SCHOOL OF COMMUNITY AND HEALTH SCIENCES RESEARCH ETHICS COMMITTEE (SCHS REC)DRAFT POLICY AND PROCEDURES STATEMENT v5

Nick Drey17/11/2008

INTRODUCTION

This document outlines the principles governing the ethical review of research proposals involving staff and students associated with the School of Community and Health Sciences, City University. It then explains the procedures which need to be followed in order to obtain ethical approval.

Appendices include the Research Registration Form (Appendix One), Social Research Association’s Safety Code for Researchers (Appendix Two), British Sociology Association Guidelines to Research Ethics (Appendix Three) and National Children’s Bureau’s (NCB) Guidelines for Research (Appendix Four).

The dates and deadlines for SCHS REC meetings, together with further guidance, advice and instructions concerning the submission of applications can be found online at http://www.city.ac.uk/sonm/research/researchgovernance.html.

Students who have queries about their proposals for ethical approval should direct any enquiries to their course tutor in the first instance. Academic members of staff, including course tutors should direct enquiries to the CC&HS research ethics committee administrator, Carol Dossett, c.dossett@city.ac.uk who will approach the Chair of the committee as required. Students and academic members of staff are requested to respect these requirements which are designed to ensure that a large volume of applications and enquiries can be dealt with quickly and efficiently.

PRINCIPLES UNDERLYING SCHOOL RESEARCH ETHICS PROCEDURE

The School requires all research proposals involving human participation to undergo formal ethical peer review. ‘Human participation’ covers direct data collection from people, for example surveys, observation and physiological measurement. It also includes retrieving data from individual records such as case notes. Research involving animals should be submitted for consideration by Senate REC http://www.city.ac.uk/adu/academic_framework/re/research_ethics.html.

Natural sciences research and project from the Department of Optometry & Visual Science should be submitted to the Optometry & Visual Sciences Research Ethics Committee (O&VS REC) [Link]. Research involving anonymised secondary data, such as reviews of published or otherwise disseminated documents and analysis of aggregated data does not require ethics committee approval.

Research must be distinguished from audit and service evaluation, although this distinction is not always clear-cut. If the primary purpose of data collection is to improve a specific service, for example through use of a satisfaction questionnaire, the activity can be classified as audit, and does not require research ethics committee approval. (However, another type of approval may be required, for example from the organisation that’s owns the data.)

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If the primary purpose of data collection is to advance knowledge, then the proposal comes within the remit of the Research Ethics Committee. Crucially, the results of audits can be hard to publish in a peer-reviewed journal or similar type of output unless research ethics committee approval was obtained before data collection commenced. Because this distinction is not clear-cut, applicants who are uncertain about whether research ethics committee approval is required are advised to consult the Chair of the SCHS REC who will refer the matter to the committee if necessary.

The SCHS REC is concerned with safeguarding the human rights of potential research participants as well as students and staff undertaking the research. In order to do so, it will need to be satisfied, directly or indirectly about the following:

a. That potential participants are clearly informed in printed form about the aims and purpose of the research, the procedures which will be followed, the overall aims of analysis and the intended form of dissemination of research findings.

b. That due allowance is made for issues of comprehension such as linguistic diversity and also cognitive limitations.

c. That potential participants are capable of giving informed consent and that appropriate measures are taken if this cannot be assumed (e.g. for children and the cognitively impaired). Please note that if your research involves anyone who might fall under the terms of the Mental Capacity Act 2005 this research MUST be approved by an NRES authorised committee.

d. That informed consent is obtained and signed consent forms are completed and retained by the researchers.

e. That potential research participants are informed that they may decline to participate or withdraw from the study at any time without it affecting them in any way.

f. That research participants have appropriate channels for expressing concerns about the conduct of the research.

g. That research participants are not placed at unreasonable risk of harm.h. That researchers are not placed at unreasonable risk of harm and that appropriate safety

procedures are established if necessary, for example if researchers need to visit research participants’ homes (see Appendix Two for guidance).

i. That procedures exist for dealing with matters of concern which might be identified in the course of the research, for example child protection issues, poor treatment, unmet needs or illegal activity, and that potential participants are informed of those procedures.

j. Any research that involves venerable adults or children needs special care and researchers should think carefully through potential ethical pitfalls. Appendix 4 has guidance on conducting research with children. (We are currently developing a more detailed University policy on research and the Child Protection Act, which will be made available when it is finalised.) All researchers having contact with vulnerable adults or children will be required to prove that they have current and appropriate Criminal Records Bureau Clearance.

k. All research MUST comply with the Data Protection Act 1998. (We are currently developing University guidance, which will be made available when it is finalised.)

(Please note that the polices & procedures in the Appendices 2, 3 & 4 are currently for guidance and have not been formally adopted by the university but that we are working towards adopting a formal policy across the University. In the mean time, deviation from this guidance, in a research ethics submission would need to be justified.)

The committee is not primarily concerned with the value or validity of the research. However, in cases in which it is considered that research is not worth doing due to gross methodological shortcomings, this becomes an ethical matter because patients, clients or other participants should not be asked to spend time contributing to worthless research and the committee is liable to withhold permission for the research to go ahead.

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PROCEDURES

The process for obtaining research ethical approval has been made as simple as possible, consistent with ensuring that the human rights of research participants and researchers are protected. As far as possible, this system is paperless, and utilises email authorisation. Please note:

A. That paper copies of documents will only be accepted in exceptional circumstancesB. That applications which do not follow the guidelines will be returned for further workC. Applications must be complete, finalised and submitted in one single word document.D. Applications for unfunded work will not be considered unless they fulfil one of the two

following criteria A) funding is not required to complete the project B) an application for funding requires prior ethical approval.

E. That students should always approach their tutor or programme leader with queries in the first instance. (This point and the next note are designed to ensure that the system is not overwhelmed and that queries can be dealt with quickly and helpfully!)

F. That academic members of staff should approach the research ethics committee administrator Carol Dossett, c.dossett@city.ac.uk in the first instance with queries.

G. That sponsorship, required for NHS research, and authorising signatures on full applications should be dealt with by the host academic department, not by the research ethics committee. The research ethics committee administrator can provide provisional and full indemnity insurance, as indicated below.

The SCHS REC procedure involves a two stage process:

1. First, registration of the project via the Research Registration Form (Appendix 1) which sets out the route to be followed towards full ethical approval; and,

2. Secondly, obtaining ethical approval via a full application following an approved route.

All research projects requiring ethical approval must initially be logged via a Research Registration Form (Appendix 1) submitted by email to the SCHS REC administrator. This requirement encompasses research undertaken by staff and students (although special arrangements exist for approving undergraduate projects within individual departments). The form asks for a short summary of the intended research and an indication of the route to be followed for ethical approval. Forms will be approved, or modification requested, within a week by the Chair of the School Research Ethics Committee who will consult members of the committee if necessary. Provisional indemnity will be issued by the University insurer at this point but will not become activated until full research ethics approval has been granted by an appropriate research ethics committee.

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Once a project has been registered, applicants will need to obtain full ethical approval from one, and only one, of the routes listed below.

1. The National Research Ethics Service (NRES) http://www.nres.npsa.nhs.uk/ (mainly for research involving NHS patients, facilities or staff)

2. City University Senate Research Ethics Committee http://www.city.ac.uk/adu/academic_framework/re/research_ethics.html.

