What potential research participants want to know about research: a systematic review

Helen Michelle Kirkby, 1 Melanie Calvert,

1 Heather Draper,

2 Thomas Keeley,

1

Sue Wilson 1

ABSTRACT Objective: To establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES).

Data sources: Medline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis index’s, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors.

Study selection: Original research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included.

Study appraisal and synthesis methods: Studies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet.

Results: 14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items.

Conclusions: There is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and

a more tailored evidence-based approach may be necessary.

INTRODUCTION Medical research is central to the advance- ment of treatments, services and tech- nology.1e3 Potential participants have the right to choose whether they participate in medical research,4 5 and individuals must give their consent prior to participating in research. As part of this ongoing process,

To cite: Kirkby HM, Calvert M, Draper H, et al. What potential research participants want to know about research: a systematic review. BMJ Open 2012;2: e000509. doi:10.1136/ bmjopen-2011-000509

< Prepublication history and an additional appendix for this paper are available online. To view these files please visit the journal online (http://dx.doi.org/10.1136/ bmjopen-2011-000509).

Received 15 December 2011 Accepted 3 April 2012

This final article is available for use under the terms of the Creative Commons Attribution Non-Commercial 2.0 Licence; see http://bmjopen.bmj.com

1MRC Midlands Hub for Trials Methodology Research (HTMR), University of Birmingham, Edgbaston, Birmingham, UK 2Medicine, Ethics, Society and History, Primary Care Clinical Sciences, School of Health and Population Science, University of Birmingham, Edgbaston, Birmingham, UK

Correspondence to Helen Michelle Kirkby; [email protected]

ARTICLE SUMMARY

Article focus - What information do potential participants want

to know when they are deciding whether to take part in research?

- What is the established empirical evidence base? - How does the current empirical evidence base

relate to current guidance from the NRES?

Key messages - There is little empirical evidence of what

information potential participants want to know about research when they are making the decision to take part.

- The limited empirical evidence available suggests that potential participants may have very different information needs.

- Further research is required to determine what potential participants really want to know about research and how this can be delivered in a way that takes into account their different informa- tional needs.

Strengths and limitations of this study - An extensive search strategy ensured that the

review was systematic in capturing all available empirical evidence.

- Papers included in the review differed in their methodologies and presentation of results, making comparisons between papers extremely difficult.

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 1

Open Access Research

potential participants must be provided with sufficient information to make a voluntary and informed deci- sion.2 6e11 In research settings, study information is usually conveyed to potential participants in the form of a written participant information sheet (PIS), which is later reinforced by a verbal consent interview with a member of the research team.12

In the UK, the National Research Ethics Service (NRES) provides extensive guidance on how a PIS should be written and presented. The guidance suggests that a PIS should be split into two parts where part one provides a brief and clear explanation of the essential elements of the specific study and allows participants to make an initial choice of whether the study is of interest. Part two should then contain additional information on matters such as confidentiality, indemnity and publication intentions. There is some concern that PIS have become

increasingly lengthy over recent years.10 13 14 Complex studies, for example, where the potential participant might, for example, on the basis of test results be invited to participate in a further phase of the study, often use detailed and lengthy PISs. This can lead to poor understanding by participants15e17 and a corresponding concern that consent criteria are not always met. The NRES guidance is not explicit in the level of detail to be included in a PIS, and there is disagreement among experts about how much information to include.18 If PISs become so complex that only the most confident and educated participants are able to digest all the information, this may result in selection bias meaning that research is less generalisable.19 Furthermore, there is a risk that healthcare researchers are becoming increasingly paternalistic in their information provision without recognising individual participant needs. In order to help address the problem of how much infor- mation to include in PIS, we conducted a systematic review that aimed to establish the empirical evidence base for the information that potential participants want to know when they are deciding about participation.

METHODS Selection criteria and literature search This systematic review included all studies that asked participants to indicate how much or what type of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information. We included studies published between 1950 and 27 October 2010 with no limit to language or participant group. We only included studies of participant opinion and excluded studies of health- care professional or other expert opinion. We combined Mesh terms Patient, Research Subjects,

Consent forms, Informed Consent and Research ethics with terms relating to information provision (online appendix 1). We conducted searches in Medline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information

Consortium and the Cochrane Library electronic data- bases. We also searched thesis index’s, grey Literature databases, reference and cited article lists, key journals and Google Scholar and we asked expert authors to identify relevant studies. We did not conduct a formal quality assessment of

included literature because there were both quantitative and qualitative studies, widely varied study methods and different types of results that were often not comparable between papers. Instead, we conducted a critical appraisal of each paper using five quality indicators (response rate, sample size, demographics, participant characteristics and strengths and limitations of study methods). The strengths and limitations of each study are presented in table 1.

Data extraction and synthesis One researcher (HMK) extracted data from papers using a pre-defined data extraction sheet and a second researcher (TK) checked it for accuracy with disagree- ments resolved by discussion between these two authors (table 1). A metadata analysis using basic thematic analysis was used to analyse the data from the 14 papers. Themes were based on the sections of information that NRES recommends should be included in a PIS (table 2).10 Each paper was assessed to identify any further themes relating to what information research participants may want to know. A metadata analysis coded individual results based on their relevance to each theme and then themes were collated to report overall results. For themes where more than one quantitative study reported a proportion of participants wanting to know the information, pooled proportions with random effects were calculated using StatsDirect statistical software (StatsDirect Ltd).

