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Guidelines
Standard ethical practice in clinical research
Introduction
This document aims to define and categorise the standards of expected conduct for doctors [in this document refers to medics, dentists and veterinarians] and other healthcare professionals [in this document refers (but not limited) to biomedical scientists, chiropodists / podiatrists, dieticians, nurses, occupational therapists, orthoptists, pharmacists, paramedics, physiotherapists, psychologists, prosthetists / orthotists, radiographers and speech and language therapists] involved in clinical research. This comprises observational and interventional clinical research, including clinical trials, which cover a wide range of possible experiments involving the direct use of medications and/or treatments.
Though the research type may vary, ethical principles should remain constant in order to safeguard the participants and uphold the accuracy and reputation of the clinical research record. It is imperative that doctors and other healthcare professionals are professional in their attitude and are fully aware of the directives and protocols that govern their actions while conducting clinical research.
Adhering to robust and ethical principles is an obligatory requirement for all personnel involved in clinical research. Ensuring that the necessary steps are taken in order to uphold ethical standards is the foremost way of maintaining a safe, legal, and professional domain free from any infringement to the pre-set codes of conduct. The research team, as well as the institutions they work for, have a duty to maintain the necessary framework and safety systems that regulate the behaviour of all those involved in the clinical research process. All projects must also be thoroughly planned and designed to hinder instances of malpractice, misconduct or breach of confidentiality. Of course, clinical research is a nuanced and complex affair, and no pre-determined parameters of behaviour can ever be considered truly definitive. Upon studying the following stipulations, however, all clinical researchers will be equipped with a plethora of background details that should influence their thought process. This will help them to foster an ethical working environment for both themselves and their colleagues.
1 Good research principles
1.1 Researchers involved in clinical research must follow all directional guidelines and laws, both specific to their area of research, in addition to more general procedures. All researchers have a duty to keep themselves informed about any new developments, updates, guidelines, or legislations relating to the conduct in the clinical research environment. The highest professional standards must be maintained at all times. Any individual found to be infringing upon any pre-set procedural ruling must be reported at once to the relevant authorities.
1.2 Maintaining public confidence is a compulsory requirement; therefore all research must be performed to the highest quality standards of honesty, integrity, and respect. Clinical research institutes should have a robust internal monitoring and review system to ensure that ethical and legal conduct is maintained.
1.3 No researcher should proffer inaccurate information or try to sway the decision of a potential participant in a clinical trial. Commercial concerns should never take precedence over the quality or thoroughness of the research. Researchers must never proffer manipulated or fabricated data in the results of their research. This includes leaving out data which is not expedient for the research project hypothesis.
1.4 Researchers must conduct themselves with complete honesty at all times. Plagiarism is a serious breach to the ethical code of conduct and will be disciplined accordingly. All clinical research projects should be registered and authorised with the relevant authorities and be approved by the local ethics committee.
2 Research study design
2.1 Any research programme must first go through a stringent planning phase that meets all recognised legislation and guidelines.
It should then be submitted for an ethics committee review and if there are any concerns then these must be answered before the commencement of the project.
2.2 All studies must make a calculation of the potential risk compared to the potential benefits in the planning phase; only if the positive effects seriously outweigh the negative (to a participant in a trial or otherwise), should the trial commence.
2.3 Legislation varies depending upon a number of different circumstances, so all research staff must have a clear understanding of any legal obligations or procedures in the planning phase that could take effect when the trial is running. It is the responsibility of all research staff to ensure this stipulation comes to fruition.
2.4 All trials need to go through stringent protocols before being sanctioned. Significant consideration as to the suitability of the potential test candidate regarding previous exposures to dangerous elements and medical history e.g. medication, must be made in full. This also includes a research ethics committee review for the trial plan.
2.5 Under no circumstance should the expected benefits of a clinical trial or research project overrule the risks to the participant or the surrounding environment. This is not to say researchers should be risk-averse, but that the rights of the participants and environmental concerns must take priority over advancing knowledge at any cost.
2.6 All research institutes must have readily accessible guidelines for their staff members that outline the exact process by which they should design a research project or clinical trial.
