79C3C34C52B45572883A05D425EB0F82
CSO:Research Governance Framework for Health and Community Care (2006)
https://www.cso.scot.nhs.uk/wp-content/uploads/2013/02/RGF-Second-Edition-February-06.pdf
http://leaux.net/URLS/ConvertAPI Text Files/8422FD9662FB1A79E80ED2867436E3A0.en.txt
Examining the file media/Synopses/8422FD9662FB1A79E80ED2867436E3A0.html:
This file was generated: 2020-12-01 07:23:53
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
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p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
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p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
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Health / Drug Usage
Searching for indicator drug:
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p.000015:
p.000015: • Arranging for an appropriate person to give permission for research involving their patients, service users,
p.000015: carers or staff, before the research starts.
p.000015: • Ensuring any such research is conducted to the standards set out in this research governance framework.
p.000015: • Requiring evidence of ethical review before recruitment to any research that affects their duty of care.
p.000015: • Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical
p.000015: trials authorisation.
p.000015: • Retaining responsibility for the care of participants to whom they have a duty. See 3.29 to 3.34
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p.000016: 16
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p.000016: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN HEALTH RESEARCH
p.000016:
p.000016: SCENARIO: WHO IS RESPONSIBLE FOR WHAT? SOME QUESTIONS AND ANSWERS
p.000016:
p.000016: The Scenario: the Medical Research Council (MRC) awards a university Senior Lecturer in General Practice a grant for a
p.000016: clinical trial of a medicine. The grant is paid to the university. The MRC was closely involved in developing the
p.000016: trial design. The research is taking place in general practices. The Medicines and Healthcare products Regulatory
p.000016: Agency (MHRA) has agreed that the university and the relevant NHS Board form a group to take on the sponsor’s
p.000016: responsibilities. The manufacturer of the drug has agreed to provide it free. The drug has a marketing authorisation
p.000016: covering the use of the product described in the research protocol.
p.000016:
p.000016: PATIENT
p.000016:
p.000016: Q: I did tell my GP that I might be interested in joining the study, but that does not commit me definitely, does
p.000016: it?
p.000016: A: Your GP agreed to collaborate with the research team, and invite her patients to participate. Whether or not
p.000016: you agree is entirely up to you. Unless you consent, you won’t be in the study.
p.000016:
p.000016: Q: How can I know the study is worthwhile?
p.000016: A: Through independent expert review (“peer review”), the MRC assessed the clinical importance of the questions
p.000016: addressed by the study. It also assessed the design and oversight arrangements. An ethics committee checked it is
p.000016: ethical. The MHRA authorised it.
p.000016:
p.000016: Q: How can I find out more about it?
p.000016: A: You can take away this patient information leaflet to study, and you can ask your GP or anyone on the research
p.000016: team for further details.
p.000016:
p.000016: Q: What if the drug involved does not agree with me?
p.000016: A: Your GP is still responsible for your care. She knows how we plan to monitor people who are in the trial. We
p.000016: will advise her immediately if we detect any problems, and you can approach her at any time. It is important for you
p.000016: to say if you have a bad reaction to the drug.
p.000016:
p.000016: G.P.
p.000016:
p.000016: Q: How do I know that this study is well designed?
p.000016: A: The university and NHS Board are together sponsoring the study. The protocol names the sponsors’ contact
p.000016: points. The scientific design went through the MRC’s review system. It has ethical approval, and regulatory approval
p.000016: from the licensing authority. But you must decide whether you feel able to collaborate with it.
p.000016:
p.000016: Q: Who is responsible for the care of my patients if they agree to take part?
p.000016: A: You are. The protocol explains the procedures the research team will follow and the circumstances when they
p.000016: will alert you to anything they observe in your patients. You must ensure you are satisfied with these arrangements
p.000016: and discuss them with the chief investigator if you are not.
p.000016:
p.000016: Q: Who is responsible for ensuring that the study follows the protocol and data are monitored to detect any
p.000016: possible problems?
p.000016: A: The chief investigator is responsible for ensuring that you and every other person involved in the study is
p.000016: well informed, and able to carry out their roles properly. This is a trial of a medicine, so there is a legal
p.000016: responsibility to follow the protocol. If you have any concerns about this, you should contact the chief investigator.
p.000016: If you are not satisfied, you should inform the sponsor’s representative.
p.000016:
p.000016: Q: Who is responsible for the quality of the drugs?
p.000016: A: The pharmaceutical company supplying the drugs is responsible for their quality. Medicines have to be made in
p.000016: licensed facilities, and must be correctly labelled for trials.
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p.000017: 17
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p.000017: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN RESEARCH (CONTINUED)
p.000017:
p.000017: Q: I have agreed to join the study, but a number of my patients are having trouble understanding what they are
p.000017: being asked to take part in. It's taking up an enormous amount of time. What should I do?
p.000017: A: Please talk to the chief investigator. A better understanding of the consent process could resolve the
p.000017: issues. Perhaps communication with your patients could be improved, for example by revising the patient information
p.000017: leaflet. If there are still problems you are free to withdraw.
p.000017:
p.000017: Q: One of my patients seems much worse since I entered him into the trial. He is keen to continue, but I am
p.000017: concerned. What should I do?
p.000017: A: Your primary responsibility is the patient’s care. You have a duty to put his safety before anything required
p.000017: by the research. You should advise him to withdraw if you think that the trial drug caused his problems. Explain to
p.000017: him that you will talk to the research team on his behalf. It is very important you inform the chief investigator of
p.000017: any concerns about treatment under the trial. In trials of medicines, it is a legal requirement to report harmful
p.000017: reactions to the MHRA so that everyone can learn from them.
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p.000017: CHIEF INVESTIGATOR
p.000017:
p.000017:
p.000017: Q: How do I know when the trial is authorised?
p.000017: A: As it falls under the Medicines for Human Use (Clinical Trials) Regulations 2004, the trial has to be
p.000017: authorised by the MHRA. The MHRA notifies sponsors when trials are authorised. The sponsor’s representative will tell
p.000017: you when the drugs can be released for use in the trial.
p.000017:
p.000017: Q: What about ethical review?
p.000017: A: You have submitted the study to an ethics committee recognised for this kind of study, using the electronic
p.000017: form available on the Central Office for Research Ethics Committees (COREC) website. You need a positive ethics
p.000017: committee opinion as well as a Clinical Trial Authorisation before you can start the trial.
p.000017:
p.000017: Q: To whom must I report an adverse event?
p.000017: A: For this trial, the sponsors have delegated to you the responsibility for recording and reporting adverse
p.000017: events. The MHRA will issue the Clinical Trial Authorisation on that basis so you have to follow the agreed process
p.000017: for recording adverse events, assessing seriousness, relatedness and expectedness, and reporting. You must arrange to
p.000017: report any worrying reaction immediately to the patient’s GP. Adverse drug reactions must also be reported to the
p.000017: Trial Steering Committee, the drug manufacturer, the MHRA, the ethics committee and the Data Monitoring Committee.
p.000017: Under the Clinical Trials Regulations, there is a legal obligation to report suspected unexpected serious adverse
p.000017: reactions (SUSARs) to the MHRA within a set period.
p.000017:
p.000017: Q: I am concerned that the staff in the university labs may not follow health and safety rules. What do I do?
p.000017: A: You should raise this concern through the university's local health and safety systems.
p.000017:
p.000017: Q: I am concerned that not all the investigators will follow the protocol closely. What should I do?
p.000017: A: Inform the sponsor’s representative immediately and agree a course of action.
p.000017:
p.000017: Q: If my team need training, whom should I talk to?
p.000017: A: Their employer is normally responsible for their training.
p.000017:
p.000017: Q: To whom do I talk if I suspect a university colleague is fabricating data?
p.000017: A: Your university as your colleague’s employer is responsible for investigating the suspected misconduct.
p.000017: Others such as the General Medical Council may also be responsible for looking into your suspicions if they appear to
p.000017: involve professional misconduct. If you suspect someone employed by another organisation, raise your concerns with
p.000017: your employer, who as sponsor will contact your colleague’s employer. In any case, record the evidence carefully so
p.000017: that there can be a proper investigation.
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p.000018: 18
p.000018:
p.000018: Q: I have new information that makes me think that we could improve the design of this study. What do I do?
p.000018: A: You should discuss this with the Trial Steering Committee. If they agree, you will need to draw up a revised
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p.000019: 19
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p.000019: Responsibilities of Participants
p.000019:
p.000019: 3.8 Effective and responsive services depend on good research. Through this framework and related provisions, the
p.000019: Government and its partners strive to ensure that research conducted in Scotland offers the likelihood of real benefits
p.000019: either to those who participate, or to those who use services subsequently, or to both. Anyone using
p.000019: health services should give serious consideration to becoming involved in developing or undertaking research
p.000019: studies.
p.000019:
p.000019: 3.9 Researchers are responsible for selecting means of communication that ensure that potential participants are
p.000019: fully informed before deciding whether or not to join a study. In clinical trials involving medicines, there
p.000019: is a legal requirement to provide an interview with a member of the research team and a contact point
p.000019: offering further information about the trial. Potential participants should not hesitate to ask if they do not
p.000019: understand the information and explanations given.
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p.000019: Responsibilities of Researchers
p.000019:
p.000019: 3.10 Researchers bear the primary day-to-day responsibility for the conduct of research. They are responsible for:
p.000019:
p.000019: • Ensuring that any research they undertake follows the current version of the agreed protocol (or proposal);
p.000019: • helping care professionals to ensure that participants receive appropriate care while involved in research;
p.000019: • reporting any adverse drug reactions or other adverse events;
p.000019: • protecting the integrity and confidentiality of clinical and other records and data generated by the research; and
p.000019: reporting any failures in these respects, or suspected misconduct, through the appropriate systems.
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p.000019: Responsibilities of Investigators and the Chief Investigator
p.000019:
p.000019: 3.11 A senior individual must be designated as the chief investigator for the research. This person
p.000019: normally takes responsibility for the conduct of the research at a site and is accountable for it to their employer,
p.000019: and, through them, to the sponsor of the research. They are also directly accountable to the care organisation(s)
p.000019: where the research takes place (or through which the research team has access to participants, their organs, tissue
p.000019: or data). If the research is at more than one site, the chief investigator takes on personal
p.000019: responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the
p.000019: lead at each site.
p.000019:
p.000019: 3.12 Chief investigators must have suitable experience and expertise in the design and conduct of research12 so that
p.000019: they are able either to undertake the design, conduct, analyses and reporting of the study to the standards set out in
p.000019: this framework or lead and manage others with delegated responsibility for some of these aspects.
p.000019:
p.000019: 3.13 It is the chief investigator’s responsibility to ensure that:
p.000019:
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p.000019: 12 For clinical trials involving medicines, the chief investigator and other investigators must be authorised
p.000019: healthcare professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.
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Health / Healthy People
Searching for indicator volunteers:
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p.000004: launched by Quality Improvement Scotland (QIS) in 2005. The performance of NHS Boards and Special Health
p.000004: Boards will be assessed against these standards which include compliance with research governance.
p.000004:
p.000004: 2.2 Health research is not the province of a single discipline, profession or organisation and no single document
p.000004: adequately captures the full range of legislation, standards and good practice guidelines that apply to this wide-
p.000004: ranging body of work. They are presented here in six domains:
p.000004:
p.000004: ◻ ethics
p.000004: ◻ science
p.000004: ◻ information
p.000004: ◻ health and safety
p.000004: ◻ finance
p.000004: ◻ quality research culture.
p.000004:
p.000004: 2.3 Each domain has been grouped as follows:
p.000004:
p.000004: ◻ requirements in legislation and regulations
p.000004: ◻ standards required by SEHD
p.000004: ◻ other established principles of good practice from recognised international and national authorities and
p.000004: professional organisations.
p.000004:
p.000004: 2.4 The Chief Scientist Office website will provide regular updates of detail. The following sections
p.000004: set out principles in each domain.
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p.000004: Ethics
p.000004:
p.000004: 2.5 The dignity, rights, safety and well-being of participants must be the primary consideration in any research
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
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Health / Mentally Disabled
Searching for indicator disabled:
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p.000006: analysis by the original or other research teams subject to consent and to support monitoring by regulatory and other
p.000006: authorities.
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p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
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p.000006:
p.000006: 7 The Medicines for Human Use (Clinical Trials) Regulations transposed Directive 2001/20/EC into UK law.
p.000006: 8 The Medical Research Council (MRC) issued guidelines in 1998 for Good Clinical Practice in clinical trials in
p.000006: the public and charity sectors. The MRC guidelines apply the principles of Good Clinical Practice in the 1996
p.000006: statement of the International Conference on Harmonisation (ICH GCP).
p.000006: 9 There is an international consensus that, with certain exemptions, information identifying a clinical trial of a
p.000006: treatment should be available on a public register from the time the first participant is recruited.
p.000007: 7
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p.000007: should be presented in a format understandable to the public. Reports need to be comprehensible and take language and
p.000007: other needs into account.
p.000007:
p.000007: 2.18 Some advances in healthcare need to be developed commercially if they are to be made widely available. Medicines,
p.000007: medical devices and aids for disabled people are examples. Successful commercial development often depends upon the
p.000007: protection of intellectual property or commercial confidentiality at critical points in the innovation
p.000007: process. The timing of the publication of research findings needs to take account of this.
p.000007:
p.000007: 2.19 All those conducting health research must open their work to critical review through the accepted scientific and
p.000007: professional channels. Once established, findings must be made accessible to those participating10 and to all those
p.000007: who could benefit from them. This may be through publication and/or other means appropriate to the type of research.
p.000007: Data relevant to findings should also be accessible.
p.000007:
p.000007: Health and Safety
p.000007:
p.000007: 2.20 Health research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The
p.000007: safety of participants and of research and other staff must be given priority at all times, and health and safety
p.000007: regulations must be strictly observed - including the provision of information, containment, shielding and
p.000007: monitoring as required.
p.000007:
p.000007: Finance
p.000007:
p.000007: 2.21 Financial probity and compliance with the law and with the rules laid down by the Scottish Executive and H M
p.000007: Treasury for the use of public funds are as important in research as in any other area. Organisations employing
p.000007: researchers must be in a position to compensate anyone harmed by their negligence. If an organisation
p.000007: offers to compensate participants in the event of non-negligent harm, it must be in a position to do so.
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Searching for indicator disability:
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p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
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p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
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p.000010: 10
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p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
p.000010: ready access to the findings at the end of the study.
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
p.000010: sponsors and has systems in place to deter, detect and deal with fraud.
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Social / Access to Social Goods
Searching for indicator access:
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p.000006: or costly proposal. In others, many organisations allow established research teams to determine details
p.000006: of the elements of an overall programme of research which has been reviewed externally. For student
p.000006: research projects, the university supervisor is normally able to provide adequate review.
p.000006:
p.000006: 2.14 The Medicines for Human Use (Clinical trials) Regulations 20047 regulate trials of medicines on people.
p.000006: Authorisation by the Medicines and Healthcare products Regulatory Agency is required. The Agency
p.000006: offers advice and undertakes inspections for such trials - and the manufacture and assembly of products used in
p.000006: them - against international standards. The same Agency regulates research involving new medical devices.
p.000006: The principles of Good Clinical Practice apply to all health research involving patients, not just clinical trials.8
p.000006:
p.000006: 2.15 Special regulations govern the use of human embryos, the release of genetically modified organisms
p.000006: and food or food processes and further information on these areas should be sought where appropriate.
p.000006:
p.000006: 2.16 Data collected in the course of health research must be retained for an appropriate period to allow further
p.000006: analysis by the original or other research teams subject to consent and to support monitoring by regulatory and other
p.000006: authorities.
p.000006:
p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
p.000006:
p.000006:
p.000006:
p.000006: 7 The Medicines for Human Use (Clinical Trials) Regulations transposed Directive 2001/20/EC into UK law.
p.000006: 8 The Medical Research Council (MRC) issued guidelines in 1998 for Good Clinical Practice in clinical trials in
p.000006: the public and charity sectors. The MRC guidelines apply the principles of Good Clinical Practice in the 1996
p.000006: statement of the International Conference on Harmonisation (ICH GCP).
p.000006: 9 There is an international consensus that, with certain exemptions, information identifying a clinical trial of a
p.000006: treatment should be available on a public register from the time the first participant is recruited.
p.000007: 7
p.000007:
p.000007: should be presented in a format understandable to the public. Reports need to be comprehensible and take language and
p.000007: other needs into account.
p.000007:
p.000007: 2.18 Some advances in healthcare need to be developed commercially if they are to be made widely available. Medicines,
p.000007: medical devices and aids for disabled people are examples. Successful commercial development often depends upon the
p.000007: protection of intellectual property or commercial confidentiality at critical points in the innovation
p.000007: process. The timing of the publication of research findings needs to take account of this.
p.000007:
...
p.000009: earmarking funds specifically for R&D training across the professions. The organisation plays its role in developing
p.000009: research capacity with appropriate training and updating. This includes taking action to ensure that the
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
p.000010: ready access to the findings at the end of the study.
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
p.000010: sponsors and has systems in place to deter, detect and deal with fraud.
p.000010: • When research findings have commercial potential the organisation takes action to protect and
p.000010: exploit them, in collaboration with its research partners and – when appropriate – commercial
p.000010: organisations.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: 3. RESPONSIBILITIES AND ACCOUNTABILITIES
p.000011:
p.000011: General
p.000011:
p.000011: 3.1 Everyone involved in research with human participants, their organs, tissue or data is responsible for knowing
p.000011: and following the law and the principles of good practice relating to ethics, science, information, health and safety,
p.000011: and finance set out in this framework.
p.000011:
p.000011: 3.2 All those involved in research also have a duty to ensure that they and those they manage are appropriately
p.000011: qualified, both by education and experience, for the role they play in relation to any research. They must be aware
p.000011: of, and have ready access to, sources of information and support in undertaking that role.
p.000011:
p.000011: Agreements
p.000011:
p.000011: 3.3 A complex array of organisations and individuals may be involved in a health research study. It
p.000011: is essential that clear agreements describing allocation of responsibilities and rights are reached, documented
p.000011: and enacted.
p.000011:
p.000011: 3.4 Many agreements will relate to individual studies. Organisations that collaborate on a range of research
p.000011: work are encouraged to develop and document framework agreements to facilitate the agreement of responsibilities
p.000011: for specific studies; for example:
p.000011:
p.000011: ◻ NHS organisations who work together regularly on research, whether or not in a formal network;
p.000011: ◻ Universities and NHS organisations, primary care practices and research networks that work together
p.000011: regularly on research;
p.000011: ◻ local authorities and/or other community care providers, NHS organisations, and primary care practices that work
p.000011: together regularly on research whether or not in a formal research network.
p.000011:
p.000011: 3.5 It is particularly important to reach clear, documented agreements for complex studies where there may
p.000011: be:
p.000011:
p.000011: ◻ work on more than one site; and/or
p.000011: ◻ researchers employed by more than one organisation; and/or
p.000011: ◻ patients, service users and carers, and care professionals from more than one care organisation; and/or
p.000011: ◻ more than one funder.
p.000011:
p.000011: A recommended approach is for the scheme of organisation in the protocol to include a detailed allocation of
p.000011: responsibilities. Each site can then subscribe to its own responsibilities by an exchange of letters that refer to the
p.000011: protocol.
p.000011:
...
p.000019: fully informed before deciding whether or not to join a study. In clinical trials involving medicines, there
p.000019: is a legal requirement to provide an interview with a member of the research team and a contact point
p.000019: offering further information about the trial. Potential participants should not hesitate to ask if they do not
p.000019: understand the information and explanations given.
p.000019:
p.000019: Responsibilities of Researchers
p.000019:
p.000019: 3.10 Researchers bear the primary day-to-day responsibility for the conduct of research. They are responsible for:
p.000019:
p.000019: • Ensuring that any research they undertake follows the current version of the agreed protocol (or proposal);
p.000019: • helping care professionals to ensure that participants receive appropriate care while involved in research;
p.000019: • reporting any adverse drug reactions or other adverse events;
p.000019: • protecting the integrity and confidentiality of clinical and other records and data generated by the research; and
p.000019: reporting any failures in these respects, or suspected misconduct, through the appropriate systems.
p.000019:
p.000019: Responsibilities of Investigators and the Chief Investigator
p.000019:
p.000019: 3.11 A senior individual must be designated as the chief investigator for the research. This person
p.000019: normally takes responsibility for the conduct of the research at a site and is accountable for it to their employer,
p.000019: and, through them, to the sponsor of the research. They are also directly accountable to the care organisation(s)
p.000019: where the research takes place (or through which the research team has access to participants, their organs, tissue
p.000019: or data). If the research is at more than one site, the chief investigator takes on personal
p.000019: responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the
p.000019: lead at each site.
p.000019:
p.000019: 3.12 Chief investigators must have suitable experience and expertise in the design and conduct of research12 so that
p.000019: they are able either to undertake the design, conduct, analyses and reporting of the study to the standards set out in
p.000019: this framework or lead and manage others with delegated responsibility for some of these aspects.
p.000019:
p.000019: 3.13 It is the chief investigator’s responsibility to ensure that:
p.000019:
p.000019:
p.000019:
p.000019: 12 For clinical trials involving medicines, the chief investigator and other investigators must be authorised
p.000019: healthcare professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000020: 20
p.000020:
p.000020: • The research team gives priority at all times to the dignity, rights, safety and well-being of
p.000020: participants;
p.000020: • The study complies with all legal and ethical requirements;
p.000020: • The research is carried out to the standards in this research governance framework;
p.000020: • Controlled trials are registered and for clinical trials involving medicines, the research follows
p.000020: any conditions imposed by the licensing authority;
p.000020: • The Chief Executive of the care organisation(s) involved and/or any other individual(s) with
p.000020: responsibilities within this framework are informed that the study is planned, and their permission is obtained
...
p.000021: channels;
p.000021: • Once established, findings from the work are disseminated promptly and fed back as appropriate to
p.000021: participants;
p.000021: • The chief investigator accepts a key role in detecting and preventing scientific misconduct by adopting the
p.000021: role of guarantor on published outputs;
p.000021: • Arrangements are kept in place for the management of financial and other resources provided for
p.000021: the study, including for the management of any intellectual property arising;
p.000021: • All data and documentation associated with the study are available at the request of the inspection
p.000021: and auditing authorities.
p.000021:
p.000021: Responsibilities of Research Funders
p.000021:
p.000021: 3.14 Organisations that fund health research have a responsibility for ensuring that the work is a proper use of the
p.000021: funds they control and provides value for money.
p.000021:
p.000021: 3.15 The main research funder plays a critical role in assuring the quality of a study. It will normally take the
p.000021: lead in establishing that the research proposal is worthwhile, of high scientific quality, and represents good value
p.000021: for money.17
p.000021:
p.000021: 3.16 The main research funder is normally the organisation that makes the arrangements for independent expert
p.000021: review to assess the quality of the research proposed; the experience and expertise of the chief
p.000021: investigator and other key researchers involved; whether there is appropriate research infrastructure for
p.000021: the study: for example, management and governance arrangements, access to potential participants
p.000021: (or their organs, tissue or data); specialised facilities such as equipment, materials or support staff; and
p.000021: for trials on medicines, expert clinical trial management and the capacity to comply with the
p.000021: principles of Good Clinical Practice. If the main funder is unable to arrange for the independent expert review, it
p.000021: should expect the sponsor to arrange for it before taking on responsibility for the research, or to require another
p.000021: organisation to arrange for it. It is good practice for funders to make scientific judgements related to their
p.000021: responsibilities with expert advice independent of the investigators.
p.000021:
p.000021: 3.17 Funders are expected to provide assistance to any enquiry, audit or investigation related to the
p.000021: funded work.
p.000021:
p.000021: 3.18 Funders are expected to make their funding conditional on identifying a sponsor. Organisations wishing
p.000021: to fund research which requires the collaboration of the NHS in Scotland will either take on sponsorship themselves, or
p.000021: collaborate with another organisation which is willing and able to do so.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: 17 The value for money assessment compares the potential benefits with the resources that the study requires. These
p.000021: resources include any additional care or treatment costs, as well as the research costs that the funder is to meet.
p.000022: 22
p.000022:
p.000022: Responsibilities of the Sponsor
p.000022:
p.000022: 3.19 The sponsor is the individual, or organisation (or group of individuals or organisations)
p.000022: that takes on responsibility for confirming there are proper arrangements to initiate, manage and
p.000022: monitor, and finance a study18. For any research that takes place in the context of the NHS in
p.000022: Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for
p.000022: particular aspects of the arrangements for the study. It may be the chief investigator’s
p.000022: employing organisation, or the lead organisation providing healthcare, or the main funder. If
p.000022: the sponsor is outside the United Kingdom, it must have a legal representative in the United Kingdom.19 For
p.000022: any health research study covered by this research governance framework, it is for the sponsor to be
p.000022: satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management,
p.000022: monitoring and financing. Others will rely on reasonable assurances that the sponsor has taken steps to do this.
p.000022:
p.000022: 3.20 The sponsor is responsible for ensuring before a study begins that arrangements are in place for the research
p.000022: team to access resources and support to deliver the research as proposed and that arrangements are in place
p.000022: allocating responsibilities for the management, monitoring and reporting of the research. The sponsor also has to
p.000022: be satisfied there is agreement on appropriate arrangements to record, report and review significant
p.000022: developments as the research proceeds, particularly those which put the safety of individuals at risk and to approve
p.000022: any modifications to the design, obtain any regulatory authority required, implement them and make them known.
p.000022:
p.000022: 3.21 It is the sponsor’s responsibility to be satisfied with the arrangements for management and monitoring.
p.000022: Normally, if the chief investigator’s employer takes on the sponsor’s responsibilities (alone or as a member of a
p.000022: group), it will assume responsibility for operating the management and monitoring systems
p.000022: in collaboration with the employers of other members of the research team. Exceptionally, it may be inappropriate for
p.000022: the organisation employing the chief investigator to take responsibility for the management and monitoring of a study.
p.000022: In that case, the sponsor should make arrangements with one or more other organisations that will operate
p.000022: the management and monitoring systems.