3. The SCHS REC [link]. (This committee covers research projects previously dealt with by former School of Nursing & Midwifery Ethics Committee and School of Allied Health Sciences Ethics Committee )

4. The SCHS Optometry & Visual Sciences REC [link]. (This Research Ethics Committee has a widened scope to include other natural science projects, e.g. some radiography research.)

5. The Language and Communication Science Undergraduate REC (undergraduate projects only)

6. A research ethics committee of another UK or international university (preferred for research led from elsewhere or located in another region or country)

7. Another type of external research committee which is approved by the Chair of the School Committee who will consult other members if necessary.

In general, projects need to go to NRES if they involve research conducted on staff or patients contacted through the NHS. Such projects must be registered with the appropriate NHS Trust research and development offices. Applicants will also need to obtain an honorary NHS contract or a research passport through one of their R&D offices.

Some NHS R&D offices no longer require some health service research projects to be approved by NRES. Providing that the applicant can produce evidence that this is the case such as a confirmatory email from the appropriate R&D office and or NRES Local REC, the project can be considered by the SCHS REC instead of by NRES.

Applicants whose research is approved by the SCVHS REC will be automatically issued with University indemnity insurance. Insurance will be issued to applicants whose research has been fully approved by an NHS or other approved external research ethics committee as soon as they submit evidence of approval to a School research ethics administrator, usually a copy of the letter of approval.

The SCHS REC will use revised versions of the attached forms, one for project registration and the second for presentation of full proposals. The latter must be accompanied by information sheets and consent forms.

The SCHS research ethics committee system is approved by the University Senate Research Ethics Committee, http://www.city.ac.uk/adu/academic_framework/re/research_ethics.html chaired by Prof Roland Petchey. Certain proposals may be referred to this committee; this will arise if unusually difficult issues are identified. For example this might include research involving vulnerable adults or children, research that exposes participants or researchers to high risks or research where the ethical issues are very complex and the SCHS REC wishes to refer it to a higher committee.

Meetings of the SCHS committees will be timed as far as possible so that they are followed by Senate Committee meetings within a two week period, allowing applications to be processed reasonably quickly.

For further information on the SCHS Research Ethics Committee, please see the web links provided above.

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APPENDIX ONEBRIEF INITIAL RESEARCH PROJECT REGISTRATION FORM

REQUIRED FOR ALL SCHS RESEARCH PROJECTSINVOLVING THE PARTICIPATION OF HUMAN OR NON-HUMAN ANIMALS

OR PERSONAL RECORDS

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School of Community and Health Sciences Research Ethics CommitteeRESEARCH REGISTRATION FORM (Replaces form EC3 for SCHS approvals)

This form must be completed for all research projects regardless of whether the proposal is going to an NHS, School or other approved research ethics committee. You must complete all sections of the form as indicated. Failure to do so will lead to the form being returned to you, and the project remaining unregistered. You will need to receive confirmation of registration and a provisional indemnity letter before submitting a full proposal to an appropriate research ethics committee, as indicated below. Projects will be registered by Chair’s action. You should receive a response to your registration request within one week of submission.

Please complete this form and email it to Carol Dossett (C.Dossett@city.ac.uk). PhD, Masters and other students must ensure that an email of support containing the project title in the email title is sent to Carol Dossett by the main project supervisor. These emails will be verified.

Application date: / / 2 0Name of Principal Investigator(s):

Department or Unit:

Name of Supervisor:(For Students Only)

Course:

Student number:

Title of research proposal:

External organisation(s) involved: (if any)

Funding bodies: (if any)

Planned completion date: / / 2 0

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A Research Proposal

Please provide a brief summary of the research involved in this proposal (<500 words). This should include aims, rationale, methodology, and dissemination plans, as well as the ethical implications of the research. [PLEASE DO NOT ATTACH YOUR FULL PROJECT PROPOSAL. PROPOSALS WILL NOT BE REGISTERED UNLESS THIS SECTION IS COMPLETED.]

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B Research Ethics Approval

After you have received confirmation of initial registration, you will need to prepare a full application and submit it to one approved research ethics committee. Further details and application forms can be obtained by following the web links provided.

In general, projects involving the participation of patients recruited through the NHS or NHS staff will need to go through the NRES http://www.nres.npsa.nhs.uk/ system of health service local and multiple research ethics committees, as will projects involving non-anonymised patient records and patient tissues. You will also need to register such projects with NHS Trust R&D offices and obtain an honorary NHS contract or research passport.

However, some NHS research ethics committees do not require approval for health services research. If you can submit an email or letter from the appropriate R&D office(s) or NHS Ethics Committee confirming that NRES approval is not required, you may instead submit your proposal to a SCHS Ethics Committee, as listed below.

Please indicate to which one of the following you intend to submit a full research ethics application

(Please check as appropriate)

1. NRES (NHS research ethics committee) YES NO

2. Senate Research Ethics Committee* YES NO

3. SCHS Research Ethics Committee† YES NO

4. Optometry & Visual Science Research Ethics Committee YES NO

5. Language and Communication Science (undergraduate projects only) YES NO

6. Another research ethics committee (please give details below) YES NO

7. This project dose not require ethical approval

Because:

i) It is a service evaluation or audit

ii) It does not involve human subjects or participants

(Please check as appropriate)

C Research involving staff or Students at City University

Projects which involve the recruitment of School staff or students require approval by the School Research Committee, and the appropriate Deans for undergraduate and postgraduate students. * A full application on form EC3 will have to be made to Senate REC for research ethical approval† A full application on form EC3 (SCHS version) will have to be made to SCHS REC for research ethical approval

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This ensures that the same group of staff/students are not repeatedly contacted to become involved in research projects. Principal investigators should not contact students or staff directly. If you wish to recruit staff or students into a research project please contact the administrator to the SCCH REC Carol Dossett C.Dossett@city.ac.uk in the first instance to discuss obtaining approval.

Does this project involve the recruitment of staff or students at City University:

1) This project will recruit staff YES NO

2) This project will recruit postgraduate students YES NO

3) This project will recruit undergraduate students YES NO

(Please check as appropriate)

I confirm that the accuracy of the information supplied above.

1 Principal Researcher

Name (print)_________________________ Position_____________________________

Signature____________________________ Date________________________________

2 Supporting Researcher / Signature of Supervisor (required for all students)

Name (print)_________________________ Position_____________________________

Signature____________________________ Date________________________________

For further information and advice on the School research governance system please see the research website at http://www.city.ac.uk/sonm/research/governance.

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Appendix TwoA Code of Practice for the Safety of Social Researchers

Introduction to the Code

This is the Social Research Association (SRA)'s Code of Practice for the safety of social researchers, particularly those conducting research in the field on their own. The code focuses on safety in interviewing or observation in private settings but is of relevance to working in unfamiliar environments in general.

There are a number of dimensions to the risk that social researchers may face when involved in close social interaction:

risk of physical threat or abuse risk of psychological trauma, as a result of actual or threatened violence or the nature of

what is disclosed during the interaction risk of being in a comprising situation, in which there might be accusations of improper

behaviour increased exposure to risks of everyday life and social interaction, such as road accidents

and infectious illness risk of causing psychological or physical harm to others.

The Code is designed for research funders, employers, research managers and researchers carrying out fieldwork. The aims are to point out safety issues which need to be considered in the design and conduct of social research in the field and to encourage procedures to reduce the risk. The intention is not to be alarmist about potential dangers but to minimise anxieties or insecurities which might affect the quality of the research.

