Ethics in Research and Publications

Abstract

Background

The purpose of this study is to present a comprehensive overview of the ethical issues and the processes involved in research and publishing in India. The study examines the present ethical norms, guidelines, frameworks and developments in India, providing insights into the nation’s current status of research and recommendations for publication. This document will be a useful starting point and reference document for those embarking on research and publication in Orthopaedics in India.

Materials

A survey of the literature was done, which included scholarly papers, reports, rules, and policies pertaining to Indian publishing norms and research ethics. the document starts with a general introduction to ethics, followed by the evolution of ethics in research and the current International as well as Indian codes of ethics. Subsequently, the discussion is divided into two broad headings of ethics in research and ethics in publishing. Under each heading, there are many specific areas in orthopaedics that would require the application of a unique set of ethics. These areas are discussed separately as subheadings.

Results and Discussion

The review draws attention to the complexity of ethical issues in Indian and international research and publishing in orthopaedics. Where available, specific guidelines about the topic in India or international guidelines are discussed. The importance of informed consent, data integrity, plagiarism, authorship disputes, and conflicts of interest are only a few of the key results. It is obvious that ethical norms and regulations, such as those offered by the University Grants Commission (UGC), the Indian Council of Medical Research (ICMR), and the Council of Publication Ethics (COPE) are crucial in determining how research is conducted and how papers are published. The types of studies discussed include research in humans and animals, research with stem cells, metal implants and devices, orthobiologics, Artificial Intelligence, Robotics, computer modelling, virtual reality, 3D printing and bioprinting, tissue banking and data management. The roles of different personnel in research and publications are discussed.

Conclusions

Ethics in research and publishing play a crucial role in establishing the authority and standard of scholarly work in India. This study underlines the key concepts of ethics that guide various types of studies and the publication process. It also highlights the requirement for frameworks and guidelines for certain unique areas of research in orthopaedics.

Introduction

The Oxford dictionary defines Ethics as moral principles that govern a person’s behaviour or a system of moral principles or the rules of behaviour. It is clear from the definition that ethics involves people and activities. In the biomedical fields, the people involved in research are the researchers and the subjects they do research on and the activities involved are how they design, execute, analyse, report and disseminate research findings for the peers and the broader public to benefit.

The researchers do different roles as team leaders, team members, authors, contributors, reviewers and editors and interact with publishers at different points of time in the research activity. Subjects of research including devices can be other people, tissues, materials, machines and devices, and/or software (including Artificial Intelligence, Robots, and ChatGPT). Ethics in research, therefore, involves a complex interaction of the researchers, subjects, devices, authors, editors, reviewers and publishers. Each of them has a role to play in the quality of outcome of research. Ethics in research is an essential element of the scientific process and is critical for ensuring the integrity and reliability of research results.

This review deals with the ethical aspects (mostly published) for each of the groups of people in the context of research and publication (Table 1).

Table 1.

Outline of this review

Ethics in research	Metal Implants and medical devices in research
Ethics in Research in India	Roles of hospitals, departments, consultants and postgraduates in research
Role of ICMR, CDSCO and DCGI
Ethical committees in research (Institutional and Independent)
Human research	Ethics in publishing
Animal research
Laboratory research	Ethics in reporting and publication of research—journal articles, books and chapters
Stem Cell and Orthobiologics Research
Artificial Intelligence and ChatGPT like applications in Research	Author responsibilities Reviewer responsibilities
Robotics in Research	Editor responsibilities
Computer Modelling, Simulation and Virtual Reality	Publisher responsibilities
3D printing and 3D bioprinting in Research	Addressing ethical misconduct, COPE processes and consequences
Data Banking and data management	Responsibilities of society towards research
Tissue banking

Evolution of Ethics in Research

Ethics in research has its roots from the Second World War. The Nuremberg Code was created on August 1947 as a result of the horrors that Nazi doctors carried out in the name of scientific studies. The code gave a list of moral guidelines or ethical principles for using humans as test subjects in medical research. These included the need for prior animal experimentation as a foundation for the research, voluntarily informed consent for human subjects in the studies, and avoiding needless suffering of subjects.

Following this, the World Medical Association (WMA) at the 18th general assembly in 1964 developed the Declaration of Helsinki which laid down guidelines for research involving human subjects. This has been amended nine times, the latest being at the 64th general assembly at Brazil in October 2013 [1]. In the USA, the Belmont Report in 1976 identifies three core principles that guide research involving human subjects. These include respect for persons, beneficence and justice. Respect for persons requires that researchers treat individuals as autonomous agents who have the right to make decisions about their own lives. This includes aspects of informed consent, voluntary participation, privacy and confidentiality and dignity and well-being of participants. Beneficence requires that researchers ensure that the benefits of the research outweigh its potential harms. Justice requires that the benefits and burdens of research be distributed fairly among individuals and groups.

Various guidelines have been framed for ethical conduct of research and these include the ones from World Health Organization (WHO), International Council of Harmonization (ICH), United States Department of Health and Human Services (HHS) and Indian Council Of Medical Research (ICMR). The core of these guidelines is to protect the interests of subjects of research, especially vulnerable groups, minimising harm and risk, regulation of research with a view to produce legal and high-quality research.

