Ethics Workshop4 November 2014

Ethics & Research: the OU Framework

Dr Duncan Banks, Chair, Open University

Human Research Ethics Committee

Copy of talk at: http://tinyurl.com/pxh7uxb

The Open University is committed to maintaining standards of professional conduct in all research activities and central to the principles that guide research is that it must be conducted in accordance with the highest contemporary ethics standards.

Research Ethics

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Research Ethics

To ensure this OU research ethics support includes the:

•Human Research Ethics Committee (HREC)•Research Ethics Reference Group (RERG)•Animal Welfare and Ethical Review Body (AWERB)

More information on how each can offer support and guidance for your research is available from the Research Ethics website including information on research ethics approval processes and frequently asked questions.

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Overview

• Brief history of development of research ethics

• Ethics principles

• Research benefits, risks and constituencies

• The OU HREC structure and process

• Initial checklist, Important areas to include and Protocols

• Updated Research Ethics Advice

• When things go wrong

• Discussion

A brief and highly selective history of the development of research ethics to identify the elaboration of issues and practices

1750 BC Hammurabi’s code (Babylon)

• 113. If a physician make a large incision with an operating knife and cure it, or if he open a tumour (over the eye) with an operating knife, and saves the eye, he shall receive ten shekels in money.

• 115. If a physician make a large incision with the operating knife, and kill him, or open a tumour with the operating knife, and cut out the eye, his hands shall be cut off.

500 BC Hippocrates

I will give no deadly medicine to any one if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion....

Into whatever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption ...

Whatever, in connection with my professional service, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.

1833 Beaumont’s code (USA)

• There must be recognition of an area where experimentation in man is needed.

• Some experimental studies in man are justifiable when the information cannot otherwise be obtained.

• The investigator must be conscientious and responsible ... for a well considered, methodological approach is required so that as much information as possible will be obtained whenever a human subject is used. No random studies are to be made.

• The voluntary consent of the subject is necessary.

• The experiment is to be discontinued when it causes distress to the subject.

• The project must be abandoned when the subject becomes dissatisfied.

1931 The Reich circular (Germany)

• 5. Innovative therapy may be carried out only after the subject or his legal representative has unambiguously consented to the procedure in light of relevant information provided in advance. Where consent is refused, innovative therapy may be initiated only if it constitutes an urgent procedure to preserve life or prevent serious damage to health and prior consent could not be obtained under the circumstances.

• 7. Exploitation of social hardship in order to undertake innovative therapy is incompatible with the principles of medical ethics.

After WW2, in October 1946, the Nuremberg Medical Trial began, lasting until August of 1947. Twenty-three German

physicians and scientists were accused of performing cruel and lethal medical experiments on concentration camp inmates and

other living humans between 1933 and 1945.

Fifteen defendants were found guilty, and eight were acquitted. Of the 15, seven were executed and eight were imprisoned.

1947 The Nuremberg Code

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

1947 The Nuremberg Code

• The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

• The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

1964 Declaration of Helsinki (Finland)

“In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.”

1966-2008

• 1966 formation of first British REC

• 1978 British Psychological Society research ethics code

• 1991 Department of Health guidance for RECs

• 1999 Association of Research Ethics Committees

• 2000 Central Office for Research Ethics Committees

• 2001 European Union Directive 2001/20/EC

• 2004 UK Clinical Trials Regulations

• 2004 RESPECT framework - socio-economic research

• 2004 ESRC Research Ethics Framework

• 2007 National Research Ethics Service

• 2008 Integrated Research Application System (IRAS)

Code for European Social Science:

1.Upholding scientific standards2.Compliance with the law3.Avoidance of social and personal harm

RESPECT project (socio-economic)

Respect for the dignity of persons

1. Responsible caring2. Integrity in relationships3. Responsibility to society

Canadian Psychological Association

The six key principles:

1. Research should be designed, reviewed and undertaken to ensure integrity, quality and transparency.

2. Research staff and participants must normally be informed fully about the purpose, methods and intended possible uses of the research, what their participation in the research entails and what risks, if any, are involved. Some variation is allowed in very specific research contexts.

