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Ethics Reviewer Training Workshops

For the Faculty of Medicine, Dentistry and Health

Combined ReportSynopsis

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:1. ‘Introducing the University Research Ethics Committee’ (Professor Richard

Jenkins, Chair of the UREC)2. ‘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:http://www.shef.ac.uk/ris/gov_ethics_grp/ethics/newethicsreviewerworkshop.html

The Group Discussion sessions

Following the presentations, the audience split into small groups for discussion sessions.

http://www.shef.ac.uk/ris/gov_ethics_grp/ethics/newethicsreviewerworkshop.html

The main discussion involved 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.

Ethics Reviewer Training Workshop for the Faculty of Medicine,

Dentistry and HealthDiscussion Session 1: Research Ethics

Applications

EXAMPLE ETHICS APPLICATION 1: People with learning disabilities’ perceptions of oral health care

University Research Ethics Application FormUniversity Research Ethics Application Formfor Undergraduate & Postgraduate-Taught Students

I confirm that I plan to inform the prospective participants about the research project by using an Information Sheet/Covering Letter/Pre-Written Script:

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

Mark 1 Box

Mark 1 Box



Applications

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 NO

If 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 x



Applications

Letter 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.



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;

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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 FormUniversity 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’:


x

(if relevant then this should be enclosed)

Part AA1. 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





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Mark 1 Box

Mark 1 Box



Applications



involves only identifiable personal data with no direct contact with participants

involves only anonymised or aggregated data



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)


(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.


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.


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.


YES x NO

A9.1. This question is only applicable if you are planning to obtain informed consent:


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.


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.


YES NO x

A12. Will the research involve the production of recorded media such as audio and/or video recordings?

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Yes

YES NO

A12.1. This question is only applicable if you are planning to produce recorded media:

How will you ensure that there is a clear agreement with participants as to how these recorded media may be stored, used and (if appropriate) destroyed?

Informed consent statement to the effect that recordings will be used only for transcription and data analysis.

CONSENT FORM

Title of Project: Experiences of drug or alcohol using parents

Name of Researcher:

***

Please tick each box

1. I confirm that I have read and understand the information leaflet for the above study and have had the opportunity to ask questions.

2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my treatment or legal rights being affected.

3. I understand that sections of any of my case notes may be looked at by the researcher. I give permission for the researcher to have access to my records.

4. I understand that if during the interview the researcher is made aware of any child protection

issues they will have to take appropriate action.

4. I understand that the interview will be tape-recorded. Only the research team will access the tape, and use this for transcription and analysis only.

5. I agree to take part in the above study.

____________________ __________________ _______________Name of Client Date Signature

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__________________________ __________________ ______________

Researcher Date Signature

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Client Information Sheet: Experiences of drug or alcohol using parents

You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part. Thank you for reading this.

What is the project’s purpose?

We would like to find out more about people’s experiences of being a drug or alcohol using mum or dad.

Why have I been chosen?

We are aiming to speak to 20-30 drug or alcohol using parents to find out about their experiences of parenthood. *** has been selected as one of the study settings because the team here is interested in the same questions and we have previously worked on a research study together.

Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep (and be asked to sign a consent form) and you can still withdraw at any time and it will not affect your treatment in any way. You do not have to give a reason.

What will happen to me if I take part?

If you are happy to take part, I would arrange to see you for a one-off 30-60 minute interview. If you agree, you may also be invited to participate in a group discussion with other clients here at the service. I would like to ask for you permission to look at your case notes to record data about your age, gender, treatment history, drug problems, as well as how you get on in treatment. This will allow me to make the interview much briefer – rather than asking you all the same questions again, I will use what staff have noted down already.

Will I be recorded, and how will the recorded tape be used?

To make it easier to analyse the data, I would like to tape-record our conversation so I do not have to keep interrupting to make notes. I will use the recording to write down accurately what you said and, together with my team, analyse the interviews. At no time will your name be associated with what you said (in our reports we use expressions such as “a 33-year old mother of two said…”).

What are the possible disadvantages and risks of taking part?

If parenting is a topic that makes you feel sad or vulnerable, you may feel down after our talk. The staff team here know about the study, and have promised to be available for you to talk if you need it.

What are the possible benefits of taking part?

Whilst there are no immediate benefits for those people participating in the project, we hope that this work will help us understand better the difficulties that using parents face in their every-day lives and ways in which treatment services can help with these difficulties.

Will my taking part in this project be kept confidential?

All information collected will be kept strictly anonymous (just using numbers not names) and confidential on password-protected files at the University of Sheffield computing facilities. As mentioned before, you will not be able to be identified in any reports or publications.

What will happen to the results of the research project?

The anonymised results of the project will be presented at academic conferences and published in the academic press. We will also inform drug and alcohol service managers of what they can do to better care for drug using parents. Data collected during the course of the project might be used for subsequent research on what makes treatment effective if that is ok with you (if not, just say so).

Who is organising and funding the research?

The research is carried out by *** from the University of Sheffield. This is an unfunded piece of research.

Who has ethically reviewed the project?

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Applications

Sheffield University’s Research Ethics Committee monitors the application and delivery of the University’s Ethics Review Procedure across the University. It has approved this study.

