Guidelines for Proper Scientific Conduct in Research

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Introduction

1. It is the responsibility of every member of staff to uphold the good reputation of the College and, consequently, it is expected that they will conduct research with integrity. These guidelines describe practices that have been established by several professions and are generally accepted by members of academic staff in the College. Their purpose is to encourage the education and training of junior staff by senior colleagues and to ensure that the quality and integrity of research is maintained in the College.

2. Research is defined as all research, scholarly and creative activity that supports the academic mission of the College. It is recognised that the practices of investigators will vary according to the type of research. The College cannot be prescriptive about individual approaches taken by scientists to answer specific research questions and therefore this document is intended to provide only guidelines.

3. Notwithstanding this comment, it is clear that rather different guidelines are appropriate for activities that are related to Biomedicine from those of other disciplines. Accordingly, two Annexes have been developed to this general guidance for two cognate groups of disciplines: Biomedical Sciences, and Science and Engineering, to provide more detailed advice.

4. It is the responsibility of the Heads of Department/Division/Centre to ensure that this set of more specific guidelines are promulgated in their Department and that members of staff and students are aware of their obligations with respect to proper scientific conduct.

5. The College has adopted the Council for Science and Technology universal ethical code for scientists, and upholds its three principles, these being:

a. Rigour, Honesty and Integrity.

  • Act with skill and care in all scientific work. Maintain up to date skills and assist their development in others.
  • Take steps to prevent corrupt practices and professional misconduct. Declare conflicts of interest.
  • Be alert to the ways in which research derives from and affects the work of other people, and respect the rights and reputation of others.

b. Respect for Life, the Law and the Public Good.

  • Ensure your work is lawful and justified.
  • Minimise and justify any adverse effect your work may have on people, animals and the natural environment.

c. Responsible Communications: Listening and Informing

  • Seek to discuss the issues that science raises for society. Listen to the aspirations and concerns of others.
  • Do not knowingly mislead, or allow others to be misled, about scientific matters. Present and review scientific evidence, theory or interpretation honestly and accurately.

6. Finally, this document should be considered in tandem with the College Scientific Misconduct Policy (Ordinance D17), because scientific misconduct in research includes, but is not limited to, any deviation from the Guidelines below.

Culture

7. The preservation of research integrity must be largely dependent on self-regulation. The primary way to encourage appropriate conduct is to promote and maintain a climate consistent with high ethical standards. It is imperative that all members of the College, whether students, staff or administrators, recognise the responsibilities that they share for developing and maintaining a culture in which sound research practices are adopted and inappropriate ones detected (see College Regulation C6). To do this, honesty, openness and guidance from professional bodies should be encouraged to ensure that professional standards are upheld.

a. Honesty.

(1) Regardless of discipline and Institution, the fundamental factor in ensuring the quality of research and research practices has to be the honesty of the individual investigator. Investigators should be honest with respect to their own work, which means subscribing to proper scientific practices such as acknowledging the contributions of colleagues or collaborators and ensuring veracity of data.

(2) However, investigators are also expected to be honest in relation to the work of their colleagues and peers. Colluding in, or concealing, the misconduct of others is not compatible with an environment which encourages Intellectual Honesty and is, therefore, in itself misconduct. Every employee of the College has a duty to inform the appropriate authorities if they know or suspect that there has been a breach of good conduct (see College Regulation C6).

b. Openness. The College recognises the need for scientists to protect their own research interests and both the College and the funding bodies encourage scientists to be as open as possible. This openness includes such common practices as the scholarly exchange of ideas and data and the submission of work to peer review or to another forum where it can be challenged and questioned without the loss of face. Such an environment is essential not only to the establishment of good scientific conduct, but to the development of good and innovative science itself. Openness also implies that all steps will be taken to avoid, or at least declare, conflicts of interest.

c. Guidance from Professional Bodies.

