Ethics Reviewer Training Workshops
For the Faculty of Medicine, Dentistry and Health
Combined Report
Synopsis
The workshops’purpose was to deliver training in how to ethically review research ethics applications, primarily for new ethics reviewers, in the Faculty of Medicine, Dentistry and Health. The initial workshop was held in November 2009, with a repeat (although slightly shorter format) workshop in March 2010. The key aims were to:
- Help ethics reviewers to gain an understanding of what their role entails;
- Help ethics reviewers gain an understanding of the type and level of information they should to expect to see in a University research ethics application form;
- Help ethics reviewers gain a greater awareness of the ethical considerations required as a reviewer and of what constitutes appropriate feedback to applicants;
- Provide a toolkit of resources to assist ethics reviewers in their role.
The initial November workshop also aimed to:
- Provide an opportunity to discuss ethical scenarios to develop ethical awareness and thinking.
The workshop opened with two presentations:
- ‘Introducing the University Research Ethics Committee’ (Professor Richard Jenkins, Chair of the UREC)
- ‘An Introduction to the Ethics Review Procedure for New Ethics Reviewers’ (Ms Lindsay Cooper, Minute Secretary to the UREC)
The presentations can be viewed and downloaded from:
The Group Discussion sessions
Following the presentations, the audience split into small groups for discussion sessions.
The main discussioninvolved consideration of a number of real examples of research ethics applications from the Faculty of Medicine, Dentistry and Health, in order to help attendees to gain familiarity with the application form, an understanding of the type and level of information that a reviewer should expect to receive in an application form and to consider what constitutes appropriate feedback.
The second discussion (only included in the initial November workshop) was based on general ethical scenarios relevant to the disciplines within the Faculty, in order to help develop ethical awareness and thinking (sourced from the Online Ethics Centre at the US National Academy of Engineering).
The discussion material, along with the key points raised in each discussion session, are included on the following pages.
Brief summary of the conclusions drawn by Professor Richard Jenkins, Chair of the University Research Ethics Committee, following the discussions:
During the discussion of the case study material some consistent themes, of general application, emerged, as follows:
First, the ethics review form should contain sufficient detail to allow properly informed ethical review to take place. If there is insufficient information it should be returned to the applicant with clear instructions about extra material or information required.
At the other end of the spectrum, however, it is also clear that too much (irrelevant) detail is sometimes included: this too makes proper ethical review difficult and such cases should also be returned to the applicant.
Ethics review forms are supposed to be comprehensible to a non-specialist (because ethical issues are not matters of specialist science). If they are not they should be sent back.
Practical detail aside, there is sometimes what appears to be a superficial or perfunctory approach to the ethics form. It is not intended to be merely a box-ticking exercise: one of the key objectives of the review procedure is to encourage researchers to think in proper depth about the ethical dimensions of their work. If the content of the ethics review form appears to be simply a cut-and-paste job, taken from an application for funding, for example, this should also be sent back.
The distinction between 'the science' and 'the ethics' is not always obvious. Ethics approval can, it is clear, sometimes improve the science. However, care should be taken to avoid gratuitous interference in the science.
Finally, reviewers should make a point of looking out for inconsistencies in the ethics form - particularly between the 'box ticking' part of the form and its more 'narrative' sections - and where these exist they should be pointed out to the applicant and the form returned for rewriting and, if appropriate, more rigorous review.
Discussion Session 1: Research Ethics Applications
EXAMPLE ETHICS APPLICATION 1: People with learning disabilities’ perceptions of oral health care
University Research Ethics Application Form
for Undergraduate & Postgraduate-Taught Students
Yes / No:
X (covering letter only)
(if yes, then this must be enclosed)
I confirm that I plan to invite prospective participants to sign a consent form:
Yes: / No:
(if yes, then this must be enclosed) / X
A1.Title of research project:
People with Learning Disabilities’ perceptions of oral health care
A2.Name of Student: ***
Name of Supervisor: ***
A3.Proposed Project Duration: 8 months
A4.Mark ‘X’ in one or more of the following boxes if your research:
x / has the primary aim of being educational (e.g. student research, a project necessary for a postgraduate degree or diploma, other than an MD or PhD)involves children or young people aged under 18 years
x / involves only anonymised or aggregated data
involves prisoners or others in custodial care (e.g. young offenders)
involves adults with mental incapacity or mental illness
involves using samples of human biological material collected before for another purpose
involves testing a medicinal product *
involves investigating a medical device *
involves additional radiation above that required for clinical care *
involves taking new samples of human biological material (e.g. blood, tissue) *
A5. Briefly summarise the project’s aims, objectives and methodology?
