How to Seek Ethical Approval for your Research

Research staff and students at the University of Aberdeen must assess whether formal ethical approval is required for their proposed research.

There are ethics committees for each broad research area and governance arrangements for researchers whose work requires NHS approval or permissions under Home Office regulations animals (for example under the Animals (Scientific Procedures) Act Amended 2012).

If your work involves NHS staff, data, patients, tissue, resources or facilities, you may need to apply to the local NHS Research and Development (R&D) department for access permission. Further information on gaining approvals or contacts for further advice are available from the following link: http://www.abdn.ac.uk/medical/researchgovernance/clinicalresearch/

Each of the Schools have an ethical review process in place and researchers, where appropriate, should submit their proposed research to one of the following Boards for ethical review.

Some areas of research are governed by external legislation and/or external regulatory requirements and where this is the case, specific governance and ethical review arrangements are in place. This applies to (for example) clinical research and research involving the use of animals (under the Animals (Scientific Procedures) Act Amended 2012).

Further Information

Further information on the University’s framework for ethical review is available in the Aberdeen Research Governance Handbook.

Do I need ethical approval for my research?

Guidance has been produced by the research ethics and governance committees to help establish whether formal ethical approval is required for a research proposal. This can be accessed via the discipline sections below. The checklists of questions are not exhaustive – they aim to cover most areas of research and disciplines, focusing on studies that involve human participants. If you need further clarification on whether your proposed research project needs ethical approval, please contact the relevant research ethics and governance lead for your area:

 

Arts, Social Sciences and Business

The Policy and Procedure for Ethical Review of Research (Committee for Research Ethics & Governance in Arts, Social Sciences & Business) is available here.

When considering an application for ethical review, researchers should first consider this checklist which provides useful information on possible ethical considerations during research activity. 

Researchers are responsible for obtaining ethical approval for research projects regardless of whether the project is externally funded and whether ethical approval is mandated by the funders. Colleagues are required to undergo formal ethical review and gain approval for each defined research project, and, on a biennial basis, for ongoing research activity where:

  • Research (including public engagement) involves human subjects (or their remains).
  • There are any issues which they feel might raise any ethical concerns during proposed research activity (for example, potential conflicts of interest; the use of artefacts; environmental impact; financial inducements for subjects). 
  • Research activity might involve the sharing of data or confidential information beyond the initial consent given (including where research relies solely on secondary data).

Ethical Review Process

Staff and postgraduate research students can apply for ethical approval of research activity through the electronic review process on SharePoint.

Undergraduate students and taught postgraduate students from within the School can apply for ethical approval of research activity by downloading and completing the Ethics form.

Any queries should be directed to the appropriate School Ethics Officer in the first instance.

NHS Management Permission

If your work involves NHS staff, data, patients, tissue, resources or facilities, then you should contact researchgovernance@abdn.ac.uk in the first instance for advice.

Further information on gaining ethical approval and contacts for further advice are available from the following link: http://www.abdn.ac.uk/medical/researchgovernance/clinicalresearch/

Life Sciences and Medicine

Applications

  • Login to make or revise an application, or to review applications as a committee member

Contact Information

Background

As part of the requirements for research governance, the University of Aberdeen requires that approval from a research ethics committee is required for all research involving human participants or biological samples. The Life Sciences and Medicine Ethics Review Board (CERB) has been established to ensure that all research carried out by staff and students is reviewed by an appropriate ethics committee.

For projects not covered by the remit of North of Scotland Research Ethics Committee, the Psychology Ethics Committee or an ethics review board in a different country, the Board provides the ethical review. CERB operates primarily as a virtual committee with applications being submitted and reviewed electronically to allow a rapid response. Members of the committee meet several times a year to review decisions and procedures. For research carried out overseas, approval by a local research ethics committee is preferred.

CERB accepts projects for review where
  1. The study is 'research'.
    Research is defined by the University as "a process of systematic enquiry leading to new insights which contribute to a body of knowledge, effectively shared". Research is discriminated from audit or service evaluation by whether it is designed to generate knowledge beyond local circumstances that can be applied more generally. For practical purposes, this tends to mean that research studies are those designed to generate knowledge that may be published.
  2. The primary investigator is a member of staff within Life Sciences and Medicine
  3. Where the project requires an ethical opinion according to the University of Aberdeen Handbook for Research Governance
  4. Where the project does not require ethical review by another ethics board such as that based in the NHS.

The local NHS ethics review service is called The North of Scotland Research Ethics Service. For information about NOSRES, meeting dates and closing dates, please visit the North of Scotland Research Ethics Service page on the NHS Grampian website.