Contact for further information: If you have any queries, complaints or comments about the study, please contact ****

Participants at the November and March workshops made the following points about example ethics application 2 (points are not listed in order of importance – all points have equal merit):

It felt that insufficient information had been provided in the application for the ethics reviewer to make an informed judgement, in particular the basis for the research and its aims and method;

It was felt that it would have been useful to know the subject areas on which participants were to be questioned;

None of the tick boxes in question A4 had been ticked, but the study could potentially include young people, and adults with mental incapacity or mental illness; no consideration has been given to this possibility;

There was little detail about the treatment centre where the research was to take place, the service that was provided at the centre, the resident population, or whether it was linked to the NHS;

No information had been provided on where the interviews would be taking place;

It was felt that the consent form should have included a request for consent for both the individual and group interviews that were proposed;

The application mentions that staff at the drug treatment centre would ascertain the eligibility of potential participants, but no information is provided regarding the eligibility criteria;

It was felt that the participants’ information sheet could have provided more information on why the study was being conducted (ie potential benefits etc);

It was agreed that the language used in question A5 was not particularly suitable for the lay person;

In question A6, the application cites the potential for ‘possible mild distress’ as a result of participating; however, it was felt that there was a potential for quite considerable distress due to the fact that these are drug- or alcohol-abusing parents, who may well have additional problems (eg depression or other mental incapacities) and their experiences of parenthood could have been traumatic as a result;

Concerns were raised about the fact that the researcher proposed to approach potential participants at the start of their treatment for drug or alcohol abuse, a time when they would be likely to be feeling most vulnerable;

There was a chance that participants could be reported to the authorities (if child protection issues are raised, as mentioned in the consent form) which could raise the stress levels experienced;

It was agreed that there was a potential risk to the researcher that had not been considered in this application, since interviews would be conducted with drug- or alcohol-abusers with the potential to be mentally unstable; more consideration should have been given to the mitigation of this risk;

It was agreed that insufficient consideration had been given to whether the researcher was qualified/prepared enough for an emergency situation;

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Applications

Since the participants in this study were likely to be in a vulnerable state, it was felt that the consideration given to their psychological support in the application was perfunctory;

The information sheet did not provide details about the fact that participants may be reported to the authorities, it was only mentioned in the consent form that the researcher may have to ‘take appropriate action’, with no further explanation;

It was felt that the participants’ cognitive and physical state at the time of recruitment could be an issue for the consent process (i.e. would they be capable of giving informed consent?);

It was agreed that there should have been an additional section on the consent form to confirm that participants agreed to the planned use of the findings of the study (as detailed in the information sheet);

It was felt that further information should have been provided concerning the management of the proposed group discussion sessions, since there was potential for distress as a result of having to share personal information in front of others.

Little consideration was given to how participants’ confidentiality would be maintained, especially considering the potential for obtaining incriminating information during interviews;

No information was provided about how recordings of interviews would be stored and destroyed;

It was agreed that the application should be rejected and that the applicant should be asked to revise and resubmit it.

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EXAMPLE ETHICS APPLICATION 3: Relationships between body mass index (BMI), amount of physical activity, and social exclusion in young people (18-30 years) with Asperger syndrome (high-functioning autism) (AS/HFA) compared with other young people

University Research Ethics Application FormUniversity Research Ethics Application Form

I confirm that due to the nature of the project, in my judgment the use of a‘Participant Information Sheet’ (mark 1 box):


X

I confirm that due to the nature of the project, in my judgment the use of a‘Participant Consent Form’ (mark 1 box):


X

Part AA1. Research Project Title:

Relationships between body mass index (BMI), amount of physical activity, and social exclusion in young people (18-30 years) with Asperger syndrome (high-functioning autism) (AS/HFA) compared with other young people.

A1.1 URMS number (if known): Not applicable

A.2 Contact person (normally the Principal Investigator, in the case of staff-led research projects, or the student in the case of supervised-student research projects):

A2.1 Is this a supervised-student research project? Yes, the data will be largely gathered and analysed by *** placement students in the periods: ***.

If yes, please provide the Supervisor’s contact details:As above.

A.3 Other key investigators/co-applicants (within or outside the University):***

A.4 Proposed Project Duration:

A.5 Mark ‘X’ in one or more of the following boxes if your research:involves testing a medicinal product *







X involves only anonymised or aggregated data



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A.6 Briefly summarise the project’s aims, objectives and methodology?

(it must be in language comprehensible to a lay person)

Aims, objectives and research questionsBackground

AS/HFA is an autistic spectrum disorder (ASD), which is generally considered to be a pervasive developmental disorder (PDD). Like all people with an ASD, those with AS/HFA have the triad of social impairments of interpersonal interaction and communication, and imagination. Unlike other people on the autistic spectrum however, those with AS/HFA are not significantly delayed in intellectual functioning, including language development.

A small-scale interview study of five 15-17-year-old males with AS/HFA and their mothers, conducted by one of us and others, suggests that pupils with AS/HFA tend to adopt a low profile, keep their heads down, avoid the hustle and bustle of the school yard, etc., probably to avoid the distress of being bullied, which is a common experience for them. A development of this study has been conducted by us with 15 1b SSC placement students in each of the years 2006 and 2007. This interview case-control study was on the social relationships of mainstream secondary school pupils with AS/HFA during a school day.

Amongst other findings, this study found that by comparison with controls, cases with AS/HFA were significantly less physically active (as measured by pedometers), and were much more likely to be bullied by peers (verbally, physically and through social exclusion), but BMI data were not gathered. We suggest four possible interpretations of these findings:

cases were physically less active because of their typical clumsiness (diagnostically associated with AS/HFA), and so opt out of playing football at lunch and break times (cases were all boys);

or, they were excluded by peers from engaging in physical activity during school lunch and break times because of their social integration difficulties and ‘odd’ behaviours, including their clumsiness;

or, they excluded themselves from spending lunch and break time outside the school buildings to reduce the risk of being bullied in these relatively adult unsupervised spaces;

or, some combination of these possibilities.AimsThis proposal is concerned with trying to find out if these findings are upheld with an older sample of people (18-30 year-year-olds) with AS/HFA compared with others, and if so, if any light can be shed on the relationships between BMI, physical activity, and social exclusion.

MethodResearch designGiven the relative rarity of AS/HFA (prevalence estimates vary widely but the consensus seems to be between 2 and 6 per 1000), a case-control design is deemed to be the most feasible.