RESULTS The search yielded 11 943 unique references. We discarded 11 291 after reviewing the title, 620 after reviewing the abstract and a further 18 after reviewing the full paper (figure 1). HMK conducted the citation screening and TK independently validated approxi- mately 10% of the references identified from electronic databases (96.0% k agreement rate). All 14 included studies were identified from searches of Medline and Applied Social Sciences Index and Abstracts. Expert authors identified 37 unique references; 13 were dupli- cates from the electronic searches and 24 did not meet the inclusion criteria. Of the 14 studies included in the review, three specif-

ically considered the return of research results to participants and six considered only investigator conflicts of interest. Five studies looked broadly at what information potential research participants wanted to know. Of the 20 sections of information NRES suggest

should be included in a PIS, there were seven categories where no empirical evidence was identified that

2 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

T a b le

1 S u m m a ry

o f s tu d ie s in c lu d e d in

th e s y s te m a ti c re v ie w

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

W a lk u p ,2 0

U S A , 2 0 0 9

N o n e

p ro v id e d

N o n e

G e n d e r: n o t

re p o rt e d

5 7 (n o t

p ro v id e d )

E x p lo ra ti o n o f

c o n v e rs a ti o n

a n d

q u e s ti o n n a ir e

C o n v e n ie n c e

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s

S tu d y p u rp o s e ,

v o lu n ta ri n e s s ,

s tu d y m e th o d ,

ri s k s , b e n e fi ts ,

c o n fi d e n ti a lit y

a n d re v ie w

b o a rd

a p p ro v a l

P a rt ic ip a n ts

a p p ro a c h e d

in a p u b lic

s e tt in g a n d

in v it e d to

c o m p le te

a

q u e s ti o n n a ir e

a n d re s e a rc h e r

re c o rd e d s tu d y

in fo rm

a ti o n

s p o n ta n e o u s ly

re q u e s te d

D id

n o t

s p e c if y

a d is e a s e

g ro u p

N o in c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

d e m o g ra p h ic s

n o t re p o rt e d

A g e : n o t

re p o rt e d

E d u c a ti o n /

d e p ri v a ti o n :

n o t re p o rt e d

E th n ic it y : n o t

re p o rt e d

B e n to ,2 1

B ra z il,

2 0 0 8

F e m a le

p a rt ic ip a n ts

a g e d

1 8 e 4 9 y e a rs

w h o h a d ta k e n

p a rt in

a c lin ic a l

tr ia l o f w o m e n ’s

h e a lt h in

th e

p re v io u s

1 2 m o n th s a n d

liv e d in

M e tr o p o lit a n

a re a o f

C a m p in a s , S a o

P a u lo , B ra z il

W o m e n ’s

h e a lt h

G e n d e r:

o n ly

fe m a le

5 1 p a rt ic ip a n ts

8 fo c u s

g ro u p s

(n o t p ro v id e d )

F o c u s

g ro u p s

C o n v e n ie n c e

F ra m e w o rk

a n a ly s is

S tu d y

m e th o d s ,

ri s k s a n d

b e n e fi ts

P a rt ic ip a n ts

o f

d if fe re n t a g e s

a n d e d u c a ti o n a l

le v e l lik e ly

to h a v e

d if fe re n t n e e d s

a n d o p in io n s

re g a rd in g to p ic

F o c u s g ro u p s

h o m o g e n e o u s

fo r a g e a n d

e d u c a ti o n a l

le v e l; s u it a b le

to e n s u re

th e y

w e re

c o m fo rt -

a b le

e x p re s s in g

o p in io n s

R e c ru it m e n t

c o n ti n u e d u n ti l

d a ta

s a tu ra ti o n

p o in t

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f th e g e n e ra l

p o p u la ti o n a s

th e s tu d y o n ly

in c lu d e d w o m e n

a n d w a s lim

it e d

to p a rt ic ip a n ts

fr o m

a tr ia l o f

a c o n tr a c e p ti v e

in te rv e n ti o n

A g e : 1 8 e 4 9

E d u c a ti o n /

d e p ri v a ti o n :

4 fo c u s g ro u p s

8 th

g ra d e o r le s s , 4

fo c u s

g ro u p s a b o v e

8 th

g ra d e e d u c a ti o n

E th n ic it y : n o t re p o rt e d

C o n ti n u e d

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 3

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

H u tc h in s o n ,7

A u s tr a lia ,

1 9 9 6

P a rt ic ip a n ts

o f

c lin ic a l tr ia ls

o f

C O P D , a s th m a ,

d ia b e te s ,

o s te o p o ro s is ,

rh e u m a to id

a rt h ri ti s a n d

th e in fl u e n z a

v a c c in e .

E x c lu d e d if

c lin ic a l tr ia l

fo r a c u te ,

lif e -t h re a te n in g

o r d e b ili ta ti n g

c o n d it io n s w it h

in a d e q u a te

th e ra p y

C h ro n ic

ill n e s s

G e n d e r: 5 2 %

m a le

2 5 9 /3 2 4

(8 0 % )

Q u e s ti o n n a ir e

C o n v e n ie n c e

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s a n d

m u lt iv a ri a te

lo g is ti c

re g re s s io n

C o n fl ic ts

o f

in te re s t (C

o I) /

o rg a n is a ti o n

a n d fu n d in g

o f th e re s e a rc h

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f th e g e n e ra l

p o p u la ti o n a s

m e d ia n a g e 7 0

A g e : m e d ia n

a g e 7 0 (r a n g e

n o t re p o rt e d )

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : n o t

re p o rt e d

G ra y ,2 2

U S A , 2 0 0 7

P a rt ic ip a n ts

e n ro lle d o n to

a p h a s e I

re s e a rc h tr ia l,

s p o k e E n g lis h

a n d w e re

m e d ic a lly

a n d

m e n ta lly

c a p a b le

o f p a rt ic ip a ti n g

P h a s e I

re s e a rc h

tr ia l

G e n d e r:

5 2 %

m a le

1 0 2 /1 1 9

(8 6 % )

Q u e s ti o n n a ir e

C o n s e c u ti v e

p a rt ic ip a n ts

e n ro lli n g

o n to

p a re n t

tr ia l

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s , c 2

te s ts

a n d

m u lt iv a ri a te

lo g is ti c

re g re s s io n

C o I/

o rg a n is a ti o n

a n d fu n d in g

o f th e

re s e a rc h

S a m e

in te rv ie w e r

c o n d u c te d

a ll in te rv ie w s

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f th e g e n e ra l

p o p u la ti o n a s th e

m e d ia n a g e w a s

6 1 a n d w a s

lim it e d to

c a n c e r

p a ti e n ts

p a rt ic ip a ti n g in

a n

e a rl y p h a s e

c lin ic a l tr ia l

A g e : m e d ia n

a g e 6 1 (r a n g e

2 6 e 8 2 )