2.7 The doctor in authority (principal investigator) must thoroughly brief his/her team and be unreservedly sure that every member understands the expected modes of behaviour determined by the relevant guidelines and legislation. This is an ongoing process and support for every individual must be made available throughout the clinical research project.
2.8 Research projects are to be designed so that financial contributors cannot overrule the truthful outcome of the published result e.g. when the conclusions are not expedient for the contributor’s agenda. Ideally, written confirmation of this stipulation should be sought before commencing the project.
2.9 All staff who are to be involved in a clinical research project must sign confidentiality forms and be fully briefed on what the forms entail regarding their conduct.
2.10 Research projects and clinical trials must be designed to eliminate prejudice, discrimination, and bias. Any discriminatory action must have sound logic e.g. the test population for a clinical trial on testicular cancer will only use male test subjects.
2.11 Outside assessment (evaluation) from either private or public bodies may be worthy of consideration to highlight any areas of possible concern in the planning phase.
2.12 All research projects must be designed with up to date information regarding relevant guidelines and legislation; outdated modes of behaviour are not an acceptable recourse for questionable actions.
3 Recruiting candidates
3.1 Research performed on a larger scale involving a significant amount of data is considered to be of higher accuracy. However, researchers should not use this fact to pursue dubious practice in either sourcing data or acquiring recruits for a clinical trial.
3.2 Discrimination is a criminal offence and must be completely eradicated when recruiting and vetting both potential participants for a clinical trial as well as new members of the research team.
3.3 If human test subjects are to be directly involved in the process of a trial, then they must be fully informed to give their consent, along with an appropriate amount of time, to consider the ramifications of their decision. Safeguards should be put in place to ensure volunteers are appropriately recruited to the clinical trials.
3.4 Financial motivations as well as personal emotive ties to the subject matter may influence the decision of the participant, both undermining their consent and putting their health at unnecessary risk. This is why record keeping, and due attention to the records, is such a vital practice that must be promoted.
3.5 Clinical trials often involve people who are in a vulnerable position so the research team must ascertain the relevant benefits in comparison to the risks. Once the trial is underway, intense focus must be maintained to curtail any problematic circumstances.
3.6 Participants must be informed that if at any point in the clinical trial a participant is found to be at extreme risk or is suffering from adverse effects then the trial will halt at once. The same applies if the expected benefits to the participants do not occur.
3.7 An immediate notice of risk must be signalled if the clinical test is to be performed upon children under the age of eighteen, those with disabilities, people with mental conditions, or foreign nationals differs from that which the details of the trial were described to them in.
3.8 If the clinical research indirectly affects human participants, then consent laws and guidelines must be scrutinised to ascertain the level of intrusion that is ethically allowable without consent forms being sourced.
3.9 No research participant should be pressurised to take part in a clinical study; all decisions must be independent, informed, and unbiased.
3.10 Remuneration for participation in a clinical study must never be proffered or promoted as an incentive to override the potential dangers of the trial. Financial stipulations should not affect the person’s free will to leave, and all financial contributions to the trial must be disclosed and transparent.
3.11 When recruiting new members of the research team, the candidate’s suitability and qualifications must be rigorously checked for accuracy. If this task cannot be performed in-house, then third-party organisations can perform background checks. Due diligence must be utilised when the participant has personal ties to the subject matter of the trial e.g. a parent with a child suffering from a disease for which a new medicine is being trialled.
4 Consenting candidates
4.1 Informed consent is a legal obligation in research projects that involve the direct exposure of a human participant to experimental medicinal agents or procedures. The participants must be fully briefed before the start of the trial so that they can make an educated decision with full knowledge of the potential risks and benefits. Furthermore, the participant must be willing and able to make the decision independently. An informed consent form can only be legally valid if it meets the above criteria. Any deviations from the above principles, including participants unable to give informed consent (for example, dementia, coma), if unavoidable, would require discussion with the local ethics committee.
4.2 All members of the research team in a clinical trial need to be satisfied that consent procedure has been accurately followed and adhered to. In order for this to be so, all members must be well-versed, to begin with, in the guidelines.
