1. Research Ethics Committees’ role in constructing the PIS to secure informed consent: tensions in the role of the PIS as a contract and a prospectus Carolyn Tarrant, Emma Angell, Mary Dixon-Woods Department of Health Sciences University of Leicester

2. Background: RECs and PIS Autonomy and ‘informed consent’ key principles in research ethics PIS seen as means of securing informed consent RECs scrutinise PIS and accompanying documents as part of their review process RECs frequently raise issues relating to PIS, and are concerned about full disclosure Interest in the role that RECs play in shaping the informed consent process 2

3. Background: RECs and PIS Critiques of ‘informed consent’ – Recall and understanding? (need better and clearer information) – Insist that patients are fully informed, or allow to make decisions on their own grounds (autonomy)? Role of the PIS in informed consent – Prospectus: clear and accessible account of what’s involved – Contract: specification of limits of what researchers are allowed to do, and patients’ rights PIS as a contract – Research on consent to treatment - danger of informed consent being seen as a ritual serving the interests of researchers / institutions 3

4. Aims – To explore the role of NRES guidance, and REC input, in shaping the content of PIS and the informed consent process – To assess the extent to which the PIS is framed in ‘contractual’ terms 4

5. Analysis of... 13 applications to conduct trials in oncology (Phase I, II & III), 2004/5 Funded by NRES, had access to: – Original REC application form – REC correspondence and applicants’ responses – Final PIS used in trials Focus on PIS and text relating to consent Ethnographic content analysis and discourse analysis (content and style) 5

6. Informed consent practices demonstrate ‘ethical’ research In the text in application forms, applicants seem keen to demonstrate – non-coercive recruitment practices – protection of vulnerable participants, – efforts to secure fully informed consent through provision of comprehensive PIS and opportunities to discuss the study If interested in participation, the patient will be advised to read all the information on the patient information sheet carefully, discuss the information with family/friends or their GP if they wish. (Form05) 6

7. REC concerns relating to consent 12 / 13 applications received provisional opinion 71% of text in REC letters to applicants related to consent RECs highly sensitive to – risks of participants not being fully informed / being misled – lack of clarity around what participants were consenting to – insufficient detail on dealing with harm 7

8. REC concerns relating to consent Commonly made suggestions aimed at making sure things were done ‘properly’ – in accordance with national guidelines – editorial level suggestions The information sheets and consent forms should be separate documents and headed up as such. The standard COREC Consent form should be used. (Provisional08) 8

9. Applicant responses Complied with majority of REC requests Non-compliance (4 examples) justified with reference to ‘usual practice’ or national guidelines All received final favourable opinion 9

10. Content and layout of PIS Tended to follow NRES guidance in terms of content; often use NRES standard wording All included sections on: – why patients selected – voluntary nature of participation – details of the intervention and what participation would involve (usually extensive!) – risks, benefits and possible side effects (usually extensive!) – arrangements for managing harm – contact details Long and potentially difficult to read – Mean word count 4561.85 (2644 - 6799) – Mean Gunning Fog index 12.92 (11.09 - 14.07) (A level) Designed to meet needs of patients? 10

11. 7 textual elements indicating ‘contract’ function of PIS Informing participants of their rights – It is up to you to decide whether or not to take part. […] If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part will not affect the standard of care that you receive. (PIS07) Informing participants of their duties – You should ask your doctor before taking any new medication and always comply with your doctor’s instructions during the study. (PIS04) 11

12. 7 textual elements indicating ‘contract’ function of PIS Describing researchers’ entitlements (so long as consent was in place), and setting limits to these – The duration of your involvement in this study will be dependent on the number of chemotherapy cycles (<drug1/drug2) that you receive. One complete cycle of chemotherapy will last for 21 days and you can receive a maximum of 10 cycles. (PIS06) Informing participants of researchers’ duties – Your study doctor will monitor you closely for any potential side effects of the study treatment and also to follow your medical condition. If side effects occur, the study doctor may stop your treatment temporarily or permanently. (PIS03) 12

13. 7 textual elements indicating ‘contract’ function of PIS Demonstrating ‘full disclosure’ – [study] will reimburse the hospital for your involvement in the study. The reimbursement will cover necessary costs for staff time, the laboratory tests and other tests, and the overall work involved. (PIS06) Using language relating to guarantees and hedges – However, no one can guarantee that you will benefit from taking part and you may receive no direct benefit. (PIS03) – You may experience some, none, or all of the side effects listed below, and they may be mild, moderate or severe. (PIS10) Referring explicitly to the PIS as a contract – By signing the consent form you agree to this access for the current study and any further studies which may be done related to the study drug and/or in this field. (PIS03) 13

14. So what can we conclude from this? The process of gaining ethical approval involves researchers attempting to satisfy RECs through demonstrating compliance with standard practice and guidelines PIS highly structured by NRES guidance Oriented towards satisfying contractual requirements Little evidence that informed consent process driven by understanding of patients needs in relation to their decision-making about research participation 14

15. Tensions in role of PIS PIS is the only auditable trace of information giving – special status as the ‘official’ account of the research Important role in setting out rights, entitlements and duties But... Length and complexity a barrier to patient understanding and engagement with information (prospectus role) Research participation decisions better understood as informal, relational and trust based - at odds with contract- based approach. 15

16. Suggestions More research (of course!) into how patients make decisions to take part in research, and the nature and format of the information they need to make decisions consistent with their values and preferences Separate the contract and prospectus elements of PIS? Set of principles for good PIS design, rather than standard template Involve potential participants in PIS design 16