Seeking SACHS Research Ethics Approval
The only information we have so far on the design of this pilot study is:
"Esther and her team will carry out a pilot project to investigate whether it is possible to look at two different approaches to the intervention and treatment of Chronic Fatigue Syndrome/ME (CFS/ME) in Children."
"The team will carry out a pilot project to investigate how to recruit to a randomised controlled trial looking at the Phil Parker Lightning Process and specialist medical care. This will be the first study of its kind in this area, and the team hopes to establish a basis for a larger scale multicentre research project."
"The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Royal National Hospital for Rheumatic Diseases."
It remains to be established which Research Ethics Committee(s) this pilot is obtaining/has obtained ethics approval through. I'm told that more than one body might be involved.
I have this week made enquiries of the South West Office of the National Research Ethics Service.
I have asked:
"If a member of the public, a patient organisation or other stakeholder in the project (other than individuals directly involved with the carrying out of the project or involved as potential participants in the project) had concerns about whether that project should have received ethics approval is there a mechanism through which a review of the decision that led to approval can be requested?"
I may approach the lady who started one of the other LP threads to enquire whether her child was expected to complete the application form and if not, whether the parent was required to complete on the child's behalf and if not, on what basis their "coach" assesses a child for "readiness" and how a child's health status prior to commencing the "training" was assessed by the "coach" (see last section of
Application form) - if this member would be comfortable providing this information.
From the website of University of Bristol (refer to site for clickable links):
http://www.bristol.ac.uk/sachs/research/ethicsapproval.html
Seeking SACHS Research Ethics Approval
Which Committee should I apply to?
Procedures for applying to the SACHS Research Ethics Committee
What will the Committee be looking for?
Research Governance Policy and insurance
Dates of Committee Meetings
Examples of materials
Which Committee should I apply to?
Ethical approval is normally required for all research carried out in the SACHS. This includes research involving face-to-face interaction, postal surveys, telephone interviews, and internet surveys.
However, projects that involve participants recruited through the NHS, involving NHS staff, or using NHS premises must seek ethical approval through NRES (now IRAS). SACHS REC cannot grant approval for NHS-related research.
In reality, ethical approval can be obtained from any formal research ethics committee and where research is conducted away from the university such as in another city this may be worth consideration.
SACHS staff
All staff research projects requiring ethical approval need to be submitted to SACHS REC. Some projects, usually where they cross international boundaries, may be referred to the Faculty research ethics committee.
Research students
All PhD, EdD, and MPhil projects requiring ethical approval need to be submitted to SACHS REC. An exception is EdD first year projects which are dealt with by the Norah Fry REC.
Masters and undergraduate students
Masters and undergraduate dissertations requiring ethical approval need to be submitted to the relevant department REC. Details are available on departmental websites.
Other considerations
Researchers collecting data overseas must obtain evidence that they have satisfied research ethics approval requirements for that country.
No recruitment or data collection can take place until an ethics registration number or letter of approval has been received.
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Procedures for applying to the SACHS Research Ethics Committee
Applicants must submit one electronic copy by email and one unstapled, single sided paper copy of their application form and all accompanying documentation to Luana Gaddeo (L.S.Gaddeo@bristol.ac.uk) by 4.30pm on the deadline date. Application received after this time will not be considered until the following months meeting. Please ensure that all relevant signatures on the application form are in place BEFORE submitting your application.
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What will the Committee be looking for?
Does the application satisfy the following criteria?
26 pointers you should consider before submission:
1. The application is clear, complete, easy to understand, and competently written enabling the committee to make its judgements
2. The application indicates where the research involves participants from vulnerable groups which include children, older people, those with mental illness.
3. The application establishes that overall the likely benefits of the research outweigh the risks (if any) to the participants.
4. The research address a worthwhile question.
5. The quality of the research design and procedures is good enough to justify the burden placed on the participant
6. In the case of students or an inexperienced researcher, the investigation has an identified supervisor or experienced co-applicant.
7. The possible risks to participants are no greater than they would normally encounter in their life outside research. If they are greater, then participants are adequately informed and safeguards are in place to minimise any harm.
8. The degree of discomfort, distress or deception, if any, are fully foreseen and explicitly described.
9. Where participants have diagnosed illnesses or conditions, particularly with children, adequate care is taken not to label the individual or assume that they are aware of their condition.
10. Where an approach to participants is being made through an existing data base of contact points, there is a guarantee that participants have given permission to be approached by a third party If not, any invitations to participate must first be through the keeper of the data base (such as head teacher) rather than the researcher.
11. There is no coercion in the recruitment of participants (as might occur where researchers are in a position of authority or power over participants) and right to withdraw is made clear.