The Code covers: clarifying responsibilities budgeting for safety planning for safety in research design risk assessment preparing for fieldwork setting up fieldwork interview precautions maintaining contact conduct of interviews strategies for handling risk situations safety of respondents debriefing and support after the event making guidelines stick.

Clarifying responsibilities

Employers of researchers, generally universities or research institutes, have a 'duty of care' towards their employees under the terms of the Health and Safety at Work Act, extended by the Management of Health and Safety at Work Regulations which are supported by a European Union Framework Directive. The European Directive provides a code covering elements of guidance such as:

avoid risk altogether combat risks at source adapt work to the individual make sure employees understand what they need to do

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ensure that an understanding of risk is integrated within the organisation's overall policy framework.

Although a personnel officer might legally stand as the employer, the duty of care might be regarded as reverting to the research manager who might be, for example, either the head of the research unit or the grant-holder.

Safety at work is a dual responsibility of the employer and the employee. A number of situations can arise in the conduct of social research where the responsibility for safety might be contested, if, for example, a researcher has to stay overnight in a hotel while on fieldwork.

Budgeting for safety

All research proposals and funding agreements should include the costs of ensuring the safety of researchers working on the project. It may be helpful to distinguish infrastructure costs which are apportioned to all projects, from costs particular to the project.

Infrastructure costs might cover training on risk assessment, communication aids, personal or vehicle insurance cover, a named member of staff responsible for fieldwork safety, staffing a fieldwork contact point. It will be important to clarify which of these costs fall to the employer and which are to be borne by the funder.

Project costs might include extra fieldwork time (working in pairs, providing a 'shadow' or reporting back to base), taxis or hired cars, appropriate overnight accommodation, special training and counselling for staff researching sensitive topics. These extra costs elements may need to be discussed with funders as the proposal is being drafted.

The research institute should be prepared to devote resources to safety issues: raising awareness; clarifying responsibilities and lines of accountability; creating and implementing procedures; carrying out regular reviews.

Planning for safety in research design

Researcher safety can be built into the design of proposals.

Choice of methods - include safety in the balance when weighing up methods to answer the research questions. Challenge research specifications which take for granted face-to-face interviews in potentially risky sites.

Choice of interview site - consider whether home interviews are necessary for the research. Interviews in a public place may be acceptable and safer substitutes; for example, meeting a working person during the lunch break rather than at home in the evening.

Staffing - consider designs where it is possible to use pairs of researchers to conduct an interview, or to interview two members of the household simultaneously.

Choice of researchers - consider whether the research topic requires the recruitment of researchers with particular attributes or experience. Research managers may have to decide against using existing staff if the content of the interview will arouse strong feelings or cause distress.

Recruitment methods - where possible, design methods of recruitment to allow for prior telephone contact. This provides an opportunity to assess the respondent and their circumstances.

Time-tabling - take account of the tiring effects of spells of intensive fieldwork. A more relaxed schedule may mean that researchers are more alert to risk and better able to handle incidents.

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Assessing risk in the fieldwork site

Once the fieldwork site has been selected try to reconnoitre the area before fieldwork starts. Questions to ask include:

Is there reliable local public transport? Are reputable taxis firms easy to access? Is it safe to use private cars and leave them in the area? Is there a local rendezvous or contact point for researchers? Are there appropriately priced and comfortable hotels within easy reach? Are there local tensions to be aware of such as strong cultural, religious or racial divisions? What do local sources, such as the police, say about risks in the research territory? It may be useful to prepare the ground by: meeting local 'community leaders' to explain the research and gain their endorsement. informing other significant local actors, such as statutory and community organisations in

touch with potential interviewees notifying the local police in writing about the purpose and conduct of the research and

asking for a contact telephone number.

Risk and respondents

The topics for discussion in many social research interviews - for example, poverty, unemployment, relationship breakdown, social exclusion, bereavement and ill-health - may provoke strong feelings in respondents and prompt angry reactions. Some research may be concerned explicitly with phenomena where the threat of violence is likely - investigating criminal behaviour, working across sectarian divides or studying homophobic violence, for example.

Some respondents may present a greater possibility of risk than others. Some research involves people who have a history of psychological disturbance or violent behaviour. If such characteristics are known in advance, the researcher and supervisor should be as fully briefed as possible on the risks involved and understand the precautions they need to undertake.

Issues of race, culture and gender may impact significantly on the safety of researchers. Lone female researchers are generally more vulnerable than lone males. More orthodox cultures may be hostile towards them. Certain racialised contexts may make the conduct of non-ethnically-matched interviewing more fraught than otherwise. Risk situations of these kinds may be avoided by contacting respondents in advance to ask about preferences and expectations.

Setting up fieldwork

Wherever possible, interviewers should try to obtain prior information about the characteristics of selected respondents, their housing and living environments.

Study a map of the area for clues as to its character. Look for schools, post offices, railway stations and other hubs of activity. Think about escape routes from dense housing areas.

If doubts about safety are indicated, reconnoitre the vicinity in advance to assess the need for accompanied interviews, shadowing and pre-arranged pick-ups.

If the design allows, telephone in advance to assess the respondent and enquire whether any other members of the household will be at home.

If 'cold-calling' in a potentially risky area, travel in pairs to set up interviews. Arrange alternative venues, already assessed for safety, if security is in doubt.

Interview precautions

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Research managers should instruct interviewers to take precautions to minimise risk in the interview situation and ensure that help is at hand. The following practical tips might be considered.

Avoid going by foot if feeling vulnerable. Use convenient public transport, private car or a reputable taxi firm. Plan the route in advance and always take a map.

Try to avoid appearing out of place. Dress inconspicuously and unprovocatively, taking account of cultural norms. Equipment and valuable items should be kept out of sight.

Where 'cold calling', assess the situation before beginning the interview and if in doubt re-arrange the interview for when a colleague can be present. Plan what to say on entry phones to maintain control while protecting confidentiality.

Try to make sure you are seen entering an interviewee's home. Greet porters or caretakers, ask in a local shop for directions or use other ways of ensuring your presence is noted. But take care not to compromise interviewee confidentiality.

In multi-storey buildings, think about safety when choosing lifts or staircases. If in the light of prior information there is any doubt about personal safety, a co-researcher

or paid escort should wait in the dwelling or in a visible position outside. If waiting outside, a system for communicating needs to be arranged in advance.

Carry a screech alarm or other device to attract attention in an emergency. Let the interviewee know that you have a schedule and that others know where you are.

Stratagems include arranging for a colleague or taxi to collect you; making phone calls; arranging for calls to be made to you. Leave your mobile phone switched on.

Assess the layout and the quickest way out. If interviewing in a private dwelling, stay in the communal rooms.

Always carry identification, a badge or a card, authenticated by the head of the research organisation and giving the researcher's work address and telephone number. Respondents should be invited to check the authenticity.

Maintaining contact

It is essential to establish reliable lines of communication between the usual office base and the fieldwork site. The research manager should designate a responsible person at the office-base fully briefed on the research team's schedule and clearly instructed on when and how to take action.