(this must be in language comprehensible to a lay person)
To explore the subjective experiences and perceptions of oral health amongst people with different learning and physical disabilities. The objective is to compare accounts with policy recommendations and look for gaps or inconsistencies that could inform policy. People will be encouraged to tell their own story and only discuss what they feel comfortable discussing. The methodology is narrative which comes from the social sciences and is increasingly being used in medicine because it allows the individual to present their own story.
A6. What is the potential for physical and/or psychological harm / distress to participants?
There is a slight potential for discomfort arising from the interviews but the degree of risk will be mitigated by the use of consent and opting out procedures, and using cues from carers as to whether the participant is tired or wishes to exit the interviewing situation.
A7.Does your research raise any issues of personal safety for you or other researchers involved in the project and, if yes, explain how these issues will be managed? (especially if taking place outside working hours or off University premises)
A trusted friend will be left details of where I am going and the approximate time of my return. I will contact them on my return to let them know I am safe.
A8.How will the potential participants in the project be (i) identified, (ii) approached and (iii) recruited?
(i)Service users deemed appropriate for the study will be selected on the advice of a voluntary organisation for which the student currently works.
(ii)By letter (attached)
(iii)Reply form attached to letter.
A9.Will informed consent be obtained from the participants?
YES / x / NOIf informed consent or consent is not to be obtained please explain why.
A9.1. This question is only applicable if you are planning to obtain informed consent:
How do you plan to obtain informed consent? (i.e. the proposed process?):
Consent will be obtained verbally using simplistic language and other communication aids where necessary at each meeting, mainly because the majority of informants cannot read and write. Carers will be included in the consent process because they have intimate knowledge of how the individual communicates and individual level of ability.
A10. What measures will be put in place to ensure confidentiality of personal data, where appropriate?
Face-to-face interviews will be conducted in an appropriate venue so that proceedings cannot be overheard. All transcription of interviews will be performed by myself and will be saved in password protected computer files. All recordings will be deleted after transcription and any hard copies will be kept in locked storage. Data analysis will be undertaken by the student and verified by the supervisor and the advisor on disability. The names, and in some cases the details, of participants will be changed to ensure anonymity.
A11.Will financial / in kind payments (other than reasonable expenses and compensation for time) be offered to participants? (Indicate how much and on what basis this has been decided)
YES / NO / xLetter to Participants:
Dear (Service user) and (Carer),
One of our members of staff, ***, is currently doing some research for part of his university degree. He is a 4th year student at the University of Sheffield, and has been working with Organisation X since 2004. He has asked Organisation X to contact you personally because you are well suited to the study.
*** would like to meet you for an informal chat about your teeth and seeing the dentist. The chat will last only about 20 minutes, your name will not be mentioned and you will be given a false name to protect your identity.
This can be done anywhere you would like and that is easiest for you; for example at home or in a favourite café.
If you would be able to help out, please return the slip in the enclosed envelope! Although he would like to know before XXXXXXX, the interviews will not be starting until XXXXXXXX.
If you have any further questions, please feel free to contact him on ***.
Many thanks and regards,
Organisation X manager name
Yes please! I’d like to help out!
Name ______
Contact Name ______
Contact Phone Number ______
No thanks, this isn’t for me.
/ / / Ethics Reviewer Training Workshopfor the Faculty of Medicine, Dentistry and HealthDiscussion Session 1: Research Ethics Applications
Participants at the November and March workshops made the following points about example ethics application 1 (points are not listed in order of importance – all points have equal merit):
- The information provided in the application was generally vague, used too much jargon, and provided insufficient detail for a reviewer to make an informed judgement;
- In question A4, the box had not been ticked to indicate that the study involved adults with mental incapacity or mental illness, an aspect which was in fact central to the project;
- In question A5, it was felt that there was insufficient information given about the methodology; for example, the method may need to be adjusted based on the participants’ particular learning or physical disability, and the extent of the disability; no consideration had been given to this;
- Participants were to be approached by letter and recruited via a reply form, but the researcher mentions that the majority of informants cannot read or write; therefore concerns were raised about the appropriateness of this method of recruiting;
- It was agreed that it would have been useful to see the basic script that was to be used when questioning the participants;
- In question A6, the researcher mentions a ‘slight potential for discomfort’ but there is no indication of the type of discomfort that might be encountered;
- In question A6, the researcher mentions that risk will be mitigated by the use of consent and opt out procedures, but very little detail is given regarding how consent will be obtained, and there is no further mention of opt out procedures;
- There were some safety concerns for the researcher which had not fully been considered, since the interviews could be taking place in the participants’ homes;
- It was not clear exactly how the researcher was proposing to obtain informed consent from the participants, particularly in relation to the fact that participants would be individuals with mental incapacity (e.g. would they be capable of consenting for themselves, how would their capacity to consent be assessed, and if they were judged not capable, how else would their consent be obtained)?
