Ethical Review Processes


The ESRC will only fund institutions that have processes in place that comply with the Council’s minimum expectations as set out in this Framework. However, the ESRC will not seek to impose a particular model for achieving these expectations. It will ensure that its peer review of proposals addresses ethical issues, and engage in dipstick testing of institutions with awards to check that commitments to ethical review have indeed been followed through by institutions.

ESRC REF, p2

This section summarises the ESRC’s requirements for ethical review by institutions. However, it is a non-definitive summary and the reader is referred to the ESRC REF, available at http://www.esrc.ac.uk/ESRCInfoCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf

The ESRC’s procedures

The ESRC does not itself play a direct role in the ethical review process. However, it has procedures to ensure that the proposed review processes are adequate and appropriate. It is not necessary to complete ethical review processes prior to application. However, the ESRC will not release funds for projects until agreed review processes are complete. The following paragraphs from the ESRC REF summarise the ESRC’s process:

  • The ESRC does not require that ethical approval should be secured prior to submission of a research proposal. A proposal must state what the applicant considers to be the ethical approval that will be required for their proposed research, and if so how it will be obtained. The administering authority in signing the application form will be confirming that it concurs with that judgment and is prepared to administer any resulting award on that basis , carrying out expedited or full (possibly iterative) ethical review where necessary. If a research organisation does not have arrangements to ensure, as far as possible, that its research complies with this Framework it will not be possible for it to undertake ESRC-funded research.
  • During peer review, referees and assessors will be asked to comment specifically on whether they agree with the ethical self-assessment in the proposal.
  • If referees or assessors disagree with the proposed ethical review, this will either be grounds for rejection of an application where it calls into question researcher competence or the feasibility or validity of their proposal, or for a conditional award requiring further review.
  • Before the start of a project, funds will not flow until the administering institution provides written confirmation that the required ethical approval has been received. This notification should precede or accompany the starting certificate. If ethical review is required at a later stage in the project, this should be discussed and funding arrangements agreed in advance with the ESRC.

ESRC REF, p.2
http://www.esrc.ac.uk/ESRCInfoCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf

The ESRC Framework (1): the six principles

The ESRC’s ‘Research Ethics Framework’ (REF) states:

There are six key principles of ethical research that the ESRC expects to be addressed whenever applicable:

  • Research should be designed, reviewed & undertaken to ensure integrity and quality
  • Research staff and subjects must be fully informed about the purpose, methods and intended possible uses of research, what their participation entails and what risks might be involved
  • Confidentiality of the information supplied by subjects and the anonymity of subjects must be respected
  • Research participants must participate voluntarily, free from coercion
  • Harm to participants must be avoided
  • The independence of research must be clear, and any conflicts of interest or partiality must be explicit.

ESRC REF, p.1
http://www.esrc.ac.uk/ESRCInfoCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf

The ESRC Framework (2): the role of institutional RECs as guardians of ethics

The ESRC REF states that “responsibility for the conduct of the research in line with relevant principles rests with the principle investigator” but that

responsibility for ensuring that research is subject to appropriate ethical review, approval and monitoring lies with the institution holding an award with ESRC and which employs the researchers performing it, or some of the researchers when it is acting as the coordinator for collaborative research involving more than one organisation.

Institutions should have clear, transparent, appropriate and effective procedures in place for ethical approval whenever it is necessary.

ESRC REF, p.1

Whilst not imposing a model, the ESRC REF envisages that the vehicle to fulfil the obligation for clear, transparent and appropriate ethical review will be a Research Ethics Committee. A ‘Research Ethics Committee’ (REC) is defined as

…a multidisciplinary, independent, body charged with reviewing research involving human participants to ensure that their dignity, rights and welfare are protected. The independence of a REC is founded on its membership, on strict rules regarding conflict of interests, and on regular monitoring of and accountability for its decisions.

ESRC REF, p.7

RECs are responsible for

… reviewing all research involving human participants, or drawing on secondary data carrying personal or organisational information (such as corporate data) conducted under their auspices, that is, by individuals employed by the institution.”

ESRC REF, 1.6.1, p.11

And their primary purpose is to

… protect the dignity, rights and welfare of research participants. RECs should also give due regard to the consequences of the proposed research for others directly affected by it and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future. RECs may also want to consider the safety of researchers. Such consideration should refer to the institution’s research governance provisions.