The main elements of a fieldwork contact system are as follows:

Details of the researcher's itinerary and appointment times - including names, addresses and telephone numbers of people being interviewed or called and overnight accommodation details - should be left with a designated person at the office base or a temporary fieldwork base (taking care about interviewee confidentiality)

The researcher should notify base of any changes during fieldwork. Fieldworkers should carry mobile phones so that base can contact them. Where more than researcher is working in the site they should meet or communicate by

mobile phone at pre-arranged times. If such an arrangement is not kept, the other researcher should inform the responsible person at base.

Ideally, at the end of the day's work a telephone call should be placed informing base that the schedule of work has been completed. This may require the designated person being on duty outside normal office hours to receive the call or check for recorded messages, and to follow-up if no call arrives. Or the employer might contract with an alarm service.

If the researcher prefers to call in to a household member or friend, then this should be agreed with the employer, whose responsibility it is to ensure researcher safety.

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Conduct of interview

Despite taking precautions, risk situations may arise in the course of the interview. Issues in race, culture and gender may prompt hostility.

To avoid engaging in inappropriate or provocative behaviour researchers:

should be briefed on cultural norms need to be aware of the gender dynamics of interactions. need to appreciate the use of body language and the acceptability or not of physical

contact need to establish the right social distance - neither over-familiar nor too detached.

Strategies for handling risk situations

Employers should ensure that researchers are trained in techniques for handling threats, abuse or compromising situations, and research managers could consider ways of refreshing their knowledge. External trainers may be useful, both for initial training and in keeping the issue live.

Carrying mobile phones and/or personal alarms may be helpful, as long as these are considered only as part of a comprehensive safety policy. Over-reliance on mobile phones and alarms must not substitute for proper training in inter-personal skills.

Researchers should always carry enough money for both expected and unexpected expenses, including the use of taxis. It is sensible not to appear to be carrying a lot of money, however, and to carry a phone-card, in case it is necessary to use a public telephone.

Household dogs may make some researchers uncomfortable. It is reasonable to ask the owner to put the dog in another room until the researcher has left.

Researchers should also be prepared to deal with the effects of the interview on respondents, and be ready to spot signs that the respondent is becoming upset or angry. Often, the researcher's training means that strong feelings of this kind can be acknowledged and contained, but there may be occasions when it is more sensible to end the discussion and leave. Such a withdrawal should be decisive and quick, offering an appropriate reason. A lost interview may be made up, if this seems appropriate after discussion with the research manager.

Debriefing and support after the event

When research fieldwork is complete, it is helpful for researchers and their supervisors to reflect on their adherence to the guidelines and raise any difficulties encountered in meeting them. Some research institutes routinely conduct project reviews, and these should include an assessment of fieldwork safety. Researchers should be encouraged to cover fieldwork safety dimensions in reporting their research findings to funders.

If incidents have occurred, these should be recorded. Serious incidents should be discussed with safety officers or professional associations. If violent incidents have occurred which may have some impact on the well-being of the researcher, these should be reported to the employer's health and safety officer and to the local police force.

If incidents arise during the course of the fieldwork, these need to be dealt with straight away for the well-being of the researcher. The trauma of violence or the threat of violence may require structured support through counselling or the use of victim support organisations, or by providing leave of absence (taken as sickness leave). If the fieldwork is not complete, there may be a need for particular forms of support to enable the researcher to undertake any remaining work.

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Appropriate debriefing - which should also protect the confidentiality of the respondent - may also help the researcher come to terms in a healthy way with the incident and feel free to continue his/her work programme, as well as providing further material to inform the development of safety codes.

Making guidelines stick

Ways of making guidelines stick will include awareness raising among both new and experienced staff.

Safety issues should feature in the training of all new research staff, and guidelines should be included in induction packs and staff handbooks.

There is a need for continual reminders and reinforcement throughout a researcher's career.

Supervisors and research managers may need to take staff through procedures with each new fieldwork period.

Support staff responsible for setting up fieldwork arrangements should be trained in the procedures.

There may be role for safety officers and outside bodies, such as the Suzy Lamplugh Trust advisers, to visit occasionally to bring fresh perspectives and maintain interest in issues.

It will always be important to remind research staff that if they ignore their employers' policies and procedures for health and safety at work, they may be considered negligent should an incident occur.

The authors are grateful to all those individuals and organisations which provided comments and ideas or simply encouraged us to write this code.

Some further reading on the subject

Arksey, H. and Knight, P., (1999), Interviewing for social scientists (esp. Ch. 9), Sage, London. Association of University Teachers, (1996), Personal guidelines for staff conducting interviews off campus, Circular LA/5674, February, AUT, London, mimeo. Paterson, B.L., Gregory, D. and Thorne, S., (1999), 'A protocol for researcher safety', Qualitative Health Research, Vol. 9, No. 2, March :259-269. Rai, D.K., (1995), In the margins: current practices in qualitative social research with Asian communities, Social Research Paper No. 2, University of Lincolnshire and Humberside, Hull. Sandell, A., (1998), Oxford Handbook of patients' welfare: a doctor's guide to benefits and services, Oxford University Press, Oxford. Social Research Association, (n.d.), Ethical guidelines, Social Research Association, London, mimeo. Suzy Lamplugh Trust, (n.d.), Personal safety at work: guidance for all employees, Suzy Lamplugh Trust, London, mimeo.

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APPENDIX THREE

STATEMENT OF ETHICAL PRACTICE FOR THE BRITISH SOCIOLOGICAL ASSOCIATION

MARCH 2002 (Appendix updated May 2004)

Statement of Ethical Practice

This statement is one of a set of Guidelines on a variety of fundamental aspects of professional sociology.

The British Sociological Association gratefully acknowledges the use made of the ethical codes and statements of the Social Research Association, the American Sociological Association and the Association of Social Anthropologists of the UK and the Commonwealth.

1) The purpose of the statement is to make members aware of the ethical issues that may arise throughout the research process and to encourage them to take responsibility for their own ethical practice. The Association encourages members to use the Statement to help educate themselves and their colleagues to behave ethically.

2) The statement does not, therefore, provide a set of recipes for resolving ethical choices or dilemmas, but recognises that it will be necessary to make such choices on the basis of principles and values, and the (often conflicting) interests of those involved.

3) Styles of sociological work are diverse and subject to change, not least because sociologists work within a wide variety of settings. Sociologists, in carrying out their work, inevitably face ethical, and sometimes legal, dilemmas which arise out of competing obligations and conflicts of interest.

4) The following statement advises members of the Association about ethical concerns and potential problems and conflicts of interest that may arise in the course of their professional activities. The statement is not exhaustive but summarises basic principles for ethical practice by sociologists. Departures from the principles should be the result of deliberation and not ignorance.

The strength of this statement and its binding force rest ultimately on active discussion, reflection, and continued use by sociologists. In addition, the statement will help to communicate the professional position of sociologists to others, especially those involved in or affected by the activities of sociologists.

Professional Integrity

5) Sociological research is a valuable activity and contributes to the well-being of society. Members should strive to maintain the integrity of sociological inquiry as a discipline, the freedom to research and study, and to publish and promote the results of sociological research including making data available for the use of researchers in the future

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6) Members have a responsibility both to safeguard the proper interests of those involved in or affected by their work, and to report their findings accurately and truthfully. They need to consider the effects of their involvements and the consequences of their work or its misuse for those they study and other interested parties. Sociologists should note that there are national laws and administrative regulations (for example Data Protection Acts, the Human Rights Act, copyright and libel laws) which may affect the conduct of their research, data dissemination and storage, publication, rights of research subjects, of sponsors and employers etc..