p.000022:
p.000022: 3.22 Provided the sponsor keeps in place arrangements for performance management and audit, the responsibility for
p.000022: design and management may be delegated to the research team. The extent of delegation should be
p.000022: specified, even for a research team with proven expertise and track record. Commercial sponsors may
p.000022: arrange their own audit processes.
p.000022:
...
p.000022: allocation of sponsorship responsibilities within a group.
p.000022: 19 The Regulations require a sponsor to be established, or have a legal representative, in the European Community.
p.000022: Neither of them need to be established in the United Kingdom.
p.000023: 23
p.000023:
p.000023: external sponsor. When research is undertaken for research training purposes, research supervisors normally
p.000023: carry out the sponsorship responsibilities on behalf of their employers. Exceptionally, a university may authorise a
p.000023: suitably experienced postgraduate student to carry out these responsibilities on its behalf.
p.000023:
p.000023: 3.24 It is the sponsor’s responsibility to be satisfied that:
p.000023:
p.000023: • The research proposal respects the dignity, rights, safety and well-being of participants and the
p.000023: relationship with care professionals;
p.000023: • An appropriate process of independent expert review has demonstrated that the research proposal is
p.000023: worthwhile, of high scientific quality and good value for money;
p.000023: • An appropriate ethics committee has given a favourable opinion;
p.000023: • In the case of a clinical trial involving a medicine, someone acting on behalf of the sponsor obtains a
p.000023: clinical trial authorisation and the arrangements for the trial comply with the law;
p.000023: • Appropriate arrangements are in place for the registration of a trial;
p.000023: • The chief investigator, and other key researchers, including those at collaborating sites,
p.000023: have the necessary expertise and experience and have access to the resources needed to conduct the proposed research
p.000023: successfully;
p.000023: • The arrangements and resources proposed will allow the collection of high quality, accurate data and
p.000023: the systems and resources proposed are those required to allow appropriate data analysis and data protection;
p.000023: • Arrangements proposed for the work are consistent with this research governance framework;
p.000023: • Organisations and individuals involved in the research agree the division of responsibilities between
p.000023: them;
p.000023: • There is written agreement about the arrangements for the management and monitoring of the study;
p.000023: • Arrangements are in place for the sponsor and other stakeholder organisations to be alerted if significant
p.000023: developments20 occur as the study progresses, whether in relation to the safety of individuals or to scientific
p.000023: direction21;
p.000023: • Agreement has been reached about compensation in the event of harm to research participants22and
p.000023: if any organisation, or the sponsor itself, offers compensation without proof of negligence, it has made the
p.000023: necessary financial arrangements;
p.000023: • There are arrangements for the conclusion of the study including appropriate plans for disseminating the
p.000023: findings;
p.000023: • Scientific judgements made by the sponsor in relation to these responsibilities should be based on independent
p.000023: and expert advice;
p.000023: • The sponsor is expected to assist any enquiry, audit or investigation related to the funded work.
p.000023:
p.000023:
...
p.000027: the chief investigator and the appropriate authority. Then the chief investigator and the organisation
p.000027: will need to seek legal advice.
p.000027:
p.000027: 3.41 RECs require researchers working in the NHS to keep them informed of the progress of a study. The
p.000027: committees are responsible for reviewing their advice on the ethical acceptability of a study in the light of
p.000027: such information. The chief investigator and his or her employer, the sponsor and the care organisation
p.000027: are responsible for ensuring that a study follows the agreed protocol, and for monitoring and
p.000027: reporting on its progress.28
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 27 and the sponsor, for clinical trials involving medicines.
p.000027: 28 For clinical trials of medicines, sponsors have a legal duty to notify the ethics committee and the licensing
p.000027: authority if there are adverse events, a change to the design of the trial, and the conclusion of the trial.
p.000028: 28
p.000028:
p.000028: 4. ACHIEVING GOVERNANCE
p.000028:
p.000028: 4.1 Organisations conducting, sponsoring, funding or hosting health research must have systems to ensure that they
p.000028: and their staff understand and follow the standards and good practice set out in this framework.
p.000028:
p.000028: Delivery
p.000028:
p.000028: 4.2 They must have access to independent expert review that enables the main funder and the sponsor to be satisfied
p.000028: of the scientific and ethical standing of the work, its strategic relevance and value for money. This review must
p.000028: be appropriate to the scale and complexity of each research proposal.
p.000028:
p.000028: 4.3 Sponsors must be satisfied there are arrangements to ensure that each study is conducted according
p.000028: to the current agreed protocol, monitor and report on its general progress, and require written agreement
p.000028: on behalf of the sponsor to any modifications to the protocol or proposal, (and if necessary, ethical and
p.000028: regulatory approval). One of the organisations involved in the research will normally manage these arrangements. The
p.000028: sponsor must satisfy itself that a suitable organisation has accepted this responsibility.
p.000028:
p.000028: 4.4 Healthcare providers must have systems that ensure they are aware of research conducted in or through
p.000028: their organisation, whether or not it is externally funded. No study should begin until a person with authority
p.000028: to do so has given written permission29 on behalf of the care organisation. Healthcare organisations
p.000028: are expected to manage risk, minimise bureaucratic process and facilitate high quality research. They are not
p.000028: normally expected to withhold permission when a sponsor offers reasonable assurances that there are
p.000028: arrangements to carry out the responsibilities set out in this framework.
p.000028:
p.000028: 4.5 Healthcare providers may take on the sponsor’s responsibilities if they have systems to discharge them. It is
...
Social / Age
Searching for indicator age:
(return to top)
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
...
Social / Child
Searching for indicator child:
(return to top)
p.000019: this framework or lead and manage others with delegated responsibility for some of these aspects.
p.000019:
p.000019: 3.13 It is the chief investigator’s responsibility to ensure that:
p.000019:
p.000019:
p.000019:
p.000019: 12 For clinical trials involving medicines, the chief investigator and other investigators must be authorised
p.000019: healthcare professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000020: 20
p.000020:
p.000020: • The research team gives priority at all times to the dignity, rights, safety and well-being of
p.000020: participants;
p.000020: • The study complies with all legal and ethical requirements;
p.000020: • The research is carried out to the standards in this research governance framework;
p.000020: • Controlled trials are registered and for clinical trials involving medicines, the research follows
p.000020: any conditions imposed by the licensing authority;
p.000020: • The Chief Executive of the care organisation(s) involved and/or any other individual(s) with
p.000020: responsibilities within this framework are informed that the study is planned, and their permission is obtained
p.000020: before the research starts;
p.000020: • When a study involves participants under the care of a doctor, nurse or other worker for the
p.000020: condition to which the study relates, those care professionals are informed that their patients or users are being
p.000020: invited to participate and agree to retain overall responsibility for their care;
p.000020: • When the research involves a service user or carer or a child, looked after or receiving services
p.000020: under the auspices of the local authority, the agency director or their deputy agrees to the person (and/or
p.000020: their carer) being invited to participate and is fully aware of the arrangements for dealing
p.000020: with any disclosures or other relevant information;
p.000020: • Potential participants and other service users and carers are involved in the design and management
p.000020: of the study whenever appropriate;
p.000020: • The study is submitted for ethics review and it does not start without a favourable opinion, and
p.000020: the research team acts on any conditions attached to the ethics opinion;
p.000020: • Unless participants or the ethics opinion says otherwise, participants’ care professionals are given
p.000020: any information directly relevant to their care that arises in the research;
p.000020: • Each member of the research team, including those at collaborating sites, is qualified by education,
p.000020: training and experience to discharge his/her role in the study and their qualifications are documented;
p.000020: • Each investigator in a clinical trial involving medicines is aware of his/her legal duties;
p.000020: • Students and new researchers have adequate supervision, support and training;
...
Searching for indicator children:
(return to top)
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
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p.000008:
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p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: BOX A: FEATURES OF A QUALITY RESEARCH CULTURE IN THE NHS
p.000009:
p.000009: Quality Research Culture
p.000009: • The organisation supports and promotes high quality research as part of a service culture receptive
p.000009: to the development and implementation of best practice in the delivery of care. There is strong leadership
p.000009: of research and a clear strategy linking research to national priorities and needs, the organisation's
p.000009: business, and to clinical governance.
p.000009: • The organisation’s research strategy values diversity in its patients or service users and its staff,
p.000009: and promotes their active participation in the development, undertaking and use of research.
p.000009:
p.000009: Ethics
p.000009: • To safeguard the dignity, rights, safety and well-being of participants all research involving
p.000009: patients, service users, carers or care professionals and other staff, or their organs, tissue or data, is referred for
p.000009: independent ethical review.
p.000009: • Consent is sought in the way agreed during ethical review.
p.000009: • Research is pursued with the active involvement of service users and carers including, where appropriate, those
p.000009: from hard- to- reach groups such as homeless people.
p.000009: • If organs or tissue are used following post mortems, informed consent is obtained from relatives, and
p.000009: there is a commitment to respectful disposal of material.
p.000009: • If using animals is unavoidable, the highest standards of animal husbandry are maintained under
p.000009: veterinary supervision.
p.000009:
p.000009: Science
p.000009: • There is commitment to the principle and practice of scientific review by independent experts, with scrutiny of
p.000009: the suitability of protocols or proposals and research teams for all work in the organisation.
p.000009: • There is close collaboration with partner organisations in higher education and care to ensure quality and
p.000009: relevance of joint work and avoidance of unnecessary duplication of functions.
p.000009: • The organisation’s human resource strategy includes commitment to support research careers (full and part-time) by
p.000009: earmarking funds specifically for R&D training across the professions. The organisation plays its role in developing
p.000009: research capacity with appropriate training and updating. This includes taking action to ensure that the
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
...
Social / Incarcerated
Searching for indicator prison:
(return to top)
p.000001: community care. The public has a right to expect high scientific, ethical and financial standards,
p.000001: transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements.
p.000001:
p.000001: 1.2 This document sets out a framework for the governance of research in health and community care.
p.000001: The principles underpinning the framework apply to all research which relates to the responsibilities of the Minister
p.000001: for Health and Community Care. That is, research concerned with the protection and promotion of
p.000001: public health, research undertaken in or by the Scottish Executive Health Department, (SEHD), its non-
p.000001: Departmental Public Bodies and the NHS, and community care research. Within this context, it applies to
p.000001: clinical and non-clinical research; research undertaken by NHS or community care staff using the resources of health
p.000001: and community care organisations; and any research undertaken by industry, charities, research councils and
p.000001: universities within the health and community care systems that might have an impact on the quality of those services.
p.000001:
p.000001: 1.3 This framework does not apply to research concerned with the delivery of local authority services outwith the
p.000001: Minister for Health and Community Care's responsibilities unless they are carried out in NHS settings or
p.000001: in collaboration with NHS care providers. In addition, the framework does not apply to research in the Scottish
p.000001: Prison Service except where this involves medical treatment or the provision of other health services. Although this
p.000001: work is governed by separate arrangements, the principles underpinning this framework should be
p.000001: applied whenever possible.
p.000001:
p.000001: 1.4 Important differences between health and community care research mean that the precise mechanisms by which
p.000001: relevant standards and requirements are achieved will differ. Compared with much research in the NHS, research
p.000001: in community care differs in nature, scale, volume and funding as well as in the mix of stakeholders, the
p.000001: organisational context and the range of academic disciplines. This framework focuses on requirements and standards,
p.000001: delivery mechanisms, and arrangements to monitor quality for health research. It is expected that
p.000001: organisations involved in community care research will develop their own mechanisms for the delivery, monitoring
p.000001: and assessment of research which reflect the principles set out in this framework, are proportionate to the
p.000001: risk involved and have regard to existing codes of good practice. The Scottish Executive is reviewing and
p.000001: improving existing ethical assurance processes for social research it commissions or undertakes to support
p.000001: Ministers and policy development taking account of the framework principles.
p.000001:
p.000001: 1.5 The aim of this framework is to bring together general principles of good practice. It refers to the law on
p.000001: clinical trials involving medicines. That does not mean it imposes the same procedures on other research when the
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000024: framework, and under the law. They may do this, for example, through terms of employment, staff handbooks,
p.000024: and training. They will normally take on some or all of the responsibility for ensuring that a study is
p.000024: properly managed and for monitoring its progress. When the employing organisation is not the sponsor, it should agree
p.000024: its responsibilities with the sponsor and the organisation(s) providing care. The sponsor has to be
p.000024: satisfied with the arrangements for the management of a study, and that there is agreement on appropriate
p.000024: arrangements for monitoring and reporting23.
p.000024:
p.000024: 3.27 Employers should ensure there are agreements between them and their staff and between them and
p.000024: research funders and care organisations about ownership, exploitation and income from any intellectual property
p.000024: that may arise from research conducted by their employees. They have a responsibility for ensuring that
p.000024: employees identify and protect intellectual property.
p.000024:
p.000024: 3.28 Universities and other employers of staff engaged in research are responsible for:
p.000024:
p.000024: • Compliance with all current employment and health and safety legislation;
p.000024: • Demonstrating the existence of clear codes of practice in other areas for their staff and
p.000024: mechanisms to monitor and assess compliance;
p.000024: • Ensuring that investigators and other research staff are aware of understand and comply with this framework;
p.000024: • Discharging their agreed role in the management and monitoring of work undertaken by their
p.000024: organisation;
p.000024: • Demonstrating systems for continuous professional development of staff at all levels;
p.000024: • Having agreements and systems to identify, protect and exploit intellectual property;
p.000024: • Ensuring that they are able to compensate anyone harmed as a result of negligence on the part of
p.000024: staff, students and others for whom they have liability; and, if they have agreed to do so, to compensate participants
p.000024: for non-negligent harm arising from the research;
p.000024: • Having systems to detect and address fraud, and other scientific or professional misconduct by their staff;
p.000024:
p.000024:
p.000024: 23 For clinical trials involving medicines, the sponsor has to put and keep in place arrangements for the purpose of
p.000024: ensuring that the conditions and principles of Good Clinical Practice are satisfied or adhered to.
p.000025: 25
p.000025:
p.000025: • Having systems to process, address and learn lessons from any errors or complaints brought against
p.000025: their employees;
p.000025: • Permitting and assisting in any statutory inspection, audit, or investigation arising from errors or
p.000025: complaints associated with their employees.
p.000025:
p.000025: Responsibilities of Organisations Providing Care
p.000025:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000006: and food or food processes and further information on these areas should be sought where appropriate.
p.000006:
p.000006: 2.16 Data collected in the course of health research must be retained for an appropriate period to allow further
p.000006: analysis by the original or other research teams subject to consent and to support monitoring by regulatory and other
p.000006: authorities.
p.000006:
p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
p.000006:
p.000006:
p.000006:
p.000006: 7 The Medicines for Human Use (Clinical Trials) Regulations transposed Directive 2001/20/EC into UK law.
p.000006: 8 The Medical Research Council (MRC) issued guidelines in 1998 for Good Clinical Practice in clinical trials in
p.000006: the public and charity sectors. The MRC guidelines apply the principles of Good Clinical Practice in the 1996
p.000006: statement of the International Conference on Harmonisation (ICH GCP).
p.000006: 9 There is an international consensus that, with certain exemptions, information identifying a clinical trial of a
p.000006: treatment should be available on a public register from the time the first participant is recruited.
p.000007: 7
p.000007:
p.000007: should be presented in a format understandable to the public. Reports need to be comprehensible and take language and
p.000007: other needs into account.
p.000007:
p.000007: 2.18 Some advances in healthcare need to be developed commercially if they are to be made widely available. Medicines,
p.000007: medical devices and aids for disabled people are examples. Successful commercial development often depends upon the
p.000007: protection of intellectual property or commercial confidentiality at critical points in the innovation
p.000007: process. The timing of the publication of research findings needs to take account of this.
p.000007:
p.000007: 2.19 All those conducting health research must open their work to critical review through the accepted scientific and
p.000007: professional channels. Once established, findings must be made accessible to those participating10 and to all those
p.000007: who could benefit from them. This may be through publication and/or other means appropriate to the type of research.
p.000007: Data relevant to findings should also be accessible.
p.000007:
p.000007: Health and Safety
p.000007:
p.000007: 2.20 Health research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The
p.000007: safety of participants and of research and other staff must be given priority at all times, and health and safety
p.000007: regulations must be strictly observed - including the provision of information, containment, shielding and
p.000007: monitoring as required.
p.000007:
p.000007: Finance
p.000007:
p.000007: 2.21 Financial probity and compliance with the law and with the rules laid down by the Scottish Executive and H M
p.000007: Treasury for the use of public funds are as important in research as in any other area. Organisations employing
...
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
p.000010: ready access to the findings at the end of the study.
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000003: 3
p.000003:
p.000003: ◻ Local authorities
p.000003:
p.000003: 1.12 Achieving high quality in research depends on co-operation between all those involved. SEHD will continue to work
p.000003: with patients, service users, carers and care professionals, the public and its research partners to develop and
p.000003: implement this research governance framework to assure quality in health and community care research.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 2. STANDARDS
p.000004:
p.000004: 2.1 Clinical governance aims continually to improve the overall standards of clinical care in the NHS and
p.000004: to reduce unacceptable variations in clinical practice. Clinical Governance and Risk Management (CGRM) standards2 were
p.000004: launched by Quality Improvement Scotland (QIS) in 2005. The performance of NHS Boards and Special Health
p.000004: Boards will be assessed against these standards which include compliance with research governance.
p.000004:
p.000004: 2.2 Health research is not the province of a single discipline, profession or organisation and no single document
p.000004: adequately captures the full range of legislation, standards and good practice guidelines that apply to this wide-
p.000004: ranging body of work. They are presented here in six domains:
p.000004:
p.000004: ◻ ethics
p.000004: ◻ science
p.000004: ◻ information
p.000004: ◻ health and safety
p.000004: ◻ finance
p.000004: ◻ quality research culture.
p.000004:
p.000004: 2.3 Each domain has been grouped as follows:
p.000004:
p.000004: ◻ requirements in legislation and regulations
p.000004: ◻ standards required by SEHD
p.000004: ◻ other established principles of good practice from recognised international and national authorities and
p.000004: professional organisations.
p.000004:
p.000004: 2.4 The Chief Scientist Office website will provide regular updates of detail. The following sections
p.000004: set out principles in each domain.
p.000004:
p.000004: Ethics
p.000004:
p.000004: 2.5 The dignity, rights, safety and well-being of participants must be the primary consideration in any research
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
...
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
p.000010: ready access to the findings at the end of the study.
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
p.000010: sponsors and has systems in place to deter, detect and deal with fraud.
p.000010: • When research findings have commercial potential the organisation takes action to protect and
...
p.000022: Normally, if the chief investigator’s employer takes on the sponsor’s responsibilities (alone or as a member of a
p.000022: group), it will assume responsibility for operating the management and monitoring systems
p.000022: in collaboration with the employers of other members of the research team. Exceptionally, it may be inappropriate for
p.000022: the organisation employing the chief investigator to take responsibility for the management and monitoring of a study.
p.000022: In that case, the sponsor should make arrangements with one or more other organisations that will operate
p.000022: the management and monitoring systems.
p.000022:
p.000022: 3.22 Provided the sponsor keeps in place arrangements for performance management and audit, the responsibility for
p.000022: design and management may be delegated to the research team. The extent of delegation should be
p.000022: specified, even for a research team with proven expertise and track record. Commercial sponsors may
p.000022: arrange their own audit processes.
p.000022:
p.000022: 3.23 When no external sponsor takes on responsibility for it, a study may proceed only if a care organisation takes on
p.000022: sponsorship. For example, an NHS organisation may be willing and able to act as the sponsor for research
p.000022: which does not have an
p.000022:
p.000022:
p.000022: 18 For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution,
p.000022: company or organisation) who takes responsibility for the initiation, management and financing (or arranging the
p.000022: financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials)
p.000022: Regulations 2004. Regulation 3 defines options for sponsorship, including single sponsorship, joint sponsorship and
p.000022: allocation of sponsorship responsibilities within a group.
p.000022: 19 The Regulations require a sponsor to be established, or have a legal representative, in the European Community.
p.000022: Neither of them need to be established in the United Kingdom.
p.000023: 23
p.000023:
p.000023: external sponsor. When research is undertaken for research training purposes, research supervisors normally
p.000023: carry out the sponsorship responsibilities on behalf of their employers. Exceptionally, a university may authorise a
p.000023: suitably experienced postgraduate student to carry out these responsibilities on its behalf.
p.000023:
p.000023: 3.24 It is the sponsor’s responsibility to be satisfied that:
p.000023:
p.000023: • The research proposal respects the dignity, rights, safety and well-being of participants and the
p.000023: relationship with care professionals;
p.000023: • An appropriate process of independent expert review has demonstrated that the research proposal is
p.000023: worthwhile, of high scientific quality and good value for money;
p.000023: • An appropriate ethics committee has given a favourable opinion;
p.000023: • In the case of a clinical trial involving a medicine, someone acting on behalf of the sponsor obtains a
p.000023: clinical trial authorisation and the arrangements for the trial comply with the law;
p.000023: • Appropriate arrangements are in place for the registration of a trial;
p.000023: • The chief investigator, and other key researchers, including those at collaborating sites,
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
p.000005: to informed consent, and to the recruitment of minors and incapacitated adults.
p.000005: 6 Unless the risk to them is negligible, it is unethical to involve adults without capacity to consent, or minors, in
p.000005: research that could have no therapeutic benefit for the group involved.
p.000006: 6
p.000006:
p.000006: enforced by the Home Office. Before a researcher can use animals, a series of special licences must be
p.000006: obtained. Primates are only to be used if less advanced animals could not provide the information. Researchers
p.000006: must have the necessary skills, training and experience, and the research laboratory must have the facilities to
p.000006: care for the animals properly. The highest standards of animal husbandry and welfare under veterinary supervision
p.000006: must be maintained and an ethical review process must operate in accordance with Home Office requirements.
p.000006:
p.000006: Science
p.000006:
p.000006: 2.13 All existing sources of evidence, especially systematic reviews, must be considered carefully before undertaking
p.000006: health research. Research which duplicates other work unnecessarily or which is not of sufficient quality to
p.000006: contribute something useful to existing knowledge is unethical. Every proposal for health research must be
p.000006: subjected to review by experts in the relevant fields able to offer independent advice on its quality. Arrangements
p.000006: for peer review should be in proportion to the scale of the research and the risks involved. For example, in
p.000006: some circumstances, an external panel of independent experts may be invited to review a programme or a controversial
p.000006: or costly proposal. In others, many organisations allow established research teams to determine details
p.000006: of the elements of an overall programme of research which has been reviewed externally. For student
p.000006: research projects, the university supervisor is normally able to provide adequate review.
p.000006:
p.000006: 2.14 The Medicines for Human Use (Clinical trials) Regulations 20047 regulate trials of medicines on people.
p.000006: Authorisation by the Medicines and Healthcare products Regulatory Agency is required. The Agency
p.000006: offers advice and undertakes inspections for such trials - and the manufacture and assembly of products used in
p.000006: them - against international standards. The same Agency regulates research involving new medical devices.
p.000006: The principles of Good Clinical Practice apply to all health research involving patients, not just clinical trials.8
p.000006:
...
Searching for indicator property:
(return to top)
p.000006:
p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
p.000006:
p.000006:
p.000006:
p.000006: 7 The Medicines for Human Use (Clinical Trials) Regulations transposed Directive 2001/20/EC into UK law.
p.000006: 8 The Medical Research Council (MRC) issued guidelines in 1998 for Good Clinical Practice in clinical trials in
p.000006: the public and charity sectors. The MRC guidelines apply the principles of Good Clinical Practice in the 1996
p.000006: statement of the International Conference on Harmonisation (ICH GCP).
p.000006: 9 There is an international consensus that, with certain exemptions, information identifying a clinical trial of a
p.000006: treatment should be available on a public register from the time the first participant is recruited.
p.000007: 7
p.000007:
p.000007: should be presented in a format understandable to the public. Reports need to be comprehensible and take language and
p.000007: other needs into account.
p.000007:
p.000007: 2.18 Some advances in healthcare need to be developed commercially if they are to be made widely available. Medicines,
p.000007: medical devices and aids for disabled people are examples. Successful commercial development often depends upon the
p.000007: protection of intellectual property or commercial confidentiality at critical points in the innovation
p.000007: process. The timing of the publication of research findings needs to take account of this.
p.000007:
p.000007: 2.19 All those conducting health research must open their work to critical review through the accepted scientific and
p.000007: professional channels. Once established, findings must be made accessible to those participating10 and to all those
p.000007: who could benefit from them. This may be through publication and/or other means appropriate to the type of research.
p.000007: Data relevant to findings should also be accessible.
p.000007:
p.000007: Health and Safety
p.000007:
p.000007: 2.20 Health research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The
p.000007: safety of participants and of research and other staff must be given priority at all times, and health and safety
p.000007: regulations must be strictly observed - including the provision of information, containment, shielding and
p.000007: monitoring as required.
p.000007:
p.000007: Finance
p.000007:
p.000007: 2.21 Financial probity and compliance with the law and with the rules laid down by the Scottish Executive and H M
p.000007: Treasury for the use of public funds are as important in research as in any other area. Organisations employing
p.000007: researchers must be in a position to compensate anyone harmed by their negligence. If an organisation
p.000007: offers to compensate participants in the event of non-negligent harm, it must be in a position to do so.
p.000007: Consideration must be given to the exploitation of intellectual property rights.11
p.000007:
p.000007: Quality research culture
p.000007:
p.000007: 2.22 Some of the principles and requirements applying to health research are clear-cut but many require judgement and
p.000007: interpretation. A quality research culture, where excellence is promoted and where there is visible and strong
p.000007: research leadership and expert management, is essential if researchers and managers are to understand and apply
p.000007: standards, principles and requirements correctly.
p.000007:
p.000007: 2.23 The key elements of a quality research culture are:
p.000007:
p.000007: ◻ respect for participants’ dignity, rights, safety and well being
p.000007: ◻ valuing the diversity within society
p.000007: ◻ personal and scientific integrity
p.000007: ◻ leadership
p.000007:
p.000007:
p.000007: 10 Including the relatives of deceased patients who have consented to the use of organs or tissue in the research. 11
p.000007: Guidance for NHSScotland is set out in the document “A Framework and Guidance on the Management of Intellectual
p.000007: Property in the NHSScotland” (HDL (2004) 9).
p.000008: 8
p.000008:
p.000008: ◻ honesty
p.000008: ◻ accountability
p.000008: ◻ openness
p.000008: ◻ clear and supportive management
p.000008:
p.000008: 2.24 Box A illustrates how research is managed in a health organisation with a quality research culture. A quality
p.000008: research culture is essential for proper governance of health research.