Recruiting and sampling cases (young adults with AS/HFA)People with AS/HFA who live in the Sheffield area will be recruited through Charity X and possibly Charity Y with whom we have good relations. Given that the prevalence of AS/HFA is generally estimated to be between 0.4-0.6% of the general population, and given that the population within 15 miles of Sheffield city is centre is around 0.8 million, somewhere between 3200 and 4800 will have this disorder. Since we shall be recruiting from the 18-30 year old age group of people with AS/HFA, we expect that the pool of recruits from which we shall be able to draw is 300-500, or about 10 times the number required.

Ascertaining AS/HFAFor the purposes of the research only (i.e., not for clinical purposes) and in order to keep project costs to a minimum we shall rely on the assessments made by competent professionals (e.g., paediatricians, psychiatrists, clinical and educational psychologists) in ascertaining AS/HFA in the case sample which we select for inclusion in this project.

Recruiting controlsWe shall recruit controls from University of Sheffield students. Recognising the multi-dimensional identities of people with AS/HFA, the cases and controls will be matched for: age and gender; and if possible, educational attainment at 16 years of age, socio-economic background and ethnicity. (Gender effects will not be investigated in this exploratory study because males with AS/HFA outnumber females with this syndrome by about 4:1)

Sample sizeFor there to be sufficient statistical power in the study (the chance that we be able to detect any real differences between groups that exist), we estimate that we shall need to aim for a minimum of 30 case-control dyads.

Measures

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BMIIdeally, in order to obtain independent measures, we shall weigh and measure the height of each participant in the study andTogether with his/her self-reported age, we shall use the calculator at:www.nhsdirect.nhs.uk/magazine/interactive/bmi/index.aspx#Results (Retrieved 05 October 2007) to establish his/her BMI. We may, however, have to rely on self- reports of weight and height as well as age to establish each participant’s BMI. The selection ofan adequately matched cohort of controls is inevitably going to risk a degree of selection bias. So we will access nationally available norms for height and weight for the age group of the study, to assess how far the controls are representative of 18-30-year-olds nationally so that they may be used as a second means of comparison for the cases.

Social exclusion and its emotional impactWe shall ask each participant to record his/her social interactions in a time sampling diary to be designed for the purpose for one or more days (max seven). In order to evaluate the emotional impact of social interaction (exclusion) we shall also ask each participant to complete the GHQ-12, a 12-item general health questionnaire designed for use with young people.

Physical activityWe shall measure our case-control dyads’ physical activity by asking each member of the dyad to carry with him/her a pedometer throughout his/her waking hours. We shall ask these people to record when the pedometer was first carried in the day and when it was removed from the body each day so that we can calculate the mean movements per hour for each participant.

Likely benefit (people with autism, families, professionals and public)This research will help to inform young people with AS/HFA and other young people cases about the relationships between BMI, physical activity and social exclusion. With appropriate dissemination this information should lead to improvements in public policies and practices regarding people with AS/HFA and others. Our experience of conducting the proposed study and considering its outcomes will help us to construct proposals for much larger and more scientifically rigorous follow-up studies on the social experiences of people with AS/HFA.

Student learning outcomes

Under supervision, the attachment will involve students working as a team to: refine the research design in light of Research Ethics Committee and other requirements; negotiate access to young people with AS/HFA and others in the Sheffield area; devise the time-sampling diary, pilot and check reliability of its use; pilot data collection procedures on selves; collect, analyse and share data; write individual reports.

A.7 What is the potential for physical and/or psychological harm/distress to participants?

For participating people, keeping diary records of their daily social interactions may be distressing to those who have had very few and/or poor quality social interactions. We will be mindful of these possibilities and we will advise such people to seek support from sources external to ourselves as researchers. We will refer people with AS/HFA who experience distress to Charity X and Charity Y and controls (University of Sheffield students) to the University’s Counselling Service.

A.8 Does your research raise any issues of personal safety for you or other researchers involved in the project? (especially if taking place outside working hours or off University premises)

None other than the remote possibility of being physically or verbally attacked by a participant whilst gathering data from her/her. We shall minimise the risk of these possibilities by ensuring that all meetings between participants and researchers are held during working hours on University premises or in other public places of work such as GPs surgeries.

A.9 How will potential participants in the project be (i) identified, (ii) approached and (iii) recruited?

Participants (age, diagnosis, ability level)

Young adults (18-30 years).

Ascertaining AS/HFA or dyslexiaFor this pilot study we shall rely on self-nomination but we shall ask volunteer participants for any independent confirmation of their diagnoses that they can provide.

Recruiting controls We will recruit controls by posting e-mail messages for volunteer participants.

Recognising the multi-dimensional identities of pupils with AS/HFA, we will ensure, that the case-control participants are matched for:

age; gender; and, as far as is possible, educational attainment at 16 years of age, and ethnicity.

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To keep project costs to a minimum, we will endeavour to recruit participants from within 15 miles of the University of Sheffield.

A.10 Will informed consent be obtained from the participants?

YES X NO

Please explain the proposed process for obtaining informed consent. If informed consent or consent is not to be obtained please explain why. You may want to consult Section 2.4.3 of the University’s Ethics Policy or the guidance fact-sheet on consent at: www.shef.ac.uk/r/researchoffice/RO/ethicsreviewsystem.html

The research team will obtain informed written consents from potential participants prior to any data collection. (See appended information sheets and consent form.)

In all data gathering, analysis and storage close attention to issues of participant anonymity and confidentiality will be observed.

A.11 What measures will be put in place to ensure confidentiality of personal data, where appropriate?

All participant data will be either encrypted or anonymised.

A.12 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)

Each participant, including those who withdraw early from the study, will be offered a £15 Boots Gift Voucher for their participation in the study.