7) While recognising that training and skill are necessary to the conduct of social research, members should themselves recognise the boundaries of their professional competence. They should not accept work of a kind that they are not qualified to carry out. Members should satisfy themselves that the research they undertake is worthwhile and that the techniques proposed are appropriate. They should be clear about the limits of their detachment from and involvement in their areas of study. (Also see 45.-47)

8) Social researchers face a range of potential risks to their safety. Safety issues need to be considered in the design and conduct of social research projects and procedures should be adopted to reduce the risk to researchers.

9) In their relations with the media, members should have regard for the reputation of the discipline and refrain from offering expert commentaries in a form that would appear to give credence to material that, as researchers, they would regard as comprising inadequate or tendentious evidence. (Also see 20.-24).

Relations with and Responsibilities towards Research Participants

10) Sociologists, when they carry out research, enter into personal and moral relationships with those they study, be they individuals, households, social groups or corporate entities.

11) Although sociologists, like other researchers are committed to the advancement of knowledge, that goal does not, of itself, provide an entitlement to override the rights of others.

12) Members should be aware that they have some responsibility for the use to which their data may be put and for how the research is to be disseminated. Discharging that responsibility may on occasion be difficult, especially in situations of social conflict, competing social interests or where there is unanticipated misuse of the research by third parties.

Relationships with research participants

13) Sociologists have a responsibility to ensure that the physical, social and psychological well-being of research participants is not adversely affected by the research. They should strive to protect the rights of those they study, their interests, sensitivities and privacy, while recognising the difficulty of balancing potentially conflicting interests.

14) Because sociologists study the relatively powerless as well as those more powerful than themselves, research relationships are frequently characterised by disparities of power and status. Despite this, research relationships should be characterised, whenever possible, by trust and integrity.

15 ) In some cases, where the public interest dictates otherwise and particularly where power is being abused, obligations of trust and protection may weigh less heavily. Nevertheless, these obligations should not be discarded lightly.

16) As far as possible participation in sociological research should be based on the freely given

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informed consent of those studied. This implies a responsibility on the sociologist to explain in appropriate detail, and in terms meaningful to participants, what the research is about, who is undertaking and financing it, why it is being undertaken, and how it is to be disseminated and used.

17) Research participants should be made aware of their right to refuse participation whenever and for whatever reason they wish.

18) Research participants should understand how far they will be afforded anonymity and confidentiality and should be able to reject the use of data-gathering devices such as tape recorders and video cameras.

19) Sociologists should be careful, on the one hand, not to give unrealistic guarantees of confidentiality and, on the other, not to permit communication of research films or records to audiences other than those to which the research participants have agreed.

20) Where there is a likelihood that data may be shared with other researchers, the potential uses to which the data might be put must be discussed with research participants and their consent obtained for the future use of the material.(iv). When making notes, filming or recording for research purposes, sociologists should make clear to research participants the purpose of the notes, filming or recording, and, as precisely as possible, to whom it will be communicated. It should be recognised that research participants have contractual and/or legal interests and rights in data, recordings and publications.

21) The interviewer should inform the interviewee of their rights under any copyright or data protection laws

22) Researchers making audio or video recordings should obtain appropriate copyright clearances

23) Interviewers should clarify whether, and if so, the extent to which research participants are allowed to see transcripts of interviews and field notes and to alter the content, withdraw statements, to provide additional information or to add glosses on interpretations

24 ) Clarification should also be given to research participants regarding the degree to which they will be consulted prior to publication. Where possible, participants should be offered feedback on findings, for example in the form of a summary report.

25) It should also be borne in mind that in some research contexts, especially those involving field research, it may be necessary for the obtaining of consent to be regarded, not as a once-and-for-all prior event, but as a process, subject to renegotiation over time. In addition, particular care may need to be taken during periods of prolonged fieldwork where it is easy for research participants to forget that they are being studied.

In some situations access to a research setting is gained via a 'gatekeeper'. In these situations members should adhere to the principle of obtaining informed consent directly from the research participants to whom access is required, while at the same time taking account of the gatekeepers' interest.

Since the relationship between the research participant and the gatekeeper may continue long after the sociologist has left the research setting, care should be taken not to compromise existing relationships within the research setting

26) It is, therefore, incumbent upon members to be aware of the possible consequences of their work. Wherever possible they should attempt to anticipate, and to guard against, consequences for research participants that can be predicted to be harmful. Members are not absolved from this

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responsibility by the consent given by research participants.

27) In many of its forms, social research intrudes into the lives of those studied. While some participants in sociological research may find the experience a positive and welcome one, for others, the experience may be disturbing. Even if not harmed, those studied may feel wronged by aspects of the research process. This can be particularly so if they perceive apparent intrusions into their private and personal worlds, or where research gives rise to false hopes, uncalled for self-knowledge, or unnecessary anxiety. 28) Members should consider carefully the possibility that the research experience may be a disturbing one and should attempt, where necessary, to find ways to minimise or alleviate any distress caused to those participating in research. It should be borne in mind that decisions made on the basis of research may have effects on individuals as members of a group, even if individual research participants are protected by confidentiality and anonymity.

29) Special care should be taken where research participants are particularly vulnerable by virtue of factors such as age, disability, their physical or mental health. Researchers will need to take into account the legal and ethical complexities involved in those circumstances where there are particular difficulties in eliciting fully informed consent. In some situations proxies may need to be used in order to gather data. Where proxies are used, care should be taken not to intrude on the personal space of the person to whom the data ultimately refer, or to disturb the relationship between this person and the proxy. Where it can be inferred that the person about whom data are sought would object to supplying certain kinds of information, that material should not be sought from the proxy.

30) Research involving children requires particular care. The consent of the child should be sought in addition to that of the parent. Researchers should use their skills to provide information that could be understood by the child, and their judgement to decide on the child’s capacity to understand what is being proposed. Specialist advice and expertise should be sought where relevant. Researchers should have regard for issues of child protection and make provision for the potential disclosure of abuse.

Covert Research

31) There are serious ethical and legal issues in the use of covert research but the use of covert methods may be justified in certain circumstances. For example, difficulties arise when research participants change their behaviour because they know they are being studied. Researchers may also face problems when access to spheres of social life is closed to social scientists by powerful or secretive interests.

32) However, covert methods violate the principles of informed consent and may invade the privacy of those being studied. Covert researchers might need to take into account the emerging legal frameworks surrounding the right to privacy. Participant or non-participant observation in non-public spaces or experimental manipulation of research participants without their knowledge should be resorted to only where it is impossible to use other methods to obtain essential data.

33) In such studies it is important to safeguard the anonymity of research participants. Ideally, where informed consent has not been obtained prior to the research it should be obtained post-hoc.

Anonymity, privacy and confidentiality

34) The anonymity and privacy of those who participate in the research process should be respected. Personal information concerning research participants should be kept confidential. In some cases it may be necessary to decide whether it is proper or appropriate even to record

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certain kinds of sensitive information.

35) Where possible, threats to the confidentiality and anonymity of research data should be anticipated by researchers. The identities and research records of those participating in research should be kept confidential whether or not an explicit pledge of confidentiality has been given.

