Ethical Review Processes

Academic Institutions’ review processes

It is important to be aware of the arrangements, requirements and timelines for ethical review that operate in one’s own institution. The following is based on the general guidelines for institutional RECs and researchers developed by the ESRC. In general there are likely to be two main categories of review:

  • Full review, which is applicable to all research involving greater than minimal risk to participants and most research involving primary data collection (see below for elaborated criteria).
  • Expedited review, where the potential for risk of harm to participants and others affected by the proposed research is minimal, or for research involving secondary data analysis.

It is likely that institutions will have a preliminary procedure to determine whether full or expedited review is appropriate.

Review of student research projects may be undertaken within the expedited review process; alternatively there may be separate arrangements for reviewing undergraduate and postgraduate proposals.

Questions/issues researchers are expected to address

Institutions will have their own procedures for submission of key information necessary for ethical review. Below, however, are some key areas, which research proposals should address:

  • aims of the research
  • scientific background of the research
  • study design
  • participants – who (inclusion and exclusion criteria), how many, how potential participants are identified and recruited, vulnerable groups
  • methods of data collection
  • methods of data analysis
  • response to any conditions of use set by secondary data providers
  • principal investigator’s summary of potential ethical issues and how they will be addressed
  • benefits to research participants or third parties
  • risks to participants or third parties
  • risks to researchers
  • procedures for informed consent – information provided and methods of documenting initial and continuing consent
  • expected outcomes, impacts and benefits of research
  • dissemination (and feedback to participants where appropriate)
  • measures taken to ensure confidentiality, privacy and data protection.

ESRC REF, 1.8.1, p12

Work requiring full review

Research involving primary data collection will always raise ethical issues that must be addressed. The following research scenarios may be seen as “involving more than minimal risk”:

  • research involving vulnerable groups – for example, children and young people, those with a learning disability or cognitive impairment, or individuals in a dependent or unequal relationship
  • research involving sensitive topics – for example participants’ sexual behaviour, their illegal or political behaviour, their experience of violence, their abuse or exploitation, their mental health, or their gender or ethnic status
  • research involving groups where permission of a gatekeeper is normally required for initial access to members – for example, ethnic or cultural groups, native peoples or indigenous communities
  • research involving deception or which is conducted without participants’ full and informed consent at the time the study is carried out
  • research involving access to records of personal or confidential information, including genetic or other biological information, concerning identifiable individuals
  • research which would induce psychological stress, anxiety or humiliation or cause more than minimal pain
  • research involving intrusive interventions – for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not encounter such interventions, which may cause them to reveal information which causes concern, in the course of their everyday life

ESRC REF 1.2.2, pp8-9

Particular forms of research with “emergent designs” may require arrangements for phased review to take place as the research process progresses. Issues relating to reflexive anthropological work(see Global Context: Ethics, politics and the reflexive researcher) and participant research (see Participatory Research and the Ethical Review Process) are discussed in the relevant sections of this web-resource and revisited with regard to Critiques of the REC model.

Expedited review

Where research involves minimal risk or the uncontroversial use of secondary data, Universities may operate expedited ethical review processes. The ESRC REF, for example, states that expedited review of research proposals

… can occur and is likely to do so for a number of reasons. One is where the potential for risk of harm to participants and others affected by the proposed research is minimal, … The secondary use of some datasets may be uncontroversial and require only light touch, expedited review. Expedited review may also be needed for research projects that have a short lead time and are commissioned in response to a demand of pressing importance.

ESRC REF, p8

Ethical review may not be required at all for anonymised records and data sets that exist in the public domain. (ESRC REF 1.3.2.6)

Student projects

Many Universities have their own ethical review processes in place for student projects. Students and teaching staff are advised to check this with their own institution before proceeding with any student project involving human participants or the collection of primary data.

The ESRC states:

Student projects are carried out primarily as educational exercises rather than to generate new theoretical or empirical insights and this should be taken into account in reviewing the content, though not the ethics, of the study.
It should be made clear to potential research participants that the study is a student project.

ESRC REF 1.13.2, p16

and suggests that:

A case could be made for considering student research through a particular form of expedited review. Undergraduate and taught postgraduate research might be reviewed by multidisciplinary committees with a proportion of the members from outside the school or faculty but within the University. As student projects are not externally funded individually, there is less of a conflict of interests within the University.”

ESRC REF 1.13.3, p16

Multi-institution work, joint funding and non-University RECs

Collaboration

In situations where two academic institutions collaborate it may not be necessary for ethical review processes to take place in both institutions. Researchers should check with their own institutions, but the organisations concerned “may agree to use the services of one of their RECs to review a joint project on behalf of all participants.” (ESRC REF, p4) In such situations:

Each institution would retain formal responsibility for overseeing the ethical review of research conducted under its auspices but would accept the decisions made by the REC of the institution where the Principal Investigator is based.

ESRC REF 1.14.4, p17

When work is done in collaboration with non-academic organisations, it may be necessary for both organisations to use the ethical review processes of the academic partner if the non-academic partner does not have the necessary resources.

Joint funding

In situations where the ESRC is the joint funder of a project with another funder, that funder must be fully aware of ESRC REF and agree to comply with its terms. (ESRC REF 1.14.3, p.16)

Research in the NHS (avoiding duplication of submission)

Researchers should check the ethical review requirements within their own institution. As a general rule of thumb, researchers who are required to submit their research proposals to ethical review through an NHS REC are not required to further submit their proposal through a University REC (thought this may depend on the nature of the research so it is important to check).

The ESRC REF states:

Researchers and their employing organisations should avoid duplication of ethics review, especially in regard to research that may fall under the rubric of other ethical frameworks such as the Department of Health’s Research Governance Framework. Researchers must submit proposals either to their institution’s REC or to a Department of Health Local or Multi-site Research Ethics Committee L(M)REC as appropriate. The ESRC does not require both bodies to be involved. The appropriate body will be determined by the issues raised by the research, the nature of the data to be obtained and the population of respondents to be included in the study. This will apply to both single-discipline and interdisciplinary research where social and biomedical scientists are working together.

ESRC REF 1.15.1, p17

See ‘NHS Research Ethics Committees’ for further information.

Research conducted outside the UK

Where research is to be conducted outside the UK, … [institutions] … should require researchers to establish whether local ethical review is required by the host country, and if not, how the principles of the REF can be followed in developing and undertaking the research.

ESRC REF 1.14.8, p17

It is arguable that engagement with a local ethics committee is desirable whenever feasible. See the Ethics committees in host countries (under ‘Decorum, context and awareness of laws’ in the Global Context section for more information).

 

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