YES NO X

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http://www.shef.ac.uk/r/researchoffice/RO/ethicsreviewsystem.html



Applications

Information letter for potential adult participants:

Dear Potential Participant,

Relationships between body mass index (BMI), amount of physical activity, and social exclusion in young people (18-30 years) with Asperger syndrome (high-functioning autism) (AS/HFA) compared with other young people.

***, *** and I (the Research Team) are involved in a research study on this topic and we should be pleased if you would agree to your participation in the project. Before making your decision, however, we would like to tell you some more about the project by answering some questions that you may want to ask.

Q What is the purpose of the study?

A AS/HFA is an autistic spectrum disorder (ASD). Like all people with an ASD, those with AS/HFA have the triad of social impairments of interpersonal interaction and communication, and imagination. Unlike other people on the autistic spectrum however, those with AS/HFA are not significantly delayed in intellectual functioning, including language development.

A recent research study suggests that by comparison with secondary age pupils without AS/HFA those with the syndrome were significantly less physically active (as measured by pedometers), and were much more likely to be bullied by peers (verbally, physically and through social exclusion).

This study is trying to find out if young adults with AS/HFA (18-30 years) are more or less physically active than other young adults, and why this may be, and if so, what effect does this have on their body mass index (weight).

Q Why have I been contacted?

A The research team has asked Charity X to pass this letter to anyone who has AS/HFA and who is between 18 and 30 years old, or you have opened an e-mail message addressed to University of Sheffield students.

Q What will be involved if I agree to participate in the study?

A Once you confirm that you are willing to participate in this study a University of Sheffield medical student will contact you to organise a brief meeting with you. At this meeting you will be told what is expected from you. These things are that you will be asked:

to give your name (only so that we can contact you again), date of birth, height and current weight, or, even better, to allow the medical student to weigh you and measure your height

to give your current employment or that of a parent and your ethnic group membership so that we can match as closely as possible people with AS/HFA with those who do not have this syndrome;

to complete a brief questionnaire on your general current health; for a 7-day period to wear a pedometer (to measure your physical activity) from the time that get you get

dressed in the morning until you go to sleep at night; for the same 7-day period to keep a simple diary of your social activity.

At the end of the 7-day period the medical student will meet you to discuss the project, if you wish, and to collect the pedometer and diary records, and you will be given a £15 Boots Gift Voucher for taking part in the study.

Q What are the possible disadvantages and risks of taking part?

A We believe that this project will be minimally disruptive of participants’ normal lives. Each participating person would need to meet for a few minutes at the beginning and end of the 7-day period.

It is possible that asking people to complete a diary of their social activity may be distressing, for example, if there has been little activity on a particular day. If you do experience any distress please let your medical student researcher know, and please contact a responsible person such as your GP, University counsellor or member of Charity X for help.

Q Can I withdraw from the study at any time?

A Yes. You simply need to let your allocated medical student researcher know that you are withdrawing from the study and you do not need to provide any reason for doing so. We would, however, be grateful if you would return the pedometer to your allocated medical student so that it can be used by somebody else. When you let the medical student know that you are withdrawing from the study you will be given a £15 Boots Gift Voucher for taking part in the study.

Q Will the information obtained in the study be confidential?

A Yes. The only people who will have access to information about you will be members of the research team, including the student researchers. This information will not be given to any unauthorised body, and it will be kept securely in

19



Applications

the University of Sheffield. By June 2012 the information will be safely destroyed. For the purposes of any publication, all research data will be anonymised.

Q Who has approved the project?

A The University of Sheffield’s Research Ethics Committee has approved the project.

Q What if I wish to complain about the way in which this study has been conducted?

A Please contact: The University of Sheffield, Research Office, New Spring House, 231 Glossop Road, Sheffield, S10 2GW, UK.

If you have any further questions please do not hesitate to contact me and I shall do my best to answer them. Please let meknow as soon as possible whether or not you would like to participate in this project.

Yours sincerely,***

Participant consent form:

Title of project: Relationships between body mass index (BMI), amount of physical activity, and social exclusion in young people (18-30 years) with Asperger syndrome (high-functioning autism) (AS/HFA) compared with other young people

Name of lead researcher: ***

Participant Identification Number for this project is ____________________ (To be inserted by a researcher)

Please initial

I was given a copy of the letter about this project on

____________________ (date) _________

I understand that all information about me will be kept securelyin the University of Sheffield and that it will be confidential to theresearchers on the project, and that if it is used in any publications it will be anonymised so that nobody not associate with the projectwill be unable to identify me. _________

I am willing:

to carry a pedometer with me during my waking hours for seven days as agreed with a researcher; to complete a diary of my social activities for the same seven day period; to complete a brief general health questionnaire; to give the researcher my date of birth, height and current weight so that my Body Mass Index (BMI) can be calculated.

__________

I understand that I can ask any questions that I have about the project from:

***, University of Sheffield. Phone: *** __________

I know that I can complain about the project to: The University of Sheffield, Research Office, New Spring House, 231 Glossop Road, Sheffield, S10 2GW, UK. Telephone: 0114 2221469. __________ Name in capital letters: _______________________

Signature: _________________________ Date: ________________

_________________________ ________________ ____________________

Name of Person taking consent Date Signature

(if different from researcher)

_______________________ ________________ ____________________

Researcher Date Signature

Copies: One for the participant and one for the Principal Investigator/Supervisor

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Applications

Participants in the November and March workshops made the following points about example ethics application 3 (points are not listed in order of importance – all points have equal merit):

It was agreed that the project was a healthcare research project and therefore should have been registered on the URMS system, and the URMS number should have been provided on the form;

The study involved mentally incapacitated participants but the relevant box in question A5 had not been ticked to indicate this;

It was agreed that the information provided in Question A6 was much too long and detailed, and could not have been considered to be in lay person’s language;

Not enough information had been provided on the methods of recruiting the two types of participant;

In question A12, the box had been ticked to say no financial or in kind payments would be offered, but in the text, it was stated that a £15 Boots voucher would be offered;