For questions about NOSRES applications please contact NOSRES on:

  • Ethics Co-ordinator: Mrs Carol Irvine, Tel: 01224 558503
  • Scientific Officer: Dr Rachel Venables, Tel: 01224 558480
  • email: nosres@nhs.net | +44 01224 558474

In addition, visit pages linked from http://www.hra.nhs.uk/news/2012/03/21/gafrec-and-nres-sops/ for algorithms to help you to determine whether or not application to an NHS ethics committee is required.

Research being conducted outside of Aberdeen

For research (deemed to require review according to the University Research Ethics Framework) being conducted at multiple sites within the UK, that include Aberdeen as a site, evidence of ethical review obtained by the primary investigator is required. This would usually be conducted by the PI's local institution or NHS ethics committee. Additional local review by CERB is not normally required.

Research being conducted abroad

For projects where research is being conducted abroad (deemed to require review according to the University Research Ethics Framework), CERB expects to undertake ethical review of these projects, regardless of whether local ethical review is also conducted.

Applying to CERB – some general points

Please read this carefully before making an application.
 

  1. CERB uses a ‘virtual’ reviewing process. Applications that are submitted to CERB are sent out electronically to selected members of the board who feed comments back electronically to applicants. This means that most applications are not discussed at board meetings and the reviewing process can commence immediately after application.
  2. Either students or supervisors may make the application, as long as they are registered to the University of Aberdeen. Nevertheless, if the student makes the application it will require approval by the supervisor before it is actually submitted. Principal investigators must be staff employed by the University of Aberdeen.

    Important note: Until the supervisor has approved the application it will not be accepted into the reviewing system.
  3. On making an application please look at the requirements carefully. Most projects require several documents to be uploaded including an experimental protocol, information sheet, consent form and evidence of peer review. New questionnaires or interview schedules should also be submitted.
  4. Peer review. CERB considers that to be ethical, a study needs to be scientifically valid. Whilst CERB may have the scientific expertise to judge whether an application is good science, we don’t assume this to be the case and so also rely on evidence of scientific peer review to advise us. If your project has not already been peer-reviewed e.g. because it is unfunded, we ask that you obtain internal or external peer review. We are not asking for your peers to judge if a study is ethical – that is clearly our job. You should upload your peer review with your application so that it can be considered by the committee along with the rest of the application.
    Completion of a pro forma is very useful though not necessary and you can find this here. You should upload your peer review (or evidence such as approval of a student based project by an appropriate process) with your application so that it can be considered by the committee along with the rest of the application.
  5. Once an application has been made and reviews have been received by the Chairperson, she or he will send out a letter to the applicant which will either approve the application or contain requests for changes that will need to be made before approval can be given.
  6. Please make changes to documents using a tracking or highlighting tool and compose a reply to the letter from the Chairperson addressing the points made by the reviewers. Again, this will need to be submitted or approved by the supervisor if it is a student project.
  7. Depending upon the types of change requested by reviewers the Chairperson will use his or her discretion to decide whether to send the application back out for re-review or whether to accept the changes and approve the application. The applicant will be notified accordingly.
  8. Paying participants - see general advice document
Resources

The following Participant Information Sheet (PIS) and Consent form are provided for guidance only and there may be reasons why these forms are not applicable to your study. The same applies to the exemplar form for obtaining peer review.

Further guidance may be obtained from:

Presentations from CERB training day (PDFs)

Physical Sciences and Engineering
Academic-Led Research Projects

All academic research projects should be ethically assessed by the researcher to identify whether there is a need for formal ethical approval, using the self-assessment process detailed below. 

Ethical approval should be sought as early in the research proposal process as possible. For externally funded projects, the applicant should complete the self-assessment Ethical Review Checklist (Annex A) as described below to determine whether further ethical review will be required.  This should be done before the proposal is submitted to the Head of School and Research & Innovation (R&I) for first review - see also the   

If further review is required then, depending on the funding body's rules, full approval may not be needed at the application stage, but the applicant must obtain it before the research commences.  Any application for external funding should include a signed declaration that the applicant has understood his/her obligations under the institutional Research Ethics Framework and, where appropriate, the RCUK requirements. This is included on the grant application cover sheet.  

The ethical review process has two stages:

1.Self-Assessment
The Principal investigator shall determine by self-assessment if the research is requires formal ethical approval, using the Ethical Review Checklist (Annex A).  If the answer to any of the questions is YES, the project must be reviewed according to this Ethical Review and Approval Policy by completing the Ethics Review and Approval Form (Annex B).

Please note the following types of research are handled using different processes.