36) Appropriate measures should be taken to store research data in a secure manner. Members should have regard to their obligations under the Data Protection Acts. Where appropriate and practicable, methods for preserving anonymity should be used including the removal of identifiers, the use of pseudonyms and other technical means for breaking the link between data and identifiable individuals. Members should also take care to prevent data being published or released in a form that would permit the actual or potential identification of research participants without prior written consent of the participants. Potential informants and research participants, especially those possessing a combination of attributes that make them readily identifiable, may need to be reminded that it can be difficult to disguise their identity without introducing an unacceptably large measure of distortion into the data.

37) Guarantees of confidentiality and anonymity given to research participants must be honoured, unless there are clear and overriding reasons to do otherwise, for example in relation to the abuse of children. Other people, such as colleagues, research staff or others, given access to the data must also be made aware of their obligations in this respect. By the same token, sociologists should respect the efforts taken by other researchers to maintain anonymity.

38) Research data given in confidence do not enjoy legal privilege, that is they may be liable to subpoena by a court and research participants should be informed of this.

39) There may be fewer compelling grounds for extending guarantees of privacy or confidentiality to public organisations, collectivises, governments, officials or agencies than to individuals or small groups. Nevertheless, where guarantees have been given they should be honoured, unless there are clear and compelling public interest reasons not to do so.

40) During their research members should avoid, where they can, actions which may have deleterious consequences for sociologists who come after them or which might undermine the reputation of sociology as a discipline.

41) Members should take special care when carrying out research via the Internet. Ethical standards for internet research are not well developed as yet. Eliciting informed consent, negotiating access agreements, assessing the boundaries between the public and the private, and ensuring the security of data transmissions are all problematic in Internet research. Members who carry out research online should ensure that they are familiar with ongoing debates on the ethics of Internet research, and might wish to consider erring on the side of caution in making judgements affecting the well-being of online research participants.

Relations with & Responsibilities towards Sponsors and/or Funders

42) A common interest exists between sponsor, funder and sociologist as long as the aim of the social inquiry is to advance knowledge, although such knowledge may only be of limited benefit to the sponsor and the funder. That relationship is best served if the atmosphere is conducive to high professional standards.

43) Members should ensure that sponsors and/or funders appreciate the obligations that sociologists have not only to them, but also to society at large, research participants and professional colleagues and the sociological community. The relationship between sponsors or funders and social researchers should be such as to enable social inquiry to be undertaken

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professionally. In research projects involving multiple funders or inter-disciplinary teams, members should consider circulating this Statement to colleagues as an aid to the discussion and negotiation of ethical practice.

44) Research should be undertaken with a view to providing information or explanation rather than being constrained to reach particular conclusions or prescribe particular courses of action.

Clarifying obligations, roles and rights

45) Members should clarify in advance the respective obligations of funders and researchers where possible in the form of a written contract. They should refer the sponsor or funder to the relevant parts of the professional code to which they adhere. Members should also be careful not to promise or imply acceptance of conditions which are contrary to their professional ethics or competing research commitments.

46) Where some or all of those involved in the research are also acting as sponsors and/or funders of research the potential for conflict between the different roles and interests should also be made clear to them.

47) Members should also recognise their own general or specific obligations to the sponsors whether contractually defined or only the subject of informal and often unwritten agreements. They should be honest and candid about their qualifications and expertise, the limitations, advantages and disadvantages of the various methods of analysis and data sources, and acknowledge the necessity for discretion with confidential information obtained from sponsors.

48) They should also try not to conceal factors that are likely to affect satisfactory conditions or the completion of a proposed research project or contract.

Pre-empting outcomes and negotiations about research

49) Members should not accept contractual conditions that are contingent upon a particular outcome or set of findings from a proposed inquiry. A conflict of obligations may also occur if the funder requires particular methods to be used.

50) Members should clarify, before signing the contract, how far they are entitled to be able to disclose the source of their funds, the personnel, aims and purposes of the project.

51) Members should also clarify their right to publish and disseminate the results of their research.

52) Members have an obligation to ensure sponsors grasp the implications of the choice between alternative research methods.Guarding privileged information and negotiating problematic sponsorship

53) Members are frequently furnished with information by the funder who may legitimately require it to be kept confidential. Methods and procedures that have been utilised to produce published data should not, however, be kept confidential unless otherwise agreed.

54) When negotiating sponsorships members should be aware of the requirements of the law with respect to the ownership of and rights of access to data.

55) In some political, social and cultural contexts some sources of funding and sponsorship may be contentious. Candour and frankness about the source of funding may create problems of access or co-operation for the social researcher but concealment may have serious consequences for colleagues, the discipline and research participants. The emphasis should be on maximum

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openness.

56) Where sponsors and funders also act directly or indirectly as gatekeepers and control access to participants, researchers should not devolve their responsibility to protect the participants' interests onto the gatekeeper. Members should be wary of inadvertently disturbing the relationship between participants and gatekeepers since that will continue long after the researcher has left.

Obligations to sponsors and/or Funders During the Research Process

57) Members have a responsibility to notify the sponsor and/or funder of any proposed departure from the terms of reference of the proposed change in the nature of the contracted research.

58) A research study should not normally be undertaken where it is anticipated that resources will be inadequate.59) When financial support or sponsorship has been accepted, members must make every reasonable effort to complete the proposed research on schedule, including reports to the funding source.

60) Members should, wherever possible, disseminate their research findings as widely as possible and where required make their research data available to other researchers via appropriate archives.

61) Members should normally avoid restrictions on their freedom to publish or otherwise broadcast research findings.

A list of further sources of information, advice and support is appended to these guidelines.

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APPENDIX

Further sources of information, advice and support.

Ethics Websites (all web addresses were working as of 18.05.2004)

Animals

The Home Office: Animals In Scientific Procedures

The Animals Act 1986 – A Summary

Guidance on the operation of the Act including links to electronic forms and guidance notes

www.homeoffice.gov.uk/comrace/animals

www.homeoffice.gov.uk/docs/animallegislation.html

www.archive.official-documents.co.uk/document/hoc/321/321-01.htm

Association of Clinical Research for the Pharmaceutical Industry

www.acrpi.com

Best Value www.odpm.gov.uk/stellent/groups/odpm_localgov/documents/page/odpm_locgov_605046-06.hcsp

Biotechnology and Biological Sciences Research Council (BBSRC)

www.bbsrc.ac.uk

British Association for Accident and Emergency Medicine (BAEM)

www.baem.org.uk

British Psychological Association

www.bps.org.uk/index.cfm

British Sociological Association

www.britsoc.co.uk

Bulletin of Medical Ethics www.bullmedeth.info

Caldicott Committee Report on the Review of Patient-identifiable Information Dec 1997

www.publications.doh.gov.uk/ipu/confiden/report/intro.htm

CCTA Government Information Service

www.direct.gov.uk/Homepage/fs/en

The Chartered Society of www.csp.org.uk

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PhysiotherapyCouncil of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regards to the Application of Biology and Medicine; Convention on Human Rights and Biomedicine

www1.umn.edu/humanrts/euro/z37.html

Declaration of Helsinki. Adopted by the 18th World Medical Assembly, 1964 and amended in Tokyo 1975, Venice 1983, Hong Kong 1989 and in South Africa 1996.