It was felt that the risks of participants experiencing distress as a result of sharing potentially sensitive information in their diary of social activity, and the safety of the researcher, had been sufficiently considered;

It was felt that the information sheet for participants was not in suitable lay person’s language, and that it was too long; there were doubts about whether participants would read it fully;

The information letter also seemed to be rather coercive, due to the language used (e.g. ‘once you confirm that you are willing to participate’; ‘let me know as soon as possible whether or not you would like to participate’);

The information letter did not provide the details of anyone to contact within the research team should a participant experience any problems or require further details;

It was felt that information on the funding of the project should have been included so that the potential participant could make an informed judgement about whether they wished to be involved;

Very little detail is provided concerning the method of obtaining consent, and no consideration has been given to the fact that the study involves mentally incapacitated individuals who may not be capable of giving consent in the standard way (e.g. is witnessed consent an option; can the participant bring someone else to support them?);

Greater detail was required to clarify how the researcher proposed to ensure the confidentiality of participants’ data;

It was felt that consideration should have been given to feeding back the results of the study to the participants, so that they could recognise the benefits;

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Applications

Some issues were raised about the methodology of the study (eg appropriateness of the control group of students); however, this was felt to be on the boundary between ethical review and scientific review;

It was agreed that the application should not be approved, with reasons provided.

22

EXAMPLE ETHICS APPLICATION 4: Trunk muscle activation – a comparative study between dynamic weight-training exercises and isometric instability exercises

University Research Ethics Application FormUniversity Research Ethics Application Formfor Undergraduate & Postgraduate-Taught Students

I confirm that I plan to inform the prospective participants about the research project by using an Information Sheet/Covering Letter/Pre-Written Script:

Yes

(if yes, then this must be enclosed)

I confirm that I plan to invite prospective participants to sign a consent form:

Yes

(if yes, then this must be enclosed)

A1. Title of research project: Trunk Muscle Activation - A Comparative study between Dynamic Weight-Training Exercises And Isometric Instability Exercises.

A2. Name of Student: Name of Supervisor:

A3. Proposed Project Duration:

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)











The purpose of this study is to examine the extent of activation in various trunk muscles during dynamic weight- training and isometric instability exercises. The objective is to see whether dynamic weight-training has an increased activation of trunk muscles over that of isometric instability exercises. 20 subjects will perform deadlifts and sumo deadlifts with a weight equilivant to 50% and 75% of their body mass, as well as body weight as resistance and 2 unstable callisthenic-type exercises (superman and the long bridge). Electromyographic (EMG) activity will be measured from the lower abdominals, external obliques, upper lumbar erector spinae and lumbar-sacral erector spinae muscle groups.


Minimal as the population will have experience of weight training and will be supervised throughout the experiment

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?

No as experiment will be undertaken on campus

Mark 1 Box

Mark 1 Box



Applications


Participants will be students who have no injuries at the time of the study and who are familiar with the prescribed exercises


YES X NO

If 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?):

Each participant will be required to complete a consent form


The only person to have access to personal data of the participants will be the researcher


YES NO X



Applications

INFORMATION SHEET

Project Title Trunk Muscle Activation – A Comparative Study Between Dynamic Weight-training Exercises And Isometric Instability Exercises.

Supervisor/Director of Studies ***

Principal Investigator ***

Principal Investigator telephone/mobile number

***

Purpose of Study and Brief Description of Procedures(Not a legal explanation but a simple statement)The purpose of this study is to examine the extent of activation in various trunk muscles during dynamic weight-training and isometric instability exercises. The objective is to see whether dynamic weight-training has an increased activation of trunk muscles over that of isometric instability exercises. Each participant will perform deadlifts and sumo deadlifts with a weight equilivant to 50% and 75% of their body mass, as well as body weight as resistance and 2 unstable callisthenic-type exercises (superman and the long bridge). Electromyographic (EMG) activity will be measured from the lower abdominals, external obliques, upper lumbar erector spinae and lumbar-sacral erector spinae muscle groups.

It has been made clear to me that, should I feel that these Regulations are being infringed or that my interests are otherwise being ignored, neglected or denied, I should inform *** who will undertake to investigate my complaint.

INFORMED CONSENT FORM

TITLE OF PROJECT:

Trunk Muscle Activation – A Comparative Study Between Dynamic Weight-training Exercises And Isometric Instability Exercises.

The participant should complete the whole of this sheet himself/herself

Have you read the Participant Information Sheet? YES/NO

Have you had an opportunity to ask questions and discuss this study?YES/NO

Have you received satisfactory answers to all of your questions? YES/NO

Have you received enough information about the study? YES/NO

To whom have you spoken?

.........................................................................Do you understand that you are free to withdraw from the study:

at any time

without having to give a reason for withdrawing

and without affecting your future medical care YES/NO

Have you had sufficient time to consider the nature of this project? YES/NO

Do you agree to take part in this study? YES/NO

Signed ........................................................ Date .........................………….

(NAME IN BLOCK LETTERS)....................................................……………………



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Signature of Parent / Guardian in the case of a minor

.........................................................................................

Participants in the November and March workshops made the following points about example ethics application 4 (points are not listed in order of importance – all points have equal merit):

It was agreed that there was generally a lack of information provided in the application, and it was unclear what the benefits of the study were;

It was agreed that there was a lack of information provided concerning the recruitment of participants: where they would be found, how they would be identified and approached etc;

No information had been given concerning the selection criteria to be used; for example, it was felt that the participants should have been asked to complete a health questionnaire so that those with a history of heart problems etc. could be excluded;

No information was given concerning who would assess the suitability of a participant; i.e. have they the necessary experience/ability to conduct the exercises safely?