  • Research involving NHS staff, patients, facilities and premises is subject to ethical review by the NHS North of Scotland Research Ethics Service (NOSRES) (see www.nhsgrampian.org).  This includes research involving individuals when their status as NHS staff or patients is relevant to the research, even when a medical condition is not the subject of the research.
  • Research involving animal and biological materials is subject to Home Office regulations. Forms and guidance can be obtained from the Medical Research Facility. Please also refer to the University's Statement on the Use of Animals in Research (downloadable from the Policy Zone).
  • Research involving adults who do not have the capacity to consent is subject to NHS ethical review procedures (www.nhsgrampian.org).
  • If collection of genetic resources (organisms, microorganisms, DNA, RNA, proteins, small molecules) from signatories to the Convention on Biodiversity/Nagoya Protocol is involved, then a relevant agreement must be in place before this can begin. This agreement must provide prior informed consent with mutually agreed terms and the must be in keeping with the Convention on Biodiversity/Nagoya Protocol and be obtained via the national focal point of the provider country. A statement to this effect must be included in grant applications that intend to make such collection.

2. Full Ethical Review and Approval
Once completed, the Ethical Review form will be forwarded to the Ethics Board.

The application will be forwarded to the School representative on the Ethics Board for consideration. In the event of a conflict of interest, or a particular specialist piece of research, this will be forwarded to a delegated alternative.

Proposals demonstrating potentially complex ethical issues will be reviewed by the Ethics Board. Some projects may require additional advice from the University Data Protection Officer, or on intellectual property issues by colleagues in Research & Innovation.

The University is required to report on ethical review activity. Therefore it is important that all reviews are directed to the Clerk of the Ethics Board (copsethics@abdn.ac.uk).

A response will normally be provided to the applicant within 7-14 days, although very complex proposals may take longer. Most reviews will be undertaken by circulation to appropriate reviewers within the University. The outcome of the review will be communicated to you by the Clerk of the Ethics Board as soon as practicable.

Taught Postgraduate and Undergraduate Research Projects

The University is responsible for all research activities undertaken at the institution.  As a result, the University must also be satisfied that research undertaken by students is also in compliance with these ethics procedures.  Ethical approval should be sought as
early in the research proposal process as possible.

ALL taught postgraduate students and Undergraduate Honours students preparing research projects must follow the steps below prior to the commencement of the research project.

 

1.Self-Assessment
Complete the Ethical Review Checklist (Annex A).  Once completed you should hand it into to your research/dissertation supervisor.  If the answer to any of the questions is YES, the research project needs further ethical review, as described below.  The project cannot begin until approval has been granted. 

Please note the following important exceptions to this process:

  • Research involving NHS staff, patients, facilities and premises is subject to ethical review by the NHS North of Scotland Research Ethics Service (NOSRES) (see www.nhsgrampian.org).  This includes research involving individuals when their status as NHS staff or patients is relevant to the research, even when a medical condition is not the subject of the research.
  • Research involving animal and biological materials is subject to Home Office regulations. Forms and guidance can be obtained from the Medical Research Facility. Please also refer to the University's Statement on the Use of Animals in Research (downloadable from the Policy Zone).
  • Research involving adults who do not have the capacity to consent is subject to NHS ethical review procedures (www.nhsgrampian.org).
  • If collection of genetic resources (organisms, microorganisms, DNA, RNA, proteins, small molecules) from signatories to the Convention on Biodiversity/Nagoya Protocol is involved, then a relevant agreement must be in place before this can begin. This agreement must provide prior informed consent with mutually agreed terms and the must be in keeping with the Convention on Biodiversity/Nagoya Protocol and be obtained via the national focal point of the provider country. A statement to this effect must be included in grant applications that intend to make such collection.

 

2.Ethical Review and Approval
The precise nature of the review process depends on the discipline; students should consult their supervisor and/or Programme Co-ordinator for details.  All PGR project students and most PGT project students must complete the Ethics Review and Approval Form (Annex B).  Often, but not always, undergraduate project students go through a different process and their supervisor and/or Programme Co-ordinator will provide specific guidance on this matter.

For those using the Ethics Review and Approval Form (Annex B) process, the application form should be submitted to the Ethics Board. The application will then be forwarded to the School representative on the Ethics Board for consideration. In the event of a conflict of interest, or a particular specialist piece of research, this will be forwarded to a delegated alternative. Proposals demonstrating potentially complex ethical issues will be reviewed by the Ethics Board. Some projects may require additional advice from the University Data Protection Officer, or on intellectual property issues by colleagues in Research & Innovation.

For those using the Ethics Review and Approval Form (Annex B) process, a response will normally be provided to the applicant within 7-14 days, although very complex proposals may take longer.  Most reviews will be undertaken by circulation to appropriate reviewers within the University.  The outcome of the review will be communicated to you by the Clerk of the Ethics Board as soon as practicable.

Ethics Review Policy & Approval Documents - REVISED

Please ensure you are using the most up-to-date version by always downloading from below.

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