3. The confidentiality of information supplied by research participants and the anonymity of respondents must be respected.

4. Research participants must take part voluntarily, free from any coercion.

5. Harm to research participants must be avoided in all instances.

6. The independence of research must be clear, and any conflicts of interest or partiality must be explicit.

ESRC Framework for Research Ethics

• Respect for the Autonomy and Dignity of Persons

• Scientific Value

• Social Responsibility

• Maximising Benefit and Minimising Harm

BPS Code of Human Research Ethics

Respect for the Autonomy and Dignity of Persons

Adherence to the concept of moral rights is an essential component of respect for the dignity of persons. Rights to privacy, self-determination, personal liberty and natural justice are of particular importance to psychologists, and they have a responsibility to protect and promote these rights in their research activities. As such, psychologists have a responsibility to develop and follow procedures for valid consent, confidentiality, anonymity, fair treatment and due process that are consistent with those rights.

BPS Code of Human Research Ethics

Scientific Value

Research should be designed, reviewed and conducted in a way that ensures its quality, integrity and contribution to the development of knowledge and understanding. Research that is judged within a research community to be poorly designed or conducted wastes resources and devalues the contribution of the participants. At worst it can lead to misleading information being promulgated and can have the potential to cause harm.

BPS Code of Human Research Ethics

Social Responsibility

The discipline of psychology, both as a science and a profession, exists within the context of human society. Accordingly, a shared collective duty for the welfare of human and non-human beings, both within the societies in which psychology researchers live and work, and beyond them, must be acknowledged by those conducting the research.

BPS Code of Human Research Ethics

Maximising Benefit and Minimising Harm

… psychologists should consider all research from the standpoint of the research participants, with the aim of avoiding potential risks to psychological well-being, mental health, personal values, or dignity.

BPS Code of Human Research Ethics

Research risks and harm, benefits and goods,and constituencies

Risks and Harm

• physical trauma/injury?

• distress?

• offence?

• breach of confidentiality?

• inconvenience?

• coercion?

• waste of time?

• waste of resources / funds?

• disrepute or litigation?

• failure to publish

Benefits and Goods

• research as intrinsic good?

• contribution to knowledge?

• development of theories?

• improvements to lives?

• training researchers?

• career advancement?

• enhancing reputation/image?

• increasing commercial success?

• entertainment and enjoyment?

Constituencies

• participants

• researchers

• institutions

• sponsors / funding bodies

• society

The Open UniversityHuman Research Ethics Committee

structure and processes

Governance structure

Research Degrees Committee (RDC)

Research Degree Examination Results Ratification Sub Committee (RRAT)

MRes Award Board (MRes AB)

Affiliated Research Centres Management Group (ARCMG)

MRes Management Group (MRes MG)

Life & Biomolecular Sciences Management Group (LBSMG)

Theology and Religious Studies Management Group (TRS)

Human Research

Ethics Committee (HREC)

RESEARCH COMMITTEE

Innovation & Enterprise Advisory Group (IEAG)

Research Careers Working Group (RCWG)

Research Strategy Advisory Group (RSAG)

Indicates governance reporting lineIndicates advisory/management reporting line

HREC scope and roles

• All persons carrying out research with a contract of employment with The Open University – ethics review and approval role

• Taught undergraduate and postgraduate students of The Open University and students in ARCs and sponsoring establishments – advisory and review role

• The Open University research community –education and policy development role

• National HEI research community –research ethics environment scanning and contributions to national developments

HREC committee

Membership

1. Four external members appointed by the Pro-Vice-Chancellor (Research & Enterprise), to include: a medical practitioner, a researcher from a research institution other than the Open University, a lay person and a representative from a corporate body

2. The chair of the Research Committee ex officio, or nominee

3. Two members nominated by the Research Committee

4. Up to seven members co-opted by the committee so as to cover any aspect, professional, scientific or ethical, of a research proposal which lies beyond the expertise of existing members

HREC process

• Extensive intranet and WWW support site

• Informal advice and support

• Workshops, training and induction sessions

• Responsive ethics review and approval system:

– pre-review scan and advice

– electronic submission using AMS

– scrutiny panel, 3 HREC members, inc. external

– 15 day maximum turnaround

Research Ethics website

http://www.open.ac.uk/research/ethics/index.shtml

Code of Practice for Research

http://www.open.ac.uk/research/main/our-research/research-strategy-and-policiesGo to the bottom of this page for the CoP

Frequently Asked Questions

http://www.open.ac.uk/research/ethics/human-FAQs.shtml

Q1. Do I need ethics approval for my research?Q2. How do I apply for ethical approval?Q3. Are you conducting research in the NHS?Q4. I want to gather data from OU students. Do I apply to the Human Research Ethics Committee (HREC)?Q5. Which guidelines should I follow?Q6. What is a 'protocol'?Q7. What is data protection?Q8. I am submitting an application for a grant for a project collecting data from human participants. Do I need ethical approval?Q9. Why 'participant' and not 'subject'?Q10. What is DBS and do I need it?Q11. I want to run a Web survey. Does it need ethical clearance?Q12. Are payments made to Research volunteers defined as 'earnings'?Q13. Is my research covered by OU insurance?Q14. How do I obtain consentQ15. Are generic protocols and templates available?

Frequently Asked Questions

HREC Ethics review process

• Review and approval of proposed research projects by HREC are undertaken through a virtual process of emails but may also include telephone discussions or face-to-face meetings.

• HREC applications can be stand alone for projects that are OU funded or linked to an externally funded bid/project.

The OU’s Ethics Review Process

The Ethics checklist (see hand-out)1. Does the study involve participants who are particularly vulnerable

or unable to give informed consent? (e.g. children, people with learning disabilities)

2. Will the study require the co-operation of a gatekeeper for initial access to the groups or individuals to be recruited? (e.g. students at school, members of a self-help group, residents of nursing home)

3. Will it be necessary for participants to take part in the study without their knowledge and consent at the time? (e.g. covert observation of people in non-public places)

4. Will the study involve discussion of sensitive topics (e.g. sexual activity, drug use)?

5. Are drugs, placebos or other substances (e.g. food substances, vitamins) to be administered to the study participants or will the study involve invasive, intrusive or potentially harmful procedure of any kinds?

6. Is pain or more than mild discomfort likely to result from the study?7. Could the study induce psychological stress or anxiety or cause

harm or negative consequences beyond the risks encountered in normal life?

8. Will the study involve prolonged or repetitive testing?9. Will financial inducements (other than reasonable expenses and

compensation for time) be offered to participants?10. Will the study involve recruitment of patients or staff through the

NHS or the use of NHS data?11. Will the study involve the collection of human tissue or other

human biological samples?

The Ethics checklist (see hand-out)

HREC Ethics proforma headings,ethics ‘protocol’

HREC Ethics headings (see hand-out)• Project: a short, descriptive title.

• Project SharePoint Link: (intranet – requires VPN)

• Description: a summary of the main points of the research, written in terms easily understandable by a non-specialist and containing no technical terms.

• Investigators: Give names and institutional attachments of all persons involved in the collection and handling of individual data. Name one person as Principal Investigator (PI). Research students should ask their primary supervisor to endorse their application quoting the HREC reference number assigned to them. Research students should normally name themselves as Principal Investigator.

HREC Ethics headings

• Literature review: Provide an indicative brief review of the existing literature or previous research. Clarify whether the proposed study replicates prior work AND/OR duplicates work done elsewhere AND/OR has an element of originality.

• Methodology: Outline the method(s) that will be employed to collect and analyse data.

• Participants: Give details of the population targeted or from which you will be sampling and how this sampling will be done. Give information on the diversity of the sample.

• Recruitment procedures: Give details of how potential participants will be identified and approached.

• Consent: Give details of how valid consent will be sought and attach copies of information sheet(s) and consent form(s) if applicable. Give details and a timeframe of how participants can withdraw consent and what will happen to their data in such a case (see the Research Ethics website for a guidance document).

• Location(s) of data collection: Give details of where and when data will be collected. If on private, corporate or institutional premises, indicate what approvals are gained/required. Explain why the research needs to be conducted in the chosen setting or location.

HREC Ethics headings

HREC Ethics headings• Schedule: Time frame for the research and its data

collection phase(s).