The application used a lot of jargon and technical language and was not easily understandable by the lay person; the researcher assumes prior knowledge of the area of research;

Insufficient consideration had been given to the potential for harm to participants; although participants were stated to be experienced in weight training, there was still a risk of injury, and plans should have been put in place for dealing with an injury should it occur;

It was unclear where the research was to be carried out, and therefore it was difficult to fully assess the potential risks to the participants and the researcher;

There was very little information about the methodology to be used and the potential risks of this: e.g. how often will the exercises be conducted, and for how long? How will electromyographic activity be measured? Will it hurt?;

It was felt that illustrations of the exercises to be performed would have been useful in the information sheet;

The information sheet was felt to contain far too little information about what was involved and the potential risks, and was not in lay person’s language; it was felt that participants would not actually be providing informed consent due to the lack of information provided;

The information sheet did not mention that participation was voluntary or that participants could withdraw at any time;

A sentence referring to regulations was included at the end of the information sheet which was inappropriate;

It was felt that a separate consent form should have been provided for any parents/guardians of minors, rather than asking them to sign the same form as the participant (and the involvement of minors would raise other issues that had not been considered);

It was agreed that the consent form should have asked the participant to confirm who they had spoken to about the study;

It was also agreed that the researcher’s signature should have been required on the consent form since it represented an agreement between the researcher and participant.

Insufficient information was provided about how participants’ confidentiality would be ensured; for example, how the data would be stored, whether the students’



Applications

supervisor would have access to it, and whether the data would be made anonymous;

It was agreed that the application should not be approved and reasons for this provided.



Applications

EXAMPLE ETHICS APPLICATION 5: The neural basis of sensory-motor timing: a transcranial magnetic stimulation study

University Research Ethics Application FormUniversity Research Ethics Application FormCover Sheet

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. ‘Participant Information Sheet’ / ‘Covering Letter’ / ‘Pre-Written Script’):

Is relevant: Is not relevant:X


I confirm that in my judgment, due to the project’s nature, the use of a‘Participant Consent Form’:

Is relevant: Is not relevant:X


Part AA1. Research Project Title: The neural basis of sensory-motor timing: a transcranial magnetic stimulation study

A.2 Contact person (normally the Principal Investigator, in the case of staff-led research projects, or the student in the case of supervised-student research projects):

A2.1 Is this a supervised-student research project? No

A.3 Other key investigators / co-applicants (within or outside the University):

A.4 Proposed Project Duration:

A.5 Mark ‘X’ in one or more of the following boxes if your research:












A.6 Briefly summarise the project’s aims, objectives and methodology?

(it must be in language comprehensible to a lay person)

The perception of time alters in a number of psychiatric disorders and in normal ageing. This study addresses fundamental questions about the brain structures involved in the synchronization between internally initiated movement and external sensory

Mark 1 Box

Mark 1 Box



Applications

stimuli. A number of lines of evidence (functional imaging and behavioural work) implicate the involvement of the cerebellum, right inferior parietal cortex and motor- and pre-motor cortices during this task. However, few studies have been able to functionally differentiate between the exact roles of each of these structures in motor timing. Here we will address the differential contributions of each of these brain structures to motor timing.

We adopt a widely used and well studied motor timing task referred to as sensorimotor synchronization, in which a subject attempts press a button with the index finger in synchrony with a train of tones. One task can be carried out in 15 – 20 minutes. Recent work at Sheffield has demonstrated that steady state transcranial magnetic stimulation (TMS) can inactivate the stimulation site for periods of up to 60 minutes. Each subject will carry out an identical motor timing task before and after a period of TMS. Subjects will be divided into four experimental groups and will either receive real TMS to stimulation sites comprising of the cerebellum, right inferior parietal cortex and right pre-motor cortex or sham (ineffective) TMS which serves as a control condition. This experimental set-up will allow threshold determination before and after stimulation and individual-subject inference about any effect. We will test a total of sixty subjects who will all be healthy volunteers who have given full consent.

A.7 What is the potential for physical and/or psychological harm / distress to participants?

TMS is considered as safe. TMS does not cause long-term adverse neurological or cognitive effects in healthy subjects. The most common side effect is transient tension headache resulting from contraction of head and neck musculature during the procedure. This usually responds to simple analgesia. There is a very small risk of seizure associated with magnetic stimulation (6 cases worldwide over ten years - 1985-1996). This risk is associated with people who have a prior history of epilepsy, or other neurological conditions. We will exclude participants with such history. Our study procedure will follow the safety procedures recommended in the International TMS Guidelines.

A.8 Does your research raise any issues of personal safety for you or other researchers involved in the project? (especially if taking place outside working hours or off University premises)

No

A.9 How will potential participants in the project be (i) identified, (ii) approached and (iii) recruited?

i) Potential participants will be identified through different channels using convenience sampling, e.g. advertisement in the university (including emails to the volunteer list), community centres etc.

ii) After the potential participants are identified, the researcher will approach them to explain the purpose of the study. An information sheet will also be provided. Time will be given for questions.

iii) The participants will be formally recruited if they agree to consent.

A.10 Will informed consent be obtained from the participants?

YES X NO

If informed consent or consent is not to be obtained please explain why. You may want to consult Section 2.4.3 of the University’s Ethics Policy or the guidance fact-sheet on consent at: http://cms.shef.ac.uk/content/1/c6/03/25/85/ethics_guidance_consent.pdf

A.10.1 This question is only applicable if you are planning to obtain informed consent:


The project will be explained to them and an information sheet given. There will be a chance to ask questions and they will be given time to think about whether they’d like to take part. They will then be asked to sign the consent form. They will be reminded that participation is entirely voluntary, and that they have the right to change their minds and withdraw consent at any time.

A.11 What measures will be put in place to ensure confidentiality of personal data, where appropriate?

Confidentiality of personal data will be ensured by following the Good Research Practice issued by the University of Sheffield and the legal requirements of Data Protection Act.

