INTRODUCTION AND SCOPE Research is essential for the progress of science. Research builds upon the already available knowledge base and expands the horizons by enhancing the scientific evidence incrementally. Similar to other branches of medicine, psychiatry also requires research to be conducted ethically, safeguarding the rights and privileges of the research participants.[1] Ethics deals with the appropriate manner of conduct of professionals and provides the guiding principles of how decisions should be taken. Ethics is broad in scope and applies to many facets of research. Consideration of ethics and ethical issues starts from the time of conceptualization of research and continues to operate even after the completion of the research. Medical ethics has been built upon the principles of autonomy, beneficence, nonmaleficence, and justice.[2] However, there are many other considerations and nuances that pertain to ethics and ethical decision-making [Table 1]. The conduct of research should aim to adhere to ethical principles, though not all principles would be applicable equally in all situations. For example, a study on sexual perversions would probably need to have a greater emphasis on autonomy and confidentiality than a study that looks at the sexual side effects of medications. Researchers should be mindful of the various ethical issues while planning research.Table 1: Terms relevant to ethics in psychiatry researchAnother issue is that though ethical principles are largely consistent, the conceptualization of what is ethical and what is not, is likely to vary with time in history, geographical location and perceptions of the community.[3] For example, it might have been considered ethical to conduct research on minors with just parental approval in the past, but current-day ethical practices in research necessitate that assent from the minor should also be obtained in addition to parental or guardian’s consent. The reverse is also essential in the current-day context. Getting assent from minor may not be sufficient, and additional consent from the parents/guardian is also required. Thus, current-day ethical notions should be followed in the planning and conduct of research. The best practices have generally been adopted the world over, though there may be variations in the manner in which some aspects are considered relevant and applicable. One needs to be aware of the current ethical standards, and the present guidelines attempt to provide an insight into the current ethical yardsticks with respect to psychiatry research. This guideline aims to discuss and describe the ethics of psychiatry research. The ethical principles and concepts in relevance to psychiatry research are discussed and described. One does need to consider that there might be dilemmas (i.e., two or more correct courses of action) and ethical conflicts (a contest between ethically correct and incorrect). While much leeway is granted for dealing with ethical dilemmas, ethical conflicts should be completely avoided. These guidelines should be read with the Declaration of Helsinki and ethical guidelines issued by the national organizations, such as the Indian Council of Medical Research (ICMR). However, if still some of the issues remain unanswered, then the researchers should seek guidance from the Institutional Ethics Committees or other bodies recognized by the ICMR for supervising research. DECLARATION OF HELSINKI The World Medical Association (WMA) has adopted the Declaration of Helsinki in 1964,[4] which is a statement of ethical principles for medical research involving human subjects. The declaration primarily addresses the physicians, though the WMA envisions adopting these principles by others involved in medical research involving human subjects. Since psychiatry is a discipline of medicine, the Declaration of Helsinki applies to psychiatry as well. The original declaration has been further amended on several occasions, the last one being in the 64th General Assembly of WMA, Fortaleza, Brazil, in October 2013.[5] The various provisions of the Declaration of Helsinki cover different aspects of ethics in the medical field and provide guidance about planning, conducting, and disseminating research. The Declaration has become a standard for compliance to ethical issues and are often referred to before publication of research findings in most reputable journals. The principles emphasize that physicians should work in the best interests of their patients and also remarks that continued research is important. The principles underscore the need to promote and ensure respect for all human subjects and protecting the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The principles suggest that ethical, legal, and regulatory norms should be followed while conducting any kind of research [Table 2]. Minimization of the risk of harm to the participants should be attempted, and the research endeavors should be carried out by those who have adequate training and competence. Adequate compensation for those harmed by research needs to be ensured, and caution has been expressed for the referral and recruitment of patients by physicians who combine research and medical care. Risks, benefits, and burden of research should be carefully weighed, with attempts to minimize risk, conduct of research when the importance of objectives outweighs risks, and involvement of physicians in research if the risks have been suitably evaluated and are deemed to be satisfactorily manageable.Table 2: Some of the basic general principles of declaration of helsinkiIn addition, the Declaration of Helsinki specifically takes into consideration the protection of vulnerable populations. The health needs and priorities of the vulnerable groups should be considered while planning a research study among them so that they are final beneficiaries. The Declaration also mandates protocolization of the research proposal, which should have mention of the