(1) As stated above, these guidelines cannot and do not encompass every element of proper scientific conduct. The number of different types of research and their combinations is endless and thus the area which "proper scientific conduct" has to address is equally vast. No one document can possibly encompass it all. Some areas such as Ethics, which is an important part of proper scientific conduct, are not even the preserve of one body or group. They lie partly in the public sphere of what is deemed acceptable and are constantly changing. For this reason the College expects individual investigators, research groups, Centres and Departments to follow guidelines provided by other bodies which relate to their work. In the case of Ethics, for example, this may include the BMA, the NHS Ethics Committees operated by the National Research Ethics Service, the Imperial College Research Ethics Committee and the CBS Policy Committee where applicable (see Animal Research below).

(2) Investigators are also under an obligation to comply with all the legislation relevant to their field of study including that of external bodies such as the Health and Safe ty Executive, the Home Office and the individual Research Councils themselves, as well as internal bodies such as the College's Health and Safety Unit and Occupational Health Service.

8. Guidelines.

a. Each head of Department/Division/Centre should ensure that this culture is promulgated within their own area.

b. Mentoring relationships between academic leaders and new practitioners should seek to guarantee the transmission of proper scientific standards.

Supervision of Research Students

9. While the following recommendations refer to research students, many points are also applicable to junior members of academic staff and research assistants. Supervision of research students is vital in establishing proper conduct and scientific excellence in the College. New investigators often lack substantial laboratory experience and require significant input from their supervisors to successfully understand complex scientific methods, interpret data, and to undertake statistical analysis. The College has produced a booklet entitled "Research Students and Supervisors: Their Responsibilities and Dutie s" which has further information and is available from the Registry.

10. Guidelines.

a. Every student should be assigned at least one supervisor who specialises in a relevant research area.

b. The ratio of research students to supervisors should be such that close interaction and oversight of research is possible for the supervisor.

c. It is the responsibi lity of a supervisor to ensure that the student is aware of any relevant College regulations pertaining to their work, as well as the standards of conduct which are expected of them in their research.

d. The supervisor should oversee all aspects of the student's work including the design of the research, whether it be experimental, theoretical or numerical and the process of acquiring, recording, examining and interpreting data; it is not acceptable for the supervisor to have a role which involves simply the editing of a student's thesis.

e. Supervisors should emphasise the importance of keeping and maintaining an accurate record of research undertaken.

f. To encourage peer review, there should be regular communication within a Research Group, for example through group meetings or dissemination of written work.

g. In addition, there should be regular meetings to present, discuss and scrutinise work in progress.

h. PhD students are required to acknowledge that theses are their own work by signing the College PhD entry form and the reproduction of theses form.

Data Collection and Retention

11. It is important that primary results are recorded accurately during research and they can be retrieved or reproduced if necessary. For data which requires statistical analysis, the same methodology should be used in the design of the research as in its evaluation. The existence of verifiable data will allow research results to be tested by a third party if an allegation of scientific misconduct is made.

12. Guidelines.

a. If some aspects of a study are outside the expertise of the investigator, he or she should consult other specialists before conducting the research.

b. Primary data should be recorded promptly, accurately and permanently by an appropriate method. Entries should be signed and dated by the investigator where possible. This is consistent with the requirements of US Patent Law, and will provide protection from allegations of misconduct as well as having positive benefits for the individual researcher.

c. Where computer and/ or instrument printouts are the main record of results, these should be kept in numerical order and affixed to any relevant laboratory notebooks.

d. Any changes made to primary data during the conduct of a study should be identified separately and the reason for the change should be indicated. Under no circumstances should data be modified in an improper manner.

e. Primary data are the property of Imperial College and should remain in the laboratory where it was generated for as long as reference needs to be made to it and for no less than ten years.