Current Ethical Codes in Research—International and Indian Perspectives

Research ethics codes are a set of principles, guidelines, and standards that provide guidance for ethical and responsible conduct of research. These codes are intended to ensure that research is conducted in a way that protects the dignity, rights, safety, and welfare of research participants and promotes the integrity and credibility of research findings. Ethical codes in research influences all aspects of research including availing financial resources, undertaking scientific activities, management of human, animal and material resources, processing and data analysis and dissemination of information. Ethical codes may vary depending on country, institution, or field of study. Several international codes of research provide guidance to researchers. These include the Helsinki declaration (1964), The Belmont report (1979), Council for International Organizations of Medical Sciences (CIOMS) Guidelines (1982), and International Conference on Harmonisation (ICH) Guidelines (1990). These ethical codes are frequently updated to align with contemporary technical, social, and legal frameworks. Many countries have their own codes of research ethics that are based on international standards and tailored to their own cultural and legal contexts. In India, the Indian Council of Medical Research (ICMR) Guidelines for Biomedical Research, Indian Council of Social Science Research (ICSSR) Guidelines for Research, and the Department of Science and Technology (DST) Guidelines for Research Ethics provide ethical guidance for all research activities in India. Institutional Ethics Committees (IEC) are responsible for reviewing and approving research proposals involving human subjects in India. These committees are required to follow the guidelines of the ICMR and other relevant codes of ethics.

Ethics in Research in India

Ethics research in India is guided by multiple national and international guidelines These guidelines focus on respect for human rights and dignity, informed consenting, beneficence including payments for involvement in research and non-maleficence including compensation for harm induced to the subjects during research, maintaining high standards of scientific integrity and rigour, transparency in the process and accountability of those doing the projects. To ensure these qualities are upheld, ICMR stipulated formation of Ethical committees (EC) which scrutinise every study on human subjects and provide approval to conduct. The role of ECs is discussed elsewhere.

Role of ICMR in Research

The planning, coordination, and promotion of biomedical research in India are within the purview of the Indian Council of Medical Research (ICMR), which is a premier national body governing research. The ICMR plays the following roles:

• Conducting and supporting research through funding with a particular emphasis on clinical and public health studies.

• Developing the skills of researchers and other stakeholders in the field of biomedical research, through its research centres and training programmes.

• Creating policies and guidelines including ethical standards for the use of human subjects in research.

• Collaboration and networking by fostering collaboration and networking among researchers and institutions in India and abroad.

• Dissemination and translation of biomedical research findings to guide policy and practise and to advance the use of evidence-based therapies and technology.

• Monitoring the results of biomedical research in India and determining where there are still unmet needs and untapped potential in the field.

ICMR has published a document called National Ethical Guidelines for Biomedical and Health Research involving Human Participants in 2017 [2]. This document forms the core of research ethics in India on any study involving human subjects. All topics in research have been discussed in detail in this document including formation and functions of Ethical Committees, informed consent process, definition and dealing with vulnerable humans in research, clinical trials and interventional procedures, biological materials, banking of tissues and datasets and research during emergencies and disasters. ICMR has established the Clinical Trials Registry of India (CTRI) exclusively for all human trials as a free online system to register all trials conducted in India from 2007 and starting 2009. The Drugs Controller General of India (DGCI), who heads the Central Drugs Standard Control Organization (CDSCO) has made it mandatory to register all regulatory trials (trials registered under Drugs and Cosmetics act) in the CTRI to make these trials transparent and improve quality. Registration is voluntary for other biomedical trials but the editors of major biomedical journal of India have declared that only trials on public databases would be eligible for publication. The Declaration of Helsinki mandates that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” [2]

Ethical Committees (EC) in Research

All research proposals on biomedical, behavioural science or social research involving human subjects including their biological materials and data pertaining to them must be reviewed by an EC and approved before the project can be initiated. ICMR has stipulated the composition, structure, duration and nature of functions of these ECs with respect to conducting research in India. There are two types of ECs—Institutional EC (Inst EC) and Independent EC (Ind EC). Every project that is being carried out in an institution must be reviewed by the Inst EC. Projects that are done outside an institution may be reviewed by Ind ECs. There are more than one thousand ECs established in India as of August 2016 [3].

ECs are self-regulated through accreditation programs. The WHO, through their Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) initiative, identified five ECs in India between 2009 and 2013 of international standards functioning in India [3]. More than 4500 EC members were trained in India between 2009 and 2017. All the ECs are required to be registered with CDSCO, which is the national regulatory body of pharmaceuticals and medical devices in India, and as of 2016, there were 1083 ECs registered with CDSCO comprising of 77.7% Inst ECs and 22.3% Ind ECs. Maharashtra had the maximum number of ECs followed by Gujarat and Karnataka. All ECs submit Standard Operating Procedures (SOPs) while registering with CDSCO. Independent ECs were not allowed to oversee clinical trials.

