Building on progress

The balance of evidence submitted to this review highlights that ethics review is rarely a rate-limiting step. This view is consistent with NReS statistics that show that the average application time is currently around 35 days (Box 8.1). It is important that the momentum achieved by NReS is maintained and that opportunities are taken to further reduce timescales and enhance the quality and efficiency of the process.

8.4.1 A proportionate approach to ethics review

The need for a proportionate approach to regulation and governance is discussed in chapter 2. It is particularly important to adopt a proportionate approach to ethics review because of the diversity of research that undergoes this assessment, which includes:

questionnaires for staff and patients, minimally interventional studies and clinical trials of new drugs. The benefits of a proportionate approach are recognised in both the US and canadian ethics review systems, as discussed in Box 8.3.

77

Box 8.3 Proportionality in ethics review in the USA and Canada

Institutional Review Boards (IRBs) in the USA and Research ethics Boards (ReBs) in canada undertake all the ethical approvals required for studies with human participants, their data and tissue.

USA

In the USA, the federal department of health and human Services oversees regulation on the Protection of human Subjects, which includes a categorisation of projects according to the risk posed to the participant:

• Studies exempt from IRB review include research involving survey or interview procedures, observations of public behaviour, or diagnostic specimens where the subject cannot be identified.

• Studies are subject to expedited IRB review where ‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests’. This category of minimal risk includes research on drugs for which an investigational new drug application is not required or the collection of biological specimens or data for research through non-invasive means.

• Research on human subjects that is deemed to present more than minimal risk is subject to full IRB review.

Canada

Proportionate review is a key feature of the canadian tri-council policy statement (TcPS), which acknowledges that ‘research involving humans covers the full spectrum from minimal to significant risks...A reduced level of scrutiny of a research project with minimal risks does not imply a lower level of adherence to the core principles. Rather, the intention is to reduce unnecessary impediments and facilitate the progress of ethical research.’

The TcPS sets out categories of research that are exempt from ReB review. Minimal risk research is defined as ‘research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research’ and is generally eligible for delegated review by an individual designated by a ReB.

In 2009, in response to a review of the operation of NhS Recs by an ad hoc advisory group set up by lord Warner,¹¹⁵ NReS introduced a pilot scheme for proportionate review of studies that represent ‘no material ethical issues’. The scheme is designed to increase the efficiency of the service and enable studies such as questionnaires for NhS staff, and research on anonymous tissue or data, to be reviewed within 10 days. The pilot started at four london Recs and has since been expanded. The average review

time in the pilot is currently 7.2 days from validation of the application to notification of opinion. The application is considered by a sub-committee of at least three members, including a lay member, either at a meeting or by correspondence. NReS expects that the number of Recs could be further decreased on full implementation of proportionate review.

Several respondents to the first call for evidence raised concerns about the lack of proportionality in the ethics review system,

115 department of health (2005). Report of the ad hoc advisory group on the operation of NHS Research Ethics Committees.

http:www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4112417.pdf

for example, questionnaires of healthcare practitioners requiring full ethics review.

however, the proportionate review pilot is now available to all researchers in the UK, albeit only through a small selection of the Recs. We support the further roll out of this pilot, which will be important to address the existing lack of proportionality.

Although the proportionate review pilot has reduced the time taken to obtain an opinion for certain types of study, this evidence suggests that there would also be value in extending a proportionate approach to other study requirements. One respondent noted that even minor changes to the protocol that are required after approval are often deemed to be

‘substantial’ amendments. The application of a proportionate approach across health research is addressed further in chapter 9.

8.4.2 Consistent advice and guidance consistency in the application of ethical principles is an important feature of an effective, transparent and reasonable ethics review. Some respondents raised the lack of consistency in decisions by Recs as a concern although no specific examples were provided. A small scale evaluation in 2007 did highlight some lack of consistency between Rec decisions,¹¹⁶ although it has been acknowledged that consistency of decision making across Recs is difficult to assess in a robust way. In addition, because each study involves the consideration of multiple factors, apparently different decisions do not necessarily imply inconsistency. The NReS submission to the Academy noted that further improvements to quality and consistency are the ‘most important challenge’ facing the service and NReS plans to use training and quality assurance to address these issues.

Some of the evidence suggested that the current ethical guidance to researchers can be variable and inconsistent and respondents encouraged the further development of clear

advice. NReS has introduced a pilot scheme that has sought to improve the ethics review process by providing guidance to researchers before their application is sent to the Rec.

This should enable problems with the

application to be identified and resolved before consideration by the Rec. We encourage the wider implementation of this system in order to address these concerns.

high ethical standards are integral to successful research practice, but can only be partly achieved through regulation and governance.

For example, it is important that researchers take responsibility to identify the ethical issues arising in their research. chapter 3 notes the important role that culture plays in the conduct of research and this approach will require an appropriate research culture that considers the ethical dimensions of studies, and the development of the ethical skills of researchers, to be central to good practice. On a practical level, researchers need to be supported by advice and training that is available to them independently of obtaining a Rec opinion.

Recommendation 12 sets out an approach to achieve this.

8.4.3 Specialist expertise

A few responses to the call for evidence questioned the level of specialist expertise on some Recs, for example in paediatrics.

They noted that ethics review is a far more constructive process with an informed committee with relevant expertise. In the current system, certain Recs are ‘flagged’ for their expertise in a particular area such as mental capacity, tissue banks and databases, medical devices, certain types of cTIMPs and low-risk gene therapy. Such a system could be extended to cover other areas where specific expertise is important and committee expertise may need to continue to develop in response to scientific advances in areas such as genomics.

79

Recommendation

We welcome the progress that the National Research Ethics Service (NRES) has made in recent years. Under the new arrangements outlined in Chapter 9, NRES should maintain this momentum to ensure that further improvements are made, for example to increase consistency and specific committee expertise and reduce timescales. High ethical standards in research can only be partially achieved through regulation and governance and researchers need support to identify and address the ethical issues arising in their research, outside of applying for an ethics opinion. In addition to the need to embed a proportionate approach within the ethics system, including implementation of ‘proportionate review’ following the NRES pilot, we recommend that:

Recommendation 12: NReS should lead on improving support and advice for researchers