ethical considerations along with funding, institutional affiliations, potential conflicts of interest, incentives for subjects and information about treatment and/or compensation of those who are harmed as a consequence of research. A transparent and independent ethics committee should have approved the protocol before the conduct of the study. The Declaration lays emphasis on the privacy and confidentiality of the personal information of the participants. Emphasis has been laid on obtaining informed consent from the participant or legally authorized representative, ensuring that there was no duress. The Declaration allows proceeding with the research. Even if the participant is incapable of giving informed consent, no legally authorized representative is available. If the research cannot be delayed, provided such a situation has been stated in the research protocol and a research ethics committee has approved the study. The Declaration also provides for all medical research subjects being given the option of being informed about the outcomes and results of the study. The Declaration generally dissuades against the use of placebo except when no proven intervention exists, or where no intervention is acceptable. Furthermore, the continuation of intervention after the completion of the research should be given consideration. Finally, the Declaration suggests that studies should be registered in repositories before recruitment of the first participant and that the research findings should be disseminated. Unproven intervention should only be used in research for situations where the proven intervention are not available or are ineffective. In such circumstances, the information should be available publicly. SELECTION OF RESEARCH TOPICS IN THE FIELD OF PSYCHIATRY Whether there is a need for research is the first consideration for the conduct of the research. Inane or duplicitous research creates confusion, wastes human and material resources, and may lead to societal discomfort with the research endeavors. Thus, the first consideration for any research after the decision of the topic is whether the research is needed [Table 3].Table 3: Selection of research topics in the field of psychiatryThere can be several ways of considering whether research is required in a specific field, sub-branch, or topic in psychiatry. The need can be guided by what is necessary to advance the field. For example, Genome-Wide Association Studies may be needed to understand what Single Nucleotide Polymorphisms are related to a disorder, though it may be resource-intensive and many need multi-centric collaboration. The need may also be guided by what is relevant to clinical practice and what describes the availability, impression, efficiency, variety, and execution of care and care processes. For example, what are the issues experienced during care provided for dissociative disorders? What is relevant is generally dictated by the research trends or interests of the time. Repeating an experiment or research findings is useful to a certain extent to provide external validity for the research and address some of the issues that have not been covered by the existing study. But such replication of studies beyond a certain point makes research endeavors irrelevant. In the current scenario of expansion of research endeavors, it is furthermore necessary to adhere to ethical frameworks. Ethics dictate professional domains of work. It is important to have regulation of the practice so that the profession thrives, is taken seriously, can weed out gross incompetence and misdemeanors, and can cater to social needs responsively. Research in the professional framework also operates in the ethical boundaries of the profession. This would help to keep the profession’s standing intact in society’s opinion, which is likely to enhance confidence, application, and acceptability of the professional services. For example, enhancing psychedelic research in the field of psychiatry is liable to send mixed messages to the community in the current circumstances and probably requires closer scrutiny and regulation. The ethical implication of consideration of the need for research endeavor is the potential harms to the research participants and blocking of resources for research pursuits that can be utilized elsewhere. All studies, even survey based, have some risk to the participants, even though it may be minimal. Some kinds of studies, for example, drug trials, may have a higher risk of harm to the participants. Thus, the considerations for participants would be important while designing and planning research in psychiatry. Furthermore, research endeavors take up some resources, in the form of time and energy of researchers and participants, and material resources from healthcare or other services. While the allocation of such resources is important to produce effective research, duplication/replication of research after certain extent must be avoided which have negligible incremental benefit for science. Yet, considered leeway is important to enable diverse opinions and points of view to be expressed. STUDY DESIGNING: LANGUAGE AND PERMISSIONS FOR THE USE OF INSTRUMENTS One of the important issues while planning research in psychiatry pertains to the selection of instruments [Table 4]. The two most important issues which are of paramount importance are the language in which the instrument is available and whether the use of the instrument requires any prior permission. At times, researchers end up using questionnaires/scales developed in other countries without considering the socio-cultural issues and linguistic issues, which would be important when conducting the research. On-the-spot translation of a scale developed in another language and cultural background should be avoided.Table 4: Ethical issues, related to the selection of instruments for the studyMany of the instruments are available free of cost in the public domain. Some of