Ethics in Human Research

The key aspects in human research include informed consent, confidentiality and privacy and risk–benefit analysis. Major codes on ethics such as the Nuremberg code, Declaration of Helsinki, and Belmont Report have influenced research on humans.

The fundamental tenets of beneficence, non-malfeasance, justice and autonomy are adhered to for any research involving human participants as laid down by ICMR in the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 [2]. There are basically 12 principles that need to be adhered to while doing research on humans according to this document. These include the principles of essentiality, voluntariness, non-exploitation, social responsibility, privacy and confidentiality, risk minimisation, professional competence, maximisation of benefit, institutional arrangements, transparency and accountability, totality of responsibility and environmental protection. Vulnerable individuals include those who are disadvantaged and cannot look after or decide for themselves. Examples include elderly people, paediatric age group, people who are mentally retarded or with psychiatric illnesses, etc. ICMR has given clear guidance on doing research on vulnerable individuals. Informed consent is the cornerstone of ethical human subject research. Participants must be informed of the nature and aim of the study, the possible risks and benefits of participation, and their right to withdraw at any time. Consent must be received in a manner that is voluntary, understandable, and free from compulsion.

In human research, confidentiality and privacy are also crucial ethical considerations.

Researchers are obligated to respect the privacy and confidentiality of study participants and ensure that their personal information is not shared to unauthorised parties.

Risk–benefit analysis is another significant ethical factor to be considered. Researchers must perform a thorough assessment of the potential hazards and benefits of the study and take precautions to limit participant damage. This may involve planning the study to minimise the risk of harm, ensuring that participants have access to medical care if necessary, and monitoring participants for adverse effects. Guidelines have been given on compensations to individuals in case of occurrence of adverse events.

Ethics in Animal Research

Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 [4] published by the Ministry of Environment and Forests as a requirement under the Prevention of Cruelty to Animals Act, 1960, gives clear guidelines on methods of registration and approval of experiments on animals, procuring animals for research, maintaining records of animals and experiments done, environment in which they are cared and experimented, actions to be taken in case of adverse events and indications for euthanasia. The Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 was amended in 2006 with some changes which have been noted below. Key points in this act include.

• The regulations stipulate that experiments must be designed to minimise the pain and suffering of animals. They also outline the types of experiments that are prohibited, such as those that cause extreme pain or distress to animals.

• The regulations also govern the breeding of experimental animals including the minimum age, weight of animals that may be used and mandate that animals be bred under conditions that promote their well-being.

• Institutional Animal Ethics committee (IAEC) may be established where experiments on animals are done frequently. This committee would take the role similar to IECs in human research.

• Experiments on animals would be supervised by qualified persons who holds a degree or diploma in veterinary science form an institution recognised for the purpose. Anaesthesia may be required where appropriate for operative procedures.

• The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) will conduct regular inspections of institutions to ensure compliance with the regulations.

• Amendments in 2006 [5]: Researchers would be responsible for the welfare, aftercare and rehabilitation until normal existence of the animals used for experiments. There are specific rules and indications for euthanasia of animals. The costs incurred for the above would be part of research costs.

• Animals for experiment must be acquired from registered breeders or legal sources only. Research may be undertaken only under of provisions of Prevention of cruelty to animals.

• Violation of the rules of the act could lead to order in writing, suspend or revoke the registration of the facility.

• CPCSEA, now called Committee for Control and Supervision of Experiments on Animals (CCSEA) [6] comes under the Ministry of Fisheries, Animal Husbandry and Dairying department of Animal Husbandry and Dairying.

• By 2004, 665 laboratories were registered under CPCSEA in India and each of them had an IAEC [7].

Ethics in Laboratory Research

Good Laboratory Practice [8], published by United Nations Development Programme (UNDP), the World Bank and the WHO, was designed to serve countries to upgrade their laboratory to GLP status. They are a set of principles to improve quality of non-clinical laboratory research and development of drugs. These guidelines cover all aspects of laboratory administration and research, including personnel, facilities, equipment, documentation, SOPs, quality assurance and data management. They emphasise the significance of planning, conducting and reporting such studies in a way that ensures accuracy, dependability and reproducibility of the results. Some of the key principles include:

• Maintaining records of all procedures and results.

• Adequate training of personnel.

• Using SOPs for all aspects of the study.

• Validation of equipment and methods used in the studies.

• Regular monitoring and maintenance of the equipment and facilities and quality control measures to produce results of high standards.

• Appropriate storage of data and materials.

Ethics in Stem Cell Research and Orthobiologics

The basic tenets of ethics in human research laid down of ICMR apply here too since stem cells are human tissues used in humans. However, there are specific issues related to use of stem cells and ethics related to their use has been dealt by the document (National Guidelines for Stem Cell Research) published by ICMR and Department of Biotechnology (DBT) in 2017 [9]. A National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has been established to monitor and oversee national level research activities and to establish guidelines for both basic and clinical research. The Institutional Committee for Stem Cell Research (IC-SCR) authorises and oversees basic and clinical stem cell research at the institution level. The composition, function and responsibilities of both NAC-SCRT and IC-SCR have are given under the document on stem cell research [9]. Institutions doing stem cell research will establish and IC-SCR and register it under NAC-SCRT. The ethical considerations related to stem cell research include Health, safety and rights of the donors. Key features include.