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : 8 1 %

w h it e

C o n ti n u e d

4 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

F e rn a n d e z ,2 3

C a n a d a ,

2 0 0 7

E n g lis h -s p e a k in g

a d o le s c e n t w it h

c a n c e r o r p a re n ts

o f c h ild re n w it h

c a n c e r. E x c lu d e d

a c u te ly

u n w e ll o r

re c e n tl y re la p s e d

C a n c e r

G e n d e r:

a d o le s c e n ts

n o t re p o rt e d

P a re n ts

m o s tl y

w o m e n (2 3 /3 0 ;

7 7 % )

4 0 /4 3 d 1 0

a d o le s c e n t,

3 0 p a re n t

p a rt ic ip a n ts

(9 3 % )

Q u e s ti o n n a ir e

R a n d o m

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s

a n d c 2 te s ts

R e tu rn

o f

s tu d y re s u lt s

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s

p a rt ic ip a n ts

w e re

w e ll e d u c a te d ,

m o s tl y C a u c a s ia n

a n d lim

it e d to

a d o le s c e n ts

w it h

c a n c e r/ p a re n ts

o f c h ild re n w it h

c a n c e r

A g e :

a d o le s c e n ts

m e d ia n a g e 1 6

(r a n g e 1 3 e 2 0 )

P a re n ts

m e d ia n a g e

4 0 .9

(r a n g e

2 8 e 5 3 )

E d u c a ti o n /

d e p ri v a ti o n :

a d o le s c e n ts

p re d o m in a n tl y

in e d u c a ti o n

(n o fi g u re s

re p o rt e d )

P a re n ts

5 0 %

w it h p o s t

s e c o n d a ry

e d u c a ti o n

E th n ic it y :

a d o le s c e n ts

8 0 %

C a u c a s ia n

P a re n ts

1 0 0 %

C a u c a s ia n

C o n ti n u e d

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 5

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

B e n to ,3 3

U S A , 2 0 0 6

P a rt ic ip a n ts

o f

H IV , h e p a ti ti s ,

a rt h ri ti s a n d

s u rg ic a l o n c o lo g y

tr ia ls

w h o w e re

> 1 8 y e a rs

a n d

E n g lis h s p e a k in g

V a ri o u s

G e n d e r:

6 1 %

m a le

3 3 (n o t

p ro v id e d )

F a c e -t o -f a c e

s e m i-

s tr u c tu re d

in te rv ie w s

C o n v e n ie n c e

T ra n s c ri p ts

c o d e d a n d

th e m e s a n d

m a jo r

c o n c e p ts

id e n ti fi e d

C o I/

o rg a n is a ti o n

a n d fu n d in g

o f th e

re s e a rc h

O p e n q u e s ti o n s

u s e d d u ri n g

in te rv ie w s

D a ta

c o lle c ti o n

c o n ti n u e d to

s a tu ra ti o n p o in t

T w o a u th o rs

in d e p e n d e n tl y

c o n d u c te d

a n a ly s is

U s e d h y p o th e ti c a l

s c e n a ri o

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s

p a rt ic ip a n ts

w e re

m o re

o ft e n m e n

a n d lim

it e d

to a d u lt s

p a rt ic ip a ti n g in

H IV , h e p a ti ti s ,

a rt h ri ti s o r

s u rg ic a l o n c o lo g y

tr ia ls

A g e : n o t

re p o rt e d

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : 7 0 %

w h it e

H a m p s o n ,2 4

U S A , 2 0 0 6

P a rt ic ip a n ts

w it h

c a n c e r a n d

e n ro lle d in

a c lin ic a l tr ia l

w h o w e re

E n g lis h s p e a k in g

a n d > 1 8 y e a rs

C a n c e r

G e n d e r: 5 6 %

m a le

2 5 2 /2 7 2

(9 3 % )

S tr u c tu re d

fa c e -t o -f a c e

in te rv ie w s

N o t

p ro v id e d

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s a n d

F is h e rs

e x a c t

te s t/ K ru s k a le

W a lli s te s t

C o I/

o rg a n is a ti o n

a n d fu n d in g

o f th e

re s e a rc h

V a lid a te d

in te rv ie w

q u e s ti o n s

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s

th e s tu d y

p o p u la ti o n w e re

w e ll e d u c a te d ,

fi n a n c ia lly

s e c u re

a n d lim

it e d to

a d u lt p a rt ic ip a n ts

o f a c lin ic a l tr ia l

A g e : 2 4 % ,

< 5 0 ; 3 2 % ,

5 0 e 5 9 ; 2 6 % ,

6 0 e 6 9 ; 1 6 % ,

> 7 0

E d u c a ti o n /

d e p ri v a ti o n :

w e ll e d u c a te d

a n d fi n a n c ia lly

s e c u re

E th n ic it y : 9 2 %

w h it e

C o n ti n u e d

6 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

W e in fu rt ,2 5

U S A , 2 0 0 6

H e a lt h y a d u lt s o r

th o s e w it h a m ild

c h ro n ic

ill n e s s .