Authorship

13. Guidelines

a. It is recommended that all co-authors should have made a significant intellectual or practical contribution.

b. Where there are two or more co-authors involved in a study, it is suggested that one author takes responsibility for the scientific accuracy of the entire publication. This senior author should verify that each co-author has reviewed the manuscript and is able to confirm that their area of expertise is accurate to the best of their knowledge.

c. Heads of Department/Division/Centre have a responsibility to ensure that members of the Department are not engaged in the publication of research which is not authentic, or does not add substantially to existing literature. This responsibility will in practice be delegated to principal investigators.

Acknowledgements

The College wishes to gratefully acknowledge the use of the following document in writing this paper:

Faculty of Medicine Harvard University, Guidelines for Investigators in Scientific Research (1996)

Approved by the Management and Planning Group: January 2000
Revisions approved by the Management Board: October 2006

Physical Science and Engineering Research Guidelines

1. Research in the Physical Sciences and Engineering (PSE) has both theoretical and practical/applied components. The proper scientific conduct of theoretical (pencil, paper and computer simulation) research is covered by the general guidelines provided in the main body of this document. Individual researchers and Research Groups that conduct experimental research in the general area of PSE must develop methods of working and task specific guidelines that comply fully with the spirit of the general College guidelines on proper scientific conduct, and should also be consistent with the College's Health and Safety policy, and the College's Ethics Policy.

2. Ethics.

a. Subjects should not be deceived either by the withholding of information or intentional misleading regarding the procedures or purposes of research unless there is a valid methodological reason for doing so. Such methodology should always have the approval of an ethics committee. For studies that do not involve NHS subjects and/or their tissue or data, or that are collecting and using tissue outside the requirements of the Human Tissue Act 2004, ethics approval should be sought from the Imperial College Research Ethics Committee (ICREC).

b. It is difficult to conduct research with human subjects and experimental design should have clearly defined research objectives to allow for this. Every study should have distinct goals, criteria for the inclusion or exclusion of cases, and should minimise the scope for investigator bias. There should also be details of the methods and timing of follow-ups, statistical methodology and the type of outcome measures expected.

c. To improve the scientific quality of research, studies should be subject to scientific Peer Review before being submitted to a Research Ethics Committee for approval. For externally funded studies this is usually done as part of the application for funds. For internally funded research, the study should be peer reviewed by person(s) completely independent to the research team, who have appropriate expertise in the subject area. Evidence of this peer review should be submitted with the ethics application.

d. To enhance the validity of the research any substantial amendments to the conduct of the study or the interpretation of the results should be approved by the Research Ethics Committee that originally reviewed the study and, following this approval, should be explained to all research participants by the investigator. Such amendments should also be submitted to the study Sponsor and any relevant authority from which approval to conduct the study has been obtained.

3. Other Sources of Information:

Imperial College Research Ethics Committee (ICREC)

Biomedical Research Guidelines

Clinical Research

1. These principles apply to both funded and unfunded research, and are only meant as a guide. Members of staff are referred to the ICH Good Clinical Practice Guidelines, the Declaration of Helsinki, the Department of Health Research Governance Framework 2nd Edition, the General Medical Council Good Practice in Medical Research Guidelines and the Medical Research Council Ethics Series. New members of staff should be provided with these documents by their immediate supervisor. Imperial College staff should also adhere to the Clinical Research Governance Office Standard Operating Procedures.

2. Guidelines.

a. All clinical research staff are required to register their clinical research projects with the appropriate NHS Trust(s) (including projects involving private patients being treated in Trust facilities). Any clinical research conducted outside the UK which involves the College's clinical academic staff should always be carried out according to UK ethical and Good Clinical Practice standards, but should also adhere to any local requirements in place in the country where the research is being conducted.

b. For Clinical Trials of Investigational Medicinal Products, research must be carried out in accordance with the EU Directive on Good Clinical Practice 2005 and the UK Medicines for Human Use (Clinical Trials) Regulations 2004. All those undertaking research in this area must seek the appropriate external approvals (e.g. Medicines and Healthcare Regulatory Agency Clinical Trials Authorisations, registration on the EudraCT database) where applicable. Researchers should also comply with requirements to register studies on publicly accessible research databases (e.g. clinicaltrials.gov) where appropriate, to avoid publication problems.

