Ocupació vers preocupació (activació conductual)

Letters and information sheets were sent out with paperwork to committee members and to researchers with letter of invitation to the committee. Each individual potential participant was notified of my study via local co-ordinators and was able to respond if they did not consent to my attendance or to interviews. They were fully informed about the study and voluntary consent to participation was detailed in letters and information sheets at both stages of the research – observation and interviews. Prior to observations:

• Letter to Chairs

• Letter to individual committee members • Letter to researchers

Although I was advised to address a separate letter to Chairs of committees by NRES administrators, it must be stressed that individual letters to all members of each committee were also sent out. This was to ensure that Chairs did not make a decision about participation on behalf of members (in English Law, it is not permissible to consent on behalf of another person). Rather, this was intended to enable the Chair and members to discuss their views about whether they should consent to participate prior to that decision being communicated to me.

Key content of letters and information sheets endeavoured to give as much information as possible to the potential participants in order that they may be fully informed in order to make a decision. As noted earlier in the thesis,

‘This process (of consent) is much more than provision of an information sheet and a signature on a consent form and a recent review of evidence indicated (not surprisingly) that talking one–to–one was the most effective way to provide information that was understood.’

(HRA, 2013)

I feel that there was time for one-to -one questions about the purpose of the study so that participants were informed in order to make a decision whether to consent to take part or not. (This happened on the day or prior to each telephone interview). There were possibly fewer opportunities for individual questions at observations because meetings were so pressured and though all committee members had received information sheets, it is possible that they arrived on the day of the meeting not having read about the study. If invited, I spoke at the start of the meetings and explained the purpose of the study and answered questions.

Consent prior to interviews

Following observations, information sheets were provided to people who had agreed to be observed (usually via co-ordinators) including committee members and researchers requesting consent for an interview. It was not assumed that because participants had agreed to an observation that they would consent to an interview. In addition, further information about the interviews and what they were likely to include was important in ensuring participants were fully informed. The information sheets for interviews asked for a signature for consent purposes on meeting as at that point it was envisaged that I could conduct face-to-face interviews. In the event interviews were conducted by telephone and consent received via email. At this stage, there were:

• Information sheets to Chairs and committee members • Information sheets to researchers

All letters to participants and Participant Information Sheets (and the prepared Informed Consent form) are provided in Appendix 4.

In this study, as well as letters, consent to interviews was checked out directly with every single participant. Examples of consent emails are included as in Appendix 5. In addition, the design of the study and the support from NRES meant that every individual member of the committees observed was informed about the study ahead of the meetings which meant that if any single member did not want to participate then the observation would not take place. Iphofen (2009) raises a dilemma for qualitative researchers in ‘fully informing’ prospective participants in that when gathering qualitative data, the participant may not fully know what they are consenting to because the researcher may not be clear. The research may move in unanticipated ways and explore unexpected areas. In this way, the commitment may be to 'fully inform' at the outset of the research (as required by an ethics committee) with any significant changes to the study being communicated to those concerned. Although I highlight below some of the ethical concerns connected to the involvement of NRES, there were undoubtedly advantages to their administrative support. Firstly, I could not have contacted every individual in the way that co- ordinators did by sending out relevant forms and secondly, I feel it may have lessened any obligation individuals felt to take part. There were certainly committees and researchers who did not consent to observation. I was informed by the co- ordinators of this. Sometimes reassurances were needed but on other occasions I was not informed of the reason or I simply did not receive a response. In any case, there was no need to communicate directly with me as the researcher and this may have been an advantage. If any committee, individual member or researcher did not want to be involved, they did not have any need to correspond directly with me. Similarly, individual consent to interview was entirely voluntary and people who did not want to be interviewed either told the co-ordinator or did not respond to the requests made.

4.13.4 ‘potential of the study to generate findings of value ‘

My interpretation of this statement places its significance in context of the principle of justice. Accounts of the principle of justice in biomedical ethics and health more generally, usually interpret justice as fair, equitable and appropriate treatment in the light of what is due or owed to persons (Beauchamp and Childress, 2013: 250). Each of the above statements from Gelling’s quote relate to justice in its widest sense.

However, justice in research also includes the right of citizens to take part in research and therefore there is a corresponding need for justification of the research. This is because any burden or potential risk to participants must be weighed up in the balance with the scientific value, design and purpose of the research.

In this thesis, I have made clear the origins of the study, the objectives of the study and the reasons for the methodology explaining also how methods selected were aligned to the overall question. The purpose of the research has been explained and I have avoided making ambitious claims for the potential of findings to influence development and practice in ethics review. Rather, I am modest in my claims. This is because although the question is highly relevant to our understanding of review and the meaning of ethical research, one does not set out in qualitative research being certain of what will be found. The intention is for the findings to illuminate, influence and inform. Much depends on the quality of interpretation and skill of a researcher. This realistic approach demonstrates integrity and emphasises potential rather than making grand claims of research which may not be achievable, as findings are unknowable, when starting out to research. The study claims therefore to have potential to increase knowledge and understanding in this area.

Finally, in this section, I draw out any relevant ethical issues in the relationship with NRES.