the instruments are available in the public domain, but use requires seeking permission. Some of the instruments are only available with the copyright holders and the vendors. It is generally suggested that if a researcher is planning to use certain instruments, it is advisable to seek permission from the person holding the copyright for the instruments. Many a times, people end up using various instruments in research without obtaining permission and face problems at the time of publication. Hence, it is suggested that these issues must be addressed before starting of the research. Further, it is also well-known that many of the instruments, which have been designed in different parts of the world, are not directly applicable to the Indian setting and may require adaptation and translation. It is better to carry out these exercises before planning the bigger study, so the instrument’s psychometric properties, which are planned to be used, are available beforehand. If these steps are not followed beforehand, it may lead to difficulty at the time of publication and, ultimately, nonpublication of the research. Nonpublication of research basically means a lack of value attached to the time devoted by the researchers and participants in the study, which can be considered as unethical. It is important to remember than many of the authors, who have the copyright of various scales, often allow permission for the use of various instruments, free of cost, for nonfunded studies. Hence, the authors should conduct a proper search to address these issues at the time of planning the study. Another issue that often arises at the time of publication of research is the use of self-designed instruments. While doing so, it is always better to validate the instrument by using the appropriate methodology. VETTING FROM ETHICS COMMITTEES Any kind of research should preferably be conducted after approval from a competent ethics committee. Ethics committees are able to reduce the biases of individuals and provide diverse opinions on the process of research matter. Ethics committees in the present-day context are constituted in institutions which conduct research. Apart from this, there are independent ethics review boards as well, which cater to researchers who are not affiliated with institutions. The role of the ethics committee is paramount before the conduct of research. The proposal of research is evaluated by the committee, which attempts to ensure that the rights of the patients are respected, and the study is planned to be conducted in an ethical manner. Generally, the ethics committees do not delve into the merits of the methods of the research. They are more focused on whether the researchers commit to ethical benchmarks to be followed during the research. Generally, institutional ethics committees are composed of individuals from the institute and some external members and observers, some of whom may be nonexperts, or experts from legal background and lay members of the community. External members are necessary to obviate the blind spots and bias that clinicians, academicians, and researchers bring in their decision-making processes. The Indian Council for Medical Research (ICMR) has provided guidelines for setting up ethics committees.[6] A researcher who is working alone or whose institution does not have an ethics committee can approach a nearby ethics committee in another institution or an independent ethics committee. For drug trials, the Central Drugs Standard Control Organisation mandates that the ethics committee should be registered with it.[7] One question that comes up is what kinds of research should have ethics committee approval. It is desirable to have approval for any kind of research endeavor. Some research pursuits which are presented in the form of case reports and case studies may not provide an opportunity to plan and hence may not offer a prospect of ethics approval. However, for publication purposes, it is important to anonymize the details of the patient, and informed consent of the patient should be obtained before publication of the case details. Ethical consideration of confidentiality should be paid attention to while publishing pictures/images which have the potential of disclosure of the patient’s identity. However, other studies such as retrospective studies, observational studies, and interventional studies should have a-priori ethics approval before conduct of the study. Ethics approval and close oversight is very much essential for studies dealing with electroconvulsive therapy or psychosurgery and in active comparator psychotherapy studies where the group allocation is not explicitly disclosed to the participants. In certain circumstances like disasters and emergency situations, many ethics committees offer a provision for expedited review or provisional approval pending usual procedural scrutiny. A point of contention that may sometimes emerge is what to do when the ethics committee objects to some or many of the research objectives, methods, or processes. This might be disheartening to the prospective researcher, but it is important to understand the ethics committee’s concerns and reasoning. Generally, it might be possible to get the reasons of noted objections of the ethics committee. One may not totally agree and be satisfied with the reasoning provided, if at all, but the reasoning may reflect collective inference of the situation and research proposal. Sometimes, a foregoing brilliant research proposal to safeguard the research participants’ perceived interest may be important. An objection or refusal should be taken up with a sporting spirit and pondered upon after a period of “cooling off” of emotions. There is some consensus about the kind of studies, which may not require ethical clearance. Secondary analysis, such as systematic review, metanalysis, and meta-regression, may not require ethical clearance, but may be registered with the trial registry. Similarly, for