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What needs HREC review?

1. Flow chart - what needs ethics review

Long description

If, after following this flowchart, you decide that your study is exempt from HREC review, assuming you will be following all the guidelines, you can add this wording to your documentation. “This research project conforms to and complies with the OU Human Research Ethics Committee’s conditions for exemption from formal review.” Exemption letters can be sought at a future date if a publisher requests them AND if you can evidence that all the guidelines have been followed. For this situation, a retrospective application should be made to HREC.

2. Definitions

Research

Any form of disciplined enquiry that aims to contribute to a body of knowledge or theory. Involves undertaking a systematic investigation in order to generate new knowledge and findings that are generalisable/transferable beyond the local context. Outcomes will be disseminated widely externally (e.g. in scholarly peer-reviewed publications, at academic conferences, and so on).

Evaluation research (including course evaluation, teaching-learning evaluation, service evaluation)

Evaluation research sets out to systematically assess the efficacy, effects or effectiveness of a particular service, procedure or policy. This could include OU modules, programmes or initiatives relating to the taught curriculum or student-centred activity. It is generally focused on generating knowledge about the specific service that can feed into improving that service. It often involves the analysis of existing data, or data gathered from user feedback surveys, interviews or focus groups.

Audit/quality assurance

Enquiry designed in order to assess the level of service being provided against a set standard (i.e. “does this service reach a predetermined standard?”).

Market research

Systematic enquiry designed to gather feedback from consumers in order to assess and guide decisions about services or products being offered.

Research led by another institution

If an OU researcher is involved in a project led by another institution, where they are not involved in any of the data collection stages (e.g., solely assisting in the literature review, and/or write up of the research), then formal OU HREC review is not required, and the researcher is exempt from applying to the HREC and obtaining a favourable opinion. This is on the conditions that:

  • the OU researcher is not collecting data
  • the lead institution for the project has secured ethics review
  • the OU HREC have seen evidence of this

In these cases, an explanatory letter can be provided if this is requested by journal editors, or similar authorities, which will involve submitting an application to HREC for retrospective review, to ensure these criteria are met.

If an OU researcher is involved in a project led by another institution, and isIS involved in any of the recruitment and data collection stages, an application should be made to HREC.

Note on ethics review requirements

Projects that involve evaluation research, audit or market research typically do not require Human Research Ethics Committee (HREC) review. However, note the conditions and exceptions as noted in 3 and 4 below.

HREC is able to review broader research projects that have developed out of what was initially a local evaluation research project (see Definitions above). For example, this may apply to Scholarship of Teaching and Learning (SoTL) projects. HREC will look favourably upon the use of the initial evaluation data in a subsequent broader research project as long as appropriate consents have been gained from participants for this future usage. Project teams are therefore urged to plan carefully and gain appropriate consents where they anticipate such potential future developments emerging from an earlier evaluation research project. HREC will require evidence of these consents and request that they be gained retrospectively where consent has not been gained already. Research participants should normally be assured, when consenting, that any potential future use of their responses will be in entirely anonymised form.

OU researchers wishing to carry out health and social care research in England may need to submit an application for ethics review to the Health Research Authority (HRA).

You can assess whether your research will need approval from an NHS Research Ethics Committee (REC) using the decision tool provided on the HRA website. For further information is available on the Health and social care research section.

3. Conditions that MUST be met

a) the study does not involve either vulnerable* or dependent groups

b) any personal data** collected must be essential for the evaluation/review, and will be kept secure, confidential, and only processed/shared in anonymised form

c) no personally sensitive*** or confidential data are being collected

d) topics covered are not likely to be upsetting or cause distress

e) proper informed consent and data protection procedures must be employed that are GDPR compliant and conform to HREC guidelines (see SRPP student survey consent template, HREC Participant Information sheet and Consent form templates)

If conducting interviews or focus groups, all the above conditions a) - e) must apply, and in addition,

f) any audio recordings of discussions must only occur after gaining explicit consent from all participants, and the recordings must be kept secure, confidential, and be transcribed/anonymised as soon as possible and the original recordings then destroyed

g) the topics discussed must relate only to opinions and experiences relating to existing teaching-learning practices, or subjects deemed to be within participants' professional competence

h) all participants involved in a focus group must agree to keep all information shared within the group confidential

If using existing data/data sets, the following conditions must be met,

i) the data must only be processed and shared in accordance with the original permissions/informed consent agreements

j) permission from the data controller for the required usage must have been obtained (and evidence of this must be able to be provided upon request)

* Vulnerable groups include those whose capacity, age or other vulnerable circumstances may limit the extent to which they can be expected to understand or agree voluntarily to participate. This includes children aged under 16, those lacking capacity, or individuals in a dependent or unequal relationship.