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p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: BOX A: FEATURES OF A QUALITY RESEARCH CULTURE IN THE NHS
p.000009:
p.000009: Quality Research Culture
p.000009: • The organisation supports and promotes high quality research as part of a service culture receptive
p.000009: to the development and implementation of best practice in the delivery of care. There is strong leadership
p.000009: of research and a clear strategy linking research to national priorities and needs, the organisation's
p.000009: business, and to clinical governance.
p.000009: • The organisation’s research strategy values diversity in its patients or service users and its staff,
p.000009: and promotes their active participation in the development, undertaking and use of research.
p.000009:
p.000009: Ethics
...
p.000009: relevance of joint work and avoidance of unnecessary duplication of functions.
p.000009: • The organisation’s human resource strategy includes commitment to support research careers (full and part-time) by
p.000009: earmarking funds specifically for R&D training across the professions. The organisation plays its role in developing
p.000009: research capacity with appropriate training and updating. This includes taking action to ensure that the
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
...
p.000017:
p.000017: Q: If my team need training, whom should I talk to?
p.000017: A: Their employer is normally responsible for their training.
p.000017:
p.000017: Q: To whom do I talk if I suspect a university colleague is fabricating data?
p.000017: A: Your university as your colleague’s employer is responsible for investigating the suspected misconduct.
p.000017: Others such as the General Medical Council may also be responsible for looking into your suspicions if they appear to
p.000017: involve professional misconduct. If you suspect someone employed by another organisation, raise your concerns with
p.000017: your employer, who as sponsor will contact your colleague’s employer. In any case, record the evidence carefully so
p.000017: that there can be a proper investigation.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Q: I have new information that makes me think that we could improve the design of this study. What do I do?
p.000018: A: You should discuss this with the Trial Steering Committee. If they agree, you will need to draw up a revised
p.000018: protocol, and submit it to the MRC. The sponsor’s representative will then submit the amendment to the MHRA and you
p.000018: need to go back to the relevant ethics committee. You must not implement substantial changes to the protocol without
p.000018: formal agreement from those who gave permission for the study (particularly the MHRA and the ethics committee). When
p.000018: an amendment is authorised you need to tell all investigators to follow the new protocol from a specified time.
p.000018:
p.000018: Q: I may generate some important intellectual property (IP). What should I do?
p.000018: A: Your employer is one of the sponsors and will have a policy on IP that complies with the terms of funding.
p.000018: You should refer to and comply with this policy. Your employer may have an IP unit that can help you follow the right
p.000018: procedures.
p.000018:
p.000018: Q: What if the MHRA does a Good Clinical Practice inspection?
p.000018: A: You must co-operate. The inspectors have legal powers to ask for documents and take enforcement action.
p.000018: Generally, they look for evidence of good systems that are proportionate to the risks involved. The MHRA will point
p.000018: out any improvements needed for trial sites to comply with the law. They seek a prosecution only if it would be in the
p.000018: public interest because of very serious or persistent failure.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
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p.000019: 19
p.000019:
p.000019: Responsibilities of Participants
p.000019:
p.000019: 3.8 Effective and responsive services depend on good research. Through this framework and related provisions, the
p.000019: Government and its partners strive to ensure that research conducted in Scotland offers the likelihood of real benefits
p.000019: either to those who participate, or to those who use services subsequently, or to both. Anyone using
...
p.000020: accessible;
p.000020:
p.000020:
p.000020:
p.000020: 13 Investigators in clinical trials involving medicines have to report serious adverse events immediately. 14 For
p.000020: clinical trials involving medicines, it is a legal requirement to follow the protocol approved by the licensing
p.000020: authority (the Medicines and Healthcare products Regulatory Agency).
p.000020: 15 Also, for clinical trials involving medicines, to the licensing authority.
p.000020: 16 Also, for clinical trials involving medicines, procedures to comply with legal requirements concerning Good
p.000020: Clinical Practice during the trial, and Good Manufacturing Practice in manufacturing investigational medicinal
p.000020: products.
p.000021: 21
p.000021:
p.000021: • Reports on the progress and outcomes of the work required by the sponsor, funders, or others
p.000021: with a legitimate interest are produced on time and to an acceptable standard;
p.000021: • The findings from the work are opened to critical review through the accepted scientific and professional
p.000021: channels;
p.000021: • Once established, findings from the work are disseminated promptly and fed back as appropriate to
p.000021: participants;
p.000021: • The chief investigator accepts a key role in detecting and preventing scientific misconduct by adopting the
p.000021: role of guarantor on published outputs;
p.000021: • Arrangements are kept in place for the management of financial and other resources provided for
p.000021: the study, including for the management of any intellectual property arising;
p.000021: • All data and documentation associated with the study are available at the request of the inspection
p.000021: and auditing authorities.
p.000021:
p.000021: Responsibilities of Research Funders
p.000021:
p.000021: 3.14 Organisations that fund health research have a responsibility for ensuring that the work is a proper use of the
p.000021: funds they control and provides value for money.
p.000021:
p.000021: 3.15 The main research funder plays a critical role in assuring the quality of a study. It will normally take the
p.000021: lead in establishing that the research proposal is worthwhile, of high scientific quality, and represents good value
p.000021: for money.17
p.000021:
p.000021: 3.16 The main research funder is normally the organisation that makes the arrangements for independent expert
p.000021: review to assess the quality of the research proposed; the experience and expertise of the chief
p.000021: investigator and other key researchers involved; whether there is appropriate research infrastructure for
p.000021: the study: for example, management and governance arrangements, access to potential participants
p.000021: (or their organs, tissue or data); specialised facilities such as equipment, materials or support staff; and
p.000021: for trials on medicines, expert clinical trial management and the capacity to comply with the
p.000021: principles of Good Clinical Practice. If the main funder is unable to arrange for the independent expert review, it
p.000021: should expect the sponsor to arrange for it before taking on responsibility for the research, or to require another
...
p.000024: research culture in their organisation and for ensuring that their staff are supported in, and held to account
p.000024: for, the professional conduct of research. This will involve careful attention to training, career
p.000024: planning and development, and the use of clear codes of practice and systems for monitoring compliance,
p.000024: dealing with non-compliance or misconduct, and learning from errors and complaints. These responsibilities apply
p.000024: to both private and public sector employers.
p.000024:
p.000024: 3.26 Organisations that employ chief investigators and other researchers have responsibility for
p.000024: ensuring that those researchers understand and discharge the responsibilities set out for them in this
p.000024: framework, and under the law. They may do this, for example, through terms of employment, staff handbooks,
p.000024: and training. They will normally take on some or all of the responsibility for ensuring that a study is
p.000024: properly managed and for monitoring its progress. When the employing organisation is not the sponsor, it should agree
p.000024: its responsibilities with the sponsor and the organisation(s) providing care. The sponsor has to be
p.000024: satisfied with the arrangements for the management of a study, and that there is agreement on appropriate
p.000024: arrangements for monitoring and reporting23.
p.000024:
p.000024: 3.27 Employers should ensure there are agreements between them and their staff and between them and
p.000024: research funders and care organisations about ownership, exploitation and income from any intellectual property
p.000024: that may arise from research conducted by their employees. They have a responsibility for ensuring that
p.000024: employees identify and protect intellectual property.
p.000024:
p.000024: 3.28 Universities and other employers of staff engaged in research are responsible for:
p.000024:
p.000024: • Compliance with all current employment and health and safety legislation;
p.000024: • Demonstrating the existence of clear codes of practice in other areas for their staff and
p.000024: mechanisms to monitor and assess compliance;
p.000024: • Ensuring that investigators and other research staff are aware of understand and comply with this framework;
p.000024: • Discharging their agreed role in the management and monitoring of work undertaken by their
p.000024: organisation;
p.000024: • Demonstrating systems for continuous professional development of staff at all levels;
p.000024: • Having agreements and systems to identify, protect and exploit intellectual property;
p.000024: • Ensuring that they are able to compensate anyone harmed as a result of negligence on the part of
p.000024: staff, students and others for whom they have liability; and, if they have agreed to do so, to compensate participants
p.000024: for non-negligent harm arising from the research;
p.000024: • Having systems to detect and address fraud, and other scientific or professional misconduct by their staff;
p.000024:
p.000024:
p.000024: 23 For clinical trials involving medicines, the sponsor has to put and keep in place arrangements for the purpose of
p.000024: ensuring that the conditions and principles of Good Clinical Practice are satisfied or adhered to.
p.000025: 25
p.000025:
p.000025: • Having systems to process, address and learn lessons from any errors or complaints brought against
p.000025: their employees;
p.000025: • Permitting and assisting in any statutory inspection, audit, or investigation arising from errors or
p.000025: complaints associated with their employees.
p.000025:
p.000025: Responsibilities of Organisations Providing Care
p.000025:
p.000025: 3.29 It is the responsibility of organisations providing healthcare in Scotland to be aware of all research
p.000025: undertaken in their organisation, or involving participants, organs, tissue or data obtained through the
p.000025: organisation. Care providers remain responsible for the quality of all aspects of the care of their patients or
p.000025: service users and carers, whether or not they are involved in research and whoever conducts or funds that
p.000025: research. Chief Executives of NHS organisations are accountable for the quality of care and for the environment in
...
Social / Racial Minority
Searching for indicator race:
(return to top)
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
...
Social / Religion
Searching for indicator religion:
(return to top)
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
p.000005: to informed consent, and to the recruitment of minors and incapacitated adults.
...
Social / Student
Searching for indicator student:
(return to top)
p.000006: 6
p.000006:
p.000006: enforced by the Home Office. Before a researcher can use animals, a series of special licences must be
p.000006: obtained. Primates are only to be used if less advanced animals could not provide the information. Researchers
p.000006: must have the necessary skills, training and experience, and the research laboratory must have the facilities to
p.000006: care for the animals properly. The highest standards of animal husbandry and welfare under veterinary supervision
p.000006: must be maintained and an ethical review process must operate in accordance with Home Office requirements.
p.000006:
p.000006: Science
p.000006:
p.000006: 2.13 All existing sources of evidence, especially systematic reviews, must be considered carefully before undertaking
p.000006: health research. Research which duplicates other work unnecessarily or which is not of sufficient quality to
p.000006: contribute something useful to existing knowledge is unethical. Every proposal for health research must be
p.000006: subjected to review by experts in the relevant fields able to offer independent advice on its quality. Arrangements
p.000006: for peer review should be in proportion to the scale of the research and the risks involved. For example, in
p.000006: some circumstances, an external panel of independent experts may be invited to review a programme or a controversial
p.000006: or costly proposal. In others, many organisations allow established research teams to determine details
p.000006: of the elements of an overall programme of research which has been reviewed externally. For student
p.000006: research projects, the university supervisor is normally able to provide adequate review.
p.000006:
p.000006: 2.14 The Medicines for Human Use (Clinical trials) Regulations 20047 regulate trials of medicines on people.
p.000006: Authorisation by the Medicines and Healthcare products Regulatory Agency is required. The Agency
p.000006: offers advice and undertakes inspections for such trials - and the manufacture and assembly of products used in
p.000006: them - against international standards. The same Agency regulates research involving new medical devices.
p.000006: The principles of Good Clinical Practice apply to all health research involving patients, not just clinical trials.8
p.000006:
p.000006: 2.15 Special regulations govern the use of human embryos, the release of genetically modified organisms
p.000006: and food or food processes and further information on these areas should be sought where appropriate.
p.000006:
p.000006: 2.16 Data collected in the course of health research must be retained for an appropriate period to allow further
p.000006: analysis by the original or other research teams subject to consent and to support monitoring by regulatory and other
p.000006: authorities.
p.000006:
p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
p.000006:
p.000006:
p.000006:
...
p.000022: design and management may be delegated to the research team. The extent of delegation should be
p.000022: specified, even for a research team with proven expertise and track record. Commercial sponsors may
p.000022: arrange their own audit processes.
p.000022:
p.000022: 3.23 When no external sponsor takes on responsibility for it, a study may proceed only if a care organisation takes on
p.000022: sponsorship. For example, an NHS organisation may be willing and able to act as the sponsor for research
p.000022: which does not have an
p.000022:
p.000022:
p.000022: 18 For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution,
p.000022: company or organisation) who takes responsibility for the initiation, management and financing (or arranging the
p.000022: financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials)
p.000022: Regulations 2004. Regulation 3 defines options for sponsorship, including single sponsorship, joint sponsorship and
p.000022: allocation of sponsorship responsibilities within a group.
p.000022: 19 The Regulations require a sponsor to be established, or have a legal representative, in the European Community.
p.000022: Neither of them need to be established in the United Kingdom.
p.000023: 23
p.000023:
p.000023: external sponsor. When research is undertaken for research training purposes, research supervisors normally
p.000023: carry out the sponsorship responsibilities on behalf of their employers. Exceptionally, a university may authorise a
p.000023: suitably experienced postgraduate student to carry out these responsibilities on its behalf.
p.000023:
p.000023: 3.24 It is the sponsor’s responsibility to be satisfied that:
p.000023:
p.000023: • The research proposal respects the dignity, rights, safety and well-being of participants and the
p.000023: relationship with care professionals;
p.000023: • An appropriate process of independent expert review has demonstrated that the research proposal is
p.000023: worthwhile, of high scientific quality and good value for money;
p.000023: • An appropriate ethics committee has given a favourable opinion;
p.000023: • In the case of a clinical trial involving a medicine, someone acting on behalf of the sponsor obtains a
p.000023: clinical trial authorisation and the arrangements for the trial comply with the law;
p.000023: • Appropriate arrangements are in place for the registration of a trial;
p.000023: • The chief investigator, and other key researchers, including those at collaborating sites,
p.000023: have the necessary expertise and experience and have access to the resources needed to conduct the proposed research
p.000023: successfully;
p.000023: • The arrangements and resources proposed will allow the collection of high quality, accurate data and
p.000023: the systems and resources proposed are those required to allow appropriate data analysis and data protection;
p.000023: • Arrangements proposed for the work are consistent with this research governance framework;
p.000023: • Organisations and individuals involved in the research agree the division of responsibilities between
p.000023: them;
...
p.000025: research undertaken by students as part of their training;
p.000025: • Ensure patients or service users and carers are provided with information on any research that may
p.000025: affect their care;
p.000025:
p.000025:
p.000025:
p.000025: 24 If there is negligent harm during a study with NHS permission when the NHS body owes a duty of care to the person
p.000025: harmed, NHS indemnity covers NHS staff, academic staff with honorary contracts (as defined in paragraph 3.31) and those
p.000025: conducting the study. Guidance for the NHSScotland can be found in the document “Guidance Note on Research Governance
p.000025: and Honorary Contracts”, (Health Department, March, 2004).
p.000026: 26
p.000026:
p.000026: • Be aware of current legislation relating to research and ensure that it is implemented and followed within the
p.000026: organisation;
p.000026: • Require that no research study with human participants for whom the organisation is responsible (or their
p.000026: organs, tissue or data), begins until a sponsor has confirmed it has taken responsibility; the proposed research has a
p.000026: favourable ethical opinion (and if the study is a trial of a medicine, that there is a clinical trial authorisation);
p.000026: and a person authorised to do so has given written permission on behalf of the organisation
p.000026: providing care25;
p.000026: • Ensure that written agreements are in place about responsibilities for all research involving an
p.000026: external partner, funder and/or sponsor including agreement with the University or other employer on supervision of
p.000026: student research;
p.000026: • Maintain the necessary links with clinical governance and/or best value processes;
p.000026: • Ensure that NHS honorary contracts are issued where appropriate26. There should be clear accountability and
p.000026: understanding of responsibilities;
p.000026: • Put and keep in place systems to identify and learn from errors or failures associated with any research
p.000026: undertaken through or within the organisation;
p.000026: • Ensure that significant lessons learnt from errors or complaints and from internal enquiries are
p.000026: communicated to funders, sponsors and other partners;
p.000026: • Ensure that adverse incidents in the context of research are reported in line with the standard procedures of
p.000026: the organisation;
p.000026: • Permit and assist with any monitoring, auditing or inspection by relevant authorities.
p.000026:
p.000026: Responsibilities of Care Professionals
p.000026:
p.000026: 3.33 Healthcare staff retain responsibility for the care of their patients or service users when they are
p.000026: participating in research within the NHS.
p.000026:
p.000026: 3.34 Before agreeing to their patients or service users and carers being approached by the research team, care
p.000026: professionals should satisfy themselves that the chief investigator has the permission of the
p.000026: appropriate authorities within their organisation or agency. Before enrolling patients in a clinical
p.000026: study, NHS staff should look for evidence that the study has the ethical and regulatory approval it needs.
p.000026: They should then take care to follow the currently approved version of the protocol.
p.000026:
p.000026: Responsibilities Relating to Research Ethics Committees
p.000026:
...
Social / education
Searching for indicator education:
(return to top)
p.000009: business, and to clinical governance.
p.000009: • The organisation’s research strategy values diversity in its patients or service users and its staff,
p.000009: and promotes their active participation in the development, undertaking and use of research.
p.000009:
p.000009: Ethics
p.000009: • To safeguard the dignity, rights, safety and well-being of participants all research involving
p.000009: patients, service users, carers or care professionals and other staff, or their organs, tissue or data, is referred for
p.000009: independent ethical review.
p.000009: • Consent is sought in the way agreed during ethical review.
p.000009: • Research is pursued with the active involvement of service users and carers including, where appropriate, those
p.000009: from hard- to- reach groups such as homeless people.
p.000009: • If organs or tissue are used following post mortems, informed consent is obtained from relatives, and
p.000009: there is a commitment to respectful disposal of material.
p.000009: • If using animals is unavoidable, the highest standards of animal husbandry are maintained under
p.000009: veterinary supervision.
p.000009:
p.000009: Science
p.000009: • There is commitment to the principle and practice of scientific review by independent experts, with scrutiny of
p.000009: the suitability of protocols or proposals and research teams for all work in the organisation.
p.000009: • There is close collaboration with partner organisations in higher education and care to ensure quality and
p.000009: relevance of joint work and avoidance of unnecessary duplication of functions.
p.000009: • The organisation’s human resource strategy includes commitment to support research careers (full and part-time) by
p.000009: earmarking funds specifically for R&D training across the professions. The organisation plays its role in developing
p.000009: research capacity with appropriate training and updating. This includes taking action to ensure that the
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
...
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
p.000010: sponsors and has systems in place to deter, detect and deal with fraud.
p.000010: • When research findings have commercial potential the organisation takes action to protect and
p.000010: exploit them, in collaboration with its research partners and – when appropriate – commercial
p.000010: organisations.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
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p.000010:
p.000011: 11
p.000011:
p.000011: 3. RESPONSIBILITIES AND ACCOUNTABILITIES
p.000011:
p.000011: General
p.000011:
p.000011: 3.1 Everyone involved in research with human participants, their organs, tissue or data is responsible for knowing
p.000011: and following the law and the principles of good practice relating to ethics, science, information, health and safety,
p.000011: and finance set out in this framework.
p.000011:
p.000011: 3.2 All those involved in research also have a duty to ensure that they and those they manage are appropriately
p.000011: qualified, both by education and experience, for the role they play in relation to any research. They must be aware
p.000011: of, and have ready access to, sources of information and support in undertaking that role.
p.000011:
p.000011: Agreements
p.000011:
p.000011: 3.3 A complex array of organisations and individuals may be involved in a health research study. It
p.000011: is essential that clear agreements describing allocation of responsibilities and rights are reached, documented
p.000011: and enacted.
p.000011:
p.000011: 3.4 Many agreements will relate to individual studies. Organisations that collaborate on a range of research
p.000011: work are encouraged to develop and document framework agreements to facilitate the agreement of responsibilities
p.000011: for specific studies; for example:
p.000011:
p.000011: ◻ NHS organisations who work together regularly on research, whether or not in a formal network;
p.000011: ◻ Universities and NHS organisations, primary care practices and research networks that work together
p.000011: regularly on research;
p.000011: ◻ local authorities and/or other community care providers, NHS organisations, and primary care practices that work
p.000011: together regularly on research whether or not in a formal research network.
p.000011:
p.000011: 3.5 It is particularly important to reach clear, documented agreements for complex studies where there may
p.000011: be:
p.000011:
p.000011: ◻ work on more than one site; and/or
p.000011: ◻ researchers employed by more than one organisation; and/or
p.000011: ◻ patients, service users and carers, and care professionals from more than one care organisation; and/or
p.000011: ◻ more than one funder.
p.000011:
...
p.000020: condition to which the study relates, those care professionals are informed that their patients or users are being
p.000020: invited to participate and agree to retain overall responsibility for their care;
p.000020: • When the research involves a service user or carer or a child, looked after or receiving services
p.000020: under the auspices of the local authority, the agency director or their deputy agrees to the person (and/or
p.000020: their carer) being invited to participate and is fully aware of the arrangements for dealing
p.000020: with any disclosures or other relevant information;
p.000020: • Potential participants and other service users and carers are involved in the design and management
p.000020: of the study whenever appropriate;
p.000020: • The study is submitted for ethics review and it does not start without a favourable opinion, and
p.000020: the research team acts on any conditions attached to the ethics opinion;
p.000020: • Unless participants or the ethics opinion says otherwise, participants’ care professionals are given
p.000020: any information directly relevant to their care that arises in the research;
p.000020: • Each member of the research team, including those at collaborating sites, is qualified by education,
p.000020: training and experience to discharge his/her role in the study and their qualifications are documented;
p.000020: • Each investigator in a clinical trial involving medicines is aware of his/her legal duties;
p.000020: • Students and new researchers have adequate supervision, support and training;
p.000020: • Unless urgent safety measures are necessary,13 the research follows the protocol or proposal agreed by the
p.000020: relevant ethics committee and by the sponsor14;
p.000020: • Substantive changes to the protocol or proposal are submitted for ethical review and for the sponsor’s
p.000020: agreement. These amendments are implemented only when approved;15
p.000020: • Procedures are kept in place to ensure collection of high quality, accurate data and the integrity and
p.000020: confidentiality of data during processing and storage16;
p.000020: • Arrangements are made for the appropriate archiving of data when the research has finished and to make it
p.000020: accessible;
p.000020:
p.000020:
p.000020:
p.000020: 13 Investigators in clinical trials involving medicines have to report serious adverse events immediately. 14 For
p.000020: clinical trials involving medicines, it is a legal requirement to follow the protocol approved by the licensing
p.000020: authority (the Medicines and Healthcare products Regulatory Agency).
p.000020: 15 Also, for clinical trials involving medicines, to the licensing authority.
p.000020: 16 Also, for clinical trials involving medicines, procedures to comply with legal requirements concerning Good
p.000020: Clinical Practice during the trial, and Good Manufacturing Practice in manufacturing investigational medicinal
p.000020: products.
p.000021: 21
...
Social / employees
Searching for indicator employees:
(return to top)
p.000013:
p.000013: Investigator - the person responsible, individually or as the leader of the researchers at a site, for the conduct of a
p.000013: study at that site. For clinical trials involving medicines, an investigator must be an authorised health
p.000013: professional.
p.000013:
p.000013: Chief Investigator – the person who takes overall responsibility for the design, conduct and reporting of
p.000013: a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary
p.000013: responsibility for the design, conduct and reporting of the study whether or not that person is an investigator at any
p.000013: particular site.
p.000013:
p.000013: Principal Investigator – the leader responsible for a team of individuals conducting a study at a site.
p.000013:
p.000013: Funder - organisation providing funding for a study through contracts, grants or donations to an authorised member of
p.000013: the employing and/or care organisation. The main funder typically has a key role in scientific quality assurance. In
p.000013: any case, it remains responsible for securing value for money.
p.000013:
p.000013: Sponsor - individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage
p.000013: and finance a study. (A group of individuals and/or organisations may take on sponsorship responsibilities and
p.000013: distribute them by agreement among the members of the group, provided that, collectively, they make arrangements to
p.000013: allocate all the responsibilities in this research governance framework that are relevant to the study).
p.000013:
p.000013: Employing Organisation - the organisation employing the chief investigator, investigators or other researchers.
p.000013: Employers remain liable for the work of their employees. The organisation employing the chief investigator normally
p.000013: holds the contract or grant agreement with the funder of the study.
p.000013: Organisations holding contracts with funders remain responsible for the management of the funds provided.
p.000013:
p.000013: Organisation Providing Care - the organisation responsible for providing care to patients and/or service users and
p.000013: carers participating in a study. Health organisations remain liable for the quality of care and for their duty towards
p.000013: anyone who might be harmed by a study.
p.000013:
p.000013: Responsible Care Professional - doctor, nurse or other practitioner formally responsible for the care of participants
p.000013: while they are taking part in the study.
p.000013:
p.000013: Research Ethics Committee – committee established to provide participants, researchers, funders, sponsors, employers,
p.000013: care organisations and professionals with an independent opinion on the extent to which proposals for a study comply
p.000013: with recognised ethical standards. For clinical trials involving medicines, the committee must be one recognised
p.000013: by the United Kingdom Ethics Committee Authority.
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000014: PROPER CONDUCT OF A HEALTH RESEARCH STUDY
p.000014:
p.000014: Chief Investigator, Investigators, other Researchers
p.000014:
p.000014: • Developing proposals that are scientifically sound and ethical.