1. In the questionnaires subjects filled in, they will be labelled by an identifier number that is cross-referenced to the main written record of the research project. There will be no name appeared in all the questionnaires.

2. The main research record will be filed in different cabinet from the original questionnaires.

3. When raw data is entered into electronic databases for statistical analysis, identifier number will be used instead of participant's name.

4. Only the researchers directly involved in this study will have access to the data generated by the project.

http://cms.shef.ac.uk/content/1/c6/03/25/85/ethics_guidance_consent.pdf



Applications

A.12 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 X

The neural basis of sensory-motor timing: a transcranial magnetic stimulation study

RESEARCH CONSENT FORM

PLEASE DELETE AS NECESSARY

Have you understood the study information sheet? YES/NO

Have you had an opportunity to ask questions and discuss this study? YES/NO

Have you received satisfactory answers to all your questions? YES/NO

Have you received enough information about the study? YES/NO

To whom have you spoken? ...........................................................................

Do you understand that you do not need to take part in the study and if you do enter you are free to withdraw -

- at any time

- without having to give a reason for withdrawing YES/NO

Do you agree to take part in this study? YES/NO

Signed: ............................................................... Date.................................

.................................................................

(NAME IN BLOCK LETTERS)

I confirm that I have fully explained the purpose and nature of the investigation and the risks involved.

Signed ............................................. Date ................................

..............................................

(NAME IN BLOCK LETTERS)



Applications

The neural basis of sensory-motor timing: a transcranial magnetic stimulation study

VOLUNTEER INFORMATION SHEET

You are invited to participate in a study to examine whether magnetic stimulation over the cerebellum, parietal cortex or premotor cortex will produce sensorimotor timing changes. Individuals with mental health problems often have difficulty in performing sensorimotor timing tasks. We hope that the results of our research will encourage the development of pharmacological and rehabilitation programs for people with mental health concerns. Participation is entirely voluntary. You are free to refuse to participate and you may withdraw at any time.

Why have I been chosen?You have been asked to take part in this study because we need people who do not have a psychiatric disorder.

Do I have to take part?It is up to you to decide whether or not to take part. If you decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason.

What will it involve?The study will involve a button-pressing task and repetitive transcranial magnetic stimulation. If you decide to take part we will first need to ask you a few questions to make sure that it is ok for you to be involved in this study. Shortly before and after repetitive transcranial magnetic stimulation, you will be invited to a series of tasks involving pressing a button in synchrony with a series of sounds. Repetitive transcranial magnetic stimulation involves having a magnetic coil held next to your head. An electrical current is passed through this coil, but no electricity makes contact with your head. You should not notice that anything is happening to you during this, although you may here a clicking sound that comes from the machine whilst it is working.

How long will the study last?1 hour in total.

What are the possible disadvantages and risks of taking part?Magnetic stimulation is considered as safe. There is a very small risk of seizure associated with magnetic stimulation (6 cases worldwide over ten years - 1985-1996). This risk is associated with patients who have a prior history of seizures, epilepsy, or other neurological problem. If you have such history or want to discuss with us more, please let us know. The only common side effect is headache, which may occur in 1 in 5 people, but usually gets better with ordinary painkillers (e.g., paracetamol).

What if I change my mind during the study?If you decide to take part you are still free to withdraw at any time and without giving a reason.

Will anyone be informed of my participation?All information that is collected about you during the course of the research will be kept strictly confidential.

What will happen to the information from the study?All information will be entirely confidential. You will be informed of the results of the study if you wish although the full analysis will not be available for 2 years.

Contact for further information

***



Applications

Participants at the November workshop made the following points about example ethics application 5 (points are not listed in order of importance – all points have equal merit):

The language used in the application and information sheet was felt to be too technical for the lay person to understand;

The study involves de-activating part of the brain for a short period, but the information sheet doesn’t make this clear (it looks quite innocent but could be considered quite a risk – only 6 cases of adverse reactions are cited over 10 years, but how many times has this actually been carried out – risk could be higher than it seems?);

The information sheet states that the study will last 1 hour, but it was felt that this may not have been long enough (i.e. should participants be required to stay until they have been checked to ensure their brain was fully functioning again?);

The information sheet should include details on who to contact in an emergency, and who to contact if the participant has concerns after the tests;

The process used in the study is said to be safe for healthy subjects, but there is no mention of how participants will be screened for problems to ensure they are suitable (e.g. anyone with epilepsy, psychological problems?). Also could age be a factor/ raise the risks of an adverse reaction?

The consent form asks participants to confirm that they understand that they can withdraw at any time, but concerns were raised about whether this is appropriate in the middle of the tests (ie could it put them at risk to walk out half way through?);

It was felt that more information was required concerning how participants would be recruited;

There is no information about where the tests are to be conducted; this should be included in the information sheet and consideration should be given to the risks of an adverse reaction occurring in a non-hospital setting;

This appears to involve a relatively new technique, so perhaps consideration should be given to whether the participants’ GPs should be informed.


Dentistry and HealthDiscussion Session 2: General Ethical

Scenarios

THE FOLLOWING SCENARIOS WERE DISCUSSED AT THE NOVEMBER WORKSHOP ONLY:

GENERAL ETHICAL SCENARIO 1:

‘You are the principle investigator of a phase II study of refractory depression funded by a large pharmaceutical company. Mr. Smith has been unsuccessfully treated by a psychiatrist in the community. This psychiatrist has referred Mr. Smith to you at the academic medical centre where you work and are conducting the study.

The study involves hospitalisation, a washout period of four weeks, and assignment to a placebo or treatment arm. Mr. Smith agrees to the study saying, "I don't care anymore. I don't care if I get the medicine or the placebo. What difference does it make?"

Do you think Mr Smith should be allowed to participate in the study? Why or why not?

What other information would you want to help you make this decision?