E x c lu d e d if th e y

h a d p a rt ic ip a te d

in a n o th e r fo c u s

g ro u p w it h in

th e

p re v io u s

6 m o n th s

o r w e re

w o rk in g

o r h a d w o rk e d fo r

a n o rg a n is a ti o n

in v o lv e d in

th e

c o n d u c t o f

c lin ic a l

tr ia ls

H e a lt h y

G e n d e r: 4 2 %

m a le

1 6 fo c u s

g ro u p s (n o t

p ro v id e d )

F o c u s

g ro u p s

C o n v e n ie n c e

In it ia l c o n te n t

c o d e s b a s e d

o n tr a n s c ri p ts

d e v e lo p e d

th a t w e re

s u m m a ri s e d

a n d re v ie w e d

to id e n ti fy

m a in

th e m e s

C O I/

o rg a n is a ti o n

a n d fu n d in g

o f th e re s e a rc h

P a rt ic ip a n ts

n o t lim

it e d to

d is e a s e g ro u p

O n ly

o n e

m o d e ra to r

c o n d u c te d fo c u s

g ro u p s

N o n -v e rb a l

c o m m u n ic a ti o n

n o t re c o rd e d

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s th e

s tu d y p o p u la ti o n

w e re

w e ll

e d u c a te d ,

fi n a n c ia lly

s e c u re

a n d th e m a jo ri ty

h a d p re v io u s ly

s h o w n in te re s t

in re s e a rc h

A g e : 1 2 % ,

1 8 e 2 9 ; 5 1 % ,

3 0 e 4 9 ; 3 7 % , > 5 0

E d u c a ti o n /

d e p ri v a ti o n :

w e ll e d u c a te d

a n d fi n a n c ia lly

s e c u re

E th n ic it y : 5 6 %

w h it e

P a rt ri d g e ,2 6

U S A , 2 0 0 5

A ll p a rt ic ip a n ts

o f th e p a re n t tr ia l

(c h e m o th e ra p y

tr ia l)

C a n c e r

G e n d e r: o n ly

fe m a le

9 4 /1 3 5

(6 9 .6 % )

Q u e s ti o n n a ir e

C o n v e n ie n c e

S im

p le

d e s c ri p ti v e

s ta ti s ti c s

R e tu rn

o f

s tu d y re s u lt s

P a rt ic ip a n t

s e le c ti o n b ia s e d

to w a rd s

p a rt ic ip a n ts

th a t

w a n te d to

k n o w

s tu d y re s u lt s

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s th e

s tu d y p o p u la ti o n

w e re

m o s tl y

C a u c a s ia n , o n ly

in c lu d e d fe m a le s

a n d w a s lim

it e d to

p a rt ic ip a n ts

o f

a b re a s t c a n c e r

tr ia l

A g e : m e a n a g e

5 5 (r a n g e n o t

re p o rt e d )

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : 9 6 %

w h it e

C o n ti n u e d

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 7

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

K im

,2 7

U S A , 2 0 0 4

P o te n ti a l

re s e a rc h

p a rt ic ip a n ts

> 1 8 y e a rs ,

d ia g n o s e d w it h

h e a rt d is e a s e ,

b re a s t c a n c e r

o r d e p re s s io n

a n d lis te d o n th e

H a rr is

In te ra c ti v e

C h ro n ic

Il ln e s s

D a ta b a s e

V a ri o u s

G e n d e r: 5 0 %

m a le

5 4 7 8 /2 0 2 0 5

(2 7 % )

O n lin e

q u e s ti o n n a ir e

R a n d o m

T w o -w

a y

A N O V A

m o d ifi e d fo r

o rd in a l d a ta

a n d

m u lt in o m ia l

lo g is ti c

re g re s s io n

C o I/

o rg a n is a ti o n

a n d fu n d in g

o f th e re s e a rc h

V a lid a te d

q u e s ti o n n a ir e

P a rt ic ip a n ts

c h o s e n a t

ra n d o m

b u t

fr o m

th e

s u b s e t

o f th o s e

re g is te re d

o n th e H a rr is

In te ra c ti v e

C h ro n ic

Il ln e s s

D a ta b a s e

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s it

w a s lim

it e d to

in te rn e t u s e rs

A g e : 4 %

1 8 e 2 9 , 1 6 %

3 0 e 4 4 , 6 1 %

4 5 e 6 4 , 1 9 %

6 5 +

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : 9 2 %

w h it e

P a rt ri d g e ,2 8

U S A , 2 0 0 3

A n y p a rt ic ip a n t

e n ro lle d in to

th e

p a re n t s tu d y

(c h e m o th e ra p y

tr ia l)

B re a s t

c a n c e r

G e n d e r: n o t

re p o rt e d

5 1 /5 5

(9 3 % )

Q u e s ti o n n a ir e

C o n v e n ie n c e

S im

p le

d e s c ri p ti v e

s ta ti s ti c s

R e tu rn

o f

s tu d y re s u lt s

M u lt ic e n tr e

U n v a lid a te d

q u e s ti o n n a ir e

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s th e

s tu d y w a s lim

it e d

to p a rt ic ip a n ts

o f

a b re a s t c a n c e r

tr ia l. G e n d e r w a s

n o t p re s e n te d b u t

e x p e c t m o s t w e re

w o m e n g iv e n

d is e a s e a re a

A g e : m e d ia n

a g e 5 4 (r a n g e

2 9 e 8 2 )

E d u c a ti o n /

d e p ri v a ti o n : ra n g e o f

b a c k g ro u n d s

E th n ic it y : 8 4 %

w h it e

C a s a re tt ,2 9

U S A , 2 0 0 1

P a rt ic ip a n ts

w it h

a c u rr e n t

te le p h o n e

n u m b e r, e n ro lle d

a t a p a in

c lin ic ,

w h o h a d c h ro n ic

n o n -m

a lig n a n t

p a in , w e re

ta k in g

s c h e d u le d

o p io id s

a n d h a d

e x p e ri e n c e d th e

p a in

fo r a t

le a s t 6 m o n th s

C h ro n ic

p a in

G e n d e r: 4 0 %

m a le

4 0 /8 6

(4 6 .5 % )

S e m i-

s tr u c tu re d

te le p h o n e

in te rv ie w s

C o n v e n ie n c e

D e s c ri p ti v e

s u m m a ry

s ta ti s ti c s a n d

b iv a ri a te

a n a ly s is

w it h n o n -

p a ra m e tr ic

te s ts

V o lu n ta ri n e s s ,

s tu d y

m e th o d s ,

e x p e n s e s ,

ri s k s a n d th e

d ru g /d e v ic e /

p ro c e d u re

b e in g te s te d

V a lid a te d

in te rv ie w

to p ic

g u id e

Q u e s ti o n s

s p o n ta n e o u s ly

a s k e d b y

p a rt ic ip a n ts

w e re

re c o rd e d

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s

p a rt ic ip a n ts

w e re

m o re

o ft e n m e n

a n d lim

it e d to

c h ro n ic

p a in

p a ti e n ts

A g e : m e a n

a g e 4 7 (r a n g e

3 0 e 8 6 )