• Published ethics and legal guidelines to be followed: Detail which guidelines will be followed by the researchers. Examples:-

British Educational Research Association (BERA)

British Psychological Society (BPS)

British Sociological Association (BSA)

Social Research Association (SRA)

Market Research Society (MRS)

Social Policy Association (SPA)

UK Evaluation Society (UKES)

HREC Ethics headings

• Data Protection: Give details of registration of the project under the DP Act and the procedures and schedule (including dates) to be followed re: storage and disposal of data to comply with the Act. Any requirements by the funding body should also be given. Indicate the earliest and latest date for the destruction of original data if that is required – or any archiving arrangements that have been agreed/permitted/required. Ensure this is also indicated in the project schedule.

HREC Ethics headings - Data Protection

• Protecting the privacy of the individual in relation to their personal information.

• Ensuring the reliability of any information used and its fair and legitimate use by everyone.

Legal penalties may arise if personal data is not looked after properly.  Any stored personal data is covered by the Data Protection Act (1998) and if you gather such data in connection with your research whilst at the OU, you will need to register your project with  the OU Data Protection Office, Data-Protection@open.ac.uk. 

Data Protection – good practice

It is good practice to separate collected data from personal identity information as soon as possible after collection and to use codes to identify individual cases if necessary. The key linking such codes to identity information such as names, addresses and telephone numbers should be kept secure and separate from the dataset, accessible only to a strictly limited number of project staff.

HREC Ethics headings

• Recompense to participants: normally, recompense is only given for expenses and inconvenience, otherwise it might be seen as coercion/inducement to participate. Give details of any recompense to participants.

• Deception: give details of the withholding of any information from participants, or misrepresentation or other deception that is an integral part of the research. Any such deception should be fully justified.

• Risk of harm to participants: Detail any foreseen risks to participants or researchers (e.g. home visits) and, based on a risk assessment, the steps that will be taken to minimise/counter these. If the proposed study involves contact with children or other vulnerable groups, please confirm that the requirements of the DBS for each person involved in these contacts have been complied with.

• Debriefing: give details of how information will be given to participants after data collection to inform them of the outcomes of their participation and the research more broadly.

HREC Ethics headings

HREC Ethics headings

• Related risks: indicate how research risks are to be limited by anticipating potential problems.

• Benefits and knowledge transfer: state how the research may be of general benefit to participants and society in general.

• Declaration: declare here that the research will conform to the above protocol and that any significant changes or new ethics issues will be raised with the HREC before they are implemented.

• Public Disclosure of Ethics Application: In order to conform with OU governance guidelines, brief information on OU research approved by the HREC will be added to the Research Ethics website.

When things go wrong

• What happens if I carry out research on participants without HREC approval?

• What if I lose sensitive data?

• What if someone wants to withdraw from the study after I have anonymised the data?

• What happens if the risks of the research increase due to circumstances out of my control?

• I have recorded conversations without consent.

• I have used photographs of individuals or their names in publications without their consent.

Example guidelines

• British Educational Research Association• British Psychological Society• British Sociological Association• British Society of Criminology• ESRC Framework for Research Ethics (FRE)• Medical Research Council 55

Research Ethics Home Pagehttp://www.open.ac.uk/research/ethics/index.shtml

Research Ethics – Human participantshttp://www.open.ac.uk/research/ethics/human.shtml

Research Ethics – Animal usehttp://www.open.ac.uk/research/ethics/animal.shtml

Data protection FAQhttp://www.open.ac.uk/research/ethics/FAQs.shtml#p6

Student Research Project Panel FAQhttp://www.open.ac.uk/research/ethics/FAQs.shtml#p3

Useful links

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DiscussionCopy of talk at: http://tinyurl.com/pxh7uxb

Student Research Project Panel

The SRPP ensures that Open University enquirers, students or graduates are not asked to participate in institutional research that does not meet University Guidelines. All projects which involve the collection of data from samples of OU enquirers, students or graduates need to apply to SRPP for authorisation.  

You may need to get clearance from SRPP before applying for ethical approval.

Details of how to apply to SRPP can be found via the OU Research Ethics website