4.3 Informed consent needs to be obtained from participants, prior to commencements of all studies, particularly those that measures private data that the participant would normally keep private or data sourced through intrusion and interaction.
4.4 Consent forms need to be relayed to the participant in clear, plain, and neutral language. The content and design of the consent form needs to meet a number of pre-set procedures so advice from third-party experts may need to be sourced.
4.5 The potential risks, benefits, rights of the individual, aim of the study, and an invitation for any questions must be proffered to the participant. Ample time for the participant to fully grasp the details must be allowed, together with giving any information they ask for, in order to make their decision.
4.6 Clinical research staff must inform the participant of their right to discontinue in the trial at any point during its duration. Informed consent is a continuing process that needs to be re-examined throughout a human research trial.
4.7 If the participant does not have the capacity to make a conscious decision for themselves e.g. people with a mental health condition or children, then the research team must source specific permission from parents, carers, or guardians. Only in instances where the research will benefit the participant should this situation ever occur. There are many legal stipulations to consider in such circumstances, so legal advice and discussion with the local research ethics committee may need to be sought.
4.8 The clinical research team should inform all relevant party about the participation of an individual in a clinical trial. This includes the General/Family Practitioner, health-worker, and/or therapist of the participants
4.9 Only doctors or other healthcare professionals with the required level of knowledge and authority can take responsibility for the consent and recruitment process.
4.10 If the research trial is to include the use of human tissue, then the relevant legislation must be adhered to, for example, The Human Tissue Act of 2004.
4.11 Consent may not be needed if the study concerns analysis of publically available information e.g. monitoring public health statistics, retrospective studies or audits.
5 Data collection and reporting
5.1 The research team must comply with all current Data Protection laws. In addition, they must also adhere to the pre-set code of conduct of both the institution running the project as well as the research ethical committee.
5.2 An environment of honesty and transparency must be promoted in all research institutes. Researchers should answer any query honestly, and take their duty of transparency seriously. If a route of dishonesty is pursued then a report must be provided with evidence as to why it was required. Calculated deception, which has been ratified before the trial, must also be explained to the participant in a thorough debrief immediately after the completion of the trial.
5.3 All findings must be reported in the final document with the utmost accuracy and transparency. The research record must be kept free of any embellishment or outright deception.
5.4 Research institutes and practices should have a robust internal monitoring and review system to check that ethical and legal conduct is being maintained.
5.5 All participants of a research trial must be informed of the following: what data is collected? How the data will be used following the trial? Who will access the data? Whether or not consent to process forms are required to allow future research.
5.6 The collated data from a research project is confidential and must be kept secure. Stringent safety measures need to be in place to ensure there are no breaches from unauthorised personnel. Under no circumstances should confidential information be shared with any third party or used as a way to further a career.
5.7 As far as is possible, all reference toward the participant in secondary studies must be coded unless the benefit of identifying the subject is deemed higher than their right to confidentiality. If identifiable data relating to trial participants is to be disclosed either in primary or secondary studies, then it must be reviewed by an ethics committee.
5.8 If it is deemed beneficial to have the participants identified then a number of factors need to be considered; including the age of the records, the likelihood of the people in question being located, the nature of the research, and how it will be performed. Identifying participants can also be pursued under law and through specific healthcare legislation e.g. the NHS Act 2006. If any further help is needed, then contacting a professional expert for their advice is the ethical course of action.
5.9 In some cases, coding every individual’s information may be impractical for the research team. This task can therefore be outsourced to an outside institution or a relevant person brought into the research team. Both must be bound by a signed confidentiality form.
6 Dissemination of results
6.1 When disseminating the results of a clinical research project, the research team must follow all relevant guidelines and legislation to ensure the process is accurate, reliable, and sustainable.
6.2 A dissemination strategy must be ascertained in the design phase of a new research project. This strategy should outline with whom the information will be shared, how this will be achieved, and what the information or message will include. It must also state the intention of the research and at what point in time the information will be disseminated.
6.3 The research remit is one of benefiting people; therefore the results and any consequences of the results must be made available to persons who could gain any positive effect from the study.