www.wma.net/e/policy/b3.htm

Department of Health Good Laboratory Practice Monitoring Authority Code of Practice

www.dh.gov.uk/Home/fs/en

Economic and Social Research Council

www.esrc.ac.uk

Engineering and Physical Sciences Research Council (EPSRC)

www.epsrc.ac.uk/website/index.aspx

ESRC Qualitative Data Active Resource Centre (Qualidata)

www.essex.ac.uk/sociology/research/research_centres.shtm

European Medical Evaluation Agency

www.emea.eu.int

Good Research Practice Guidelines issued in 2000

www.mrc.ac.uk/pdf-good_research_practice.pdf

Government Publications www.official-documents.co.uk

Health and Safety Executive – Health and Safety at Work etc Act 1974

www.healthandsafety.co.uk/haswa.htm

Health Service Journal www.hsj.co.uk

Health and Safety Executive (HSE)

www.hse.gov.uk/hsehome.htm

HERO – Higher Educational and Research Opportunities

www.hero.ac.uk/rae/

The Human Rights Act (1998)

www.hmso.gov.uk/acts/acts1998/19980042.htm

International Conference on Harmonisation of Technical Requirements for Registration of

www.ich.org

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Pharmaceuticals for Human Use (ICH) Guideline 1996The Institute for Social Research

www.soc.surrey.ac.uk/isr.htm

King’s Fund www.kingsfund.org.uk/

Medical Research Council (MRC) policy on inquiring into allegations of scientific misconduct

www.mrc.ac.uk/pdf-mis_con.pdf

Medical Research Council guidance on ethical, legal and management issues concerning human tissue and biological sample for use in research

www.mrc.ac.uk/pdf-tissue_guide_fin.pdf

The MRC published guidance on the Ethical Conduct of Research on the Mentally Incapacitated

www.mrc.ac.uk/pdf-ethics-mental.pdf

Multi-Centre Research Ethics Committee

www.corec.org.uk/

New Scientist www.newscientist.com

Nuffield Council on Bioethics

www.nuffieldbioethics.org/home/

Pharmacological Information

www.pharmweb.net

Qualidata: Qualitative Data Archive Resource Centre

www.essex.ac.uk/qualidata

Regulation of Investigatory Powers Bill (Legislation related to intrusive investigative techniques; interception of communications)

www.hmso.gov.uk/acts/acts2000/20000023.htm

Royal College of Nursing Research and Development Coordinating Centre

www.man.ac.uk/rcn/

Safeguarding Good Scientific Practice

www.ost.gov.uk/research/councils/safe.htm

Scottish Office www.scotland.gov.uk

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The Social Research Association

www.the-sra.org.uk

Social Services Research Group

www.ssrg.org.uk

UK Data Archive www.data-archive.ac.uk

Research Ethics Resources on WWW

www.ethicsweb.ca/resources

The UN Convention on Children’s Rights

www.unicef.org/crc/fulltext.htm

World Health Organisation

www.who.dk/

Books

Beauchamp, T.I and Childress, J.F. (1994) Principles of Biomedical Ethics 2nd ed. Oxford. Blackwell.Botros, S. & Gilbert, F.C. (1993) The Moral Responsibilities of Research Ethics Committee,

Dispatches 3 (3).Campbell, A, Gillett, G and Jones, G. (1992) Practical Medical Ethics. Oxford. Oxford University

Press.Caplan, A. L. (1992) When Medicine Went Mad: Bioethics and the Holocaust. Totawa. Humana

Press.Eby, M. (1995) Ethical Issues in Nursing Research: The Wider Picture, Nurse Researcher, 3 (1), 5-

13.Ferris, L. (2002) Disclosure in research ethics. CMAJ. 167(6)Ferris, L. (2002) Industry-sponsored pharmaceutical trials and research ethics boards: Are they

cloaked in too much secrecy? CMAJ, 166 (10)Finders, D.J. In Search of Ethical Guidance: Constructing a Basis For Dialogue. Qualitative Studies

in Education, 5 (2), 101-116.Foster, C. (Ed) (1996) Manual for Research Ethics Committees (4th ed.). London. Kings College.Grodin, M., Annas, G. and Glantz, L. (1993) Medicine and Human Rights: A Proposal for

International Action. Hasting Center Report.l 23, 8-12.Hammick, M. (1996) Managing the Ethical Process in Research. Salisbury. Quay Books.Hibbert, C. (1997) Medical Therapeutic Research: Ethical and Legal Issues in Randomised

Controlled Trials in Perry, A. (ed) Sociological Insights into Health Care. London. Arnold.House, E.R. (1996) An Ethics of Qualitative Field Studies in Guba, E.G. (ed) The Paradigm Dialog.

Newbury Park. Sage.Kimmel, A.J. (1998) Ethics and Values in Applied Social Research. London. Sage.Lemmens, T, Singer, P. (1998) Conflict of Interest in research, education and patient care. CMAJ .

159:960-5Levy, P and Goldstien, H. (eds.) (1984) Test in Education. London. Academic Press.Lewis, C. (1985) Employee Selection. London. Hutchinson.Lock, S. (1995) Research Ethics – A Brief Historical Review to 1965. Journal of Internal Medicine.

238. 513-20Mann, H. (2002) Disclosure in research ethics CMAJ. 167(6)Marshall, C., Rossman, G.B. (1989) Designing Qualitative Research. London. Sage.Miles, M.B., Hubeman, A.M. (1994) Qualitative Data Analysis. London. Sage.

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Pearn, M.A., Kandola, R.S. and Mottram, R.D. (1987) Selection Tests and Sex Bias. London: Equal Opportunities Commission/HMSO.

Polit, D.F., Hungler,B.P. (1995) Nursing Research Principles and Methods. London. Lippincott.Shapin, S. (1994) The Social History of Truth. Chicago. University Of Chicago Press.Shrader–Frechette, K. (1994) Ethics of Scientific Research. Lanham. Rowman & Littlefield..Sieber, J.E. (1992) Planning Ethnically Responsible Research: A Guide for Students and Internal

Review Boards. Newbury Park. Sage.Singleton, J., McLaren, S. (1995) Ethical Foundations of Healthcare. London. Mosby.Stake, R.E. (1995) The Art of Case Study Research. London. Sage.Tschudin, V. (1994) Ethics, Education and Research. London. Scutari Press.Weijer, C. (2000) The ethical analysis of risk. Journal of Law, Medicine & Ethics . 28, 344-361Weijer, C. (2001) Continuing review of approved research by Canadian Research Ethics Boards.

Canadian Medical Association Journal, 164, 1305-1308Weijer, C., Anderson, J. (2001) The ethics wars: disputes over international research. Hastings

Centre Report 31 (3), 18-20Weijer, C., Dickens, B., Meslin, E. (1997) Research ethics (Bioethics for clinicians 10). Canadian

Medical Association Journal 156, 1153-1157Weijer, C., Glass, K., Shapiro, S. (2000) Why clinical equipoise, and not the uncertainty principle, is

the moral underpinning of the RCT. British Medical Journal. 321, 756-758Whitbeck, C. (1997) Ethics in the Works: Understanding Ethical Problems in Engineering Practice

and Research. New York. Cambridge University Press.Woolf, P. (1994) Integrity and Accountability in Research in Gustin, D.H. & Keniston, K. (Eds.) The

Fragile Contract : University and Science in the Federal Government. Cambridge. MIT Press.

Expert Groups And Their Relevant Publications.