the publication of case report/small case series, ethical clearance is not required, but many journals require the consent of the patient(s). Some of the studies may not require direct use of data but may involve the use of the system data. For example, someone wants to evaluate other clinicians’ opinions about functioning of the particular services without collecting any specific patient-related data. This can qualify for an application of waiver from the ethics committee. At other times, the researcher wants to use some of the data available in the public domain to study a particular question. For such a scenario, there are no clear-cut guidelines. However, the basic principle should be that, whenever in doubt, it is always better to seek ethical clearance for the study. NEED FOR REGISTRATION OF STUDY IN A TRIAL REGISTRY For interventional studies of any type, be it psychotherapeutic, pharmacological or stimulation based, it is desirable to have the study registered in a trial registry. The ethical considerations for such trials pertain to making information available to the general public about a trial with a particular methodology being conducted. This helps in preventing wastage of resources through duplicate efforts and thus serves the principles of justice. This also helps in participants feeling accounted for, and the results from their findings more accessible to the community in general. A research on participants does expose them to some risks, even though it may be minimal, and takes away time and resources. If the results are inaccessible to others, then the potential benefits of the research (even whose findings were negative) are not available to others. Many a times, the results are not published, with the reasons being journal preferences and thresholds and attrition of interest of the researcher. But if a trial is registered, then the researchers can be approached by interested parties about the findings. Hence, it bridges the gap between research conduct and access to the results. Thus, trial registration in a publicly accessible database is an ethically correct stance. The trial registry in India is the Central Trial Registry of India (CTRI). The researchers can apply for registration of the trials/studies after obtaining ethical clearance for the study. For observational studies, the CTRI does not clarify whether registration is required and leaves the decision to register for “purely observational study” on the researcher, stating that “The CTRI is a facilitator body that provides a platform for registering clinical studies as mandated by the drug licensing authority, ethics committees and journal editors. Further, the WHO advises “When in doubt, register.” For purely observational studies CTRI registration is not mandatory. PROFESSIONAL COMPETENCE It is, in general, suggested that research need to be taken up by persons who are qualified and have time for the same. Further, the researchers are expected to work with total integrity and impartiality and are expected to be aware of all the ethical considerations which may be required to conduct the research or experiment.[1] ETHICAL ISSUES PERTINENT TO THE ENROLMENT OF SUBJECTS INTO THE STUDY Once the research has been duly approved by the ethics committee and registered in the required trial registry, the next important step involves the enrolment of the participants. Some of the important ethical issues that are to be considered at the time of enrolment include autonomy, informed consent, and confidentiality. AUTONOMY While enrolling for a study, participants should be given a choice of whether to participate and not to participate at all in the research or leave in between after initial consent for participation on their free will without loss of benefits that they are otherwise entitled to. Potential participants may feel obligated or coerced to participate in research if their treating clinicians nudge them towards participation. This may be a consequence of perceived power differential, transference experienced by the patient, or a feeling of obligation to the care provider. It is important to explicitly clarify to the potential participants that the participation would be voluntary. This may be a point of contention from the researcher’s perspective, especially if a large number of patients refuse participation in treatment, leading to abysmal recruitment rates, which in turn may result in a lack of meaningful inferences drawn from the research endeavor. Nonetheless, the participants’ autonomy should be respected, and participants should be clearly explained that decision to participate is based on their own will. Things become a little murky when the potential participant is unable to provide consent due to lack of capacity or being a minor. An individual is deemed to lack the capacity to consent if he or she is unable to understand and appreciate the consequences of choices of actions available, to decide on a course of action, and communicate it clearly.[8] Therein, consent can be obtained from a guardian or a legally acceptable representative (LAR). Still, in such a situation, concurrence from the participant is desirable. A mere presence of a psychiatric disorder like schizophrenia or bipolar disorder, where the judgment may be grossly impaired, may not affect the capacity. Thus, capacity should be the focus when assessing the suitability of the person to give informed consent. For minors, consent should be obtained from the guardians or parents and assent should be obtained from the minor participants. If the guardian agrees and the minor disagrees to participate, in such situation, it is better to avoid including such a participant in the research. A construct that seemingly intersects with consent to participation in research pertains to inducement. Inducement is considered as any reward for participation in research, which is more than the compensation for the time and efforts invested in