• Video consenting of donors to prevent exploiting and commoditising the donors and preserve confidentiality and privacy. Information sheet provided to the donor must include need to screening for diseases, risks of procedure, possibility of banking tissue and need for further contact.

• Possible risks of benign teratoma, malignant overgrowth and failure of the cells to mature must be determined and appropriately evaluated. Especially in long stored tissues.

• Steps taken for manufacturing and quality assurance of stem cells and its products are given in the guidance from ICMR and DBT.

• Criteria for release of the cells to be used in humans are also given in the document. These include labelling viability, final cell population, their stability and requirements for release.

• The approved indications for stem cells are given in Annexure III of the document [9]. These conditions currently include only hematopoietic disorders in adults and paediatric age groups.

• Other therapeutic uses of stem cells must be investigated and conducted only in the form of a clinical trial after obtaining the necessary regulatory approvals. Consequently, their use in situations outside the realm of clinical trials is deemed unethical and prohibited.

• The Drugs and Magical Remedies (The Objectionable Advertisements) Act-1954—prohibits misleading advertisements relating to drugs and medical remedies. DGHS and relevant state authorities are mandated to take necessary action for violation of this act. (Available at: http://lawmin.nic.in/ld/P-ACT/1954/A1954-21.pdf).

• Current Regulations for different Orthobiologic Therapies in India. [10]

• Mesenchymal stem cell (MSC) therapy—investigational, clinical trial is required.

• Allografts with viable stem cells—investigational, part of clinical trial.

• Synthetic bone graft substitutes—combined with autologous blood is considered investigational, part of clinical trial requiring approval.

• Conditioned medium or secretome—derived from MSC—require approval as per schedule Y of Drugs and Cosmetics Act 1940.

• Platelet-rich plasma (PRP)—Akin to manufacturing blood component as per CDSCO (National Blood Policy). Human blood is considered ‘Drug’ under Drugs and Cosmetics Act and hence require licence from Central Licence Approving Authority.

• Bone marrow aspiration concentrate (BMAC)—they are minimally manipulated cells. Any use other than approved purposes require approval from CDSCO.

• Stromal vascular fraction (SVF)—these are more than minimally manipulated cells and hence require approval from IC-SCR, IEC, CDSCO.

• Stem cell-derived products, gene therapy and xenografts—considered new drug under New Drugs and Clinical Trials Rules 2019 part of Drugs and Cosmetics Act 1940.

• Autologous chondrocyte/osteocyte implantation—CDSCO has given conditional approval for treatment of articular cartilage defects and for AVN of hip.

Ethics in Using Artificial Intelligence (AI) and ChatGPT in Research

AI has found applications in various aspects of health care including diagnostics and screening, therapeutics, drug discovery and development, clinical care, epidemiology and prevention of disease, behavioural and mental healthcare as well as clinical and hospital management systems. The Department of Health Research (DHR) and ICMR have developed a guidance in 2023 on the ethical aspects of using AI in healthcare research [11]. The basic tenets of ethics in research have been addressed by previous publications of ICMR. The current guidance builds on this since AI involves dealing with data of humans. This document proposes ten principles specific to AI for health research. These would apply to orthopaedic research as well and include:

1. Autonomy

2. Safety and risk minimisation

3. Collaboration

4. Accessibility and equity

5. Optimisation and data quality

6. Non-discrimination and fairness

7. Validity

8. Trustworthiness and data security

9. Accountability and liability

10. Data privacy

The ethical committees (ECs) would be responsible for checking scientific rigour and ethical aspects of the research proposals. There are certain specific additional requirements by the ECs while dealing with AI projects and these have been detailed in this document. There are also specific requirements for informed consent from the subjects of the study in these projects.

The regulation of use of these technologies is in the early stages since AI itself is evolving. The European Commission proposed the AI act to build a legal framework. The Indian National Health Policy (2017) integrates digital data and introduces the Digital Health Authority. The National Digital Health Blueprint 2019 develops a system of electronic health records along International Standards integrating their ethical principles.

ChatGPT has been found to be inaccurate and it is not advisable to include passages from this chatbot in research or manuscripts unless they are checked for their veracity [12]. It is in the early stages and perhaps the later versions of this chatbot will be more accurate. Use of this chatbot is discouraged in the current time until it is validated for the purpose of using in research by good quality studies. Having said that, it may be used as an aid or a starting point to writing rather than fully relying on its output on a particular topic.

Ethics in Using Robots in Research

Robotics is a branch of engineering that deals with designing and developing machines that can perform autonomously or semi autonomously. These machine do physical work and are linked to hardware aspect of the computers as opposed to AI where the tasks are similar to normal human intelligence such as reasoning, learning, problem solving, pattern recognition, predicting and decision making involving the software aspect of computerisation. The software instilled in robot could contain AI. Institute of Electrical and Electronics Engineers (IEEE), based in New Jersey, USA, publishes Ethically Aligned Design (EAD) to ensure that emerging technologies are designed and developed with a focus on ethical considerations.