Association of Clinical Research for the Pharmaceutical Industry (1996) ICH Harmonised Tripartite Guideline for Good Clinical Practice. www.acrpi.com

Centre for Medical Law and Ethics, Kings College London (1997) Manual for Research Ethics Committees, Volumes 1 and 2. www.kcl.ac.uk/depsta/law/research/cmle/erh/manual.html

Clinical Trials Database: National Institutes of Health (US) www.clinicaltrials.gov/Committee On Science, Engineering, and Public Policy (1995) On Being a Scientist: responsible

Conduct in Research. www.nap.edu/readingroom/books/obasDepartment of Health (1991) Local Research Ethics Committees (the Red Book)

www.dh.gov.uk/assetRoot/04/01/44/57/04014457.pdfDepartment of Health (1997) The Caldicott Committee Report on the Review of Patient-Identifiable

Information. www.publications.doh.gov.uk/ipu/confiden/report/intro.htmDepartment of Health (2003) The Protection and Use of Patient Information: Guidance from the

Department of Health www.dh.gov.uk/PolicyAndGuidance/InformationTechnology/PatientConfidentialityAndCaldicottGuardians/ProtectionOfPatientInformation/fs/en

Department of Health, Education and Welfare (1979) Protection of Human Subjects (Belmont Report). Washington.

European Forum for Good Clinical Practice The ENGAGE Guideline – Optional guideline for good clinical practice compliance and quality systems auditing. www.efgcp.org/

Faculty of Occupational Medicine (1993) Guidance on Ethics for Occupational Physicians (4th ed.) London. Royal College of Physicians.

Health Ethics Archive www.ethicsweb.ca/resources/research/Her Majesty’s Stationary Office (HMSO) (1998) Public Interest Disclosure Act 1998. London. HMSO.Human Participant Protections: Education for Research Teams.

http://69.5.4.33/c01/nih_intro_01.htmInstitute of Personnel Management (1989) The IPM Code on Occupational Testing. London. IPM.

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International Committee of Medical Journal Editors (1991) Uniform Requirements for Manuscripts Submitted to Biomedical Journals. British Medical Journal 302, 338-41

IRB Guidebook http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htmMedical Research Council (1994) Responsibility in the Use of Personal Medical Information for

Research: Principles and Guide to Practice (revised edition) www.mrc.ac.uk/pdf-pimr.pdfMedical Research Council Ethics Series. www.mrc.ac.uk/index/publications/publications-

ethics_and_best_practice/publications-ethics_series.htmMedical Research Council of Canada (1987) Towards an International Ethic for Research with

Human Beings. Proceedings of the International Summit Conference on Bioethics, April 1987. Ottawa.

Midwest Nursing Research Society. (1996) Guidelines for Scientific Integrity. www.mnrs.org.Nuremberg Code Directives for Human Experimentation

http://ohsr.od.nih.gov/guidelines/nuremberg.htmlProfessional Ethics for Scientists: Annotated Bibliography. (2000)

www.towson.edu/~sweeting/ethics/ethicbib.htmReport of the Committee of Inquiry on the Case Involving Dr. Nancy Olivieri, the Hospital for Sick

Children, the University of Toronto, and Apotex Inc. www.dal.ca/~jgdownie/coi/index.htmlRoyal College of Nursing (1993) Ethics Related to Research in NursingRoyal College of Nursing (1998) Issues in Nursing and Health. Confidentiality: Using patient

records in research and development and clinical auditRoyal College of Paediatrics and Child Health (formerly The British Paediatric Association) (1992)

Guidelines for Ethical Conduct of Research Involving Children. BPA Publications, London. Ryan Commission Report, Integrity and Misconduct in Research. (1995).

www.faseb.org/opa/cri.htmlTeaching Research Ethics: An Annotated Bibliography. www.indiana.edu/~poynter/tre-bib.htmlThe British Paediatric Association and Royal College of Obstetricians and Gynaecologists. (1991) A

Checklist of questions to ask when evaluating research during pregnancy and following childbirth. London. BPA Publications.

The British Psychological Society (1992) Psychological Testing: A Guide. Leicester. BPS Publications.

The British Psychological Society. (1996) Code of Conduct, Ethical Principles and Guidelines. www.bps.org.uk/documents/Code.pdf

The Council for International Organizations of Medical Sciences (CIOMS) (1993) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. WHO.

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998) www.ncehr-cnerh.org/english/code_2

United Kingdom Central Council UKCC. (1999) Guidelines for Professional Practice . London. UKCC. www.nmc-uk.org

45 CFR 46 (The Common Rule): The federal human research subject protection policy, as mandated by the Executive Branch of the United States. http://pw1.netcom.com/~alalli/BillSite_Documents/CommonRule.html

Academic Centres:Centre for Research Ethics: Göteborg University. www.cre.gu.seHarvard University’s Program on Ethical Issues in International Health ResearchClinical Trials Research Group: McGill University www.mcgill.ca/ctrg/

Government Agencies & Committees:

Advisory Committee on Human Radiation Experiments (U.S. Department of Energy) http://tis.eh.doe.gov/ohre/roadmap/achre

Canadian Council on Animal Care www.ccac.caCanadian Institutes of Health Research www.cihr-irsc.gc.ca/index.shtml

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Central Office for Research Ethics Committees (COREC) www.corec.org.ukEuropean agency for the Evaluation of Medicinal Products (EMEA) www.emea.eu.intFDA – Food and Drug Administration (US) www.fda.govHealth Canada, Health Protection Branch, Therapeutic Products Programme

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.htmlInteragency Advisory Panel on Research Ethics (PRE Canada)

www.pre.ethics.gc.ca/english/index.cfmMedical Research Council (UK) www.mrc.ac.ukNatural Sciences and Engineering Council of Canada www.nserc.caNorway’s National Committees for Research Ethics

www.forsk.dk/eng/uvvu/publ/annreport97/kap3.htmNational Council on Ethics in Human Research www.ncehr-cnerh.org/english/home.phpNational Human Genome Research Institute’s Ethical, Legal and Social Implications of Human

Genetics Research www.genome.gov/10004617National Institutes of Health (US) www.nih.govOffice for Protection for Research Risks (US) http://ohrp.osophs.dhhs.govOffice of Human Research Protections (US) http://ohsr.od.nih.govSocial Sciences and Humanities Research Council of Canada www.sshrc.ca/web/home_e.asp

MiscellaneousBritish Association for Accident and Emergency Medicine (formally Casualty Surgeons Association,

founded 1967), The Royal College of Surgeons of England, 35-43 Lincoln’s Inn Fields, London WC2A 3PN

British Association of Paediatric Surgeons The Royal College of Surgeons of Edinburgh, Nicolson Street, Edinburgh EH8 8DW

British Paediatric Association, 5 St. Andrew’s Place, Regents Park, London NW1 4LBCanadian Association of Research Ethics Boards (CAREB) www.careb-accer.ca/index.htmlDo No Harm; The Coalition of Americans for Research Ethics www.doctorsintegrity.org/main.htmDoctors for Research Integrity www.doctorsintegrity.org/main.htmEthics in Research: An Intensive Training Course www.nih.gov/sigs/bioethics/casestudies.htmlEthics in Science http://europa.eu.int/comm/european_group_ethics/index_en.htmEthics in Science and Environmental Politics www.int-res.com/journals/esepHuman subjects and research ethics www.msu.edu/user/respeck1/HumanResearch.htmlInside Health Care www.insideinfo.comInstitutional Review Board Services www.irbservices.comPRIM&R www.primr.org

/tt/file_convert/61448a03b5d1170afb43f076/document.doc

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