c. For any research involving the use of human tissue, work must be carried out in accordance with the Human Tissue Act 2004, and in accordance with the Codes of Practice established by the Human Tissue Authority.

d. For particular types of clinical research (e.g. gene therapy, research using patient data without consent) the UK has established national bodies (e.g. Gene Therapy Advisory Committee, Patient Information Advisory Group) as the responsible approval agency. The College requires all those undertaking clinical research in these areas to obtain the appropriate approval for their work.

e. The role of named collaborators should be properly defined. As with other types of research the College expects that the Principal Investigators will share the responsibility for the project. In the case of multi-site research, the Chief Investigator as named on the grant/ethics application will be the lead project manager and will be accountable for all aspects of project performance.

3. Sponsorship and Indemnity.

For any research conducted that falls under the Research Governance Framework or UK Clinical Trials Regulations an appropriate Sponsor must be identified to take on the management and monitoring responsibilities. This would usually be the Funder of the study where commercial companies are involved, or the main employer of the researcher. In all cases formal written agreement of Sponsorship must be obtained either from the Funder, Imperial College, or the appropriate NHS Trust. All researchers carrying out clinical or healthcare studies where Imperial College is named as Sponsor, must have this formally agreed by the Imperial College Research Governance Manager within the Clinical Research Governance Office. Sponsorship will only be confirmed following a standard risk assessment. Appropriate Indemnity for the research must also be arranged for both negligent and non-negligent harm. Imperial College indemnity must be arranged with the Insurance Manager via the Clinical Research Governance Office before the study commences.

4. Ethics.

a. Any research involving NHS patients, tissue or data, relatives or carers of NHS patients, foetal material or IVF procedures involving NHS patients, the recently dead in NHS premises, the use of NHS premises or facilities, or studies involving NHS staff who are recruited because of their professional role, must have the prior approval of a NHS Research Ethics Committee (REC) before it may proceed. This also applies to healthy volunteer studies where a drug or device is being tested within the NHS. Ethics approval should be obtained following the guidance issued by the National Research Ethics Service (NREC).

b. It is the responsibility of the Principal Investigator of a study to ensure they have specific ethics approval for the work being carried out, either through submitting a new ethics application, or a substantial amendment to previously approved research to the relevant REC.

c. Researchers should adhere to the Imperial College Ethics Policy. Where research involves humans, their tissue or data, but falls outside the remit of the NHS/Clinical Trials Regulations, the project should be submitted to the Imperial College Research Ethics Committee (ICREC) for approval.

d. Potential research subjects are entitled to choose whether or not they will participate in research; obtaining valid informed consent is central to the ethical conduct of research. Before they are asked for their consent, the subjects should be fully informed about the nature of the research methods and the likelihood, nature and possible degree of any risks (either physical or psychological) that may occur as a result of their participation. They should also be briefed about the purposes (including a realistic assessment of benefit) and potential value of the experiments and the right to withdraw during the course of the experiment. Potential participants should be provided with a written information leaflet to take away with them, including contact details should they have further questions. Participants should usually be given at least 24 hours to consider taking part. Written consent should always be recorded, except in exceptional circumstances. Verbal consent is only sufficient with prior written approval from an ethics committee. The consent forms should be filed in the patient's notes. In the case of private patients the notes must not be kept by the clinician concerned, but must be held in the Trust facility for private practice and be available for a minimum period of ten years.

e. Researchers should seek consent according to the principles set out in the National Research Ethics Service guidance, which incorporates the UK Medicines for Human Use (Clinical Trials) Regulations 2004, and the European Clinical Trials Directive 2001/20/EC. The consent provisions in the Mental Capacity Act 2005 and the Human Tissue Act 2004 should also be taken into consideration where applicable.