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : 8 5 %

w h it e

C o n ti n u e d

8 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

T a b le

1 C o n ti n u e d

L e a d

a u th o r/

c o u n tr y /

y e a r

In c lu s io n /

e x c lu s io n

c ri te ri a

P a rt ic ip a n t

il ln e s s

P a rt ic ip a n t

d e m o g ra p h ic s

T o ta l

n u m b e r o f

p a rt ic ip a n ts

(r e s p o n s e

ra te )

S tu d y

d e s ig n

S a m p li n g

s tr a te g y

A n a ly s is

K e y

th e m e s

e x p lo re d

S tu d y

s tr e n g th s

S tu d y

li m it a ti o n s

M a s lin ,3 0

U K , 1 9 9 4

A tt e n d in g

a b re a s t u n it

a n d w e re

p a ti e n ts

w it h

a b re a s t c a n c e r

d ia g n o s is

o r

a s y m p to m a ti c

w o m e n w it h

a fa m ily

h is to ry

o f b re a s t c a n c e r

C a n c e r

G e n d e r: o n ly

fe m a le

2 1 3 /3 0 0

(7 1 % )

P o s ta l

q u e s ti o n n a ir e

R a n d o m

S im

p le

d e s c ri p ti v e

s ta ti s ti c s

S tu d y

p u rp o s e ,

v o lu n ta ri n e s s ,

s tu d y

m e th o d s ,

ri s k s , b e n e fi ts

a n d

c o n fi d e n ti a lit y

P a rt ic ip a n ts

c h o s e n a t

ra n d o m

b u t

fr o m

a s u b s e t

o f th o s e

a tt e n d in g

a b re a s t u n it

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f g e n e ra l

p o p u la ti o n a s th e

s tu d y o n ly

in c lu d e d

w o m e n a n d w a s

lim it e d th o s e w it h

b re a s t c a n c e r

A g e : m e d ia n

4 7 (r a n g e

2 4 e 8 1 )

E d u c a ti o n /

d e p ri v a ti o n : n o t

re p o rt e d

E th n ic it y : n o t

re p o rt e d

S a n d ,3 1

N o rw

a y ,

2 0 0 8

P a rt ic ip a n ts

e lig ib le

fo r th e

p a re n t s tu d y

(a ll lu n g c a n c e r

p a ti e n ts )

C a n c e r

G e n d e r: 5 7 %

m a le

2 1 /3 3

(6 4 % )

S e m i-

s tr u c tu re d

in te rv ie w s

C o n v e n ie n c e

Id e n ti fi c a ti o n

a n d

c a te g o ri s a ti o n

o f th e m e s a n d

a n a ly s is

b a s e d o n

d e d u c ti v e a n d

in d u c ti v e

c a te g o ri e s

V o lu n ta ri n e s s ,

s tu d y m e th o d s

a n d tr e a tm

e n t

a lt e rn a ti v e s

N o in c lu s io n /

e x c lu s io n c ri te ri a

s ta te d b u t 1 1

p o te n ti a l

p a rt ic ip a n ts

w e re

n o t in v it e d

T e c h n ic a l p ro b -

le m s

w it h 3 re c o rd in g s

D e m o g ra p h ic s

n o t re p re s e n ta ti v e

o f th e g e n e ra l

p o p u la ti o n

a s p a rt ic ip a n ts

w e re

m o re

o ft e n m e n ,

h a d a m e d ia n

a g e o f 6 9 y e a rs

a n d w e re

lim it e d

to lu n g c a n c e r

p a ti e n ts

A g e : m e d ia n

a g e 6 9 (r a n g e

4 4 e 8 4 )

E d u c a ti o n /

d e p ri v a ti o n :

ra n g e o f

b a c k g ro u n d s

E th n ic it y : n o t

re p o rt e d

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 9

What potential participants want to know about research

Table 2 Empirical evidence linked to NRES participant information sheet recommended headings

NRES Heading What does NRES say should be included?

Number of studies

Empirical evidence for inclusion in PIS from literature

What is the

purpose of the

study?

Purpose is an important

consideration for subjects

and should be included

223 32 Pooled results showed that 76%

(95% CI 27% to 100%) participants

wanted to know about study purpose

Why have

I been invited?

Why and how participants

have been chosen and how

many will be in the study

0 No empirical evidence

Do I have to

take part?/What

will happen if

I don’t want to

carry on with

the study?

The voluntary nature of the

research should be included

4 21e23 32

Pooled results from the 3 quantitative

studies20 29 30 showed that 39%

(95% CI 2% to 100%) participants

wanted to know about voluntariness

The one qualitative study reported that

it was the most important piece of

information to be included in a participant

information sheet 31

What will happen

to me if I take

part?/What will

I have to do?

How long the participant will

be involved in the research/

how long the research will last

321 23 32 Pooled results from all three studies20 29 30

showed that 61% (95% CI 16% to 97%)

participants wanted to know how long the

research would last

How often they need to

attend a clinic

121 68% (27/40; 95% CI 53% to 82%)

wanted to know the frequency of

additional study visits 29

How long visits will be 0 No empirical evidence

Exactly what will happen

to them

221 22 Specific information types varied

considerably between studies, so no

meaningful pooled results could be calculated

The proportion of people wanting to know

what would happen to them ranged from

9.5% (2/21; 95% CI 0% to 22.1%) 31

to 20%

(8/40; 95% CI 7.6% to 32.4%) 29

depending

on what the specific information was.

