Information participants wanted◦ What they will have

to do◦ Benefits◦ Risks◦ Expenses

Where to access more information◦ Study website◦ Researchers◦ Detailed paper PIS

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• Takes around 1 minute to read (200 words)

• Information participants most accessed

– Risks and benefits, what will happen if they take part, expenses

• Information required by Declaration of Helsinki

– ‘In medical research involving competent human subjects, each potential subject must be

adequately informed of the aims, methods, sources of funding, any possible conflicts of

interest, institutional affiliations of the researcher, the anticipated benefits and potential risks

of the study and the discomfort it may entail, and any other relevant aspects of the study. The

potential subject must be informed of the right to refuse to participate in the study or to

withdraw consent to participate at any time without reprisal.’