...
p.000024: for, the professional conduct of research. This will involve careful attention to training, career
p.000024: planning and development, and the use of clear codes of practice and systems for monitoring compliance,
p.000024: dealing with non-compliance or misconduct, and learning from errors and complaints. These responsibilities apply
p.000024: to both private and public sector employers.
p.000024:
p.000024: 3.26 Organisations that employ chief investigators and other researchers have responsibility for
p.000024: ensuring that those researchers understand and discharge the responsibilities set out for them in this
p.000024: framework, and under the law. They may do this, for example, through terms of employment, staff handbooks,
p.000024: and training. They will normally take on some or all of the responsibility for ensuring that a study is
p.000024: properly managed and for monitoring its progress. When the employing organisation is not the sponsor, it should agree
p.000024: its responsibilities with the sponsor and the organisation(s) providing care. The sponsor has to be
p.000024: satisfied with the arrangements for the management of a study, and that there is agreement on appropriate
p.000024: arrangements for monitoring and reporting23.
p.000024:
p.000024: 3.27 Employers should ensure there are agreements between them and their staff and between them and
p.000024: research funders and care organisations about ownership, exploitation and income from any intellectual property
p.000024: that may arise from research conducted by their employees. They have a responsibility for ensuring that
p.000024: employees identify and protect intellectual property.
p.000024:
p.000024: 3.28 Universities and other employers of staff engaged in research are responsible for:
p.000024:
p.000024: • Compliance with all current employment and health and safety legislation;
p.000024: • Demonstrating the existence of clear codes of practice in other areas for their staff and
p.000024: mechanisms to monitor and assess compliance;
p.000024: • Ensuring that investigators and other research staff are aware of understand and comply with this framework;
p.000024: • Discharging their agreed role in the management and monitoring of work undertaken by their
p.000024: organisation;
p.000024: • Demonstrating systems for continuous professional development of staff at all levels;
p.000024: • Having agreements and systems to identify, protect and exploit intellectual property;
p.000024: • Ensuring that they are able to compensate anyone harmed as a result of negligence on the part of
p.000024: staff, students and others for whom they have liability; and, if they have agreed to do so, to compensate participants
p.000024: for non-negligent harm arising from the research;
p.000024: • Having systems to detect and address fraud, and other scientific or professional misconduct by their staff;
p.000024:
p.000024:
p.000024: 23 For clinical trials involving medicines, the sponsor has to put and keep in place arrangements for the purpose of
p.000024: ensuring that the conditions and principles of Good Clinical Practice are satisfied or adhered to.
p.000025: 25
p.000025:
p.000025: • Having systems to process, address and learn lessons from any errors or complaints brought against
p.000025: their employees;
p.000025: • Permitting and assisting in any statutory inspection, audit, or investigation arising from errors or
p.000025: complaints associated with their employees.
p.000025:
p.000025: Responsibilities of Organisations Providing Care
p.000025:
p.000025: 3.29 It is the responsibility of organisations providing healthcare in Scotland to be aware of all research
p.000025: undertaken in their organisation, or involving participants, organs, tissue or data obtained through the
p.000025: organisation. Care providers remain responsible for the quality of all aspects of the care of their patients or
p.000025: service users and carers, whether or not they are involved in research and whoever conducts or funds that
p.000025: research. Chief Executives of NHS organisations are accountable for the quality of care and for the environment in
p.000025: which it is provided under the Duty of Care. They should ensure that their patients, service users and carers, and
p.000025: care professionals are provided with information about any research which may have a direct impact on their care, their
p.000025: experience of care, or their work in the organisation. They should ensure that activity is presented as research only
p.000025: if it is managed as research within this framework.
p.000025:
p.000025: 3.30 Organisations providing healthcare are responsible for satisfying themselves that there are adequate
p.000025: arrangements and resources for any research involving their patients, service users and carers, or staff
p.000025: to meet the standards set out in this framework. No research with human participants, their organs, tissue or
p.000025: data, may begin before an identified sponsor has taken on responsibility for that research, the study has received a
p.000025: positive ethical opinion and the allocation of responsibilities is agreed and documented. Accountability for this
...
p.000028: are expected to manage risk, minimise bureaucratic process and facilitate high quality research. They are not
p.000028: normally expected to withhold permission when a sponsor offers reasonable assurances that there are
p.000028: arrangements to carry out the responsibilities set out in this framework.
p.000028:
p.000028: 4.5 Healthcare providers may take on the sponsor’s responsibilities if they have systems to discharge them. It is
p.000028: acceptable for an individual employee to be a sponsor only with the written permission of that person’s employer.30
p.000028:
p.000028: 4.6 Nothing in this research governance framework is intended to transfer the legal duties of
p.000028: healthcare organisations to sponsors or to others. Whoever takes on sponsorship, if a study affects a
p.000028: healthcare organisation’s duties, it remains that organisation’s responsibility to satisfy itself that there
p.000028: are systems to conduct the study to appropriate scientific and ethical standards.
p.000028:
p.000028: 4.7 Healthcare organisations are responsible for providing a safe system of care and should normally
p.000028: expect to be kept informed of any study involving their staff, contractors or independent practitioners.
p.000028: However, they do not have responsibility
p.000028:
p.000028:
p.000028: 29 Additional guidance can be found in “Research Governance: NHS Approval for R&D Involving NHS
p.000028: Patients” (SEHD, 2004).
p.000028: 30 For clinical trials of medicines, it is within the law for an individual to be the sponsor (further guidance on
p.000028: this
p.000028: can be found at www.ct-toolkit.ac.uk/_db/_documents/sponsorship.pdf). Employers should ensure that, if their employees
p.000028: take on sponsorship, there is a system to record whether the employee has permission to do so as a private individual
p.000028: or is authorised to do so on behalf of the employer. Healthcare organisations should authorise their employees to take
p.000028: on sponsorship only if there are arrangements to perform the functions in the Medicines for Human Use (Clinical Trials)
p.000028: Regulations 2004.
p.000029: 29
p.000029:
p.000029: for private research that is clearly separate from the healthcare provided on behalf of the NHS. That is when the
p.000029: study is clearly undertaken in a private capacity, the REC is fully aware of the circumstances and participants
p.000029: understand the NHS accepts no liability.
p.000029:
p.000029: 4.8 RECs and reviewers should have systems to identify, record and address conflicts of interest that may
p.000029: compromise, or appear to compromise, the independence of their advice. They must also have systems in place to
p.000029: record their decisions and the reasons for them, and to record operational details of their meetings and handling of
p.000029: applications.
p.000029:
p.000029: 4.9 Delivery systems should be designed to facilitate adherence to requirements, and to detect failures whether
p.000029: such failures arise by intent or oversight. Such systems should include a risk-based programme of
p.000029: routine and random monitoring and audit. They should require, facilitate and support reporting of
p.000029: critical incidents, near misses, systems failures and misconduct either by self-reporting or whistle-
p.000029: blowing.
p.000029:
p.000029: 4.10 SEHD will work with key stakeholders to develop and issue explanatory material from time to time to help
p.000029: organisations discharge their responsibilities for research governance effectively and efficiently.
p.000029:
p.000029: 4.11 SEHD will work with NHS care providers to ensure that they understand their legal and other responsibilities,
...
p.000030: supports organisations’ systems for meeting standards and managing risk. Clinical trials of medicines require
p.000030: authorisation by the Medicines and Healthcare products Regulatory Agency. The Agency operates a system of
p.000030: Good Clinical Practice and Good Manufacturing Practice inspections which can involve trial sites, units
p.000030: manufacturing investigational medicinal products, and sponsors. Similar arrangements apply to medical devices.
p.000030:
p.000030: 4.17 Healthcare organisations which either lead or participate in research should have systems to ensure
p.000030: that the principles and requirements of this research governance framework are consistently applied. Failures in NHS
p.000030: organisations to comply with this framework will be addressed through the normal lines of accountability and
p.000030: performance management. NHS QIS will be responsible for reviewing the performance of NHS Boards
p.000030: against clinical governance and risk management standards launched by QIS in 2005. Research governance
p.000030: forms part of these standards and to support the review process, a self assessment tool to measure
p.000030: compliance with research governance will be launched by SEHD in 2006.
p.000030:
p.000030: 4.18 Failures on the part of staff in SEHD or the NHS to meet responsibilities relating to this framework will be
p.000030: addressed through the normal management channels and disciplinary procedures. It is the responsibility of
p.000030: other organisations to have appropriate systems to address failures by their staff. University employees
p.000030: with NHS honorary contracts may have their contracts withdrawn, subject to a joint NHS/university
p.000030: investigation.
p.000030:
p.000030: 4.19 In the case of misconduct, professional groups are subject to disciplinary action by their professional bodies.
p.000030: The Council for Healthcare Regulatory Excellence will promote best practice and co-operation between regulatory
p.000030: bodies. For example, doctors are responsible to the General Medical Council for their professional conduct
p.000030: as researchers as well as clinicians. Similarly, nurses, midwives and health visitors are responsible to the
p.000030: Nursing and Midwifery Council. State registered practitioners are responsible to the Health Professions Council
p.000030: for their professional conduct as researchers as well as clinicians.
p.000030:
p.000030: 4.20 There is public and professional concern about research misconduct and fraud, though its extent is
p.000030: unknown. Monitoring of compliance with research governance will check whether there are mechanisms to detect
p.000030: and investigate possible fraud and to take appropriate action if fraud is found. In addition,
p.000030: healthcare organisations should seek assurances that universities and any other organisations with whom they
p.000030: develop local partnerships have systems for detecting, investigating and addressing fraud by their
p.000030: employees. Universities UK aim to establish a UK Panel for Research Integrity in Health and Biomedical Sciences.
p.000030: It
p.000030:
p.000031: 31
p.000031:
p.000031: will provide advice on maintaining high standards of scientific integrity and support to those investigating
p.000031: allegations of research misconduct. Its advice and support will be available to employers of researchers
p.000031: including healthcare organisations. SEHD will continue to work with universities and others on measures to promote
p.000031: integrity in research.
p.000031:
p.000031: 4.21 SEHD looks to those with responsibilities for other organisations to address any shortcomings in them.
p.000031: SEHD and NHS funds for health research will be allocated to those competent to manage them and the work they support.
p.000031:
p.000031: 4.22 The Annex to the Research Governance Framework for Health and Social Care in England contains further information
p.000031: on legislative requirements, standards and good practice guidelines applying to research. This can be found on the
p.000031: Department of Health in England’s website at: http://www.dh.gov.uk/PolicyAndGuidance/ResearchAndDevelopment/fs/en .
p.000031: Professional judgement is involved in the interpretation of this guidance. Quality in research depends on those
p.000031: responsible being appropriately qualified, with the
p.000031: skills and experience to use their professional judgement effectively in the delivery of dependable research.
p.000031:
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p.000031:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
...
Social / parents
Searching for indicator parents:
(return to top)
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000004: set out principles in each domain.
p.000004:
p.000004: Ethics
p.000004:
p.000004: 2.5 The dignity, rights, safety and well-being of participants must be the primary consideration in any research
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
...
p.000013: any case, it remains responsible for securing value for money.
p.000013:
p.000013: Sponsor - individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage
p.000013: and finance a study. (A group of individuals and/or organisations may take on sponsorship responsibilities and
p.000013: distribute them by agreement among the members of the group, provided that, collectively, they make arrangements to
p.000013: allocate all the responsibilities in this research governance framework that are relevant to the study).
p.000013:
p.000013: Employing Organisation - the organisation employing the chief investigator, investigators or other researchers.
p.000013: Employers remain liable for the work of their employees. The organisation employing the chief investigator normally
p.000013: holds the contract or grant agreement with the funder of the study.
p.000013: Organisations holding contracts with funders remain responsible for the management of the funds provided.
p.000013:
p.000013: Organisation Providing Care - the organisation responsible for providing care to patients and/or service users and
p.000013: carers participating in a study. Health organisations remain liable for the quality of care and for their duty towards
p.000013: anyone who might be harmed by a study.
p.000013:
p.000013: Responsible Care Professional - doctor, nurse or other practitioner formally responsible for the care of participants
p.000013: while they are taking part in the study.
p.000013:
p.000013: Research Ethics Committee – committee established to provide participants, researchers, funders, sponsors, employers,
p.000013: care organisations and professionals with an independent opinion on the extent to which proposals for a study comply
p.000013: with recognised ethical standards. For clinical trials involving medicines, the committee must be one recognised
p.000013: by the United Kingdom Ethics Committee Authority.
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000014: PROPER CONDUCT OF A HEALTH RESEARCH STUDY
p.000014:
p.000014: Chief Investigator, Investigators, other Researchers
p.000014:
p.000014: • Developing proposals that are scientifically sound and ethical.
p.000014: • Submitting the design for independent expert review.
p.000014: • Submitting the study (or proposal) for independent ethical review.
p.000014: • Conducting a study to the agreed protocol (or proposal), in accordance with legal requirements,
p.000014: guidance and accepted standards of good practice.
p.000014: • Preparing and providing information for participants.
p.000014: • Ensuring participants’ welfare while in the study.
p.000014: • Arranging to make findings and data accessible following expert review.
p.000014: • Feeding back results of research to participants.
p.000014:
p.000014: See 3.10, 3.11 to 3.13
p.000014:
p.000014: Main Funder
p.000014:
p.000014: • Assessing the scientific quality of the research as proposed.
p.000014: • Establishing the value for money of the research as proposed.
p.000014: • Considering the suitability of the research environment in which the research will be undertaken, particularly
...
p.000014: responsibilities that have to be taken by or on behalf of sponsors of trials involving medicines).
p.000014: • Satisfying itself that arrangements are kept in place for good practice in conducting the study, and for
p.000014: monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.
p.000014:
p.000014: See 3.19 to 3.24
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000015: PROPER CONDUCT OF A HEALTH RESEARCH STUDY (CONTINUED)
p.000015:
p.000015: Employing Organisation
p.000015:
p.000015: • Promoting a quality research culture.
p.000015: • Ensuring researchers understand and discharge their responsibilities.
p.000015: • Ensuring studies are properly designed and submitted for independent review.
p.000015: • Ensuring studies are managed, monitored, and reported as agreed, according to the protocol.
p.000015: • Providing written procedures, training and supervision.
p.000015: • Taking action if misconduct or fraud is suspected. See 3.25 to 3.28
p.000015: Organisation Providing Care/ Responsible Care Professional
p.000015:
p.000015: • Arranging for an appropriate person to give permission for research involving their patients, service users,
p.000015: carers or staff, before the research starts.
p.000015: • Ensuring any such research is conducted to the standards set out in this research governance framework.
p.000015: • Requiring evidence of ethical review before recruitment to any research that affects their duty of care.
p.000015: • Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical
p.000015: trials authorisation.
p.000015: • Retaining responsibility for the care of participants to whom they have a duty. See 3.29 to 3.34
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN HEALTH RESEARCH
p.000016:
p.000016: SCENARIO: WHO IS RESPONSIBLE FOR WHAT? SOME QUESTIONS AND ANSWERS
p.000016:
p.000016: The Scenario: the Medical Research Council (MRC) awards a university Senior Lecturer in General Practice a grant for a
p.000016: clinical trial of a medicine. The grant is paid to the university. The MRC was closely involved in developing the
p.000016: trial design. The research is taking place in general practices. The Medicines and Healthcare products Regulatory
p.000016: Agency (MHRA) has agreed that the university and the relevant NHS Board form a group to take on the sponsor’s
p.000016: responsibilities. The manufacturer of the drug has agreed to provide it free. The drug has a marketing authorisation
p.000016: covering the use of the product described in the research protocol.
p.000016:
p.000016: PATIENT
p.000016:
p.000016: Q: I did tell my GP that I might be interested in joining the study, but that does not commit me definitely, does
p.000016: it?
p.000016: A: Your GP agreed to collaborate with the research team, and invite her patients to participate. Whether or not
...
p.000017: leaflet. If there are still problems you are free to withdraw.
p.000017:
p.000017: Q: One of my patients seems much worse since I entered him into the trial. He is keen to continue, but I am
p.000017: concerned. What should I do?
p.000017: A: Your primary responsibility is the patient’s care. You have a duty to put his safety before anything required
p.000017: by the research. You should advise him to withdraw if you think that the trial drug caused his problems. Explain to
p.000017: him that you will talk to the research team on his behalf. It is very important you inform the chief investigator of
p.000017: any concerns about treatment under the trial. In trials of medicines, it is a legal requirement to report harmful
p.000017: reactions to the MHRA so that everyone can learn from them.
p.000017:
p.000017:
p.000017: CHIEF INVESTIGATOR
p.000017:
p.000017:
p.000017: Q: How do I know when the trial is authorised?
p.000017: A: As it falls under the Medicines for Human Use (Clinical Trials) Regulations 2004, the trial has to be
p.000017: authorised by the MHRA. The MHRA notifies sponsors when trials are authorised. The sponsor’s representative will tell
p.000017: you when the drugs can be released for use in the trial.
p.000017:
p.000017: Q: What about ethical review?
p.000017: A: You have submitted the study to an ethics committee recognised for this kind of study, using the electronic
p.000017: form available on the Central Office for Research Ethics Committees (COREC) website. You need a positive ethics
p.000017: committee opinion as well as a Clinical Trial Authorisation before you can start the trial.
p.000017:
p.000017: Q: To whom must I report an adverse event?
p.000017: A: For this trial, the sponsors have delegated to you the responsibility for recording and reporting adverse
p.000017: events. The MHRA will issue the Clinical Trial Authorisation on that basis so you have to follow the agreed process
p.000017: for recording adverse events, assessing seriousness, relatedness and expectedness, and reporting. You must arrange to
p.000017: report any worrying reaction immediately to the patient’s GP. Adverse drug reactions must also be reported to the
p.000017: Trial Steering Committee, the drug manufacturer, the MHRA, the ethics committee and the Data Monitoring Committee.
p.000017: Under the Clinical Trials Regulations, there is a legal obligation to report suspected unexpected serious adverse
p.000017: reactions (SUSARs) to the MHRA within a set period.
p.000017:
p.000017: Q: I am concerned that the staff in the university labs may not follow health and safety rules. What do I do?
p.000017: A: You should raise this concern through the university's local health and safety systems.
p.000017:
p.000017: Q: I am concerned that not all the investigators will follow the protocol closely. What should I do?
p.000017: A: Inform the sponsor’s representative immediately and agree a course of action.
p.000017:
p.000017: Q: If my team need training, whom should I talk to?
p.000017: A: Their employer is normally responsible for their training.
p.000017:
p.000017: Q: To whom do I talk if I suspect a university colleague is fabricating data?
...
p.000020: • The research is carried out to the standards in this research governance framework;
p.000020: • Controlled trials are registered and for clinical trials involving medicines, the research follows
p.000020: any conditions imposed by the licensing authority;
p.000020: • The Chief Executive of the care organisation(s) involved and/or any other individual(s) with
p.000020: responsibilities within this framework are informed that the study is planned, and their permission is obtained
p.000020: before the research starts;
p.000020: • When a study involves participants under the care of a doctor, nurse or other worker for the
p.000020: condition to which the study relates, those care professionals are informed that their patients or users are being
p.000020: invited to participate and agree to retain overall responsibility for their care;
p.000020: • When the research involves a service user or carer or a child, looked after or receiving services
p.000020: under the auspices of the local authority, the agency director or their deputy agrees to the person (and/or
p.000020: their carer) being invited to participate and is fully aware of the arrangements for dealing
p.000020: with any disclosures or other relevant information;
p.000020: • Potential participants and other service users and carers are involved in the design and management
p.000020: of the study whenever appropriate;
p.000020: • The study is submitted for ethics review and it does not start without a favourable opinion, and
p.000020: the research team acts on any conditions attached to the ethics opinion;
p.000020: • Unless participants or the ethics opinion says otherwise, participants’ care professionals are given
p.000020: any information directly relevant to their care that arises in the research;
p.000020: • Each member of the research team, including those at collaborating sites, is qualified by education,
p.000020: training and experience to discharge his/her role in the study and their qualifications are documented;
p.000020: • Each investigator in a clinical trial involving medicines is aware of his/her legal duties;
p.000020: • Students and new researchers have adequate supervision, support and training;
p.000020: • Unless urgent safety measures are necessary,13 the research follows the protocol or proposal agreed by the
p.000020: relevant ethics committee and by the sponsor14;
p.000020: • Substantive changes to the protocol or proposal are submitted for ethical review and for the sponsor’s
p.000020: agreement. These amendments are implemented only when approved;15
p.000020: • Procedures are kept in place to ensure collection of high quality, accurate data and the integrity and
p.000020: confidentiality of data during processing and storage16;
p.000020: • Arrangements are made for the appropriate archiving of data when the research has finished and to make it
p.000020: accessible;
p.000020:
p.000020:
p.000020:
p.000020: 13 Investigators in clinical trials involving medicines have to report serious adverse events immediately. 14 For
p.000020: clinical trials involving medicines, it is a legal requirement to follow the protocol approved by the licensing
p.000020: authority (the Medicines and Healthcare products Regulatory Agency).
...
p.000022:
p.000022: 18 For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution,
p.000022: company or organisation) who takes responsibility for the initiation, management and financing (or arranging the
p.000022: financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials)
p.000022: Regulations 2004. Regulation 3 defines options for sponsorship, including single sponsorship, joint sponsorship and
p.000022: allocation of sponsorship responsibilities within a group.
p.000022: 19 The Regulations require a sponsor to be established, or have a legal representative, in the European Community.
p.000022: Neither of them need to be established in the United Kingdom.
p.000023: 23
p.000023:
p.000023: external sponsor. When research is undertaken for research training purposes, research supervisors normally
p.000023: carry out the sponsorship responsibilities on behalf of their employers. Exceptionally, a university may authorise a
p.000023: suitably experienced postgraduate student to carry out these responsibilities on its behalf.
p.000023:
p.000023: 3.24 It is the sponsor’s responsibility to be satisfied that:
p.000023:
p.000023: • The research proposal respects the dignity, rights, safety and well-being of participants and the
p.000023: relationship with care professionals;
p.000023: • An appropriate process of independent expert review has demonstrated that the research proposal is
p.000023: worthwhile, of high scientific quality and good value for money;
p.000023: • An appropriate ethics committee has given a favourable opinion;
p.000023: • In the case of a clinical trial involving a medicine, someone acting on behalf of the sponsor obtains a
p.000023: clinical trial authorisation and the arrangements for the trial comply with the law;
p.000023: • Appropriate arrangements are in place for the registration of a trial;
p.000023: • The chief investigator, and other key researchers, including those at collaborating sites,
p.000023: have the necessary expertise and experience and have access to the resources needed to conduct the proposed research
p.000023: successfully;
p.000023: • The arrangements and resources proposed will allow the collection of high quality, accurate data and
p.000023: the systems and resources proposed are those required to allow appropriate data analysis and data protection;
p.000023: • Arrangements proposed for the work are consistent with this research governance framework;
p.000023: • Organisations and individuals involved in the research agree the division of responsibilities between
p.000023: them;
p.000023: • There is written agreement about the arrangements for the management and monitoring of the study;
p.000023: • Arrangements are in place for the sponsor and other stakeholder organisations to be alerted if significant
p.000023: developments20 occur as the study progresses, whether in relation to the safety of individuals or to scientific
p.000023: direction21;
p.000023: • Agreement has been reached about compensation in the event of harm to research participants22and
p.000023: if any organisation, or the sponsor itself, offers compensation without proof of negligence, it has made the
...
p.000025: complaints associated with their employees.
p.000025:
p.000025: Responsibilities of Organisations Providing Care
p.000025:
p.000025: 3.29 It is the responsibility of organisations providing healthcare in Scotland to be aware of all research
p.000025: undertaken in their organisation, or involving participants, organs, tissue or data obtained through the
p.000025: organisation. Care providers remain responsible for the quality of all aspects of the care of their patients or
p.000025: service users and carers, whether or not they are involved in research and whoever conducts or funds that
p.000025: research. Chief Executives of NHS organisations are accountable for the quality of care and for the environment in
p.000025: which it is provided under the Duty of Care. They should ensure that their patients, service users and carers, and
p.000025: care professionals are provided with information about any research which may have a direct impact on their care, their
p.000025: experience of care, or their work in the organisation. They should ensure that activity is presented as research only
p.000025: if it is managed as research within this framework.
p.000025:
p.000025: 3.30 Organisations providing healthcare are responsible for satisfying themselves that there are adequate
p.000025: arrangements and resources for any research involving their patients, service users and carers, or staff
p.000025: to meet the standards set out in this framework. No research with human participants, their organs, tissue or
p.000025: data, may begin before an identified sponsor has taken on responsibility for that research, the study has received a
p.000025: positive ethical opinion and the allocation of responsibilities is agreed and documented. Accountability for this
p.000025: lies with the Chief Executive or Agency Director. He or she will normally delegate responsibility to a qualified
p.000025: and senior person.
p.000025:
p.000025: 3.31 Academic staff (university/college medical, nursing, and allied health professionals and other research
p.000025: workers) who, in the course of their NHS research duties, interact with individuals in a way which has a
p.000025: direct bearing on the quality of their care should hold an NHS honorary contract.24 When universities and
p.000025: healthcare organisations are both involved in employing clinical academic staff, they are expected to make
p.000025: joint arrangements for appointment, supervision and appraisal.
p.000025:
p.000025: 3.32 The main responsibilities of organisations providing healthcare are to:
p.000025:
p.000025: • Retain responsibility for the quality of all aspects of participants’ care whether or not some aspects of care
p.000025: are part of a research study;
p.000025: • Be aware and maintain a record of all research work undertaken through or within the organisation including
p.000025: research undertaken by students as part of their training;
p.000025: • Ensure patients or service users and carers are provided with information on any research that may
p.000025: affect their care;
p.000025:
p.000025:
p.000025:
p.000025: 24 If there is negligent harm during a study with NHS permission when the NHS body owes a duty of care to the person
p.000025: harmed, NHS indemnity covers NHS staff, academic staff with honorary contracts (as defined in paragraph 3.31) and those
p.000025: conducting the study. Guidance for the NHSScotland can be found in the document “Guidance Note on Research Governance
p.000025: and Honorary Contracts”, (Health Department, March, 2004).