- There was no justification provided for why consent would be obtained verbally rather than in writing, and no details of where or when it would be obtained;
- No information was included about who the researcher would deem to be the appropriate person to give consent on behalf of the participants, where required;
- The information letter included language that could be considered coercive, and did not clearly indicate that participation in the project was voluntary;
- It was proposed that the interviews with participants could take place in a café, but this would raise issues of confidentiality in terms of being overheard which had not been considered;
- It was felt that the application should be rejected and then resubmitted after being fully revised, since it raised fundamental ethical issues.
EXAMPLE ETHICS APPLICATION 2: Experiences of drug or alcohol using parents
University Research Ethics Application Form
I confirm that in my judgment, due to the project’s nature, the use of amethod to inform prospective participants about the project
(e.g. ‘Information Sheet’ / ‘Covering Letter’ / ‘Pre-Written Script’):
Is relevant: / Is not relevant:
x
(if relevant then this should be enclosed)
I confirm that in my judgment, due to the project’s nature, the use of a
‘Consent Form’:
Is relevant: / Is not relevant:
x
(if relevant then this should be enclosed)
Part A
A1. Title of Research Project: Experiences of drug or alcohol using parents
A2.Contact person (normally the Principal Investigator, in the case of staff-led research projects, or the student in the case of supervised-postgraduate researcher projects):
A2.1. Is this a postgraduate researcher project? NO
If yes, please provide the Supervisor’s contact details:
A2.2.Other key investigators/co-applicants (within/outside University), where applicable:
A3.Proposed Project Duration:
A4.Mark ‘X’ in one or more of the following boxes if your research
involves testing a medicinal product *involves investigating a medical device *
involves additional radiation above that required for clinical care *
involves taking new samples of human biological material (e.g. blood, tissue) *
involves children or young people aged under 18 years
involves using samples of human biological material collected before for another purpose
involves only identifiable personal data with no direct contact with participants
involves only anonymised or aggregated data
involves prisoners or others in custodial care (e.g. young offenders)
involves adults with mental incapacity or mental illness
has the primary aim of being educational (e.g. student research, a project necessary for a postgraduate degree or diploma, other than an MD or PhD)
A5.Briefly summarise the project’s aims, objectives and methodology?
(this must be in language comprehensible to a lay person)
We would like to find out more about people’s experiences of being a drug or alcohol using mother or father in residential drug treatment. The adopted methodology is that of qualitative interviews. The objectives are to be able to better understand any experiences of social exclusion or stigma experienced by substance misusing parents and to identify possible gaps in service provision for this client group.
A6.What is the potential for physical and/or psychological harm / distress to participants?
Possible mild distress if parenthood is a sensitive issue. Appropriate psychological support is available through the staff at the treatment setting in which the study takes place.
A7.Does your research raise any issues of personal safety for you or other researchers involved in the project and, if yes, explain how these issues will be managed? (especially if taking place outside working hours or off University premises)
None.
A8.How will the potential participants in the project be (i) identified, (ii) approached and (iii) recruited?
All new clients in *** will receive the information sheet and be approached by a member of the treatment staff to ascertain whether they are parents and whether they would be happy to be approached regarding this study. If affirmative, the researcher will visit the treatment service, answer any questions clients may have and ask for informed written consent.
A9.Will informed consent be obtained from the participants?
YES / x / NOA9.1. This question is only applicable if you are planning to obtain informed consent:
How do you plan to obtain informed consent? (i.e. the proposed process?):
Clients obtain information about the study at the start of treatment. Staff will ascertain eligibility and basic willingness to be approached about the study, The researcher will then meet with clients to answer any questions, and if clients are still happy to participate, get written consent.
A10. What measures will be put in place to ensure confidentiality of personal data, where appropriate?
Individual information will be collected and recorded without using names. Computer files will be password protected, paper information stored and destroyed in accordance with the DPA.
A11.Will financial / in kind payments (other than reasonable expenses and compensation for time) be offered to participants? (Indicate how much and on what basis this has been decided)