For example, 20% (8/40; 95% CI 7.6% to

32.4%) wanted to know about burdens to

friends or family caused by study participation, 29

12% (5/40; 95% CI 2.3% to 22.8%) wanted to

know how much work they would miss

because of study participation, 29

10% (4/40;

95% CI 0.7% to 19.3%) wanted to know how

much time would be spent waiting in clinic

during study visits 29

and 9.5% (2/21; 95% CI

�3% to 22.1%) wanted to know practical information about trial procedures31

Expenses and

payments

Expense claims available

and if there is any kind of

payment for participation

121 25% (10/40; 95% CI 11.6% to 38.4%) wanted

to know if free medication would be available

during or after trial 29

What is the drug,

device or

procedure that

is being tested?

Short description of the

drug, device or procedure

and given the stage of

development state the

dosage of the drug and

method of administration,

and details of any

contraindicated drugs

included over the counter

drugs

221 31 The one quantitative study29 showed that

specific questions about the medication regime

ranged from 25% (10/40; 95% CI 11.5% to

38.4%) that wanted to know what control they

had over medication dose during the study to

70% (28/40; 95% CI 55.8% to 84.2%) that

wanted to know the frequency with which

study medication must be taken.29 The study

also showed that 62% (25/40; 95% CI 47.5% to

77.5%) wanted results of previous studies of

safety and 45% (18/40; 95% CI 29.5% to 60.4%)

of efficacy, and 15% (6/40; 95% CI 3.9% to 26.1%)

wanted to know if study medication had been

approved for clinical use 29

The one qualitative study showed that participants

wanted to know how to use the intervention21

Continued

10 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

Table 2 Continued

NRES Heading What does NRES say should be included?

Number of studies

Empirical evidence for inclusion in PIS from literature

What are the

alternatives for

diagnosis or

treatment?

What other managements/

treatments are available

and a list of all important

comparative risks and

benefit

1 22

5% (1/21; 95% CI 0% to 13.9%) wanted as much

information about treatment alternatives as they

received about the study medication31

What are the

possible

disadvantages

and risks of taking

part?/What are

the side effects

of any treatment

received when

taking part?

Any risks, discomforts or

inconvenience should be

outlined

4 16 23 31 32

Specific information types varied considerably

between studies so no meaningful pooled

results could be calculated. Results ranged

from no participants that asked about study

risks (0/57) 20

to 97% (207/213; 95% CI 95%

to 99.4%) who wanted to be informed about

any possible emotional or physical discomforts

and side effects 30

Radiation and the

Ionising Radiation

Regulations

If the use of additional

ionising radiation is

required as part of the

study, then information

must be given to the

participant on the radiation

involved

0 No empirical evidence

Harm to the

unborn child:

therapeutic studies

Clear warnings must be

given where there could

be harm to an unborn child,

if there was a risk in breast

feeding or if taking the

medication is likely to

cause fertility problems

0 No empirical evidence

What are the

possible benefits

of taking part?

Benefits should be included,

but where there is no

intended clinical benefit

it should be stated clearly

323 31 32 Pooled results of the two quantitative studies20 30

suggest that 57% (95% CI 7% to 98%) wanted

to know about study benefits

Two studies provided relevant data relating to

specific benefits.29 31 Specific requests ranged

from 14% (3/21; 95% CI �0.7% to 29.3%) that wanted to know about hopes for better treatment

31

to 55% (22/40; 95% CI 39.5% to 70.4%) that

wanted an opportunity to learn about condition or

medication under study. 29

Specific information types

varied considerably between studies so no meaningful

pooled results could be calculated

What happens

when the research

study stops?

Arrangements for after

the trial finishes must be

given, and it must be

clear if participants will

have continued access

to any benefits or

intervention they may

have obtained during the

research. If treatment will

not be available after the

study, it should be

explained what treatment

will be available instead

121 55% (22/40; 95% CI 39.6% to 70.4%) wanted to

know about the availability of medication after the

study was over 29

What if there

is a problem?

How complaints will be

handled and what redress

may be available

0 No empirical evidence

Will my taking part

in the study be

kept confidential?

How data will be collected,

stored, what it will be used

for, who will have access

to it, how long it will be

retained for and how it will

be disposed of

2 23 32

Pooled results showed that 44% (95% CI 10%

to 82%) participants wanted to be given

information about confidentiality and the protection

of their privacy

Continued

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 11

What potential participants want to know about research

Table 2 Continued

NRES Heading What does NRES say should be included?

Number of studies

Empirical evidence for inclusion in PIS from literature

Involvement of the

GP/family doctor

If the participants GP needs

to be notified of involvement

or asked for consent

0 No empirical evidence

What will happen

to any samples

I give?

Clear description of whether

new samples will be taken,

if excess samples will be

taken, and if access to

existing stored samples will

be required. The same type

of information as for data is

required to be provided

0 No empirical evidence

Will any genetic

tests be done?

A separate consent form for

genetic studies should be used

0 No empirical evidence

What will happen

to the results of the

research study?

What will happen to the results

of the research, if it is intended

to be published and how results

will be made available to

participants and that they will

not be identified in any

publication

328 30 33 Pooled results showed that 91% (95% CI

85% to 95%) wanted to know about study

results

Specific information types varied considerably

between studies, so no meaningful pooled

results could be calculated. Two studies provided

relevant data relating to specific aspects of what

they wanted to know about results. 23 28

78%

(31/40; 95% CI 64.6% to 90.4%) of participants

wanted a description of what researchers had learnt

that was important, 23

35% (14/40; 95% CI 20.2%

to 49.8%) wanted it to include follow-up contacts for

the researcher23 and 98% (29/40; 95% CI 58.7% to

86.3%) wanted a list of medical publications written

as a results of the research. 23

90% (46/51; 95% CI

82% to 98.4%) wanted their family or loved ones to

be informed of the results if they were unable to

learn them 28

Continued

12 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

suggested what information research participants wanted to know (table 2). No further themes, beyond the NRES categories, were identified. We were able to calculate pooled proportions for seven themes. Participants wanted to be told about dissemination of study results (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). Although the majority of participants appeared to want information for most of these themes, some participants did not and the level of detail that participants wanted was not explored comprehensively.