** Personal data is that which can identify an individual eg PI number, contact details, audio/video records or images. This falls under the Data Protection Act (2018).

*** Sensitive data is that which provides additional personal data about characteristics which have been legislated by the Data Protection Act (2018) to be protected characteristics or special category data.

Further information on what counts as personal and sensitive data can be found on the Data Protection team’s page (internal link only)

Special category data

Data Protection Act (2018) compliance requires that participants must be informed if any special category data will be gathered and processed about them. This includes:

  • Ethnic origin
  • Political affiliation
  • Religion
  • Trade union membership
  • Genetics
  • Biometrics
  • Health
  • Sexual orientation

If this data is to be processed, a Data Protection assessment (internal link only) will be required to be completed and approved by the Data Protection Team.

If any of the above conditions are not met then HREC review using the Research Ethics Application System will be required

4. Projects doing any of the following DO require HREC review

  1. Collecting personally identifiable data, other than name, personal identifier, or other publicly available information.
  2. Recording videos or photographs of people.
  3. Employing interventions (including psychometric testing or assigning participants randomly to conditions) that are not already part of the development of the existing service/procedures.
  4. Using vulnerable or dependent groups.
  5. Collecting data on sensitive or personal topics.

If in doubt about whether your activity requires HREC review, please contact the HREC mailbox for further advice.

5. Exempt projects that do not require HREC review MUST still do the following:

Please note: These templates show the wording that you can use to recognise the attention to ethics researchers have given to a project in meeting the conditions outlined on this page, which is: “This research project conforms to and complies with the OU Human Research Ethics Committee’s conditions for exemption from formal review.”

  • Where the project does not need formal HREC review the following wording should be included in participant-facing documentation: 'This research project conforms to and complies with the OU Human Research Ethics Committee’s conditions for exemption from formal review.'

6. Exemption letters

If your study qualifies for exemption from formal ethics review, but you plan to publish your findings externally, you may still be asked for evidence of ethics review from a journal editor or funder. In this case you will need to submit an exemption application using the Research Ethics Application System. HREC can then provide formal letters of ethics exemption to provide proof of ethics consideration. Please contact the HREC mailbox for further advice.

7. Illustrative examples

Does not need HREC review

Example 1

A project that aims to survey students to find out their views on the OU prospectus, in order to feed into further developments to the prospectus, does not require HREC review.

Example 2

A project that aims to survey OU library users to find out their opinions on the library services and resources offered, in order to review and further develop these services, does not require HREC review.

Could need HREC review

Example 3

A project that aims to survey students and/or tutors to find out about their views on learning resources for a particular module (e.g. using surveys, interviews or focus groups) in order to provide recommendations for policy and/or action at a local level (e.g. on a module or program) does not generally need HREC review. However, if it involves any of the exceptions e.g. collecting special category data, or is intended to be published in academic journals as educational research, this would need an application for HREC. 

In the above examples, 1, 2 and 3, sharing the findings externally, e.g. as reports or at training events and/or conferences, is permitted as long as this complies with the consent for usage gained from participants. Participants must have been informed of the ways in which their responses will be used.

Does need HREC review

Example 4

A project that aims to address the question of whether students perform as well on online as on offline assessments, by designing an intervention study that randomly assigns students to one of two conditions (online and offline) for a module assessment, for comparison, does need HREC review.

Example 5

A project that aims to investigate the question of how children have been impacted by the COVID-19 pandemic by asking child participants to take part in discussions and focus groups does need HREC review.

Example 6

A project that aims to address the question of how students with generalised anxiety disorder (GAD) can be better supported, by asking selected students with this condition to take part in focus groups to discuss how GAD affects their studies, and their life in general, does need HREC review.