p.000026: 26
p.000026:
p.000026: • Be aware of current legislation relating to research and ensure that it is implemented and followed within the
p.000026: organisation;
p.000026: • Require that no research study with human participants for whom the organisation is responsible (or their
p.000026: organs, tissue or data), begins until a sponsor has confirmed it has taken responsibility; the proposed research has a
p.000026: favourable ethical opinion (and if the study is a trial of a medicine, that there is a clinical trial authorisation);
p.000026: and a person authorised to do so has given written permission on behalf of the organisation
p.000026: providing care25;
p.000026: • Ensure that written agreements are in place about responsibilities for all research involving an
p.000026: external partner, funder and/or sponsor including agreement with the University or other employer on supervision of
p.000026: student research;
p.000026: • Maintain the necessary links with clinical governance and/or best value processes;
p.000026: • Ensure that NHS honorary contracts are issued where appropriate26. There should be clear accountability and
p.000026: understanding of responsibilities;
p.000026: • Put and keep in place systems to identify and learn from errors or failures associated with any research
p.000026: undertaken through or within the organisation;
p.000026: • Ensure that significant lessons learnt from errors or complaints and from internal enquiries are
p.000026: communicated to funders, sponsors and other partners;
p.000026: • Ensure that adverse incidents in the context of research are reported in line with the standard procedures of
p.000026: the organisation;
p.000026: • Permit and assist with any monitoring, auditing or inspection by relevant authorities.
p.000026:
p.000026: Responsibilities of Care Professionals
p.000026:
p.000026: 3.33 Healthcare staff retain responsibility for the care of their patients or service users when they are
p.000026: participating in research within the NHS.
p.000026:
p.000026: 3.34 Before agreeing to their patients or service users and carers being approached by the research team, care
p.000026: professionals should satisfy themselves that the chief investigator has the permission of the
p.000026: appropriate authorities within their organisation or agency. Before enrolling patients in a clinical
p.000026: study, NHS staff should look for evidence that the study has the ethical and regulatory approval it needs.
p.000026: They should then take care to follow the currently approved version of the protocol.
p.000026:
p.000026: Responsibilities Relating to Research Ethics Committees
p.000026:
p.000026: 3.35 No research study within the NHS involving individuals, their organs, tissue or data may begin until it has a
p.000026: favourable opinion from a research ethics committee.
p.000026:
p.000026: 3.36 From 2004, the United Kingdom Ethics Committee Authority has been responsible for recognising ethics committees to
p.000026: review clinical trials under the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000026:
p.000026: 3.37 The NHS is responsible for establishing, supporting and monitoring NHS research ethics committees (RECs). The
p.000026: duties of NHS bodies in relation to NHS RECs are set out in the good practice guidance Governance Arrangements
p.000026: for Research Ethics Committees in Scotland (SEHD, 2001). Those outside the NHS may also
p.000026:
p.000026: 25 See section 4.4.
p.000026: 26 See footnote 24.
p.000027: 27
p.000027:
p.000027: seek the advice of these committees. Community care research involving human participants to whom the NHS has a duty
p.000027: of care (or their organs, tissue or data) must have a favourable opinion from the relevant NHS REC.
p.000027:
p.000027: 3.38 RECs are required to be independent when formulating advice on the ethics of the proposed research. Ethics
p.000027: review must be seen to be impartial. Whilst operating within a framework of standards and NHS management,
p.000027: neither SEHD nor NHS bodies are entitled to interfere with NHS RECs’ decisions. RECs’ appointing
p.000027: authorities must have systems in place to appoint members and convene them, to seek recognition if the law
p.000027: requires it, and to support them and monitor their performance.
p.000027:
p.000027: 3.39 RECs provide an independent opinion. The decision whether or not to give permission for research
p.000027: in a care organisation rests with that organisation. Healthcare organisations will not normally
p.000027: withhold permission provided that a sponsor has been identified, the ethical opinion is favourable, the
p.000027: agreements for allocation of responsibilities or indemnity and/or insurance are acceptable to the
p.000027: organisation, and conducting the research will not conflict with service delivery in some way due to local issues
p.000027: that might not have been considered by the ethics approval or sponsor.
p.000027:
p.000027: 3.40 It is not for RECs or reviewers to give legal advice, nor are they liable for any of their opinions in this
p.000027: respect. It is the researchers and the healthcare organisations27 who have the responsibility not to break the law.
p.000027: If a REC suspects that a research proposal might contravene the law, it is expected to advise both
p.000027: the chief investigator and the appropriate authority. Then the chief investigator and the organisation
p.000027: will need to seek legal advice.
p.000027:
p.000027: 3.41 RECs require researchers working in the NHS to keep them informed of the progress of a study. The
p.000027: committees are responsible for reviewing their advice on the ethical acceptability of a study in the light of
p.000027: such information. The chief investigator and his or her employer, the sponsor and the care organisation
p.000027: are responsible for ensuring that a study follows the agreed protocol, and for monitoring and
p.000027: reporting on its progress.28
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 27 and the sponsor, for clinical trials involving medicines.
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000002: GENERAL
p.000012: 12
p.000012: AGREEMENTS
p.000012: 12
p.000012: SPECIFIC RESPONSIBILITIES ………………………………………………………. 13
p.000012: RESPONSIBILITIES OF PARTICIPANTS 20
p.000012: RESPONSIBILITIES OF RESEARCHERS 20
p.000012: RESPONSIBILITIES OF INVESTIGATORS AND THE CHIEF
p.000012: INVESTIGATOR
p.000020: 20
p.000020: RESPONSIBILITIES OF RESEARCH FUNDERS 22
p.000020: RESPONSIBILITIES OF THE SPONSOR …………………………………… 23
p.000020: RESPONSIBILITIES OF UNIVERSITIES AND OTHER ORGANISATIONS
p.000020: EMPLOYING RESEARCHERS ………………………………………………………. 25
p.000020: RESPONSIBLITIES OF ORGANISATIONS PROVIDING CARE……………….….. 26
p.000020: RESPONSIBILITIES OF CARE PROFESSIONALS 27
p.000020: RESPONSIBILITIES RELATING TO RESEARCH ETHICS COMMITTEES 27
p.000020: 4. ACHIEVING GOVERNANCE
p.000020: DELIVERY …………………………………………………………………….. 29
p.000020: ADHERENCE TO THE FRAMEWORK ……………………………………………. 30
p.000020:
p.000020: Research Governance
p.000020:
p.000020: ❖ Sets out principles, requirements and standards
p.000020:
p.000020: ❖ Defines mechanisms to deliver them
p.000020:
p.000020: ❖ Describes monitoring and assessment arrangements
p.000020:
p.000020: ❖ Improves research quality and safeguards the public by:
p.000020:
p.000020: - enhancing ethical and scientific quality
p.000020: - promoting good practice
p.000020: - reducing adverse incidents and ensuring lessons are learned
p.000020: - forestalling poor performance and misconduct
p.000020:
p.000020: ❖ Is for all those who:
p.000020:
p.000020: - design research studies
p.000020: - participate in research
p.000020: - host research in their organisation
p.000020: - fund research proposals or infrastructure
p.000020: - manage research
p.000020: - undertake research
p.000020:
p.000020: ❖ Is for all managers and staff, in all professional groups, no matter how senior or junior
p.000020:
p.000020: ❖ Is for those working in all health and community care environments, including:
p.000020:
p.000020: - primary care
p.000020: - secondary care
p.000020: - tertiary care
p.000020: - community care
p.000020: - public health
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000001: 1
p.000001:
p.000001: 1. PURPOSE AND SCOPE
p.000001:
p.000001: 1.1 The Scottish Executive is committed to enhancing the contribution of research to health and community care,
p.000001: and the partnership between services and science. Research is essential to the successful promotion and
p.000001: protection of health and well-being and also to modern, effective health and community care services services.
p.000001: At the same time research can involve an element of risk, both in terms of return on investment and
p.000001: sometimes for the safety and well-being of the research participants. Proper governance of research is therefore
p.000001: essential to ensure that the public can have confidence in, and benefit from, quality research in health and
...
p.000001: organisational context and the range of academic disciplines. This framework focuses on requirements and standards,
p.000001: delivery mechanisms, and arrangements to monitor quality for health research. It is expected that
p.000001: organisations involved in community care research will develop their own mechanisms for the delivery, monitoring
p.000001: and assessment of research which reflect the principles set out in this framework, are proportionate to the
p.000001: risk involved and have regard to existing codes of good practice. The Scottish Executive is reviewing and
p.000001: improving existing ethical assurance processes for social research it commissions or undertakes to support
p.000001: Ministers and policy development taking account of the framework principles.
p.000001:
p.000001: 1.5 The aim of this framework is to bring together general principles of good practice. It refers to the law on
p.000001: clinical trials involving medicines. That does not mean it imposes the same procedures on other research when the
p.000001: interests of participants and the research methods do not call for them. The checklist of responsibilities in Section
p.000001: 3 are there to help everyone reach agreement on arrangements that are proportionate to risk, and for
p.000001:
p.000002: 2
p.000002:
p.000002: health research to be in line with Good Clinical Practice. Therefore, the framework is offered also as a model
p.000002: for the governance of research in areas outside the direct responsibility of the Minister for Health and
p.000002: Community Care where poor practice could have a direct impact on the health or well-being of the public.
p.000002:
p.000002: 1.6 The framework is of direct relevance to all those who host, conduct, participate in, fund and
p.000002: manage research. It is not just for investigators, managers or any one professional group. All service
p.000002: and academic staff, no matter how senior or junior, have a role to play in the conduct of research. Participants in
p.000002: research and the public in general can also help to ensure that standards are understood and met.
p.000002:
p.000002: 1.7 This framework seeks to promote improvements in research quality across the board. As with clinical governance,
p.000002: research governance involves bringing general performance up to that of those at the leading edge. The
p.000002: framework provides a context for the encouragement of creative and innovative research and for the
p.000002: effective transfer of learning, technology and best practice to improve care.
p.000002: 1.8 The framework aims to forestall poor performance, adverse incidents, research misconduct and
p.000002: fraud, and to ensure that lessons are learned and shared when poor practice is identified. Learning from
p.000002: adverse events will promote good practice, enhance the ethical and scientific quality of research, and safeguard the
p.000002: public.
p.000002: 1.9 Health and community care generate and draw upon a wide range of innovative work and ideas from
p.000002: professionals, organisations and the public. Services must promote innovation while protecting
p.000002: participants from risk and waste. Innovation embraces a much wider range of activities than those managed
p.000002: formally as research.
p.000002:
p.000002: 1.10 Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly
p.000002: defined questions with systematic and rigorous methods.1 This document sets out the responsibilities and
p.000002: standards that apply to work managed within the formal research context. Other documents on quality and governance in
p.000002: the NHS and community care set out standards and systems for assuring the quality of innovative work in non-research
p.000002: contexts.
p.000002:
p.000002: 1.11 Inquiries into adverse incidents relating to research have criticised a lack of clarity about responsibility and
p.000002: accountability. This is important, given the very wide range of individuals and organisations that can
p.000002: be involved. The framework pays particular attention to clarifying responsibilities and accountabilities.
p.000002: Listed are some of the individuals and organisations involved in health and community care research:
p.000002:
p.000002: ◻ The Public
p.000002: ◻ Research workers
p.000002: ◻ NHS staff
p.000002: ◻ Universities
p.000002: ◻ Students and their supervisors
p.000002: ◻ Research ethic committees
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
p.000005: to informed consent, and to the recruitment of minors and incapacitated adults.
p.000005: 6 Unless the risk to them is negligible, it is unethical to involve adults without capacity to consent, or minors, in
p.000005: research that could have no therapeutic benefit for the group involved.
p.000006: 6
p.000006:
p.000006: enforced by the Home Office. Before a researcher can use animals, a series of special licences must be
p.000006: obtained. Primates are only to be used if less advanced animals could not provide the information. Researchers
p.000006: must have the necessary skills, training and experience, and the research laboratory must have the facilities to
p.000006: care for the animals properly. The highest standards of animal husbandry and welfare under veterinary supervision
p.000006: must be maintained and an ethical review process must operate in accordance with Home Office requirements.
p.000006:
p.000006: Science
p.000006:
p.000006: 2.13 All existing sources of evidence, especially systematic reviews, must be considered carefully before undertaking
p.000006: health research. Research which duplicates other work unnecessarily or which is not of sufficient quality to
p.000006: contribute something useful to existing knowledge is unethical. Every proposal for health research must be
p.000006: subjected to review by experts in the relevant fields able to offer independent advice on its quality. Arrangements
p.000006: for peer review should be in proportion to the scale of the research and the risks involved. For example, in
...
Searching for indicator incapacity:
(return to top)
p.000004: ◻ finance
p.000004: ◻ quality research culture.
p.000004:
p.000004: 2.3 Each domain has been grouped as follows:
p.000004:
p.000004: ◻ requirements in legislation and regulations
p.000004: ◻ standards required by SEHD
p.000004: ◻ other established principles of good practice from recognised international and national authorities and
p.000004: professional organisations.
p.000004:
p.000004: 2.4 The Chief Scientist Office website will provide regular updates of detail. The following sections
p.000004: set out principles in each domain.
p.000004:
p.000004: Ethics
p.000004:
p.000004: 2.5 The dignity, rights, safety and well-being of participants must be the primary consideration in any research
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000001: At the same time research can involve an element of risk, both in terms of return on investment and
p.000001: sometimes for the safety and well-being of the research participants. Proper governance of research is therefore
p.000001: essential to ensure that the public can have confidence in, and benefit from, quality research in health and
p.000001: community care. The public has a right to expect high scientific, ethical and financial standards,
p.000001: transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements.
p.000001:
p.000001: 1.2 This document sets out a framework for the governance of research in health and community care.
p.000001: The principles underpinning the framework apply to all research which relates to the responsibilities of the Minister
p.000001: for Health and Community Care. That is, research concerned with the protection and promotion of
p.000001: public health, research undertaken in or by the Scottish Executive Health Department, (SEHD), its non-
p.000001: Departmental Public Bodies and the NHS, and community care research. Within this context, it applies to
p.000001: clinical and non-clinical research; research undertaken by NHS or community care staff using the resources of health
p.000001: and community care organisations; and any research undertaken by industry, charities, research councils and
p.000001: universities within the health and community care systems that might have an impact on the quality of those services.
p.000001:
p.000001: 1.3 This framework does not apply to research concerned with the delivery of local authority services outwith the
p.000001: Minister for Health and Community Care's responsibilities unless they are carried out in NHS settings or
p.000001: in collaboration with NHS care providers. In addition, the framework does not apply to research in the Scottish
p.000001: Prison Service except where this involves medical treatment or the provision of other health services. Although this
p.000001: work is governed by separate arrangements, the principles underpinning this framework should be
p.000001: applied whenever possible.
p.000001:
p.000001: 1.4 Important differences between health and community care research mean that the precise mechanisms by which
p.000001: relevant standards and requirements are achieved will differ. Compared with much research in the NHS, research
p.000001: in community care differs in nature, scale, volume and funding as well as in the mix of stakeholders, the
p.000001: organisational context and the range of academic disciplines. This framework focuses on requirements and standards,
p.000001: delivery mechanisms, and arrangements to monitor quality for health research. It is expected that
p.000001: organisations involved in community care research will develop their own mechanisms for the delivery, monitoring
p.000001: and assessment of research which reflect the principles set out in this framework, are proportionate to the
p.000001: risk involved and have regard to existing codes of good practice. The Scottish Executive is reviewing and
p.000001: improving existing ethical assurance processes for social research it commissions or undertakes to support
p.000001: Ministers and policy development taking account of the framework principles.
p.000001:
...
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
...
p.000013: distribute them by agreement among the members of the group, provided that, collectively, they make arrangements to
p.000013: allocate all the responsibilities in this research governance framework that are relevant to the study).
p.000013:
p.000013: Employing Organisation - the organisation employing the chief investigator, investigators or other researchers.
p.000013: Employers remain liable for the work of their employees. The organisation employing the chief investigator normally
p.000013: holds the contract or grant agreement with the funder of the study.
p.000013: Organisations holding contracts with funders remain responsible for the management of the funds provided.
p.000013:
p.000013: Organisation Providing Care - the organisation responsible for providing care to patients and/or service users and
p.000013: carers participating in a study. Health organisations remain liable for the quality of care and for their duty towards
p.000013: anyone who might be harmed by a study.
p.000013:
p.000013: Responsible Care Professional - doctor, nurse or other practitioner formally responsible for the care of participants
p.000013: while they are taking part in the study.
p.000013:
p.000013: Research Ethics Committee – committee established to provide participants, researchers, funders, sponsors, employers,
p.000013: care organisations and professionals with an independent opinion on the extent to which proposals for a study comply
p.000013: with recognised ethical standards. For clinical trials involving medicines, the committee must be one recognised
p.000013: by the United Kingdom Ethics Committee Authority.
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000014: PROPER CONDUCT OF A HEALTH RESEARCH STUDY
p.000014:
p.000014: Chief Investigator, Investigators, other Researchers
p.000014:
p.000014: • Developing proposals that are scientifically sound and ethical.
p.000014: • Submitting the design for independent expert review.
p.000014: • Submitting the study (or proposal) for independent ethical review.
p.000014: • Conducting a study to the agreed protocol (or proposal), in accordance with legal requirements,
p.000014: guidance and accepted standards of good practice.
p.000014: • Preparing and providing information for participants.
p.000014: • Ensuring participants’ welfare while in the study.
p.000014: • Arranging to make findings and data accessible following expert review.
p.000014: • Feeding back results of research to participants.
p.000014:
p.000014: See 3.10, 3.11 to 3.13
p.000014:
p.000014: Main Funder
p.000014:
p.000014: • Assessing the scientific quality of the research as proposed.
p.000014: • Establishing the value for money of the research as proposed.
p.000014: • Considering the suitability of the research environment in which the research will be undertaken, particularly
p.000014: the experience and expertise of the chief investigator, principal investigator(s) and other key
p.000014: researchers involved.
p.000014: • Requiring that a sponsor takes on responsibility before the research begins.
p.000014:
p.000014: See 3.14 to 3.18
p.000014:
p.000014: Sponsor
p.000014:
p.000014: • Confirming that everything is ready for the research to begin:
...
p.000016: it?
p.000016: A: Your GP agreed to collaborate with the research team, and invite her patients to participate. Whether or not
p.000016: you agree is entirely up to you. Unless you consent, you won’t be in the study.
p.000016:
p.000016: Q: How can I know the study is worthwhile?
p.000016: A: Through independent expert review (“peer review”), the MRC assessed the clinical importance of the questions
p.000016: addressed by the study. It also assessed the design and oversight arrangements. An ethics committee checked it is
p.000016: ethical. The MHRA authorised it.
p.000016:
p.000016: Q: How can I find out more about it?
p.000016: A: You can take away this patient information leaflet to study, and you can ask your GP or anyone on the research
p.000016: team for further details.
p.000016:
p.000016: Q: What if the drug involved does not agree with me?
p.000016: A: Your GP is still responsible for your care. She knows how we plan to monitor people who are in the trial. We
p.000016: will advise her immediately if we detect any problems, and you can approach her at any time. It is important for you
p.000016: to say if you have a bad reaction to the drug.
p.000016:
p.000016: G.P.
p.000016:
p.000016: Q: How do I know that this study is well designed?
p.000016: A: The university and NHS Board are together sponsoring the study. The protocol names the sponsors’ contact
p.000016: points. The scientific design went through the MRC’s review system. It has ethical approval, and regulatory approval
p.000016: from the licensing authority. But you must decide whether you feel able to collaborate with it.
p.000016:
p.000016: Q: Who is responsible for the care of my patients if they agree to take part?
p.000016: A: You are. The protocol explains the procedures the research team will follow and the circumstances when they
p.000016: will alert you to anything they observe in your patients. You must ensure you are satisfied with these arrangements
p.000016: and discuss them with the chief investigator if you are not.
p.000016:
p.000016: Q: Who is responsible for ensuring that the study follows the protocol and data are monitored to detect any
p.000016: possible problems?
p.000016: A: The chief investigator is responsible for ensuring that you and every other person involved in the study is
p.000016: well informed, and able to carry out their roles properly. This is a trial of a medicine, so there is a legal
p.000016: responsibility to follow the protocol. If you have any concerns about this, you should contact the chief investigator.
p.000016: If you are not satisfied, you should inform the sponsor’s representative.
p.000016:
p.000016: Q: Who is responsible for the quality of the drugs?
p.000016: A: The pharmaceutical company supplying the drugs is responsible for their quality. Medicines have to be made in
p.000016: licensed facilities, and must be correctly labelled for trials.
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN RESEARCH (CONTINUED)
p.000017:
p.000017: Q: I have agreed to join the study, but a number of my patients are having trouble understanding what they are
p.000017: being asked to take part in. It's taking up an enormous amount of time. What should I do?
...
p.000019: and, through them, to the sponsor of the research. They are also directly accountable to the care organisation(s)
p.000019: where the research takes place (or through which the research team has access to participants, their organs, tissue
p.000019: or data). If the research is at more than one site, the chief investigator takes on personal
p.000019: responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the
p.000019: lead at each site.
p.000019:
p.000019: 3.12 Chief investigators must have suitable experience and expertise in the design and conduct of research12 so that
p.000019: they are able either to undertake the design, conduct, analyses and reporting of the study to the standards set out in
p.000019: this framework or lead and manage others with delegated responsibility for some of these aspects.
p.000019:
p.000019: 3.13 It is the chief investigator’s responsibility to ensure that:
p.000019:
p.000019:
p.000019:
p.000019: 12 For clinical trials involving medicines, the chief investigator and other investigators must be authorised
p.000019: healthcare professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000020: 20
p.000020:
p.000020: • The research team gives priority at all times to the dignity, rights, safety and well-being of
p.000020: participants;
p.000020: • The study complies with all legal and ethical requirements;
p.000020: • The research is carried out to the standards in this research governance framework;
p.000020: • Controlled trials are registered and for clinical trials involving medicines, the research follows
p.000020: any conditions imposed by the licensing authority;
p.000020: • The Chief Executive of the care organisation(s) involved and/or any other individual(s) with
p.000020: responsibilities within this framework are informed that the study is planned, and their permission is obtained
p.000020: before the research starts;
p.000020: • When a study involves participants under the care of a doctor, nurse or other worker for the
p.000020: condition to which the study relates, those care professionals are informed that their patients or users are being
p.000020: invited to participate and agree to retain overall responsibility for their care;
p.000020: • When the research involves a service user or carer or a child, looked after or receiving services
p.000020: under the auspices of the local authority, the agency director or their deputy agrees to the person (and/or
p.000020: their carer) being invited to participate and is fully aware of the arrangements for dealing
p.000020: with any disclosures or other relevant information;
p.000020: • Potential participants and other service users and carers are involved in the design and management
p.000020: of the study whenever appropriate;
p.000020: • The study is submitted for ethics review and it does not start without a favourable opinion, and
p.000020: the research team acts on any conditions attached to the ethics opinion;
p.000020: • Unless participants or the ethics opinion says otherwise, participants’ care professionals are given
p.000020: any information directly relevant to their care that arises in the research;
p.000020: • Each member of the research team, including those at collaborating sites, is qualified by education,
p.000020: training and experience to discharge his/her role in the study and their qualifications are documented;
p.000020: • Each investigator in a clinical trial involving medicines is aware of his/her legal duties;
p.000020: • Students and new researchers have adequate supervision, support and training;
p.000020: • Unless urgent safety measures are necessary,13 the research follows the protocol or proposal agreed by the
p.000020: relevant ethics committee and by the sponsor14;
p.000020: • Substantive changes to the protocol or proposal are submitted for ethical review and for the sponsor’s
p.000020: agreement. These amendments are implemented only when approved;15
p.000020: • Procedures are kept in place to ensure collection of high quality, accurate data and the integrity and
p.000020: confidentiality of data during processing and storage16;
p.000020: • Arrangements are made for the appropriate archiving of data when the research has finished and to make it
p.000020: accessible;
p.000020:
p.000020:
p.000020:
p.000020: 13 Investigators in clinical trials involving medicines have to report serious adverse events immediately. 14 For
p.000020: clinical trials involving medicines, it is a legal requirement to follow the protocol approved by the licensing
p.000020: authority (the Medicines and Healthcare products Regulatory Agency).
p.000020: 15 Also, for clinical trials involving medicines, to the licensing authority.
p.000020: 16 Also, for clinical trials involving medicines, procedures to comply with legal requirements concerning Good
p.000020: Clinical Practice during the trial, and Good Manufacturing Practice in manufacturing investigational medicinal
p.000020: products.
p.000021: 21
p.000021:
p.000021: • Reports on the progress and outcomes of the work required by the sponsor, funders, or others
p.000021: with a legitimate interest are produced on time and to an acceptable standard;
p.000021: • The findings from the work are opened to critical review through the accepted scientific and professional
p.000021: channels;
p.000021: • Once established, findings from the work are disseminated promptly and fed back as appropriate to
p.000021: participants;
p.000021: • The chief investigator accepts a key role in detecting and preventing scientific misconduct by adopting the
p.000021: role of guarantor on published outputs;
p.000021: • Arrangements are kept in place for the management of financial and other resources provided for
p.000021: the study, including for the management of any intellectual property arising;
p.000021: • All data and documentation associated with the study are available at the request of the inspection
p.000021: and auditing authorities.
p.000021:
p.000021: Responsibilities of Research Funders
p.000021:
p.000021: 3.14 Organisations that fund health research have a responsibility for ensuring that the work is a proper use of the
p.000021: funds they control and provides value for money.
p.000021:
p.000021: 3.15 The main research funder plays a critical role in assuring the quality of a study. It will normally take the
...
p.000022: monitor, and finance a study18. For any research that takes place in the context of the NHS in
p.000022: Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for
p.000022: particular aspects of the arrangements for the study. It may be the chief investigator’s
p.000022: employing organisation, or the lead organisation providing healthcare, or the main funder. If
p.000022: the sponsor is outside the United Kingdom, it must have a legal representative in the United Kingdom.19 For
p.000022: any health research study covered by this research governance framework, it is for the sponsor to be
p.000022: satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management,
p.000022: monitoring and financing. Others will rely on reasonable assurances that the sponsor has taken steps to do this.