6.4 Publishing the results of a clinical research project is the most common way of disseminating its outcomes. Therefore the research team needs to follow all procedural guidelines that foster an ethical publishing practice.
6.5 Other common options for disseminating results are workshops, online resources, forwarding the results directly through mail or e-mail, and conferences.
7 Research financing
7.1 All research projects should be free of any coercive influence from financial sponsors that may undermine the accuracy of research conclusions. Financial or commercial anxieties should never overrule the successful completion of a research project. Resources should be allocated according to their need and to ensure all research projects are ethical and safe. Research institutes and professionals should be transparent about all sources of funding for each research project they undertake.
7.2 When applying for grants, the research team should follow the application guidelines of the foundation honestly and in full.
8 Research project leadership
All doctors, and other healthcare professionals, in a position of authority are obliged to ensure all guidelines and recognised procedures are followed during their tenure of leadership. Directions should be clear, open, and applicable to all forms of research activity, whether it is whilst teaching students or during a clinical research project. Clinical research institutes who have staff members working for them must provide support along with easily accessible information outlining the relevant legislation, guidelines, and expected modes of behaviour. The research project leader (principal investigator) must ensure that all contributors are fully briefed as to the aims of the project and their duties. They must also certify that if any member becomes confused, there are clear instructions for where to find help and further information. Research institutes should bestow their leading clinicians with stewardship status so that ethical standards are promoted in all research projects.
9 Conflict of interests
9.1 Clinical researchers must remain free from any outside influence or competing interest regarding their objectivity in research. This can include motivations that are political, financial, or ideological in nature. It is the duty of all research staff to identify any conflicting influences upon the end result of a project and to maintain honesty in all matters. No agreement whereby the accurate findings of a study can be censored, altered, or restricted by outside agents should ever be entered into.
9.2 It can sometimes be difficult to determine a legitimate conflict of interest, therefore any possible conflict must be reported at once to the relevant authority. This includes declaring any personal conflict, as well as that of any other member of the research team. Clinical researchers must aim to identify any possible conflict of interest in the human test subjects they recruit for clinical trials. This can include financial concerns, the participant’s relationship to members of the research team, or emotive connections to the subject matter.
9.3 Authorship status should be awarded accurately and according to each author’s contribution. It is of the utmost importance that all clinical research professionals adhere to this principle, as taking undue credit to further one’s own career or standing is a breach of plagiarism laws and will be disciplined accordingly. All authors should declare in writing that they have no competing interest regarding the study they have undertaken or are about to undertake. This form should clearly outline their obligation of confidentiality and objectivity.
10 Plagiarism and protecting intellectual property
Plagiarism is the act of utilising the work or intellectual property of another person without due reference or permission. Intellectual property refers to unique creations normally covered by copyright or trademark. Intellectual property is not the protection of an idea, but a tangible form of an idea e.g. a new medicinal agent a doctor has developed through research. Plagiarism is a serious act of misconduct and undermines the integrity and accuracy of the research record. It must be avoided by all clinical research professionals. Intellectual property can be protected through copyrights, trademarks, and/or patents, depending on what the property is. It is the duty of all those in clinical research to respect intellectual property legislation. Clinical trials and research projects proffer new inventions that must reach a certain level before being protected by patent or copyright. Therefore all staff members privy to private information during the research stages should remain honest and not divulge or take credit for work that is not their own.
11 Rights and accountability
Research organisations, those in authority, and all other clinical research professionals are fully responsible for their conduct and the outcomes of their research and behaviour.
Version 1 1st Dec 2013
Contributors
Colin Hopper - Waseem Jerjes - Hiang Boon Tan - Ramin Carbiner - Zaed Z R Hamady
© The Publication Integrity and Ethics
www.integrity-ethics.com
No permission is required for non-commercial use or redistribution of any part of these guidelines as long as a complete citation is provided.
While every effort has been made to make these guidelines accurate and comprehensive, research integrity and publication ethics are extensive disciplines and these guidelines make no claim to be exhaustive, nor should they be taken as legal advice.