Mr. Smith's wife confides to you that her husband is so depressed that he really can't make a rational decision, but she wants very much for him to participate in the drug study. After all, nothing else has worked. You agree that Mr. Smith has little to lose.

John, a psychiatric resident, wonders if you are the best person to assess Mr. Smith's competency to give informed consent to participate in this study.

How should Mrs. Smith's comments influence your decision? What about John's opinion - is there a conflict? Are you able to adequately assess

Mr. Smith's competency given your multiple roles? Who might be in a better position to obtain informed consent?’

Participants made the following points about general ethical scenario 1 (points are not listed in order of importance – all points have equal merit):

More time should be spent with Mr Smith to discuss the situation; More information should be obtained from Mr Smith’s psychiatrist (ie what

is the nature of the referral?); Consideration could be given to asking Mr Smith how he would feel to be

excluded from the study; It was felt that the situation regarding Mrs Smith could be legally

problematic; John’s opinion was felt to be valid, but was difficult to decide how best to

address the issue he raised; It was felt that there was a conflict of interest in terms of the assessment

of Mr Smith’s competency; The key issue is whether Mr Smith is capable/competent to consent to be

part of the study.



Scenarios


‘Dr. Kelly is a nurse researcher interested in working with families who have children with Trisomy 21 (Down's Syndrome). Dr. Kelly's interest is in developing a predictive model that will help identify families at risk for less-than-effective coping. She is primarily focused on demographic and social-psychological factors, such as family composition and dynamics, coping strategies, and self-efficacy, and other measures of stress and family functioning.

Her methodology involves use of several questionnaires and open-ended interviews twice a year for two years. Her subjects will include both parents and any children in the family between the ages of 6 and 12. She expects recruitment to be difficult and wants to offer an incentive for participation. She proposes offering the family £400 (£100 per interview).

If the parents consent, what, if any agreement does Dr. Kelly need from the children? How, if at all will this vary with the children's age?

One of Dr.Kelly's subjects is Mary, a 10 year old sibling of Helen, a 5 year old child with Trisomy 21. Mary completed the first interview, but when it came time for the second, said she did not want to talk about her sister because it made her sad. Dr.Kelly stopped the interview, but Mary's parents told her that it was "OK", to just keep going and finish the questionnaire. What should Dr. Kelly do?

Who gets the £400 incentive? Should a different form of payment be used?

As Dr. Kelly's research progresses, she decides to add a supplement, investigating both physiologic indicators of stress and genetic factors that might play a role in family response to stress. This will involve obtaining a blood sample from all children, affected and unaffected, and from both parents. Dr. Kelly plans to offer another incentive for this part of the study.

Since Helen, the child with Trisomy 21, is unlikely to benefit directly from this aspect of the research, what pain or risk to her is justified in carrying out the research?

How could assent be obtained in a meaningful way from Mary, Helen's sister?

Is it proper to offer an extra incentive for this blood draw, and if so, what sort of incentive and to whom?’


This scenario was felt to be particularly high risk, since the research involved children, some of whom were mentally incapacitated;

It was felt that the child’s ability to give informed consent depended on their age and level of development/maturity;

However, it was agreed that the child must assent to being involved in the research, even if the parents had given the formal consent; this should not vary according to the child’s age;



Scenarios

The information provided to the children about the research should be appropriate for their age and level of development/maturity;

It was felt that if a child does not want to continue being involved in the research then their views should be respected;

The amount of money being given as an incentive was felt to be too large and could constitute coercion; if it is given to the parents then the children may not see any benefit from it at all;

One suggestion was that vouchers (eg supermarket vouchers) could be given instead of cash to encourage the money to be spent in a way to benefit the whole family, or that toys/games could be given to the children although it would be difficult to tell whether this constituted coercion;

Another view was that no money incentive should be given, and instead involvement in the research could be billed as an opportunity to talk about experiences in a therapeutic way, and stress management/counselling could be provided;

It was felt that there was insufficient information provided in the scenario regarding why blood tests were required; the proposed benefits may be to do with the ‘greater good’ but based on the information given it was agreed that there was no justification for this part of the research;

The additional money incentive was again felt to be inappropriate



Scenarios


‘A researcher believes that breast cancer occurs only when a combination of inherited and acquired genetic mutations occur, and theorizes that biopsied breast tissue might be used to detect earlier pre-cancerous mutations that might help predict who is at increased risk of cancer. The scientist wants to use archived tissue samples and correlate them with later medical records indicating whether the person went on to develop breast cancer. The scientist wants to know whether certain early mutations are especially likely to predict later cancers, or alternatively whether the sheer number of mutations in key sites in the genome might be used as an index of risk.

Given the latency of breast cancer, the scientist prefers tissue at least ten to thirty years old, for which there is accurate and complete medical follow up. Unfortunately, at the time the tissues were obtained, informed consent for their use in research was either not asked at all, or was obtained through a very brief and general consent form. Neither researchers nor patients anticipated this kind of research when the tissues were gathered.

Were the consents given then adequate to use the tissue for research today? What if no record of consent exists for a particular sample? Should the persons be tracked down and asked to consent specifically for this

study? What are the reasons for or against this course?’


It was agreed that the original consent forms need to be seen to establish exactly what participants consented to at the time;

There are legal implications (the Human Tissue Act 2004 states that a person has the right to be asked for consent before any part of their body is used for particular purposes) as well as ethical implications; this research could be seen to be ‘opening a can of worms’;

It was felt that if no record of a person’s consent could be found then their tissue should not be used;

It was felt that the decision on whether to use this tissue depended on fact that people are needed for this study (ie potential longer-term benefits etc) versus the risk of causing harm to those people; it was felt that this decision could be very personal and subjective, but that the researcher would need to consider the pros and cons of using the tissue and explain their thinking;

It was suggested that clinicians’ support would be required to obtain access to medical records.

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