p.000022:
p.000022: 3.20 The sponsor is responsible for ensuring before a study begins that arrangements are in place for the research
p.000022: team to access resources and support to deliver the research as proposed and that arrangements are in place
p.000022: allocating responsibilities for the management, monitoring and reporting of the research. The sponsor also has to
p.000022: be satisfied there is agreement on appropriate arrangements to record, report and review significant
p.000022: developments as the research proceeds, particularly those which put the safety of individuals at risk and to approve
p.000022: any modifications to the design, obtain any regulatory authority required, implement them and make them known.
p.000022:
p.000022: 3.21 It is the sponsor’s responsibility to be satisfied with the arrangements for management and monitoring.
p.000022: Normally, if the chief investigator’s employer takes on the sponsor’s responsibilities (alone or as a member of a
p.000022: group), it will assume responsibility for operating the management and monitoring systems
p.000022: in collaboration with the employers of other members of the research team. Exceptionally, it may be inappropriate for
p.000022: the organisation employing the chief investigator to take responsibility for the management and monitoring of a study.
p.000022: In that case, the sponsor should make arrangements with one or more other organisations that will operate
p.000022: the management and monitoring systems.
p.000022:
p.000022: 3.22 Provided the sponsor keeps in place arrangements for performance management and audit, the responsibility for
p.000022: design and management may be delegated to the research team. The extent of delegation should be
p.000022: specified, even for a research team with proven expertise and track record. Commercial sponsors may
p.000022: arrange their own audit processes.
p.000022:
p.000022: 3.23 When no external sponsor takes on responsibility for it, a study may proceed only if a care organisation takes on
p.000022: sponsorship. For example, an NHS organisation may be willing and able to act as the sponsor for research
p.000022: which does not have an
p.000022:
p.000022:
p.000022: 18 For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution,
p.000022: company or organisation) who takes responsibility for the initiation, management and financing (or arranging the
...
p.000026: • Ensure that significant lessons learnt from errors or complaints and from internal enquiries are
p.000026: communicated to funders, sponsors and other partners;
p.000026: • Ensure that adverse incidents in the context of research are reported in line with the standard procedures of
p.000026: the organisation;
p.000026: • Permit and assist with any monitoring, auditing or inspection by relevant authorities.
p.000026:
p.000026: Responsibilities of Care Professionals
p.000026:
p.000026: 3.33 Healthcare staff retain responsibility for the care of their patients or service users when they are
p.000026: participating in research within the NHS.
p.000026:
p.000026: 3.34 Before agreeing to their patients or service users and carers being approached by the research team, care
p.000026: professionals should satisfy themselves that the chief investigator has the permission of the
p.000026: appropriate authorities within their organisation or agency. Before enrolling patients in a clinical
p.000026: study, NHS staff should look for evidence that the study has the ethical and regulatory approval it needs.
p.000026: They should then take care to follow the currently approved version of the protocol.
p.000026:
p.000026: Responsibilities Relating to Research Ethics Committees
p.000026:
p.000026: 3.35 No research study within the NHS involving individuals, their organs, tissue or data may begin until it has a
p.000026: favourable opinion from a research ethics committee.
p.000026:
p.000026: 3.36 From 2004, the United Kingdom Ethics Committee Authority has been responsible for recognising ethics committees to
p.000026: review clinical trials under the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000026:
p.000026: 3.37 The NHS is responsible for establishing, supporting and monitoring NHS research ethics committees (RECs). The
p.000026: duties of NHS bodies in relation to NHS RECs are set out in the good practice guidance Governance Arrangements
p.000026: for Research Ethics Committees in Scotland (SEHD, 2001). Those outside the NHS may also
p.000026:
p.000026: 25 See section 4.4.
p.000026: 26 See footnote 24.
p.000027: 27
p.000027:
p.000027: seek the advice of these committees. Community care research involving human participants to whom the NHS has a duty
p.000027: of care (or their organs, tissue or data) must have a favourable opinion from the relevant NHS REC.
p.000027:
p.000027: 3.38 RECs are required to be independent when formulating advice on the ethics of the proposed research. Ethics
p.000027: review must be seen to be impartial. Whilst operating within a framework of standards and NHS management,
p.000027: neither SEHD nor NHS bodies are entitled to interfere with NHS RECs’ decisions. RECs’ appointing
p.000027: authorities must have systems in place to appoint members and convene them, to seek recognition if the law
p.000027: requires it, and to support them and monitor their performance.
p.000027:
p.000027: 3.39 RECs provide an independent opinion. The decision whether or not to give permission for research
p.000027: in a care organisation rests with that organisation. Healthcare organisations will not normally
p.000027: withhold permission provided that a sponsor has been identified, the ethical opinion is favourable, the
p.000027: agreements for allocation of responsibilities or indemnity and/or insurance are acceptable to the
p.000027: organisation, and conducting the research will not conflict with service delivery in some way due to local issues
p.000027: that might not have been considered by the ethics approval or sponsor.
p.000027:
p.000027: 3.40 It is not for RECs or reviewers to give legal advice, nor are they liable for any of their opinions in this
p.000027: respect. It is the researchers and the healthcare organisations27 who have the responsibility not to break the law.
p.000027: If a REC suspects that a research proposal might contravene the law, it is expected to advise both
p.000027: the chief investigator and the appropriate authority. Then the chief investigator and the organisation
p.000027: will need to seek legal advice.
p.000027:
p.000027: 3.41 RECs require researchers working in the NHS to keep them informed of the progress of a study. The
p.000027: committees are responsible for reviewing their advice on the ethical acceptability of a study in the light of
p.000027: such information. The chief investigator and his or her employer, the sponsor and the care organisation
p.000027: are responsible for ensuring that a study follows the agreed protocol, and for monitoring and
p.000027: reporting on its progress.28
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 27 and the sponsor, for clinical trials involving medicines.
p.000027: 28 For clinical trials of medicines, sponsors have a legal duty to notify the ethics committee and the licensing
p.000027: authority if there are adverse events, a change to the design of the trial, and the conclusion of the trial.
p.000028: 28
p.000028:
p.000028: 4. ACHIEVING GOVERNANCE
p.000028:
p.000028: 4.1 Organisations conducting, sponsoring, funding or hosting health research must have systems to ensure that they
p.000028: and their staff understand and follow the standards and good practice set out in this framework.
p.000028:
p.000028: Delivery
p.000028:
p.000028: 4.2 They must have access to independent expert review that enables the main funder and the sponsor to be satisfied
p.000028: of the scientific and ethical standing of the work, its strategic relevance and value for money. This review must
p.000028: be appropriate to the scale and complexity of each research proposal.
p.000028:
p.000028: 4.3 Sponsors must be satisfied there are arrangements to ensure that each study is conducted according
p.000028: to the current agreed protocol, monitor and report on its general progress, and require written agreement
p.000028: on behalf of the sponsor to any modifications to the protocol or proposal, (and if necessary, ethical and
p.000028: regulatory approval). One of the organisations involved in the research will normally manage these arrangements. The
p.000028: sponsor must satisfy itself that a suitable organisation has accepted this responsibility.
p.000028:
p.000028: 4.4 Healthcare providers must have systems that ensure they are aware of research conducted in or through
p.000028: their organisation, whether or not it is externally funded. No study should begin until a person with authority
p.000028: to do so has given written permission29 on behalf of the care organisation. Healthcare organisations
p.000028: are expected to manage risk, minimise bureaucratic process and facilitate high quality research. They are not
p.000028: normally expected to withhold permission when a sponsor offers reasonable assurances that there are
p.000028: arrangements to carry out the responsibilities set out in this framework.
p.000028:
p.000028: 4.5 Healthcare providers may take on the sponsor’s responsibilities if they have systems to discharge them. It is
p.000028: acceptable for an individual employee to be a sponsor only with the written permission of that person’s employer.30
p.000028:
p.000028: 4.6 Nothing in this research governance framework is intended to transfer the legal duties of
p.000028: healthcare organisations to sponsors or to others. Whoever takes on sponsorship, if a study affects a
p.000028: healthcare organisation’s duties, it remains that organisation’s responsibility to satisfy itself that there
p.000028: are systems to conduct the study to appropriate scientific and ethical standards.
p.000028:
p.000028: 4.7 Healthcare organisations are responsible for providing a safe system of care and should normally
p.000028: expect to be kept informed of any study involving their staff, contractors or independent practitioners.
p.000028: However, they do not have responsibility
p.000028:
p.000028:
p.000028: 29 Additional guidance can be found in “Research Governance: NHS Approval for R&D Involving NHS
p.000028: Patients” (SEHD, 2004).
p.000028: 30 For clinical trials of medicines, it is within the law for an individual to be the sponsor (further guidance on
p.000028: this
...
Orphaned Trigger Words
p.000020:
p.000020: ❖ Improves research quality and safeguards the public by:
p.000020:
p.000020: - enhancing ethical and scientific quality
p.000020: - promoting good practice
p.000020: - reducing adverse incidents and ensuring lessons are learned
p.000020: - forestalling poor performance and misconduct
p.000020:
p.000020: ❖ Is for all those who:
p.000020:
p.000020: - design research studies
p.000020: - participate in research
p.000020: - host research in their organisation
p.000020: - fund research proposals or infrastructure
p.000020: - manage research
p.000020: - undertake research
p.000020:
p.000020: ❖ Is for all managers and staff, in all professional groups, no matter how senior or junior
p.000020:
p.000020: ❖ Is for those working in all health and community care environments, including:
p.000020:
p.000020: - primary care
p.000020: - secondary care
p.000020: - tertiary care
p.000020: - community care
p.000020: - public health
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
p.000020:
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p.000020:
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p.000020:
p.000020:
p.000001: 1
p.000001:
p.000001: 1. PURPOSE AND SCOPE
p.000001:
p.000001: 1.1 The Scottish Executive is committed to enhancing the contribution of research to health and community care,
p.000001: and the partnership between services and science. Research is essential to the successful promotion and
p.000001: protection of health and well-being and also to modern, effective health and community care services services.
p.000001: At the same time research can involve an element of risk, both in terms of return on investment and
p.000001: sometimes for the safety and well-being of the research participants. Proper governance of research is therefore
p.000001: essential to ensure that the public can have confidence in, and benefit from, quality research in health and
p.000001: community care. The public has a right to expect high scientific, ethical and financial standards,
p.000001: transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements.
p.000001:
p.000001: 1.2 This document sets out a framework for the governance of research in health and community care.
p.000001: The principles underpinning the framework apply to all research which relates to the responsibilities of the Minister
p.000001: for Health and Community Care. That is, research concerned with the protection and promotion of
p.000001: public health, research undertaken in or by the Scottish Executive Health Department, (SEHD), its non-
p.000001: Departmental Public Bodies and the NHS, and community care research. Within this context, it applies to
p.000001: clinical and non-clinical research; research undertaken by NHS or community care staff using the resources of health
p.000001: and community care organisations; and any research undertaken by industry, charities, research councils and
p.000001: universities within the health and community care systems that might have an impact on the quality of those services.
p.000001:
p.000001: 1.3 This framework does not apply to research concerned with the delivery of local authority services outwith the
p.000001: Minister for Health and Community Care's responsibilities unless they are carried out in NHS settings or
p.000001: in collaboration with NHS care providers. In addition, the framework does not apply to research in the Scottish
p.000001: Prison Service except where this involves medical treatment or the provision of other health services. Although this
p.000001: work is governed by separate arrangements, the principles underpinning this framework should be
p.000001: applied whenever possible.
p.000001:
p.000001: 1.4 Important differences between health and community care research mean that the precise mechanisms by which
p.000001: relevant standards and requirements are achieved will differ. Compared with much research in the NHS, research
p.000001: in community care differs in nature, scale, volume and funding as well as in the mix of stakeholders, the
p.000001: organisational context and the range of academic disciplines. This framework focuses on requirements and standards,
p.000001: delivery mechanisms, and arrangements to monitor quality for health research. It is expected that
p.000001: organisations involved in community care research will develop their own mechanisms for the delivery, monitoring
p.000001: and assessment of research which reflect the principles set out in this framework, are proportionate to the
p.000001: risk involved and have regard to existing codes of good practice. The Scottish Executive is reviewing and
p.000001: improving existing ethical assurance processes for social research it commissions or undertakes to support
p.000001: Ministers and policy development taking account of the framework principles.
p.000001:
p.000001: 1.5 The aim of this framework is to bring together general principles of good practice. It refers to the law on
p.000001: clinical trials involving medicines. That does not mean it imposes the same procedures on other research when the
p.000001: interests of participants and the research methods do not call for them. The checklist of responsibilities in Section
p.000001: 3 are there to help everyone reach agreement on arrangements that are proportionate to risk, and for
p.000001:
p.000002: 2
p.000002:
p.000002: health research to be in line with Good Clinical Practice. Therefore, the framework is offered also as a model
p.000002: for the governance of research in areas outside the direct responsibility of the Minister for Health and
p.000002: Community Care where poor practice could have a direct impact on the health or well-being of the public.
p.000002:
p.000002: 1.6 The framework is of direct relevance to all those who host, conduct, participate in, fund and
p.000002: manage research. It is not just for investigators, managers or any one professional group. All service
p.000002: and academic staff, no matter how senior or junior, have a role to play in the conduct of research. Participants in
p.000002: research and the public in general can also help to ensure that standards are understood and met.
p.000002:
p.000002: 1.7 This framework seeks to promote improvements in research quality across the board. As with clinical governance,
p.000002: research governance involves bringing general performance up to that of those at the leading edge. The
p.000002: framework provides a context for the encouragement of creative and innovative research and for the
p.000002: effective transfer of learning, technology and best practice to improve care.
p.000002: 1.8 The framework aims to forestall poor performance, adverse incidents, research misconduct and
p.000002: fraud, and to ensure that lessons are learned and shared when poor practice is identified. Learning from
p.000002: adverse events will promote good practice, enhance the ethical and scientific quality of research, and safeguard the
p.000002: public.
p.000002: 1.9 Health and community care generate and draw upon a wide range of innovative work and ideas from
p.000002: professionals, organisations and the public. Services must promote innovation while protecting
p.000002: participants from risk and waste. Innovation embraces a much wider range of activities than those managed
p.000002: formally as research.
p.000002:
p.000002: 1.10 Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly
p.000002: defined questions with systematic and rigorous methods.1 This document sets out the responsibilities and
p.000002: standards that apply to work managed within the formal research context. Other documents on quality and governance in
p.000002: the NHS and community care set out standards and systems for assuring the quality of innovative work in non-research
p.000002: contexts.
p.000002:
p.000002: 1.11 Inquiries into adverse incidents relating to research have criticised a lack of clarity about responsibility and
p.000002: accountability. This is important, given the very wide range of individuals and organisations that can
p.000002: be involved. The framework pays particular attention to clarifying responsibilities and accountabilities.
p.000002: Listed are some of the individuals and organisations involved in health and community care research:
p.000002:
p.000002: ◻ The Public
p.000002: ◻ Research workers
p.000002: ◻ NHS staff
p.000002: ◻ Universities
p.000002: ◻ Students and their supervisors
p.000002: ◻ Research ethic committees
p.000002: ◻ Non-commercial research funders
p.000002: ◻ Health and community care professionals
p.000002: ◻ Health and community care organisations
p.000002: ◻ The pharmaceutical and other industries
p.000002:
p.000002: 1 This definition includes studies that aim to generate hypotheses as well as studies that aim to test them.
p.000003: 3
p.000003:
p.000003: ◻ Local authorities
p.000003:
p.000003: 1.12 Achieving high quality in research depends on co-operation between all those involved. SEHD will continue to work
p.000003: with patients, service users, carers and care professionals, the public and its research partners to develop and
p.000003: implement this research governance framework to assure quality in health and community care research.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
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p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 2. STANDARDS
p.000004:
p.000004: 2.1 Clinical governance aims continually to improve the overall standards of clinical care in the NHS and
p.000004: to reduce unacceptable variations in clinical practice. Clinical Governance and Risk Management (CGRM) standards2 were
p.000004: launched by Quality Improvement Scotland (QIS) in 2005. The performance of NHS Boards and Special Health
p.000004: Boards will be assessed against these standards which include compliance with research governance.
p.000004:
p.000004: 2.2 Health research is not the province of a single discipline, profession or organisation and no single document
p.000004: adequately captures the full range of legislation, standards and good practice guidelines that apply to this wide-
p.000004: ranging body of work. They are presented here in six domains:
p.000004:
p.000004: ◻ ethics
p.000004: ◻ science
p.000004: ◻ information
p.000004: ◻ health and safety
p.000004: ◻ finance
p.000004: ◻ quality research culture.
p.000004:
p.000004: 2.3 Each domain has been grouped as follows:
p.000004:
p.000004: ◻ requirements in legislation and regulations
p.000004: ◻ standards required by SEHD
p.000004: ◻ other established principles of good practice from recognised international and national authorities and
p.000004: professional organisations.
p.000004:
p.000004: 2.4 The Chief Scientist Office website will provide regular updates of detail. The following sections
p.000004: set out principles in each domain.
p.000004:
p.000004: Ethics
p.000004:
p.000004: 2.5 The dignity, rights, safety and well-being of participants must be the primary consideration in any research
p.000004: study.
p.000004:
p.000004: 2.6 SEHD requires that all health research involving patients, service users, care professionals or
p.000004: volunteers, or their organs, tissue or data, is reviewed independently to ensure it meets ethical
p.000004: standards.3 Informed consent is at the heart of ethical research. Most studies involving individuals must
p.000004: have appropriate arrangements for obtaining consent and the NHS ethics review process pays particular
p.000004: attention to those arrangements.4 The law gives special protection to people who are unable to give
p.000004: consent on their own behalf. For example, The Adults with Incapacity (Scotland) Act 2000 provides safeguards
p.000004: for adults who lack
p.000004:
p.000004:
p.000004: 2 Clinical Governance and Risk Management Standards (QIS, 2005)
p.000004: 3 Under the Medicines for Human Use (Clinical Trials) Regulations 2004 it is against the law to start or conduct a
p.000004: clinical trial or to recruit participants to a clinical trial involving a medicine until there is a favourable opinion
p.000004: from an ethics committee and authorisation from the licensing authority.
p.000004: 4 The NHS Code of Practice on Protecting Patient Confidentiality published in August 2003 provides guidance
p.000004: on obtaining consent. NHS HDL (2003)37 on The Use of Personal Health Information in NHSScotland to Support Patient
p.000004: Care provides further information.
p.000005: 5
p.000005:
p.000005: capacity to consent to research.5 Care is needed when seeking consent from children and from vulnerable
p.000005: adults, such as those with mental health problems or learning difficulties. Arrangements must be made to
p.000005: ensure that relevant information is provided in appropriate written or pictorial form and that the role and
p.000005: responsibilities of parents, carers or supporters are clearly explained and understood.
p.000005:
p.000005: 2.7 Care is also needed when research involves tissue or organs. The consent of the person concerned or the
p.000005: relatives of the deceased must always be obtained. It must be recognised that agreeing to such research involves
p.000005: relatives in difficult choices. Arrangements must be described for the respectful disposal of material once
p.000005: the research is completed, and for the reporting of the findings of the research to relatives, if they
p.000005: wish it.
p.000005:
p.000005: 2.8 The appropriate use and protection of patient data are also key. All those involved in health research must
p.000005: be aware of their legal and ethical duties in this respect. Particular attention must be given to
p.000005: systems for ensuring confidentiality of personal information and to the security of those systems.
p.000005:
p.000005: 2.9 It is essential that health research reflects the practicalities of care delivery. To that end, relevant
p.000005: service users and carers or their representative groups should be involved wherever possible in the
p.000005: design, conduct, analysis and reporting of research.
p.000005:
p.000005: 2.10 Research, and those pursuing it, should respect the diversity of human society and conditions and the
p.000005: multi-cultural nature of society. Whenever relevant, it should take account of age, disability, gender, sexual
p.000005: orientation, race, culture, and religion in its design, undertaking and reporting. The body of research evidence
p.000005: available to policy makers should reflect the diversity of the population.
p.000005:
p.000005: 2.11 Some research may involve an element of risk to those participating in it. If there are any risks to
p.000005: participants, the risks must be in proportion to the potential benefit6. Risks, pain or discomfort must always be kept
p.000005: to a minimum and explained clearly both to the relevant ethics committee and to participants. It must
p.000005: always be explained whether there are arrangements for compensation in the unlikely event of non-negligent harm.
p.000005:
p.000005: 2.12 Some essential research into important illnesses and treatments can be conducted only with
p.000005: animals. When undertaking research which could involve the use of animals, three principles should be followed:
p.000005:
p.000005: • replacement of animals by non-animal methods wherever possible;
p.000005: • reduction of numbers to the minimum necessary to obtain valid results where replacement is not possible; and
p.000005: • refinement of all procedures to minimise adverse effects.
p.000005:
p.000005: Wherever possible, alternatives such as cells, tissues, computers, bacteria and plants must be used instead. Where
p.000005: animal use is unavoidable, there are strict controls,
p.000005:
p.000005: 5 Also, under the Medicines for Human Use (Clinical Trials) Regulations 2004, specific conditions and principles apply
p.000005: to informed consent, and to the recruitment of minors and incapacitated adults.
p.000005: 6 Unless the risk to them is negligible, it is unethical to involve adults without capacity to consent, or minors, in
p.000005: research that could have no therapeutic benefit for the group involved.
p.000006: 6
p.000006:
p.000006: enforced by the Home Office. Before a researcher can use animals, a series of special licences must be
p.000006: obtained. Primates are only to be used if less advanced animals could not provide the information. Researchers
p.000006: must have the necessary skills, training and experience, and the research laboratory must have the facilities to
p.000006: care for the animals properly. The highest standards of animal husbandry and welfare under veterinary supervision
p.000006: must be maintained and an ethical review process must operate in accordance with Home Office requirements.
p.000006:
p.000006: Science
p.000006:
p.000006: 2.13 All existing sources of evidence, especially systematic reviews, must be considered carefully before undertaking
p.000006: health research. Research which duplicates other work unnecessarily or which is not of sufficient quality to
p.000006: contribute something useful to existing knowledge is unethical. Every proposal for health research must be
p.000006: subjected to review by experts in the relevant fields able to offer independent advice on its quality. Arrangements
p.000006: for peer review should be in proportion to the scale of the research and the risks involved. For example, in
p.000006: some circumstances, an external panel of independent experts may be invited to review a programme or a controversial
p.000006: or costly proposal. In others, many organisations allow established research teams to determine details
p.000006: of the elements of an overall programme of research which has been reviewed externally. For student
p.000006: research projects, the university supervisor is normally able to provide adequate review.
p.000006:
p.000006: 2.14 The Medicines for Human Use (Clinical trials) Regulations 20047 regulate trials of medicines on people.
p.000006: Authorisation by the Medicines and Healthcare products Regulatory Agency is required. The Agency
p.000006: offers advice and undertakes inspections for such trials - and the manufacture and assembly of products used in
p.000006: them - against international standards. The same Agency regulates research involving new medical devices.
p.000006: The principles of Good Clinical Practice apply to all health research involving patients, not just clinical trials.8
p.000006:
p.000006: 2.15 Special regulations govern the use of human embryos, the release of genetically modified organisms
p.000006: and food or food processes and further information on these areas should be sought where appropriate.
p.000006:
p.000006: 2.16 Data collected in the course of health research must be retained for an appropriate period to allow further
p.000006: analysis by the original or other research teams subject to consent and to support monitoring by regulatory and other
p.000006: authorities.
p.000006:
p.000006: Information
p.000006:
p.000006: 2.17 Health research is conducted for the benefit of patients, users, care professionals, and the public in
p.000006: general. There should be free access to information both on research being conducted9 and on the findings of
p.000006: the research - positive or negative
p.000006: - once these have been subjected to appropriate scientific review. Information
p.000006:
p.000006:
p.000006:
p.000006: 7 The Medicines for Human Use (Clinical Trials) Regulations transposed Directive 2001/20/EC into UK law.
p.000006: 8 The Medical Research Council (MRC) issued guidelines in 1998 for Good Clinical Practice in clinical trials in
p.000006: the public and charity sectors. The MRC guidelines apply the principles of Good Clinical Practice in the 1996
p.000006: statement of the International Conference on Harmonisation (ICH GCP).
p.000006: 9 There is an international consensus that, with certain exemptions, information identifying a clinical trial of a
p.000006: treatment should be available on a public register from the time the first participant is recruited.
p.000007: 7
p.000007:
p.000007: should be presented in a format understandable to the public. Reports need to be comprehensible and take language and
p.000007: other needs into account.
p.000007:
p.000007: 2.18 Some advances in healthcare need to be developed commercially if they are to be made widely available. Medicines,
p.000007: medical devices and aids for disabled people are examples. Successful commercial development often depends upon the
p.000007: protection of intellectual property or commercial confidentiality at critical points in the innovation
p.000007: process. The timing of the publication of research findings needs to take account of this.
p.000007:
p.000007: 2.19 All those conducting health research must open their work to critical review through the accepted scientific and
p.000007: professional channels. Once established, findings must be made accessible to those participating10 and to all those
p.000007: who could benefit from them. This may be through publication and/or other means appropriate to the type of research.
p.000007: Data relevant to findings should also be accessible.
p.000007:
p.000007: Health and Safety
p.000007:
p.000007: 2.20 Health research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The
p.000007: safety of participants and of research and other staff must be given priority at all times, and health and safety
p.000007: regulations must be strictly observed - including the provision of information, containment, shielding and
p.000007: monitoring as required.
p.000007:
p.000007: Finance
p.000007:
p.000007: 2.21 Financial probity and compliance with the law and with the rules laid down by the Scottish Executive and H M
p.000007: Treasury for the use of public funds are as important in research as in any other area. Organisations employing
p.000007: researchers must be in a position to compensate anyone harmed by their negligence. If an organisation
p.000007: offers to compensate participants in the event of non-negligent harm, it must be in a position to do so.