f. For research involving either patients or healthy volunteers, where there is a dependent relationship (e.g. patient-doctor, student-supervisor, lab staff-manager), it is important to ensure that the potential subjects do not feel pressurised or coerced into taking part. Potential participants should always be clear that their involvement is entirely voluntary, and that they will not be disadvantaged in any way should they not take part.

g. Subjects should not be deceived either by the withholding of information or intentional misleading regarding the procedures or purposes of research unless there is a valid methodological reason for doing so. Such methodology should always have the approval of a recognised ethics committee.

h. It is difficult to conduct clinical research with human subjects and experimental design should have clearly defined research objectives to allow for this. Every clinical study should have distinct goals, criteria for the inclusion or exclusion of cases, and should minimise the scope for in vestigator bias.&a mp;a mp;n bsp; There should also be details of the methods and timing of follow-ups, statistical methodology and the type of outcome measures expected.

i. To improve the scientific quality of research, studies should be subject to scientific Peer Review before being submitted to a Research Ethics Committee for approval. For externally funded studies this is usually done as part of the application for funds. For internally funded research, the study should be peer reviewed by person(s) completely independent to the research team, who have appropriate expertise in the subject area. Evidence of this peer review should be submitted with the ethics application.

j. To enhance the validity of the clinical research any substantial amendments to the conduct of the study or the interpretation of the results should be approved by the Research Ethics Committee that originally reviewed the study and, following this approval, should be explained to all research participants by the investigator. Such amendments should also be submitted to the study Sponsor and relevant authority such as the Medicines and Healthcare products Regulatory Agency.

k. All clinical research must be conducted in accordance with the World Medical Association Declaration of Helsinki.

5. Data.

a. Where research involves the storage of personal information (which could include name, date of birth, NHS number, or tissue samples), the research proposal must contain provisions that the subject will be fully informed, in advance, of the nature of the information required and the subsequent use to be made of that information. Each subject is to be given the freedom to decide what additional information not currently in the public sphere of knowledge can and cannot be communicated. All data should be taken and stored in accordance with the Data Protection Act 1998. Research data should be stored for a minimum of five years.

b. Each subject has a right to maintain his or her anonymity.

c. For research involving human tissue, ideally such tissue should be anonymised from the researcher. The use of codes is strongly recommended (pseudonymisation). Such research should always have the approval of a research ethics committee and must comply with the requirements of the Human Tissue Act; including ensuring samples can be traced back to the donor.

d. Data should be consistent with the medical records used as source material and should be abstracted as the trial proceeds.

e. In both prospective and retrospective trials, data collection forms should be used.

6. Reporting Responsibilities.

Following commencement of a clinical trial, the Principal Investigator is responsible for the reporting of all Serious Adverse Events (SAEs), Adverse Reactions (ARs) and Suspected Unexpected Severe Adverse Reactions (SUSARs) to the appropriate authority e.g. the Medicines and Healthcare Regulatory Agency and Research Ethics Committee as well as to the study Sponsor.

7. Other Sources of Information:

WMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 2000

EU Directive 2001/20/EC 

The UK Medicines for Human Use (Clinical Trials) Regulations 2004

The Human Tissue Act 2004

The Mental Capacity Act 2005

Health Research Authority

The Medical Research Council MRC Ethics Guidance

Animal Research

8. Only a small percentage of medical and biological research involves the use of animals. That part remains vital, however, to further the development of treatments or cures for medical conditions that blight or destroy the lives of humans - and animals. The College's statement of its policy on animal use is available on the website.

9. All biomedical research must comply with both the letter and the spirit of the Animals (Scientific Procedures) Act 1986 (the Act) - widely viewed as the most rigorous piece of legislation of its type in the world - which regulates any experimental or other scientific procedure applied to a protected animal that may have the effect of causing that animal pain, suffering, distress or lasting harm (a regulated procedure). The overall responsibility for ensuring compliance with the provisions of the Act is held by the Certificate Holder, a representative of the governing authority of the College. This position is currently held by the Principal of the Faculty of Medicine.