The principles of EAD are threefold: human rights (preserving human rights such as privacy and non-discrimination.), well-being (promoting well-being of humans) and data agency (protects the privacy and control over ones data). These machine must be of adequate standard to be used in orthopaedic research. When humans and animals are involved, the issue related to their research also have to be addressed.

Ethics in Using Computer Modelling, Simulation and Virtual Reality in Research

Virtual reality (VR) is focussed on creating an immersive experience within a simulated environment, while simulation is the process of modelling and replicating real-world systems or processes for study or training purposes. A computer simulation is a computer program that contains a model of a particular system (either actual or theoretical) and that can be executed, after which the execution output can be analysed. While VR can be a part of a simulation, not all simulations involve VR. While all VRs are interactive, not all simulations are interactive. For the purposes of ethics, both are similar. No official guidelines have been made so far in India but ECs would be assessing the protocols of such studies and make a decision on feasibility.

The difference of these with other computer systems is that simulation and virtual reality create an environment where humans experience unreal situations and these could be misused and/or could affect the well-beings of humans involved in these experiments. There are four essential elements in VR: a virtual world, immersion, sensory feedback and interactivity [13]. The effects on the experiences on humans include motion sickness, information overload, intensification of experience and re-entry into the real world [14]. To counter these effects various measures may be considered [14]. Some examples include limiting exposure until adaptation occurs, customising exposure to individuals based in withstanding capacities, informing subjects about potential negative effects of cybertravel, avoiding or reducing content that induces negative effects such as fear, disgust and anger, screening subjects carefully for susceptibility to certain phobias or problems related to participation in the study, carefully monitoring subjects during re-entry phase for adverse effects and informing them of possible after effects like adaptation issues.

Ethics in 3D Printing and 3D Bioprinting in Research

The biomedical research councils of most countries have adopted the Council of International Organizations of Medical Sciences (CIOMS) guidelines [15]. The collection, storage, and use of biological materials and related data are given in these guidelines. The ICMR guidelines on research echo some of these basic tenets. 3D printing involves use of machine to manufacture a product and 3D bioprinting involves, in addition to the machine, biological material to be printed on the products. 3D printing and bioprinting fall under the regulatory framework of Good Laboratory Practice (GLP) published by the World Health Organization (WHO) for standardised, optimised, and controlled tissue fabrication. Medical laboratory devices and machine used for creating products in laboratories are guided by the principles laid down by this framework. In addition to these, the environment they are used and the personnel handling them are also guided by these rules. The GLPs may vary from country to country. Where human or animal tissues are involved in the biological aspect, the appropriate ethical guidelines apply in addition to the printing device regulations as the case may be. It is important that the machine and the products conform to the international standards set by such guidelines to prevent harm of the stakeholders. Sterilisation of the environment, materials and machinery are important for ensuring cell safety and quality. The use of an aseptic environment will extend to cell culture and bio fabrication machinery. There are no specific guidelines on their use in research in India yet but the ECs would be expected to make an assessment of applications of such studies.

Ethics in Data Banking and Data Management

Recent advances in healthcare delivery and research involve use of computers and digital systems to improve their efficacy and involve collection, storage and use the data of humans and patients. The National Health Policy 2017 includes use of digital services for healthcare delivery. Subsequently the National Digital Health Blueprint (NDHB) was framed in 2019 [16]. The NDHB proposed an entity called National Digital Health Mission NDHM, the responsibility to implement NDHB. Major responsibilities of NDHB include establishing core components and standards of data collection by providers and patients, developing a unique identifier, link and consolidate records for implementing various health programs, handling big data at national, state and local levels (Federated Electronic Health Records—EHR), establishing registries for diseases and capacity building on health informatics, safety, security and privacy. Recommendations are awaited for policies for use of records for research and analytics purposes. This blueprint was an effort to improve quality of health data collection, storage and dissemination for the purposes of healthcare, research and policy decisions.

• Patients should give informed consent to have their data stored

• Data should be protected with passwords and access should be restricted to authorised personnel only

• The IT systems and data management should meet requirements specified in the Data Protection Bill, IT act 2000 and Aadhar Act 2016.

Ethics in Tissue Banking

Tissue banking in Orthopaedics involves banking and storage of bone and soft tissue allografts for use in humans. ICMR defines biobanking as an organised collection of human biological materials with usually associated dataset stored for years in appropriate facilities for research and potential commercial purposes with inbuilt policies for transparency [2]. A biobank repository is the storehouse of such material. Although research on these materials do not directly involve humans, they are obtained from a donor and used on a recipient human. Hence, compliance with safety requirements and universal standards of collection and storage are paramount. The main ethical issues with these are individual informed consent, clarity on custodianship, approval of the EC and the repository governance committee and post-research benefit sharing, wherever applicable [2].