ESRC REF, 1.6.2, p.11

To this end, ethical review should always be proportionate to the potential risk, whether this involves primary or secondary data. In particular:

  • All research involving human participants, deceased people with living relatives, body parts, or other ‘human elements’ must be reviewed
  • Research involving primary data collection will always raise ethical issues that must be addressed.
  • Secondary use of some datasets may be relatively uncontroversial, and require only expedited ethical review
    Novel use of existing data and especially data linkage may, in some contexts, raise ethical issues. Research involving primary data collection will always raise ethical issues that must be addressed.

See 'University RECs' for more information of requirements.

The ESRC Framework (3): REC constitution and membership

The ESRC REF sets out that RECS must be

  • Independent

“free from bias and undue influence from the institution in which they are located, from the researchers whose proposals they consider and from the personal or financial interests of their members. To this end, institutions should ensure that RECs include members who are independent of the institution” (REF 1.4.1, p.10)

  • Impartial – Employing

“strict rules regarding conflict of interests and on regular monitoring of and accountability for their decisions.” (REF 1.4.2, p10)

and

  • Authoritative and respected

It is therefore stipulated that RECS should have a diverse membership to embody the following attributes and categories:

  • Including both men and women (1.5.2, p11)
  • At least one academic member from outside the department. (p3)
  • At least one person knowledgeable in ethics.” (1.5.2, p11)
  • There must be members who have broad experience of and expertise in the areas of research regularly reviewed by the REC and who have the confidence and esteem of the research community.
    “…and individuals with specific methodological expertise (for example, statistics or qualitative methods) relevant to the research they review.” (1.5.2, p11)
  • Multidisciplinary membership: ESRC notes that “Departmental RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers.” (1.4.3, p10)
  • At least one trained lay member (p3);
  • and more specifically, it is suggested that:

“RECs would also benefit from including individuals who reflect the ethnic diversity of the local community, users of specialist health, education or social services where these are the focus of research activities, individuals with experience of professional care or counselling…”

(1.5.2, p11)

The ESRC REF concludes that, taking all of this into account, “good practice would suggest that RECs would normally need at least seven members.” (1.5.2, p11)

It is stipulated that RECs must have a chair; however, it is emphasised that the chair must not be from department submitting the proposal (i.e. someone else should assume the role of chair if this is the case). (p3)

In addition to the requirement to provide training for lay members, the ESRC REF also points out need for awareness that “ethical expectations and norms may vary over time, hence regular training and updating is required.” (1.10.4, p14)

Further to the primary role of reviewing proposed research, institutional RECs should

…have mechanisms that make some provision for future advice and guidance beyond the initial ethics approval process. All research can develop in ways that raise unforeseen ethical implications. This is especially the case in qualitative research where the developing nature of the research agenda, especially over a long period of time, may make it harder to ensure that the rights and dignity of the subject are respected and protected without further review.

2.2 Iterative ethics review and risk, p22

Research organisations must also have “mechanisms for receiving and addressing complaints or expressions of concern about the conduct of research carried out under their auspices.” (p4)

Applicable laws within which RECs and researchers must act

The ESRC REC points out that, in addition to compliance with its own terms, institutional RECs have an obligation to be aware of and to comply with all laws relevant to research activities:

Research organizations must comply with legislative requirements and with the requirements of data providers. Privacy, health and safety, and intellectual property are especially likely to arise as ethical concerns in research, but all legal requirements must be met. Data supplier access requirements with regard to the secondary use of datasets must be complied with at all times, including any provision relating to presumed consent and potential risk of disclosure of sensitive information. Data suppliers such as the Office for National Statistics or the Economic and Social Data Service should be consulted on their particular requirements.

ESRC REC, p4

Applicable laws include:

  • Data Protection Act 1998
  • Human Rights Act 1998
  • Freedom of Information Act 2000
  • EC Clinical Trials Directive 2001/20/EC
  • Human Tissue Act 2004
  • EC Tissues and Cells Directive 2004/23/EC
  • Mental Capacity Act 2005
  • Human Fertilization and Embryo Act 2008
  • Health and Social Care Act 2008 s158

REC members and researchers should also consider matters of personal legal responsibility and arrange indemnity where appropriate.

 

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