10. Before any regulated procedure is carried out it must be part of a programme specified in a project licence and carried out only by a person holding an appropriate personal licence. Applications for the grant of a project or personal licence are made to the Secretary of State for the Home Office. Copies of the application forms and notes on their completion are available on the Home Office website.

11. No application for a project licence can be made to the Home Office until it has been through the College's Ethical Review Process (the ERP). The Central ERP Committee includes members who are vets, animal care staff, lay people (some of whom are independent of the College) and scrutinises all proposals for their scientific and ethical justification of animal use. The Committee will also provide information and advice about ethical analysis, best practice in animal welfare and new developments in techniques that avoid animal use. This is in line with the aim of the ERP to develop initiatives leading to the widest possible application of the 3Rs:

  • Replacement (of animals with non-sentient alternatives),
  • Reduction (in animal numbers) and
  • Refinement (of techniques to minimise pain and suffering).

12. A personal licence is the Home Secretary's endorsement that the holder is a suitable and sufficiently competent person to carry out specified regulated procedures. Personal licensees assume primary responsibility for the welfare of the animals on which they perform regulated procedures. All new applicants for personal licences are required to complete an appropriate training course.

13. Additional Guidelines.

a. All research must comply with the CBS protocols relating to Health and Safety Legislation.

b. No-one is permitted to work within CBS facilities unless they have been satisfactorily screened by the Occupational Health Department for Allergy to Laboratory Animals.

c. Heads of Department/ Divisions/ Project Leaders/ CBS must ensure that all staff are aware of the relevant protocols.

Biohazardous Research

14. The College acknowledges its responsibility to provide a support programme for the handling, storage and disposal o f biohazardous material through the Safety Department. However, t he investigator is responsible for ensuring work conducted within their laboratories is in conducted in a safe manner and i n comp liance with the law and College Policy. "Faculty groups", which regularly conduct research in this area, and Research Groups, should develop their own more specific guidelines to help direct staff.

15. Policy and Guidelines

a. Investigators must ensure that they comply with the Health and Safety at Work etc Act, the Control of Substances Hazardous to Health Regulations, the Management of Health and Safety at Work Regulations and the College's Health and Safety policies for work with dangerous pathogens.

b. Detailed risk assessments and Codes of Practice for handling biohazardous material must be developed by the Head of Department/Division/Centre/Research Group and approved, where required, by the Safety Department.

c. Staff and students participating in biohazardous research must be given adequate direction, training and instruction in the safe performance of their work. This is the responsibility of the principal investigator.

d. The principal investigator must ensure that the use of biohazardous material is limited to the approved facilities.

e. Appropriate emergency and decontamination procedures must be developed by the Head of Department/ Division/ Centre and Research Groups in consultation with the Safety Department.

f. The principal investigator must report all potentially hazardous incidents and accidents to the Safety Department.

Genetic Modification Work

16. All work involving genetic modification of animals, plants and micro-organisms must be carried out in a safe manner and in full compliance with College Policy and the Health and Safety at Work etc Act, the Genetically Modified Organisms (Contained Use) Regulations and all other relevant legislation, including the Regulations of the Health & Safety Executive, it's Advisory Committee on Genetic Modification and, where appropriate, the Ministry of Agriculture, Fisheries and Food.

17. All storage, use or disposal of Genetically Modified Organisms must be approved by the relevant GM Safety Committee before the material is imported to or created on College premises.

18. All requirements for biohazardous work must also be applied.

Plant Pathogens and Pests

19. All work with plant pathogens and pests, and their vectors, including bacteria, fungi, insects, viruses and other organisms, must be carried out according to the regulations of the Ministry of Agriculture, Fisheries and Food and, where necessary, the appropriate licence obtained.