Confidentiality of donors is important. However, some degree of identifiability may be maintained for research purposes and certain specific circumstances. Consent is sought for collection, storage, experimenting and right to know results of such research. The participant is the owner of the tissue and has the right to refuse its use for specific purposes. They also have the right for benefit arising out of commercial activity using their tissue unless specifically stated otherwise in the consent. Measures to ensure privacy and confidentiality include securing the tissues and related data in physical spaces and computer servers that provide access only to authorised personnel based on their roles. Data may be handled according to provisions of locally applicable Data Protection Rules [2].

If the donor is deceased without claimants, the forensic officials would authorise use of their tissue for research. The biobanks have well-structured SOPs, governing bodies and clear guidelines for collection, coding, anonymization, storage, access, retrieval and sharing of biospecimens and data.

Ethics in Using Metal Implants and Medical Devices in Research

In India, the quality and safety of medical devices and equipment is regulated by the Bureau of Indian Standards (BIS) [17]. BIS is a member of International Organisation for Standardisation (ISO). The BIS sets standards for the following orthopaedic and related devices—total joint replacement implants, anaesthetic equipment, standards for hospitals, surgical and orthopaedic instruments, artificial limbs, rehabilitation appliances and equipment for the disabled, medical lab equipment, hospital equipment, surgical dressings and disposables, imaging equipment, immunobiological diagnostic kits and medical biotechnology and nanotechnology. Equipment that fall below the standards would be recalled. The Medical Devices Rules 2017 (MDR) were enacted under the Drugs and Cosmetics Act to include a set of 22 devices under regulation. These include disposable syringes, needles, catheters, perfusion sets, bone cement, orthopaedic implants, internal prosthetic replacements and surgical dressings. The MDR classifies devices into four groups from class A (low risk) to Class D (high risk). While class A and B devices can get approvals from state Licencing Authorities, Class C and D require approval from Central Licensing Authority for use. The manufacturers would have to comply with regulations proportionate to the risk for approval of usage of their devices. Failing to comply would attract penalties in the form of fines to product recall to removal of licencing. The devices used for research must comply with standards set. When using human or animal subjects, further rules set by respective related authorities must be followed while performing the research.

Roles of Hospitals, Departments, Consultants and Postgraduates in Research Ethics

Hospitals and institutions play a crucial role of providing oversight to the ethical conduct of research. All research protocols must be reviewed by the institutional review board or ethics committee of the hospital. Hospitals must also have in place monitoring systems that detect adverse events during the course of the research. Hospitals are liable for compensation in research-related patient damage. Hospitals must also have in place a system for reporting ethical violations. Education and training of research ethics also form part of the hospital responsibility.

Individual departments should have review process focussing on patient safety. The department through its faculty should ensure ethical compliance, protect patient confidentiality, and ensure that each participated is provided with informed consent. Department also must periodically monitor research to ensure compliance to ethical guidelines. Ethical violations should be detected and reported to institutional bodies.

Faculty or consultants provide mentorship and training to junior researchers on ethical principles and guidelines for conducting research. They should lead by example. Faculty should demonstrate transparency, ensure accurate reporting and disclose conflict of interests. Students involved in research should ensure that they are well versant with ethical standards of research. They should discuss any contentious issues with their consultants. They should conduct responsibly and report any possible ethical violations immediately to the guides.

The departmental review board (DRB) is a committee constituted within the department that vets research proposals submitted by members of the department. The DRB ensures that each new research proposal meets scientific and ethical standards. Periodic review and monitoring of research activity also falls under the purview of DRB. The DRB may also provide training on ethical conduct of research and suitably advise the researcher whenever ethical issues crop up.

Ethics in Reporting and Publication

Researchers must follow the minimum reporting criteria for each type of study to produce a quality publication. There are guidelines published for each type of study. The acronyms for the guidelines are given against the type of study in Table 2. The roles involved in the publication process are authors, reviewers, editors and publishers and each role has important contribution and responsibilities in the publication process. In addition to these, there are organisations that produce guidelines to uphold ethics in publication and journals. Prominent among these include International Committee of Medical Journal Editors (ICMJE) [18], Committee on Publication Ethics (COPE) [19] and World Association of Medical Editors (WAME) [20]. These organisations regularly produce guidance on various issues involving every aspect of the publication process including framing ethics for authors, reviewers, editors and publishers.

Table 2.

Reporting guidelines for studies

Study type	Guideline acronym
Animal studies	ARRIVE
Clinical practice guidelines	AGREE
Case reports	CARE
Economic evaluation studies	CHEERS
Randomised controlled trials	CONSORT
Surgical innovations—Stage 1–4	IDEAL
Systematic reviews and meta-analysis	PRISMA
Accuracy of tests	QUADAS
Case series of surgical procedure	SCARE
Diagnostic/prognostic studies	STARD
Observational studies	STROBE