research. Inducement may be monetary, voucher or special treatment privileges that are not given to the nonparticipants. Inducements nowadays are considered to affect autonomy in decision-making, and hence are seriously considered by the ethics committees. Excessive potential rewards of participation may make the participant overlook the harms anticipated due to the participation in the study. Hence, it is important for researchers to refrain from using inducements. INFORMED CONSENT The explicit consequence of ensuring autonomy is taking informed consent from the participants (or their LARs). Informed consent has two parts: Information being provided to the prospective participant about the research, and consent being taken for voluntary participation. The first part is giving information to the participant. Ideally, all research proposals should have participant information sheets which provide information about the study in layman language. The information provided generally include who are the researchers (and their contact details), what are the aims of the research, how the research would be conducted, what steps would be taken to ensure confidentiality, what are the harms that are anticipated and who would reimburse for such harms, whether the participant is expected for pay for the research investigations or whether he/she likely to get any material benefits from participation in the research, and what are the loss of benefits that the likely to be accrued if the potential participant declines to participate or leaves during the research. The information should be provided in the language the potential participant is able to read and write easily, and should avoid jargon [Table 5]. The participants should be handed over the information before obtaining written informed consent. They should be allowed sufficient time to go through the whole information sheet and be allowed to keep a copy of the information sheet.Table 5: Particulars to be mentioned in the patient information sheet documentTo reduce the problems associated with recall biases about whether consent has been taken or not, it is better to have a ‘written informed consent’ which bears the signatures of the consent provider that he/she has understood the risks and harms associated with the research and is voluntarily participating in the research endeavor. Such written informed consent is often endorsed by witnesses to make it a formal witnessed document. In some situations, the consent informed consent process is also audio and/or video recorded to provide even further assurance that due processes have been followed. More recently, the Supreme Court of India had mandated for the audio-visual recording of informed consent to be done mandatory in cases of research on vulnerable populations, clinical drug trials and with new chemical entities (Supreme Court on India dated July 31, 2015).[910] In some cases (for example, telephonic interviews), verbal consent is deemed adequate. For online questionnaires, consent is implied if the individual ticks on the checkbox meant for eliciting the consent. The basics of the informed consent form are given in Table 6.Table 6: Basic things which needs to be mentioned in an informed consent documentIn certain special situations, the research can be conducted without consent, i. e., informed consent can be waived off. These include (1) if it is almost impracticable to obtain consent (for e. g., homeless/institutionalized patients with severe cognitive decline) (2) the research does not compromise with the principle of self-determination, i. e., the gravity of rights infringement is minor/negligible and this is outweighed by the expected value of the research to the society and (3) the research is of significant clinical relevance.[1112] However, such decision needs to be approved before the start of the study by the Institutional Ethics Committee (IEC) or Institutional Review Board (IRB). The guidelines of the ICMR do not provide for an exemption or expedited review. However, ICMR guidelines permit waiver of informed consent, provided that the study is of minimal risk or is conducted in an emergency. CONSENT AND RESEARCH IN SPECIAL POPULATIONS Special populations include children, pregnant women, those with low mental capacity (intellectually disabled/persons with dementia), and institutionalized individuals (prisoners, homeless/destitute, etc.). Psychiatric research in these special groups needs more strict protocols to be followed, emphasizing the nature of informed consent and its implications. Children and adolescents Legally a child or an adolescent below the age of 18 years cannot provide informed consent for participation in any study. Therefore, the researcher has to take informed consent from the parent or legal guardian after explaining in detail about the purpose of the study and answering to all their queries related to risks and benefits to the child/adolescent. The parent/legal guardian can sign on behalf of the child/adolescent on the written informed consent form. If a child/adolescent is capable of understanding some part of the study, then the child’s agreement for the same needs to be taken which is otherwise known as assent. Typically, a child of at least 7 years of age can be asked to provide assent for his/her participation. In detail, the researcher should mention the exact procedure of taking assent or informed consent from parents to the IRB at the time of submission of the project. The IRB’s responsibility is to thoroughly examine the cost-risk estimate of enrolment of this group of the population before approval of the study.[1314] Pregnant women The Office of Human Research Protection of United States, as well as the national health authorities of every country (ICMR for India),[6] have issued guidelines and policy statement on ethical issues to be considered in research involving Huma
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Mar 12, 2024
Cara Lewis 