DISCUSSION Of the 14 papers that met inclusion criteria, five looked broadly at what information research participants

wanted to know. These studies focused on the category of information required rather than how much detail participants wanted. All 14 studies had substantial limi- tations to generalisability when applied to the wider research population because, for example, they focused on specific subsections of the population, for example, six studies included only cancer patients23 24 26 28 30 31

and only one study conducted in the UK.30 A number of studies included only women21 26 28 30 and participants that were mostly Caucasian23 26 and well educated.23e25

In the absence of empirical evidence to suggest what information potential research participants want, the NRES have based their guidance on expert opinion. It does, however, mean that current information provision for research may not adequately address the informa- tional needs of the general population or ‘hard to reach’ groups such as socially deprived or AfricaneAmerican and minority ethnic groups. While the NRES recognise that one size does not fit all and that low-risk studies with

Table 2 Continued

NRES Heading What does NRES say should be included?

Number of studies

Empirical evidence for inclusion in PIS from literature

Who is organising

and funding the

research?

The organisation or company

sponsoring the research and

funding the research if these

are different and if the

researcher conducting the

research is being paid

6 20 24e27 34

Pooled results from the four quantitative studies

showed that 48% (95% CI 27% to 69%) wanted to

know about any type of CoI, but there was general

disagreement over whether patients wanted to be

told about financial CoI

Three studies provided relevant data relating to

what participants wanted to know about specific

aspects of COI.24 27 34 When financial CoI were

broken down into subcategories, 82.5% (4519/

5478; 95% CI 81.48% to 83.5%) wanted to be

told about commercial funding,27 69% (3779/5478;

95% CI 67.8% to 70.2%) about personal

income, 27

between 41% (105/259; 95% CI 34.6%

to 46.5%) and 82% (4492/5478; 95% CI 81%

to 83%) about patents and stocks and shares27 34

and 40% (101/253; 95% CI 34% to 46%) thought

researchers should have told participants only

about the oversight system24

One study reported that participants wanted to know

specifically how money was spent, with proportions

ranging from 25% (65/259; 95% CI 19.8% to 30.4%)

that wanted to know how much of the funding was

spent on administration34 to 38% (98/259; 95% CI

31.9% to 43.8%) that wanted to know how spare

accrued funds were used at study completion34

One qualitative study reported that participants

wanted to know the name of the sponsor 27

and

one quantitative study reported that 57% (148/259;

95% CI 51.1% to 63.2%)34 wanted to know the

name of the funder

Some participants wanted help understanding the

potential consequences of CoI, some did not 25

Specific information types varied considerably

between studies so no meaningful pooled results

could not be calculated

Who has reviewed

the study?

Explain the role of the

research ethics committees

and which committee

reviewed the current study

123 No participants asked about institutional review

board approval (0/57)20

GP, general practitioner; NRES, National Research Ethics Service; PIS, participant information sheet.

Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 13

What potential participants want to know about research

little or no intervention may need shorter information sheets, there is little empirical evidence to identify what level of information provision should be made.32 A potential difficulty in conducting research to determine what should be included in a PIS is that an individual’s information preferences may change as they move from being a potential to actual participant.35 36

Responding to individuals’ information needs may prove challenging, but the provision of high-quality appropriate information in a timely manner is crucial to the consent process. Electronic information provision may be one way to address different information needs. Recent research by Antoniou et al37 that allowed partic- ipants to access three increasingly detailed levels of information electronically found that the basic level of information was accessed by 70%e82% of participants, but only 9%e18% accessed the level of information

currently recommended in NRES guidance and only 3%e12% accessed all three levels of information. Inter- estingly, 20% (93/552) participants that said they wanted more information even though fewer than this (3%e12%) read all the information available to them. The study by Antoniou et al37 is an important first step

in determining what information potential research participants really want to know when they agree to take part in a study. Further research is required to assess the feasibility and acceptability of unfolding electronic information sheets.

Limitations Ideally, differences in informational requirements for subgroups of the population would have been explored but the small numbers of studies identified and limited data extracted from papers meant this was not feasible.

Figure 1 Results of search strategy and identification of publications included in the review.

14 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509

What potential participants want to know about research

Conclusions There is limited empirical evidence as to what informa- tion potential participants want to know at the time they are deciding whether or not to participate in research. Real-time studies need to be conducted to explore what information potential participants access when given a choice. This will enable us to determine exactly what information research participants want to know and could, in addition to other sources such as expert opinion, help tailor PIS towards specific population subgroups and enable appropriate high-quality infor- mation to be provided to meet individual needs.

Contributors HMK, MC, SW and HD conceived and designed the research. HMK and TK collected, validated and extracted the data. All authors made substantial contribution to the analysis and interpretation of the data. HMK drafted the manuscript and SW, HD, MC and TK revised it.

Funding The study was funded by the Medical Research Council Midland Hub for Trials Methodology Research (Medical Research Council Grant ID G0800808). The study sponsor had no role in study design, collection, analysis or interpretation of the data, in the writing of the report or in the decision to submit the article for publication. HMK and TK are PhD students funded by Medical Research Council Midland Hub for Trials Research Methodology and MC is Education Lead for the Medical Research Council Midland Hub for Trials Research Methodology.

Competing interests All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that (1) HMK, MC, HD, TK and SW have support from the University of Birmingham for the submitted work; (2) HMK, MC, HD, TK and SW have no relationships with any companies that might have an interest in the submitted work in the previous 3 years; (3) their spouses, partners or children have no financial relationships that may be relevant to the submitted work and (4) HMK, MC, HD, TK and SW have no non-financial interests that may be relevant to the submitted work. HD is an author of one of the papers included discussion.37 SW was also acknowledged in this paper for comments on an early draft.

Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement All authors had full access to all the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. Technical appendix and data set available from the corresponding author at [email protected]. Referenced Manager (Version 12) was used to analyse data. Stats Direct was used to calculate pooled proportions with random effects.