Responsibilities of the Authors

Ethical issues related to authors include authorship, plagiarism, data fabrication and falsification, conflicts of interest, and transparency (Table 3). The role of an author starts with finishing research and starting to prepare a manuscript. The journey should start with identifying an appropriate journal for publication and prepare the manuscript according to the guidelines of that journal. The manuscript is then prepared according to the reporting guidelines incorporating the instructions to the author of the target journal. The manuscript is then submitted to the target journal into the editorial manager and the result of review awaited patiently. Communication with the journal must be courteous. When the manuscript is sent back for revision, the corresponding author must respond to all the issues raised by the reviewers and the editors, addressing them courteously in the process. If they differ in opinion with the reviewers, the same may be conveyed courteously. One must remember that reviewers are experts in the field who have taken time off their busy schedules to review and give suggestions to improve the manuscript. The revised manuscript is submitted and decision on the manuscript awaited. Once accepted, the corresponding author must be prompt in responding to the journal production team to approve the proofs before it is sent for publication. If the paper is published under subscription model, there may be a period of embargo that the authors must respect. Since the copyright is transferred to the journal, rights on sharing the paper must be done according to the journal conditions. The published paper may not be shared in public until after the period of embargo. The author must make themselves aware of their rights in terms of sharing the published content.

Table 3.

Responsibilities of the authors [21]

(Reproduced from Kambhampati and Maini)

Responsibilities of the authors [21]

Ethical conduct of research and reporting following ethical guidelines

Register the study with appropriate organisations

Informed consent from subjects

Ethical committee/review board approvals

Ethical conduct while dealing with humans/animals

Follow rules of copyright

Designing and conducting research conforming to rules and regulations

Identify journal for publishing and start writing accordingly

Decide number and order of authorship before starting to write manuscript

Declare if work has been published elsewhere in other forms or presented anywhere

Writing the manuscript according to author instructions

Check format of abstract and sections for type of manuscript

Check font type and size, resolution of figures, tables, etc.

Follow line numbering/page numbering

Follow checklist in reporting for the type of manuscript

Check maximum permissible word count

Check maximum permissible number of tables and figures

Follow specific format of citing references and their style in bibliography for the journal

Acknowledging contributions

Disclosing conflicts of interest

Ensuring accuracy and integrity of data

Responding to peer review

Take responsibility for content produced

Responsibilities of Reviewers

There are a number of significant obligations as a reviewer of a scientific research article. Checklists have been published for reviewers for evaluating manuscripts [22]. The cited article provides tips on how to review and what to equip oneself with during the process of reviewing. The following are some important duties that one needs to remember:

• Meeting deadlines agreed upon: reviewers are expected to finish their work by the dates given by the journal or conference. They should let the editor know right away if they will not be able to make the deadline. It is important to accept the article or decline as soon as the email for review was received. Most of the time for processing an article occurs at the review stage. Reviewers should try and reduce delay from their side to save time for the whole publishing team.

• Offering an unbiased assessment of the manuscript: reviewers must offer an unbiased assessment of the manuscript, gauging its significance, originality, and scientific merit. They should stay away from any conflicts of interest or personal biases that can skew their assessment.

• Offering helpful criticism: reviewers should offer helpful criticism to help the authors improve the paper. They should offer detailed feedback that the authors can use to rectify any flaws in the research strategy, technique, or data analysis. It is important to mind the language the reviewers use to criticise the authors. Patronising and condescending language must be avoided. The authors must be addressed politely. Reviewers must remember that the corresponding author may be the leading publisher/academician in the field. Specific areas of the manuscript may be identified using line numbering and page numbering as mapping tools in the manuscript.

• Disclosure of conflicts of interest: reviewers are required to disclose any financial or personal relationships that could sway their judgement of the manuscript.

• Upholding ethical standards: when assessing the paper, reviewers should uphold ethical standards to guarantee that the study was carried out morally and that the findings were presented truthfully and accurately.

• Based on their assessment of the manuscript, reviewers should make a suggestion to the editor. The recommendation might be to accept, reject, or ask for the manuscript to be revised. They should avoid making a decision without giving any rationale for the decision. Whether accepting or rejecting or revising, the reviewers have to give the reasons or comments for their decision. This increases the standing of the reviewer favourably in the editors view.

• Maintaining confidentiality: reviewers are expected to keep the manuscript and the peer review process confidential. The manuscript and its contents should not be disclosed to anyone who is not involved in the peer review process.

Responsibilities of an Editor

Responsibilities as a scientific research editor may involve the following:

• Choosing peer reviewers: the editor is in charge of choosing knowledgeable, impartial peer reviewers who can offer helpful criticism on the article and make sound decisions on the manuscripts.

• Overseeing the peer review process: they are in charge of overseeing the peer review procedure and making sure it is carried out promptly and fairly.

• Assessing the manuscript: it is the editor’s responsibility to assess the manuscript in the light of the reviewers’ comments and decide whether to accept it for publication or not.

• Giving authors’ constructive criticism: the editor is in charge of giving authors constructive criticism on how to make their paper better. The comments from reviewers must be evaluated and decision made on the manuscript based on their recommendations.

• Enforcing ethical norms: the editor is in charge of upholding ethical standards, such as making sure the manuscript is free of fraud or plagiarism. Plagiarism or similarity checks are done using software available with the journal. It is important to evaluate the literature to see if similar studies have been carried out and the given references are genuine, especially in the age of ChatGPT.

• Assuring scientific integrity: the editor assesses and ensures the manuscript’s scientific integrity and confirms that the research is legitimate, accurate, and original.