p.000007: Consideration must be given to the exploitation of intellectual property rights.11
p.000007:
p.000007: Quality research culture
p.000007:
p.000007: 2.22 Some of the principles and requirements applying to health research are clear-cut but many require judgement and
p.000007: interpretation. A quality research culture, where excellence is promoted and where there is visible and strong
p.000007: research leadership and expert management, is essential if researchers and managers are to understand and apply
p.000007: standards, principles and requirements correctly.
p.000007:
p.000007: 2.23 The key elements of a quality research culture are:
p.000007:
p.000007: ◻ respect for participants’ dignity, rights, safety and well being
p.000007: ◻ valuing the diversity within society
p.000007: ◻ personal and scientific integrity
p.000007: ◻ leadership
p.000007:
p.000007:
p.000007: 10 Including the relatives of deceased patients who have consented to the use of organs or tissue in the research. 11
p.000007: Guidance for NHSScotland is set out in the document “A Framework and Guidance on the Management of Intellectual
p.000007: Property in the NHSScotland” (HDL (2004) 9).
p.000008: 8
p.000008:
p.000008: ◻ honesty
p.000008: ◻ accountability
p.000008: ◻ openness
p.000008: ◻ clear and supportive management
p.000008:
p.000008: 2.24 Box A illustrates how research is managed in a health organisation with a quality research culture. A quality
p.000008: research culture is essential for proper governance of health research.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: BOX A: FEATURES OF A QUALITY RESEARCH CULTURE IN THE NHS
p.000009:
p.000009: Quality Research Culture
p.000009: • The organisation supports and promotes high quality research as part of a service culture receptive
p.000009: to the development and implementation of best practice in the delivery of care. There is strong leadership
p.000009: of research and a clear strategy linking research to national priorities and needs, the organisation's
p.000009: business, and to clinical governance.
p.000009: • The organisation’s research strategy values diversity in its patients or service users and its staff,
p.000009: and promotes their active participation in the development, undertaking and use of research.
p.000009:
p.000009: Ethics
p.000009: • To safeguard the dignity, rights, safety and well-being of participants all research involving
p.000009: patients, service users, carers or care professionals and other staff, or their organs, tissue or data, is referred for
p.000009: independent ethical review.
p.000009: • Consent is sought in the way agreed during ethical review.
p.000009: • Research is pursued with the active involvement of service users and carers including, where appropriate, those
p.000009: from hard- to- reach groups such as homeless people.
p.000009: • If organs or tissue are used following post mortems, informed consent is obtained from relatives, and
p.000009: there is a commitment to respectful disposal of material.
p.000009: • If using animals is unavoidable, the highest standards of animal husbandry are maintained under
p.000009: veterinary supervision.
p.000009:
p.000009: Science
p.000009: • There is commitment to the principle and practice of scientific review by independent experts, with scrutiny of
p.000009: the suitability of protocols or proposals and research teams for all work in the organisation.
p.000009: • There is close collaboration with partner organisations in higher education and care to ensure quality and
p.000009: relevance of joint work and avoidance of unnecessary duplication of functions.
p.000009: • The organisation’s human resource strategy includes commitment to support research careers (full and part-time) by
p.000009: earmarking funds specifically for R&D training across the professions. The organisation plays its role in developing
p.000009: research capacity with appropriate training and updating. This includes taking action to ensure that the
p.000009: diversity of the workforce reflects society, and developing the capacity of consumers to participate.
p.000009: • The organisation promotes a high standard of health and safety in laboratory work. It follows Good Laboratory
p.000009: Practice, Good Manufacturing Practice in manufacturing products for clinical trials and Good Clinical Practice in
p.000009: conducting clinical trials.
p.000009: • Systems are in place to monitor compliance with standards and to investigate complaints and deal
p.000009: with irregular or inappropriate behaviour in the conduct of research.
p.000009: • The organisation assesses its research outputs and their impact and value for money.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: Information
p.000010: • Information is available on all research being undertaken in the organisation. This is held on a database
p.000010: containing details of research providers, funding, intellectual property rights, recruitment, research outputs
p.000010: and impact.
p.000010: • The organisation ensures patients, service users and carers, care professionals and other staff have
p.000010: easy access to information on research. Where necessary, special arrangements are made to ensure access
p.000010: to information for those who do not have English as a first language, cannot read, or who may need
p.000010: information in different formats because of a disability e.g. Braille.
p.000010: • An information service provides access from a single point to all up-to-date regulatory and advisory
p.000010: documentation pertaining to research governance, together with procedural guidance, for example, for
p.000010: applications for ethical approval.
p.000010: • When established, findings (including negative findings) are published in ways that allow critical review and
p.000010: dissemination to those who could benefit from them. Other researchers have access to the data on which the findings
p.000010: are based.
p.000010: • There is a strategy for making research findings accessible which addresses different media and writing styles for
p.000010: different audiences.
p.000010: • Unless the research ethics committee agrees otherwise, those consenting to be involved in a study
p.000010: (including the relatives of deceased patients who have consented to the use of organs or tissue in the research) have
p.000010: ready access to the findings at the end of the study.
p.000010:
p.000010: Finance
p.000010: • The organisation is aware of the activity involved in supporting research and of what it costs. Research
p.000010: expenditure is planned and accounted for.
p.000010: • The organisation demonstrates financial probity and compliance with the law and rules laid down by
p.000010: the Scottish Executive and H M Treasury. It complies with all audit required by external funders or
p.000010: sponsors and has systems in place to deter, detect and deal with fraud.
p.000010: • When research findings have commercial potential the organisation takes action to protect and
p.000010: exploit them, in collaboration with its research partners and – when appropriate – commercial
p.000010: organisations.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: 3. RESPONSIBILITIES AND ACCOUNTABILITIES
p.000011:
p.000011: General
p.000011:
p.000011: 3.1 Everyone involved in research with human participants, their organs, tissue or data is responsible for knowing
p.000011: and following the law and the principles of good practice relating to ethics, science, information, health and safety,
p.000011: and finance set out in this framework.
p.000011:
p.000011: 3.2 All those involved in research also have a duty to ensure that they and those they manage are appropriately
p.000011: qualified, both by education and experience, for the role they play in relation to any research. They must be aware
p.000011: of, and have ready access to, sources of information and support in undertaking that role.
p.000011:
p.000011: Agreements
p.000011:
p.000011: 3.3 A complex array of organisations and individuals may be involved in a health research study. It
p.000011: is essential that clear agreements describing allocation of responsibilities and rights are reached, documented
p.000011: and enacted.
p.000011:
p.000011: 3.4 Many agreements will relate to individual studies. Organisations that collaborate on a range of research
p.000011: work are encouraged to develop and document framework agreements to facilitate the agreement of responsibilities
p.000011: for specific studies; for example:
p.000011:
p.000011: ◻ NHS organisations who work together regularly on research, whether or not in a formal network;
p.000011: ◻ Universities and NHS organisations, primary care practices and research networks that work together
p.000011: regularly on research;
p.000011: ◻ local authorities and/or other community care providers, NHS organisations, and primary care practices that work
p.000011: together regularly on research whether or not in a formal research network.
p.000011:
p.000011: 3.5 It is particularly important to reach clear, documented agreements for complex studies where there may
p.000011: be:
p.000011:
p.000011: ◻ work on more than one site; and/or
p.000011: ◻ researchers employed by more than one organisation; and/or
p.000011: ◻ patients, service users and carers, and care professionals from more than one care organisation; and/or
p.000011: ◻ more than one funder.
p.000011:
p.000011: A recommended approach is for the scheme of organisation in the protocol to include a detailed allocation of
p.000011: responsibilities. Each site can then subscribe to its own responsibilities by an exchange of letters that refer to the
p.000011: protocol.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: Specific Responsibilities
p.000012:
p.000012: 3.6 Box B describes the terms used in this research governance framework for the main people and organisations
p.000012: involved in a health research study.
p.000012:
p.000012: 3.7 The key responsibilities of the people and organisations accountable for the proper conduct of a health
p.000012: study are summarised in Box C. Box D illustrates the responsibilities with a scenario. The remainder
p.000012: of this section sets out these responsibilities in more detail.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
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p.000012:
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p.000012:
p.000012:
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p.000012:
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p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013:
p.000013: BOX B MAIN PEOPLE AND ORGANISATIONS INVOLVED IN A HEALTH RESEARCH STUDY
p.000013:
p.000013: Participant - patient, service user, and carer, relative of the deceased, professional carer, other employee or member
p.000013: of the public, who consents to take part in a study. (In law, participants in clinical trials involving medicines are
p.000013: known as subjects).
p.000013:
p.000013: Researchers - those conducting the study.
p.000013:
p.000013: Investigator - the person responsible, individually or as the leader of the researchers at a site, for the conduct of a
p.000013: study at that site. For clinical trials involving medicines, an investigator must be an authorised health
p.000013: professional.
p.000013:
p.000013: Chief Investigator – the person who takes overall responsibility for the design, conduct and reporting of
p.000013: a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary
p.000013: responsibility for the design, conduct and reporting of the study whether or not that person is an investigator at any
p.000013: particular site.
p.000013:
p.000013: Principal Investigator – the leader responsible for a team of individuals conducting a study at a site.
p.000013:
p.000013: Funder - organisation providing funding for a study through contracts, grants or donations to an authorised member of
p.000013: the employing and/or care organisation. The main funder typically has a key role in scientific quality assurance. In
p.000013: any case, it remains responsible for securing value for money.
p.000013:
p.000013: Sponsor - individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage
p.000013: and finance a study. (A group of individuals and/or organisations may take on sponsorship responsibilities and
p.000013: distribute them by agreement among the members of the group, provided that, collectively, they make arrangements to
p.000013: allocate all the responsibilities in this research governance framework that are relevant to the study).
p.000013:
p.000013: Employing Organisation - the organisation employing the chief investigator, investigators or other researchers.
p.000013: Employers remain liable for the work of their employees. The organisation employing the chief investigator normally
p.000013: holds the contract or grant agreement with the funder of the study.
p.000013: Organisations holding contracts with funders remain responsible for the management of the funds provided.
p.000013:
p.000013: Organisation Providing Care - the organisation responsible for providing care to patients and/or service users and
p.000013: carers participating in a study. Health organisations remain liable for the quality of care and for their duty towards
p.000013: anyone who might be harmed by a study.
p.000013:
p.000013: Responsible Care Professional - doctor, nurse or other practitioner formally responsible for the care of participants
p.000013: while they are taking part in the study.
p.000013:
p.000013: Research Ethics Committee – committee established to provide participants, researchers, funders, sponsors, employers,
p.000013: care organisations and professionals with an independent opinion on the extent to which proposals for a study comply
p.000013: with recognised ethical standards. For clinical trials involving medicines, the committee must be one recognised
p.000013: by the United Kingdom Ethics Committee Authority.
p.000013:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000014: PROPER CONDUCT OF A HEALTH RESEARCH STUDY
p.000014:
p.000014: Chief Investigator, Investigators, other Researchers
p.000014:
p.000014: • Developing proposals that are scientifically sound and ethical.
p.000014: • Submitting the design for independent expert review.
p.000014: • Submitting the study (or proposal) for independent ethical review.
p.000014: • Conducting a study to the agreed protocol (or proposal), in accordance with legal requirements,
p.000014: guidance and accepted standards of good practice.
p.000014: • Preparing and providing information for participants.
p.000014: • Ensuring participants’ welfare while in the study.
p.000014: • Arranging to make findings and data accessible following expert review.
p.000014: • Feeding back results of research to participants.
p.000014:
p.000014: See 3.10, 3.11 to 3.13
p.000014:
p.000014: Main Funder
p.000014:
p.000014: • Assessing the scientific quality of the research as proposed.
p.000014: • Establishing the value for money of the research as proposed.
p.000014: • Considering the suitability of the research environment in which the research will be undertaken, particularly
p.000014: the experience and expertise of the chief investigator, principal investigator(s) and other key
p.000014: researchers involved.
p.000014: • Requiring that a sponsor takes on responsibility before the research begins.
p.000014:
p.000014: See 3.14 to 3.18
p.000014:
p.000014: Sponsor
p.000014:
p.000014: • Confirming that everything is ready for the research to begin:
p.000014: - taking on responsibility for putting and keeping in place arrangements to initiate, manage and fund the study;
p.000014: - satisfying itself the research protocol, research team and research environment have passed appropriate scientific
p.000014: quality assurance;
p.000014: - satisfying itself the study has ethical approval before it begins;
p.000014: - for clinical trials involving medicines, seeking a clinical trial authorisation and making arrangements for
p.000014: investigational medicinal products. (The Medicines for Human Use (Clinical Trials) Regulations 2004 specify the
p.000014: responsibilities that have to be taken by or on behalf of sponsors of trials involving medicines).
p.000014: • Satisfying itself that arrangements are kept in place for good practice in conducting the study, and for
p.000014: monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.
p.000014:
p.000014: See 3.19 to 3.24
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: BOX C SUMMARY OF KEY RESPONSIBILITIES OF PEOPLE AND ORGANISATIONS ACCOUNTABLE FOR THE
p.000015: PROPER CONDUCT OF A HEALTH RESEARCH STUDY (CONTINUED)
p.000015:
p.000015: Employing Organisation
p.000015:
p.000015: • Promoting a quality research culture.
p.000015: • Ensuring researchers understand and discharge their responsibilities.
p.000015: • Ensuring studies are properly designed and submitted for independent review.
p.000015: • Ensuring studies are managed, monitored, and reported as agreed, according to the protocol.
p.000015: • Providing written procedures, training and supervision.
p.000015: • Taking action if misconduct or fraud is suspected. See 3.25 to 3.28
p.000015: Organisation Providing Care/ Responsible Care Professional
p.000015:
p.000015: • Arranging for an appropriate person to give permission for research involving their patients, service users,
p.000015: carers or staff, before the research starts.
p.000015: • Ensuring any such research is conducted to the standards set out in this research governance framework.
p.000015: • Requiring evidence of ethical review before recruitment to any research that affects their duty of care.
p.000015: • Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical
p.000015: trials authorisation.
p.000015: • Retaining responsibility for the care of participants to whom they have a duty. See 3.29 to 3.34
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN HEALTH RESEARCH
p.000016:
p.000016: SCENARIO: WHO IS RESPONSIBLE FOR WHAT? SOME QUESTIONS AND ANSWERS
p.000016:
p.000016: The Scenario: the Medical Research Council (MRC) awards a university Senior Lecturer in General Practice a grant for a
p.000016: clinical trial of a medicine. The grant is paid to the university. The MRC was closely involved in developing the
p.000016: trial design. The research is taking place in general practices. The Medicines and Healthcare products Regulatory
p.000016: Agency (MHRA) has agreed that the university and the relevant NHS Board form a group to take on the sponsor’s
p.000016: responsibilities. The manufacturer of the drug has agreed to provide it free. The drug has a marketing authorisation
p.000016: covering the use of the product described in the research protocol.
p.000016:
p.000016: PATIENT
p.000016:
p.000016: Q: I did tell my GP that I might be interested in joining the study, but that does not commit me definitely, does
p.000016: it?
p.000016: A: Your GP agreed to collaborate with the research team, and invite her patients to participate. Whether or not
p.000016: you agree is entirely up to you. Unless you consent, you won’t be in the study.
p.000016:
p.000016: Q: How can I know the study is worthwhile?
p.000016: A: Through independent expert review (“peer review”), the MRC assessed the clinical importance of the questions
p.000016: addressed by the study. It also assessed the design and oversight arrangements. An ethics committee checked it is
p.000016: ethical. The MHRA authorised it.
p.000016:
p.000016: Q: How can I find out more about it?
p.000016: A: You can take away this patient information leaflet to study, and you can ask your GP or anyone on the research
p.000016: team for further details.
p.000016:
p.000016: Q: What if the drug involved does not agree with me?
p.000016: A: Your GP is still responsible for your care. She knows how we plan to monitor people who are in the trial. We
p.000016: will advise her immediately if we detect any problems, and you can approach her at any time. It is important for you
p.000016: to say if you have a bad reaction to the drug.
p.000016:
p.000016: G.P.
p.000016:
p.000016: Q: How do I know that this study is well designed?
p.000016: A: The university and NHS Board are together sponsoring the study. The protocol names the sponsors’ contact
p.000016: points. The scientific design went through the MRC’s review system. It has ethical approval, and regulatory approval
p.000016: from the licensing authority. But you must decide whether you feel able to collaborate with it.
p.000016:
p.000016: Q: Who is responsible for the care of my patients if they agree to take part?
p.000016: A: You are. The protocol explains the procedures the research team will follow and the circumstances when they
p.000016: will alert you to anything they observe in your patients. You must ensure you are satisfied with these arrangements
p.000016: and discuss them with the chief investigator if you are not.
p.000016:
p.000016: Q: Who is responsible for ensuring that the study follows the protocol and data are monitored to detect any
p.000016: possible problems?
p.000016: A: The chief investigator is responsible for ensuring that you and every other person involved in the study is
p.000016: well informed, and able to carry out their roles properly. This is a trial of a medicine, so there is a legal
p.000016: responsibility to follow the protocol. If you have any concerns about this, you should contact the chief investigator.
p.000016: If you are not satisfied, you should inform the sponsor’s representative.
p.000016:
p.000016: Q: Who is responsible for the quality of the drugs?
p.000016: A: The pharmaceutical company supplying the drugs is responsible for their quality. Medicines have to be made in
p.000016: licensed facilities, and must be correctly labelled for trials.
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: BOX D SPECIFIC RESPONSIBILITIES OF KEY PEOPLE INVOLVED IN RESEARCH (CONTINUED)
p.000017:
p.000017: Q: I have agreed to join the study, but a number of my patients are having trouble understanding what they are
p.000017: being asked to take part in. It's taking up an enormous amount of time. What should I do?
p.000017: A: Please talk to the chief investigator. A better understanding of the consent process could resolve the
p.000017: issues. Perhaps communication with your patients could be improved, for example by revising the patient information
p.000017: leaflet. If there are still problems you are free to withdraw.
p.000017:
p.000017: Q: One of my patients seems much worse since I entered him into the trial. He is keen to continue, but I am
p.000017: concerned. What should I do?
p.000017: A: Your primary responsibility is the patient’s care. You have a duty to put his safety before anything required
p.000017: by the research. You should advise him to withdraw if you think that the trial drug caused his problems. Explain to
p.000017: him that you will talk to the research team on his behalf. It is very important you inform the chief investigator of
p.000017: any concerns about treatment under the trial. In trials of medicines, it is a legal requirement to report harmful
p.000017: reactions to the MHRA so that everyone can learn from them.
p.000017:
p.000017:
p.000017: CHIEF INVESTIGATOR
p.000017:
p.000017:
p.000017: Q: How do I know when the trial is authorised?
p.000017: A: As it falls under the Medicines for Human Use (Clinical Trials) Regulations 2004, the trial has to be
p.000017: authorised by the MHRA. The MHRA notifies sponsors when trials are authorised. The sponsor’s representative will tell
p.000017: you when the drugs can be released for use in the trial.
p.000017:
p.000017: Q: What about ethical review?
p.000017: A: You have submitted the study to an ethics committee recognised for this kind of study, using the electronic
p.000017: form available on the Central Office for Research Ethics Committees (COREC) website. You need a positive ethics
p.000017: committee opinion as well as a Clinical Trial Authorisation before you can start the trial.
p.000017:
p.000017: Q: To whom must I report an adverse event?
p.000017: A: For this trial, the sponsors have delegated to you the responsibility for recording and reporting adverse
p.000017: events. The MHRA will issue the Clinical Trial Authorisation on that basis so you have to follow the agreed process
p.000017: for recording adverse events, assessing seriousness, relatedness and expectedness, and reporting. You must arrange to
p.000017: report any worrying reaction immediately to the patient’s GP. Adverse drug reactions must also be reported to the
p.000017: Trial Steering Committee, the drug manufacturer, the MHRA, the ethics committee and the Data Monitoring Committee.
p.000017: Under the Clinical Trials Regulations, there is a legal obligation to report suspected unexpected serious adverse
p.000017: reactions (SUSARs) to the MHRA within a set period.
p.000017:
p.000017: Q: I am concerned that the staff in the university labs may not follow health and safety rules. What do I do?
p.000017: A: You should raise this concern through the university's local health and safety systems.
p.000017:
p.000017: Q: I am concerned that not all the investigators will follow the protocol closely. What should I do?
p.000017: A: Inform the sponsor’s representative immediately and agree a course of action.
p.000017:
p.000017: Q: If my team need training, whom should I talk to?
p.000017: A: Their employer is normally responsible for their training.
p.000017:
p.000017: Q: To whom do I talk if I suspect a university colleague is fabricating data?
p.000017: A: Your university as your colleague’s employer is responsible for investigating the suspected misconduct.
p.000017: Others such as the General Medical Council may also be responsible for looking into your suspicions if they appear to
p.000017: involve professional misconduct. If you suspect someone employed by another organisation, raise your concerns with
p.000017: your employer, who as sponsor will contact your colleague’s employer. In any case, record the evidence carefully so
p.000017: that there can be a proper investigation.
p.000017:
p.000017:
p.000018: 18
p.000018:
p.000018: Q: I have new information that makes me think that we could improve the design of this study. What do I do?
p.000018: A: You should discuss this with the Trial Steering Committee. If they agree, you will need to draw up a revised
p.000018: protocol, and submit it to the MRC. The sponsor’s representative will then submit the amendment to the MHRA and you
p.000018: need to go back to the relevant ethics committee. You must not implement substantial changes to the protocol without
p.000018: formal agreement from those who gave permission for the study (particularly the MHRA and the ethics committee). When
p.000018: an amendment is authorised you need to tell all investigators to follow the new protocol from a specified time.
p.000018:
p.000018: Q: I may generate some important intellectual property (IP). What should I do?
p.000018: A: Your employer is one of the sponsors and will have a policy on IP that complies with the terms of funding.
p.000018: You should refer to and comply with this policy. Your employer may have an IP unit that can help you follow the right
p.000018: procedures.
p.000018:
p.000018: Q: What if the MHRA does a Good Clinical Practice inspection?
p.000018: A: You must co-operate. The inspectors have legal powers to ask for documents and take enforcement action.
p.000018: Generally, they look for evidence of good systems that are proportionate to the risks involved. The MHRA will point
p.000018: out any improvements needed for trial sites to comply with the law. They seek a prosecution only if it would be in the
p.000018: public interest because of very serious or persistent failure.