REFERENCES 1. The World Medical Association. The World Medical Association

Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 2008. http://www.ncbi.nlm.nih.gov.ezproxyd. bham.ac.uk/pmc/articles/PMC1816102/pdf/brmedj02559-0071.pdf

2. General Medical Council. Seeking Patients’ Consent: The Ethical Considerations. 1998. http://www.opengrey.eu/item/display/10068/ 387679

3. Joffe S, Cook EF, Cleary PD, et al. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 2001;93:139e47.

4. NHS East of England. NHS Values. https://www.eoe.nhs.uk/ nhs_constitution/values.php (accessed 27 Sep 2010).

5. NHS East of England. Principles That Guide the NHS. http://www.eoe. nhs.uk/nhs_constitution/principles.php (accessed 27 Sep 2010).

6. Manson N. Consent and informed consent. In: Ashcroft R, Dawson A, Draper H, et al, eds. Principles of Health Care Ethics. 2nd edn. Chichester: John Wiley & Sons Ltd, 2007:298e303.

7. Hewlett S. Consent to clinical researcheadequately voluntary or substantially influenced? J Med Ethics 1996;22:232e7.

8. Idanpaan-Heikkila JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med 1994;26:89e94.

9. Doyal L, Tobias J. Informed Consent in Medical Research. 1st edn. London: BMJ Books, 2001.

10. National Research Ethics Service. Information Sheets and Consent Forms Guidance for Researchers and Reviewers. 2009. http://www. noc.nhs.uk/research/researchers/documents/npsa-guidance.pdf

11. Wager E, Tooley PJ, Emanuel MB, et al. How to do it. Get patients’ consent to enter clinical trials. BMJ 1995;311:734e7.

12. World Health Organisation. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. 1995. http://www.nus. edu.sg/irb/Articles/WHO%20GCP%201995.pdf

13. National Cancer Institute, US National Institutes of Health. A Guide to Understanding Informed Consent. http://www.cancer gov/clinicaltrials/ conducting/informed-consent-guide/allpages (accessed 5 Jun 2009).

14. Davis TC, Holcombe RF, Berkel HJ, et al. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst 1998;90:668e74.

15. Fortun P, West J, Chalkley L, et al. Recall of informed consent information by healthy volunteers in clinical trials. QJM 2008;101:625e9.

16. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994;12:2211e15.

17. Priestley K, Campbell C, Valentine C, et al. Are patient consent forms for research protocols easy to read? BMJ 1992;305:1263e54.

18. Lynoe N, Hoeyer K. Quantitative aspects of informed consent: considering the dose response curve when estimating quantity of information. J Med Ethics 2005;31:736e8.

19. Sharpe N. Clinical trials and the real world: selection bias and generalisability of trial results. Cardiovasc Drugs Ther 2002;16:75e7.

20. Walkup J, Bock E. What do prospective research participants want to know? What do they assume they know already? J Empir Res Hum Res Ethics 2009;4:59e63.

21. Bento SF, Hardy E, Osis MJ. Process for obtaining informed consent: women’s opinions. Dev World Bioeth 2008;8:197e206.

22. Gray SW, Hlubocky FJ, Ratain MJ, et al. Attitudes toward research participation and investigator conflicts of interest among advanced cancer patients participating in early phase clinical trials. J Clin Oncol 2007;25:3488e94.

23. Fernandez CV, Santor D, Weijer C, et al. The return of research results to participants: pilot questionnaire of adolescents and parents of children with cancer. Pediatr Blood Cancer 2007;48:441e6.

24. Hampson LA, Agrawal M, Joffe S, et al. Patients’ views on financial conflicts of interest in cancer research trials. N Engl J Med 2006;355:2330e7.

25. Weinfurt KP, Friedman JY, Allsbrook JS, et al. Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure. J Gen Intern Med 2006;21:901e6.

26. Partridge AH, Wong JS, Knudsen K, et al. Offering participants results of a clinical trial: sharing results of a negative study. Lancet 2005;365:963e4.

27. Kim SY, Millard RW, Nisbet P, et al. Potential research participants’ views regarding researcher and institutional financial conflicts of interest. J Med Ethics 2004;30:73e9.

28. Partridge AH, Burstein HJ, Gelman RS, et al. Do patients participating in clinical trials want to know study results? J Natl Cancer Inst 2003;95:491e2.

29. Casarett D, Karlawish J, Sankar P, et al. Obtaining informed consent for clinical pain research: patients’ concerns and information needs. Pain 2001;92:71e9.

30. Maslin A. A survey of the opinions on ‘informed consent’ of women currently involved in clinical trials within a breast unit. Eur J Cancer Care (Engl) 1994;3:153e62.

31. Sand K, Loge JH, Berger O, et al. Lung cancer patients’ perceptions of informed consent documents. Patient Educ Couns 2008;73:313e17.

32. Edgman-Levitan S, Cleary P. What information do consumers want and need? Health Aff (Millwood) 1996;15:42e56.

33. Grady C, Horstmann E, Sussman JS, et al. The limits of disclosure: what research subjects want to know about investigator financial interests. J Law Med Ethics 2000;34:592e9.

34. Hutchinson A, Rubinfeld AR. Financial disclosure and clinical research: what is important to participants? Med J Aust 2008;189:207e9.

35. Wyke S, Entwistle V, France E, et al. Information for choice: what people need, prefer and use. 2011. Report number 08/1710/153. http://www.netscc.ac.uk/hsdr/files/project/SDO_ES_08-1710- 153_V01.pdf

36. Manson NC. Why do patients want information if not to take part in decision making? J Med Ethics 2010;36:834e7.

37. Antoniou E, Draper H, Reed K, et al. An empirical study on the preferred size of the participant information sheet in research. J Med Ethics 2011;37:557e62.

PAGE fraction trail=15 Kirkby HM, Calvert M, Draper H, et al. BMJ Open 2012;2:e000509. doi:10.1136/bmjopen-2011-000509 15

What potential participants want to know about research