• Communicating with authors, reviewers and publishers: the editor keeps in touch with authors and reviewers at all times during the publication process to let them know how the manuscript is progressing. If an undue delay occurs in processing a manuscript, the authors may have to be informed politely when they query the status of the article. The most common reason for delay occurs with reviewing of the manuscript. Once accepted, the publishing staff must be informed of any potential changes required during finalising the proof of the manuscript. During the proof and printing stage, the editor communicates with the journal staff about the order of articles and addresses any queries raised by them about the articles or the issue.

• The editor resolves any issues arising from misconduct of authors or reviewers and takes appropriate decision on the issue based on ethical guidelines published.

Responsibilities of Publisher

The principal duty of a publisher is to ensure the calibre, honesty, and accessibility of the scientific research published in your journal and to promote its effect. Your duties as a publisher of scientific research may include the following:

• Establishing rules and standards: you are in charge of establishing the journal’s policies and standards, including the journal’s scope, the kinds of papers accepted, and the peer review procedure. We have heard in the news that publishing companies have withdrawn journals, even those which are prolific publishers, publishing hundreds of articles a month, when they do not follow due procedures of ethics. This is done in order to maintain the high standards of integrity of scientific publishing.

• Managing the publication process: this involves everything from receiving and assessing manuscripts through copyediting, formatting, and publishing the finished result. Each journal has procedures established for each of the steps in publishing. These must be ethically guided. Guidance is given by organisations that oversee ethics in the publishing process such as ICMJE and COPE.

• Ensuring scientific integrity: you are in charge of making sure that the research published in your journal is original, accurate, and ethical. To do this, you must confirm the above three criteria.

• Marketing and promotion: you are in charge of marketing and promoting your journal in order to draw in high-calibre submissions and broaden its audience.

• Archiving and preservation: you are in charge of doing this in order to give the scientific community long-term access to and availability of the published content.

• Ensuring accessibility: by offering open access options and adhering to accessibility guidelines, you must make sure that your material is available to the broadest audience feasible.

• Resolving grievances and issues: you are in charge of resolving grievances and issues pertaining to the publication procedure or the published content, and you must make sure that any disputes are handled in a just and open manner.

Addressing Ethical Misconduct, COPE Processes and Consequences

Misconduct in research is a serious issue and could lead to misleading results that can affect scientific enquiry and further studies on the topic in the future. Misconduct has been defined by the US Federal Policy as fabrication of data, falsification of data, or plagiarism in proposing, performing, reviewing or reporting research [23]. There are demands to include other forms of serious misconduct such as sexual harassment, sabotage, deceptive use of statistics, and failure to disclose a significant conflict of interest. Any behaviour that is considered highly unethical, that threatens integrity of science, that can be clearly defined and for which existing methods of enforcement or deterrence are inadequate to tackle the behaviour is considered misconduct [23].

The ICMR defines research misconduct as “Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” The University Grants Commission’s (UGC) [24] guidelines on research misconduct describe it as “research misconduct is defined in terms of fabrication, falsification, or plagiarism.” The main components include fabrication, falsification and Plagiarism in the definition from ICMR and UGC [2, [24].

DBT [25] defines misconduct as follows:

• Fabrication, falsification, plagiarism, self-plagiarism, or deception in proposing, carrying out or reporting results of research.

• Deliberate, dangerous or negligent deviations from accepted practices in carrying out research.

• It includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans or the environment and facilitating of misconduct in research by collusion in, or concealment of, such actions by others.

• It also includes intentional, unauthorised use, disclosure or removal of, or damage to, research-related property of another, including apparatus, materials, writings, data, hardware or software or any other substances or devices used in or produced by the conduct of research.

The UGC proposed that the Office of Research Integrity (ORI) must promote some values to preserve research integrity. These include: ethics, rigour, relevance, transparency, respect, impartiality, independence and accountability [26].

Sanctions Imposed for Misconduct

Department of Biotechnology (DBT) Statement on the handling of allegations of research misconduct listed a few possible sanctions if misconduct is established (Table 4).

Table 4.

Possible sanctions for misconduct

A letter of reprimand

The withdrawal of funding

Requiring the withdrawal or correction of pending or published abstracts and papers emanating from the research in question

Changes to the staffing of the particular project

Special monitoring of future work

Barring of the grant holder from applying for DBT funds for a given period

Repayment of grant plus interest at the DBT’s discretion Discussion with the host organisation on its implementation of appropriate administrative disciplinary procedures

Responsibilities of Society Towards Scientific Research

Society has a major role in supporting and ensuring that research is conducted ethically and responsibly. Since ethical committees include members of the society, the attitudes of the society towards scientific research shape the way research is regulated. The main areas where society could influence research include promoting scientific literacy among its members, provide funding to good projects, creating resources for research, ensuring ethical conduct, engaging in dialogue, disseminating key research findings through open access publishing, social media and outreach programmes.

Declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standard

This article does not contain any studies with human or animal subjects performed by the any of the authors.

Informed consent

For this type of study informed consent is not required.