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
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p.000018:
p.000018:
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p.000018:
p.000019: 19
p.000019:
p.000019: Responsibilities of Participants
p.000019:
p.000019: 3.8 Effective and responsive services depend on good research. Through this framework and related provisions, the
p.000019: Government and its partners strive to ensure that research conducted in Scotland offers the likelihood of real benefits
p.000019: either to those who participate, or to those who use services subsequently, or to both. Anyone using
p.000019: health services should give serious consideration to becoming involved in developing or undertaking research
p.000019: studies.
p.000019:
p.000019: 3.9 Researchers are responsible for selecting means of communication that ensure that potential participants are
p.000019: fully informed before deciding whether or not to join a study. In clinical trials involving medicines, there
p.000019: is a legal requirement to provide an interview with a member of the research team and a contact point
p.000019: offering further information about the trial. Potential participants should not hesitate to ask if they do not
p.000019: understand the information and explanations given.
p.000019:
p.000019: Responsibilities of Researchers
p.000019:
p.000019: 3.10 Researchers bear the primary day-to-day responsibility for the conduct of research. They are responsible for:
p.000019:
p.000019: • Ensuring that any research they undertake follows the current version of the agreed protocol (or proposal);
p.000019: • helping care professionals to ensure that participants receive appropriate care while involved in research;
p.000019: • reporting any adverse drug reactions or other adverse events;
p.000019: • protecting the integrity and confidentiality of clinical and other records and data generated by the research; and
p.000019: reporting any failures in these respects, or suspected misconduct, through the appropriate systems.
p.000019:
p.000019: Responsibilities of Investigators and the Chief Investigator
p.000019:
p.000019: 3.11 A senior individual must be designated as the chief investigator for the research. This person
p.000019: normally takes responsibility for the conduct of the research at a site and is accountable for it to their employer,
p.000019: and, through them, to the sponsor of the research. They are also directly accountable to the care organisation(s)
p.000019: where the research takes place (or through which the research team has access to participants, their organs, tissue
p.000019: or data). If the research is at more than one site, the chief investigator takes on personal
p.000019: responsibility for the design, management and reporting of the study, co-ordinating the investigators who take the
p.000019: lead at each site.
p.000019:
p.000019: 3.12 Chief investigators must have suitable experience and expertise in the design and conduct of research12 so that
p.000019: they are able either to undertake the design, conduct, analyses and reporting of the study to the standards set out in
p.000019: this framework or lead and manage others with delegated responsibility for some of these aspects.
p.000019:
p.000019: 3.13 It is the chief investigator’s responsibility to ensure that:
p.000019:
p.000019:
p.000019:
p.000019: 12 For clinical trials involving medicines, the chief investigator and other investigators must be authorised
p.000019: healthcare professionals as defined in the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000020: 20
p.000020:
p.000020: • The research team gives priority at all times to the dignity, rights, safety and well-being of
p.000020: participants;
p.000020: • The study complies with all legal and ethical requirements;
p.000020: • The research is carried out to the standards in this research governance framework;
p.000020: • Controlled trials are registered and for clinical trials involving medicines, the research follows
p.000020: any conditions imposed by the licensing authority;
p.000020: • The Chief Executive of the care organisation(s) involved and/or any other individual(s) with
p.000020: responsibilities within this framework are informed that the study is planned, and their permission is obtained
p.000020: before the research starts;
p.000020: • When a study involves participants under the care of a doctor, nurse or other worker for the
p.000020: condition to which the study relates, those care professionals are informed that their patients or users are being
p.000020: invited to participate and agree to retain overall responsibility for their care;
p.000020: • When the research involves a service user or carer or a child, looked after or receiving services
p.000020: under the auspices of the local authority, the agency director or their deputy agrees to the person (and/or
p.000020: their carer) being invited to participate and is fully aware of the arrangements for dealing
p.000020: with any disclosures or other relevant information;
p.000020: • Potential participants and other service users and carers are involved in the design and management
p.000020: of the study whenever appropriate;
p.000020: • The study is submitted for ethics review and it does not start without a favourable opinion, and
p.000020: the research team acts on any conditions attached to the ethics opinion;
p.000020: • Unless participants or the ethics opinion says otherwise, participants’ care professionals are given
p.000020: any information directly relevant to their care that arises in the research;
p.000020: • Each member of the research team, including those at collaborating sites, is qualified by education,
p.000020: training and experience to discharge his/her role in the study and their qualifications are documented;
p.000020: • Each investigator in a clinical trial involving medicines is aware of his/her legal duties;
p.000020: • Students and new researchers have adequate supervision, support and training;
p.000020: • Unless urgent safety measures are necessary,13 the research follows the protocol or proposal agreed by the
p.000020: relevant ethics committee and by the sponsor14;
p.000020: • Substantive changes to the protocol or proposal are submitted for ethical review and for the sponsor’s
p.000020: agreement. These amendments are implemented only when approved;15
p.000020: • Procedures are kept in place to ensure collection of high quality, accurate data and the integrity and
p.000020: confidentiality of data during processing and storage16;
p.000020: • Arrangements are made for the appropriate archiving of data when the research has finished and to make it
p.000020: accessible;
p.000020:
p.000020:
p.000020:
p.000020: 13 Investigators in clinical trials involving medicines have to report serious adverse events immediately. 14 For
p.000020: clinical trials involving medicines, it is a legal requirement to follow the protocol approved by the licensing
p.000020: authority (the Medicines and Healthcare products Regulatory Agency).
p.000020: 15 Also, for clinical trials involving medicines, to the licensing authority.
p.000020: 16 Also, for clinical trials involving medicines, procedures to comply with legal requirements concerning Good
p.000020: Clinical Practice during the trial, and Good Manufacturing Practice in manufacturing investigational medicinal
p.000020: products.
p.000021: 21
p.000021:
p.000021: • Reports on the progress and outcomes of the work required by the sponsor, funders, or others
p.000021: with a legitimate interest are produced on time and to an acceptable standard;
p.000021: • The findings from the work are opened to critical review through the accepted scientific and professional
p.000021: channels;
p.000021: • Once established, findings from the work are disseminated promptly and fed back as appropriate to
p.000021: participants;
p.000021: • The chief investigator accepts a key role in detecting and preventing scientific misconduct by adopting the
p.000021: role of guarantor on published outputs;
p.000021: • Arrangements are kept in place for the management of financial and other resources provided for
p.000021: the study, including for the management of any intellectual property arising;
p.000021: • All data and documentation associated with the study are available at the request of the inspection
p.000021: and auditing authorities.
p.000021:
p.000021: Responsibilities of Research Funders
p.000021:
p.000021: 3.14 Organisations that fund health research have a responsibility for ensuring that the work is a proper use of the
p.000021: funds they control and provides value for money.
p.000021:
p.000021: 3.15 The main research funder plays a critical role in assuring the quality of a study. It will normally take the
p.000021: lead in establishing that the research proposal is worthwhile, of high scientific quality, and represents good value
p.000021: for money.17
p.000021:
p.000021: 3.16 The main research funder is normally the organisation that makes the arrangements for independent expert
p.000021: review to assess the quality of the research proposed; the experience and expertise of the chief
p.000021: investigator and other key researchers involved; whether there is appropriate research infrastructure for
p.000021: the study: for example, management and governance arrangements, access to potential participants
p.000021: (or their organs, tissue or data); specialised facilities such as equipment, materials or support staff; and
p.000021: for trials on medicines, expert clinical trial management and the capacity to comply with the
p.000021: principles of Good Clinical Practice. If the main funder is unable to arrange for the independent expert review, it
p.000021: should expect the sponsor to arrange for it before taking on responsibility for the research, or to require another
p.000021: organisation to arrange for it. It is good practice for funders to make scientific judgements related to their
p.000021: responsibilities with expert advice independent of the investigators.
p.000021:
p.000021: 3.17 Funders are expected to provide assistance to any enquiry, audit or investigation related to the
p.000021: funded work.
p.000021:
p.000021: 3.18 Funders are expected to make their funding conditional on identifying a sponsor. Organisations wishing
p.000021: to fund research which requires the collaboration of the NHS in Scotland will either take on sponsorship themselves, or
p.000021: collaborate with another organisation which is willing and able to do so.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: 17 The value for money assessment compares the potential benefits with the resources that the study requires. These
p.000021: resources include any additional care or treatment costs, as well as the research costs that the funder is to meet.
p.000022: 22
p.000022:
p.000022: Responsibilities of the Sponsor
p.000022:
p.000022: 3.19 The sponsor is the individual, or organisation (or group of individuals or organisations)
p.000022: that takes on responsibility for confirming there are proper arrangements to initiate, manage and
p.000022: monitor, and finance a study18. For any research that takes place in the context of the NHS in
p.000022: Scotland, there must be a sponsor. Normally, the sponsor will be one of the organisations taking the lead for
p.000022: particular aspects of the arrangements for the study. It may be the chief investigator’s
p.000022: employing organisation, or the lead organisation providing healthcare, or the main funder. If
p.000022: the sponsor is outside the United Kingdom, it must have a legal representative in the United Kingdom.19 For
p.000022: any health research study covered by this research governance framework, it is for the sponsor to be
p.000022: satisfied that clear agreements are reached, documented and carried out, providing for proper initiation, management,
p.000022: monitoring and financing. Others will rely on reasonable assurances that the sponsor has taken steps to do this.
p.000022:
p.000022: 3.20 The sponsor is responsible for ensuring before a study begins that arrangements are in place for the research
p.000022: team to access resources and support to deliver the research as proposed and that arrangements are in place
p.000022: allocating responsibilities for the management, monitoring and reporting of the research. The sponsor also has to
p.000022: be satisfied there is agreement on appropriate arrangements to record, report and review significant
p.000022: developments as the research proceeds, particularly those which put the safety of individuals at risk and to approve
p.000022: any modifications to the design, obtain any regulatory authority required, implement them and make them known.
p.000022:
p.000022: 3.21 It is the sponsor’s responsibility to be satisfied with the arrangements for management and monitoring.
p.000022: Normally, if the chief investigator’s employer takes on the sponsor’s responsibilities (alone or as a member of a
p.000022: group), it will assume responsibility for operating the management and monitoring systems
p.000022: in collaboration with the employers of other members of the research team. Exceptionally, it may be inappropriate for
p.000022: the organisation employing the chief investigator to take responsibility for the management and monitoring of a study.
p.000022: In that case, the sponsor should make arrangements with one or more other organisations that will operate
p.000022: the management and monitoring systems.
p.000022:
p.000022: 3.22 Provided the sponsor keeps in place arrangements for performance management and audit, the responsibility for
p.000022: design and management may be delegated to the research team. The extent of delegation should be
p.000022: specified, even for a research team with proven expertise and track record. Commercial sponsors may
p.000022: arrange their own audit processes.
p.000022:
p.000022: 3.23 When no external sponsor takes on responsibility for it, a study may proceed only if a care organisation takes on
p.000022: sponsorship. For example, an NHS organisation may be willing and able to act as the sponsor for research
p.000022: which does not have an
p.000022:
p.000022:
p.000022: 18 For clinical trials involving medicines, the sponsor is defined as the person (e.g. individual, institution,
p.000022: company or organisation) who takes responsibility for the initiation, management and financing (or arranging the
p.000022: financing) of that trial. Such sponsors have specific legal duties under the Medicines for Human Use (Clinical Trials)
p.000022: Regulations 2004. Regulation 3 defines options for sponsorship, including single sponsorship, joint sponsorship and
p.000022: allocation of sponsorship responsibilities within a group.
p.000022: 19 The Regulations require a sponsor to be established, or have a legal representative, in the European Community.
p.000022: Neither of them need to be established in the United Kingdom.
p.000023: 23
p.000023:
p.000023: external sponsor. When research is undertaken for research training purposes, research supervisors normally
p.000023: carry out the sponsorship responsibilities on behalf of their employers. Exceptionally, a university may authorise a
p.000023: suitably experienced postgraduate student to carry out these responsibilities on its behalf.
p.000023:
p.000023: 3.24 It is the sponsor’s responsibility to be satisfied that:
p.000023:
p.000023: • The research proposal respects the dignity, rights, safety and well-being of participants and the
p.000023: relationship with care professionals;
p.000023: • An appropriate process of independent expert review has demonstrated that the research proposal is
p.000023: worthwhile, of high scientific quality and good value for money;
p.000023: • An appropriate ethics committee has given a favourable opinion;
p.000023: • In the case of a clinical trial involving a medicine, someone acting on behalf of the sponsor obtains a
p.000023: clinical trial authorisation and the arrangements for the trial comply with the law;
p.000023: • Appropriate arrangements are in place for the registration of a trial;
p.000023: • The chief investigator, and other key researchers, including those at collaborating sites,
p.000023: have the necessary expertise and experience and have access to the resources needed to conduct the proposed research
p.000023: successfully;
p.000023: • The arrangements and resources proposed will allow the collection of high quality, accurate data and
p.000023: the systems and resources proposed are those required to allow appropriate data analysis and data protection;
p.000023: • Arrangements proposed for the work are consistent with this research governance framework;
p.000023: • Organisations and individuals involved in the research agree the division of responsibilities between
p.000023: them;
p.000023: • There is written agreement about the arrangements for the management and monitoring of the study;
p.000023: • Arrangements are in place for the sponsor and other stakeholder organisations to be alerted if significant
p.000023: developments20 occur as the study progresses, whether in relation to the safety of individuals or to scientific
p.000023: direction21;
p.000023: • Agreement has been reached about compensation in the event of harm to research participants22and
p.000023: if any organisation, or the sponsor itself, offers compensation without proof of negligence, it has made the
p.000023: necessary financial arrangements;
p.000023: • There are arrangements for the conclusion of the study including appropriate plans for disseminating the
p.000023: findings;
p.000023: • Scientific judgements made by the sponsor in relation to these responsibilities should be based on independent
p.000023: and expert advice;
p.000023: • The sponsor is expected to assist any enquiry, audit or investigation related to the funded work.
p.000023:
p.000023:
p.000023: 20 For clinical trials involving medicines, these include serious adverse events, serious adverse reactions, and
p.000023: suspected unexpected serious adverse reactions as defined in the Medicines for Human Use (Clinical Trials) Regulations
p.000023: 2004.
p.000023: 21 For clinical trials involving medicines, the sponsor has a legal duty to record and report suspected unexpected
p.000023: serious adverse reactions as soon as possible. The sponsor also has to provide annually a list of all such reactions
p.000023: occurring in the past year, and a report on the safety of the participants in the trial.
p.000023: 22 For clinical trials involving medicines it is a legal requirement that there should be insurance or indemnity to
p.000023: cover the liabilities of sponsors and investigators.
p.000024: 24
p.000024:
p.000024: Responsibilities of Universities and others Employing Researchers
p.000024:
p.000024: 3.25 Employers of staff involved in research have responsibility for developing and promoting a high quality
p.000024: research culture in their organisation and for ensuring that their staff are supported in, and held to account
p.000024: for, the professional conduct of research. This will involve careful attention to training, career
p.000024: planning and development, and the use of clear codes of practice and systems for monitoring compliance,
p.000024: dealing with non-compliance or misconduct, and learning from errors and complaints. These responsibilities apply
p.000024: to both private and public sector employers.
p.000024:
p.000024: 3.26 Organisations that employ chief investigators and other researchers have responsibility for
p.000024: ensuring that those researchers understand and discharge the responsibilities set out for them in this
p.000024: framework, and under the law. They may do this, for example, through terms of employment, staff handbooks,
p.000024: and training. They will normally take on some or all of the responsibility for ensuring that a study is
p.000024: properly managed and for monitoring its progress. When the employing organisation is not the sponsor, it should agree
p.000024: its responsibilities with the sponsor and the organisation(s) providing care. The sponsor has to be
p.000024: satisfied with the arrangements for the management of a study, and that there is agreement on appropriate
p.000024: arrangements for monitoring and reporting23.
p.000024:
p.000024: 3.27 Employers should ensure there are agreements between them and their staff and between them and
p.000024: research funders and care organisations about ownership, exploitation and income from any intellectual property
p.000024: that may arise from research conducted by their employees. They have a responsibility for ensuring that
p.000024: employees identify and protect intellectual property.
p.000024:
p.000024: 3.28 Universities and other employers of staff engaged in research are responsible for:
p.000024:
p.000024: • Compliance with all current employment and health and safety legislation;
p.000024: • Demonstrating the existence of clear codes of practice in other areas for their staff and
p.000024: mechanisms to monitor and assess compliance;
p.000024: • Ensuring that investigators and other researchXstaff are aware of understand and comply with this framework;
p.000024: • Discharging their agreed role in the management and monitoring of work undertaken by their
p.000024: organisation;
p.000024: • Demonstrating systems for continuous professional development of staff at all levels;
p.000024: • Having agreements and systems to identify, protect and exploit intellectual property;
p.000024: • Ensuring that they are able to compensate anyone harmed as a result of negligence on the part of
p.000024: staff, students and others for whom they have liability; and, if they have agreed to do so, to compensate participants
p.000024: for non-negligent harm arising from the research;
p.000024: • Having systems to detect and address fraud, and other scientific or professional misconduct by their staff;
p.000024:
p.000024:
p.000024: 23 For clinical trials involving medicines, the sponsor has to put and keep in place arrangements for the purpose of
p.000024: ensuring that the conditions and principles of Good Clinical Practice are satisfied or adhered to.
p.000025: 25
p.000025:
p.000025: • Having systems to process, address and learn lessons from any errors or complaints brought against
p.000025: their employees;
p.000025: • Permitting and assisting in any statutory inspection, audit, or investigation arising from errors or
p.000025: complaints associated with their employees.
p.000025:
p.000025: Responsibilities of Organisations Providing Care
p.000025:
p.000025: 3.29 It is the responsibility of organisations providing healthcare in Scotland to be aware of all research
p.000025: undertaken in their organisation, or involving participants, organs, tissue or data obtained through the
p.000025: organisation. Care providers remain responsible for the quality of all aspects of the care of their patients or
p.000025: service users and carers, whether or not they are involved in research and whoever conducts or funds that
p.000025: research. Chief Executives of NHS organisations are accountable for the quality of care and for the environment in
p.000025: which it is provided under the Duty of Care. They should ensure that their patients, service users and carers, and
p.000025: care professionals are provided with information about any research which may have a direct impact on their care, their
p.000025: experience of care, or their work in the organisation. They should ensure that activity is presented as research only
p.000025: if it is managed as research within this framework.
p.000025:
p.000025: 3.30 Organisations providing healthcare are responsible for satisfying themselves that there are adequate
p.000025: arrangements and resources for any research involving their patients, service users and carers, or staff
p.000025: to meet the standards set out in this framework. No research with human participants, their organs, tissue or
p.000025: data, may begin before an identified sponsor has taken on responsibility for that research, the study has received a
p.000025: positive ethical opinion and the allocation of responsibilities is agreed and documented. Accountability for this
p.000025: lies with the Chief Executive or Agency Director. He or she will normally delegate responsibility to a qualified
p.000025: and senior person.
p.000025:
p.000025: 3.31 Academic staff (university/college medical, nursing, and allied health professionals and other research
p.000025: workers) who, in the course of their NHS research duties, interact with individuals in a way which has a
p.000025: direct bearing on the quality of their care should hold an NHS honorary contract.24 When universities and
p.000025: healthcare organisations are both involved in employing clinical academic staff, they are expected to make
p.000025: joint arrangements for appointment, supervision and appraisal.
p.000025:
p.000025: 3.32 The main responsibilities of organisations providing healthcare are to:
p.000025:
p.000025: • Retain responsibility for the quality of all aspects of participants’ care whether or not some aspects of care
p.000025: are part of a research study;
p.000025: • Be aware and maintain a record of all research work undertaken through or within the organisation including
p.000025: research undertaken by students as part of their training;
p.000025: • Ensure patients or service users and carers are provided with information on any research that may
p.000025: affect their care;
p.000025:
p.000025:
p.000025:
p.000025: 24 If there is negligent harm during a study with NHS permission when the NHS body owes a duty of care to the person
p.000025: harmed, NHS indemnity covers NHS staff, academic staff with honorary contracts (as defined in paragraph 3.31) and those
p.000025: conducting the study. Guidance for the NHSScotland can be found in the document “Guidance Note on Research Governance
p.000025: and Honorary Contracts”, (Health Department, March, 2004).
p.000026: 26
p.000026:
p.000026: • Be aware of current legislation relating to research and ensure that it is implemented and followed within the
p.000026: organisation;
p.000026: • Require that no research study with human participants for whom the organisation is responsible (or their
p.000026: organs, tissue or data), begins until a sponsor has confirmed it has taken responsibility; the proposed research has a
p.000026: favourable ethical opinion (and if the study is a trial of a medicine, that there is a clinical trial authorisation);
p.000026: and a person authorised to do so has given written permission on behalf of the organisation
p.000026: providing care25;
p.000026: • Ensure that written agreements are in place about responsibilities for all research involving an
p.000026: external partner, funder and/or sponsor including agreement with the University or other employer on supervision of
p.000026: student research;
p.000026: • Maintain the necessary links with clinical governance and/or best value processes;
p.000026: • Ensure that NHS honorary contracts are issued where appropriate26. There should be clear accountability and
p.000026: understanding of responsibilities;
p.000026: • Put and keep in place systems to identify and learn from errors or failures associated with any research
p.000026: undertaken through or within the organisation;
p.000026: • Ensure that significant lessons learnt from errors or complaints and from internal enquiries are
p.000026: communicated to funders, sponsors and other partners;
p.000026: • Ensure that adverse incidents in the context of research are reported in line with the standard procedures of
p.000026: the organisation;
p.000026: • Permit and assist with any monitoring, auditing or inspection by relevant authorities.
p.000026:
p.000026: Responsibilities of Care Professionals
p.000026:
p.000026: 3.33 Healthcare staff retain responsibility for the care of their patients or service users when they are
p.000026: participating in research within the NHS.
p.000026:
p.000026: 3.34 Before agreeing to their patients or service users and carers being approached by the research team, care
p.000026: professionals should satisfy themselves that the chief investigator has the permission of the
p.000026: appropriate authorities within their organisation or agency. Before enrolling patients in a clinical
p.000026: study, NHS staff should look for evidence that the study has the ethical and regulatory approval it needs.
p.000026: They should then take care to follow the currently approved version of the protocol.
p.000026:
p.000026: Responsibilities Relating to Research Ethics Committees
p.000026:
p.000026: 3.35 No research study within the NHS involving individuals, their organs, tissue or data may begin until it has a
p.000026: favourable opinion from a research ethics committee.
p.000026:
p.000026: 3.36 From 2004, the United Kingdom Ethics Committee Authority has been responsible for recognising ethics committees to
p.000026: review clinical trials under the Medicines for Human Use (Clinical Trials) Regulations 2004.
p.000026:
p.000026: 3.37 The NHS is responsible for establishing, supporting and monitoring NHS research ethics committees (RECs). The
p.000026: duties of NHS bodies in relation to NHS RECs are set out in the good practice guidance Governance Arrangements
p.000026: for Research Ethics Committees in Scotland (SEHD, 2001). Those outside the NHS may also
p.000026:
p.000026: 25 See section 4.4.
p.000026: 26 See footnote 24.
p.000027: 27
p.000027:
p.000027: seek the advice of these committees. Community care research involving human participants to whom the NHS has a duty
p.000027: of care (or their organs, tissue or data) must have a favourable opinion from the relevant NHS REC.
p.000027:
p.000027: 3.38 RECs are required to be independent when formulating advice on the ethics of the proposed research. Ethics
p.000027: review must be seen to be impartial. Whilst operating within a framework of standards and NHS management,
p.000027: neither SEHD nor NHS bodies are entitled to interfere with NHS RECs’ decisions. RECs’ appointing
p.000027: authorities must have systems in place to appoint members and convene them, to seek recognition if the law
p.000027: requires it, and to support them and monitor their performance.
p.000027:
p.000027: 3.39 RECs provide an independent opinion. The decision whether or not to give permission for research
p.000027: in a care organisation rests with that organisation. Healthcare organisations will not normally
p.000027: withhold permission provided that a sponsor has been identified, the ethical opinion is favourable, the
p.000027: agreements for allocation of responsibilities or indemnity and/or insurance are acceptable to the
p.000027: organisation, and conducting the research will not conflict with service delivery in some way due to local issues
p.000027: that might not have been considered by the ethics approval or sponsor.
p.000027:
p.000027: 3.40 It is not for RECs or reviewers to give legal advice, nor are they liable for any of their opinions in this
p.000027: respect. It is the researchers and the healthcare organisations27 who have the responsibility not to break the law.
p.000027: If a REC suspects that a research proposal might contravene the law, it is expected to advise both
p.000027: the chief investigator and the appropriate authority. Then the chief investigator and the organisation
p.000027: will need to seek legal advice.
p.000027:
p.000027: 3.41 RECs require researchers working in the NHS to keep them informed of the progress of a study. The
p.000027: committees are responsible for reviewing their advice on the ethical acceptability of a study in the light of
p.000027: such information. The chief investigator and his or her employer, the sponsor and the care organisation
p.000027: are responsible for ensuring that a study follows the agreed protocol, and for monitoring and
p.000027: reporting on its progress.28
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: 27 and the sponsor, for clinical trials involving medicines.
p.000027: 28 For clinical trials of medicines, sponsors have a legal duty to notify the ethics committee and the licensing
p.000027: authority if there are adverse events, a change to the design of the trial, and the conclusion of the trial.
p.000028: 28
p.000028:
p.000028: 4. ACHIEVING GOVERNANCE
p.000028:
p.000028: 4.1 Organisations conducting, sponsoring, funding or hosting health research must have systems to ensure that they
p.000028: and their staff understand and follow the standards and good practice set out in this framework.
p.000028:
p.000028: Delivery
p.000028:
p.000028: 4.2 They must have access to independent expert review that enables the main funder and the sponsor to be satisfied
p.000028: of the scientific and ethical standing of the work, its strategic relevance and value for money. This review must
p.000028: be appropriate to the scale and complexity of each research proposal.
p.000028:
p.000028: 4.3 Sponsors must be satisfied there are arrangements to ensure that each study is conducted according
p.000028: to the current agreed protocol, monitor and report on its general progress, and require written agreement
p.000028: on behalf of the sponsor to any modifications to the protocol or proposal, (and if necessary, ethical and
p.000028: regulatory approval). One of the organisations involved in the research will normally manage these arrangements. The
p.000028: sponsor must satisfy itself that a suitable organisation has accepted this responsibility.
p.000028:
p.000028: 4.4 Healthcare providers must have systems that ensure they are aware of research conducted in or through
p.000028: their organisation, whether or not it is externally funded. No study should begin until a person with authority
p.000028: to do so has given written permission29 on behalf of the care organisation. Healthcare organisations
p.000028: are expected to manage risk, minimise bureaucratic process and facilitate high quality research. They are not
p.000028: normally expected to withhold permission when a sponsor offers reasonable assurances that there are
p.000028: arrangements to carry out the responsibilities set out in this framework.
p.000028:
p.000028: 4.5 Healthcare providers may take on the sponsor’s responsibilities if they have systems to discharge them. It is
p.000028: acceptable for an individual employee to be a sponsor only with the written permission of that person’s employer.30
p.000028:
p.000028: 4.6 Nothing in this research governance framework is intended to transfer the legal duties of
p.000028: healthcare organisations to sponsors or to others. Whoever takes on sponsorship, if a study affects a
p.000028: healthcare organisation’s duties, it remains that organisation’s responsibility to satisfy itself that there
p.000028: are systems to conduct the study to appropriate scientific and ethical standards.
p.000028:
p.000028: 4.7 Healthcare organisations are responsible for providing a safe system of care and should normally
p.000028: expect to be kept informed of any study involving their staff, contractors or independent practitioners.
p.000028: However, they do not have responsibility
p.000028:
p.000028:
p.000028: 29 Additional guidance can be found in “Research Governance: NHS Approval for R&D Involving NHS
p.000028: Patients” (SEHD, 2004).
p.000028: 30 For clinical trials of medicines, it is within the law for an individual to be the sponsor (further guidance on
p.000028: this
p.000028: can be found at www.ct-toolkit.ac.uk/_db/_documents/sponsorship.pdf). Employers should ensure that, if their employees
p.000028: take on sponsorship, there is a system to record whether the employee has permission to do so as a private individual
p.000028: or is authorised to do so on behalf of the employer. Healthcare organisations should authorise their employees to take
p.000028: on sponsorship only if there are arrangements to perform the functions in the Medicines for Human Use (Clinical Trials)
p.000028: Regulations 2004.
p.000029: 29
p.000029:
p.000029: for private research that is clearly separate from the healthcare provided on behalf of the NHS. That is when the
p.000029: study is clearly undertaken in a private capacity, the REC is fully aware of the circumstances and participants
p.000029: understand the NHS accepts no liability.
p.000029:
p.000029: 4.8 RECs and reviewers should have systems to identify, record and address conflicts of interest that may
p.000029: compromise, or appear to compromise, the independence of their advice. They must also have systems in place to
p.000029: record their decisions and the reasons for them, and to record operational details of their meetings and handling of
p.000029: applications.
p.000029:
p.000029: 4.9 Delivery systems should be designed to facilitate adherence to requirements, and to detect failures whether
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| employees | employees |
| gender | gender |
| home | Property Ownership |
| homeless | Homeless Persons |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| poor | Economic/Poverty |
| prison | Incarcerated |
| property | Property Ownership |
| race | Racial Minority |
| religion | Religion |
| research staff | Laboratory Staff |
| single | Marital Status |
| student | Student |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| home | ['property'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| property | ['home'] |
Trigger Words
capacity
consent
cultural
developing
ethics
exploit
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input