12. Sufficient consideration has been given to power imbalances where participants may feel obliged to please or comply with the researchers requests.
13. There are clear boundaries made between professional/clinical and researcher roles. The participant must be in no doubt that the research is separate from any professional service they may also be involved with.
14. Appropriate referral or back up procedures are in place where material is sensitive and potentially upsetting for the participant.
15. Appropriate procedures and materials (ie information sheet) are in place for informing participants about the research study and their part in it. It is critical that the material is presented in a form and at a level that can be clearly understood by participants.
16. Appropriate procedures and materials (ie consent form) are in place for obtaining consent from participants. Children can provide assent (agreement) but consent is also obtained from parents or guardians.
17. Each procedure that the participant is being asked to take part in (interviews, questionnaire, observations) has a separate indication through a check box format.
18. Additional materials including data collection tools such as questionnaires and interview protocol are provided so that the committee can make a judgement of ethical implications.
19. Anonymity and confidentiality is assured and appropriate procedures are in place, particularly where small groups are involved or observation is used and the potential for identification is high.
20. Procedures for obtaining express permission are in place where access to confidential records is involved.
21. Evidence that the project has been registered for governance and sponsorship (where appropriate) with Research and Enterprise (RED) (see governance and sponsorship guidance).
22. Unless sponsored by an organisation other than University of Bristol, all relevant letters and materials are on UoB headed paper.
23. Additional safe guards (such as CRB check, option for parents to withdraw children) are in place for vulnerable populations including children, people with learning and communication difficulties, patients in hospitals, in care, custody, or probation, and engage in illegal activities such as drug abuse.
24. Where the research requires one individual to conduct data collection on remote sites such as homes, a lone worker policy is described.
25. Feedback from the research is provided for participants in an appropriate form that is brief and accessible.
26. Statements about anonymity being maintained or assured may need qualifying. If there is disclosure by participants that individuals are harming or being harmed, then appropriate authorities need to be informed. Similarly, if research reveals previously unknown medical problems then doctors may need to be informed.
Further sources:
The British Psychological Society: Ethical Principles for Conducting Research with Human Participants
http://www.bps.org.uk/the-society/ethics-rules-charter-code-of-conduct/
ESRC Research Ethics Framework.
http://www.esrc.ac.uk/ESRCInforCentre/Images/ESRC_Re_Ethics_Frame_tcm6-11291.pdf
Public Health: Ethical Issues. Nuffield Council on Bioethics.
http://www.nuffieldbioethics.org
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Research Governance Policy, sponsorship and insurance
Ethical approval is not the only thing you need to consider before starting your research!
The university ultimately is responsible for governance, sponsorship and insurance of research conducted by staff and enrolled students and so needs to know about any research project that:
Involves human subjects (in the case of SACHS this means just about everything).
Where research funders require a formal sponsor.
The form for registering your research with Research and Enterprise Development (RED) can be downloaded from
http://www.bris.ac.uk/research/support/governance/ .
All SACHS research ethics committees require evidence that research projects have been considered for governance, sponsorship and insurance. The procedure for most ethics applications will be:
1. Complete and submit the registration form to RED before ethics submission.
2. RED will issue a registration e-mail.
3. Submit a copy of the RED email with your ethics submission.
Insurance issues are paramount where there is significant risk to participants.
You must inform Ginny Hope (ginny.hope@bris.ac.uk) if your research falls in one of the following categories:
1. It involves NHS staff, patients or premises and therefore is requiring an NRES research ethics submission
2. Research where the university is acting as the formal sponsor
3. Research involving children under 5 years old, pregnant participants, pregnancy, contraception or conception
4. Research into HIV/AIDS or CJD
5. Research involving the design and/or manufacture of a product to be tested
6. Research involving genetic engineering
7. Research involving prohibited substances such as cannabis, ecstacy.
8. Clinical research overseas
9. Any other research that you feel may present a significant risk (eg running participants to maximum on a treadmill).
If your research is a masters or undergraduate dissertation, your department may have a system where your department ethics committee is able to offer governance clearance on behalf of RED
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Dates of meetings & deadlines for applications
Date of meetings
Deadline for applications
21st September 2009 14th September 2009
12th October 2009 5th October 2009
16th November 2009 9th November 2009
7th December 2009 30th November 2009
18th January 2010 11th January 2010
15th February 2010 8th February 2010
15th March 2010 8th March 2010
19th April 2010 12th April 2010
17th May 2010 10th May 2010
14th June 2010 7th June 2010
12th July 2010 5th July 2010
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Examples of materials
SACHS Research Ethics Application Form
Research Registration Checklist
Self Assessment Questionnaire for Researchers Using Personal Data
Information Sheet Template
Consent Form Template
