Responsible Conduct of Research

RESPONSIBLE CONDUCT OF RESEARCH

(extracted from ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participant)

3.0 The value and benefits of research are dependent on the integrity of the researchers. Scientists have a significant social responsibility to prevent research misconduct and misuse of research. Responsible researchers abide by the standards prescribed by their professions, disciplines and institutions and also by relevant laws. All members of a research team are expected to maintain high standards and to uphold the fundamental values of research. The responsible conduct of research (RCR) involves the following major components: values; policies; planning and conducting research; reviewing and reporting research; and responsible authorship and

3.1  VALUES OF RESEARCH

RCR is guided by shared values including honesty, accuracy, efficiency, fairness, objectivity, reliability, accountability, transparency, personal integrity, and knowledge of current best practices, and these should be reflected in the policies related to RCR.

3.1.1      THE SCIENTIST AS A RESPONSIBLE MEMBER OF SOCIETY

Scientific research is vital to improving our understanding of various health related problems and their solutions. All research components depend on cooperation and shared expectations as part of inter-professional ethics. Unethical behaviour in scientific research can destroy the public’s trust in science and have a negative impact on the research team. Without trust between scientists and the public, or within research teams, meaningful research is compromised. Researchers should be aware that the resources of biomedical research are precious and to be used judiciously. Wherever possible they should also seek opportunities to plan translation of research findings into public health outcomes.

3.1.2      CONTEMPORARY ETHICAL ISSUES IN BIOMEDICAL AND HEALTH RESEARCH

Emerging new areas of research give rise to new ethical issues. Among the contemporary issues recently under debate are the use of underprivileged and vulnerable groups as participants, post-trial access of research benefits to participants and their communities, research on emerging technologies, etc. Continuing education is necessary to keep researchers apprised of contemporary issues.

3.1.3      SENSITIVITY TO SOCIETAL AND CULTURAL IMPACT OF BIOMEDICAL AND HEALTH RESEARCH

To understand the social and cultural impact of research, one must analyse how the health sector and general public engage with the results of biomedical and health research. It is essential that researchers bear this in mind while planning, conducting and evaluating research as it will improve public accountability and enhance public, private and political advocacy.

3.1.4      MENTORING

Mentoring is one of the primary means for one generation of scientists to pass on their knowledge, values and principles to succeeding generations. Mentors, through their experience, can guide researchers in ways above and beyond what can be gathered from reading textbooks. The relationship between mentors and trainees should enable trainees to become responsible researchers. Mentors should ensure their trainees conduct research honestly, do not interfere with the work of other researchers and use resources judiciously. A mentor should be knowledgeable, teach and lead by example and understand that trainees differ in their abilities. She/he should devote sufficient time and be available to discuss, debate and guide trainees ably. A mentor should encourage decision making by the trainees and the trainee should take an active role in communicating her/his needs.

3.2     POLICIES

3.2.1 The protection of human participants

Institutions must establish policies and mechanisms for the protection of human research participants. Such policies should assign responsibilities to the institution, the EC and the researchers. Additionally, there should be mechanisms and policies for monitoring research including data capture, management , conflicts of interest, reporting of scientific misconduct, and appropriate initial and continuing training of researchers and EC members. Policies can be made available on the websites of the institutes or organizations. Researchers should also follow their respective professional codes of conduct.

3.3    PLANNING AND CONDUCTING RESEARCH – SPECIFIC ISSUES

3.3.1 Conflict of interest issues

COI refers to a set of conditions whereby professional judgement concerning a primary interest, such as participant’s welfare or the validity of research either is, or perceived to be unduly influenced by a secondary interest. The secondary interest may be financial or non-financial, personal, academic or political. This is not inherently wrong, but COI can influence the choice of research questions and methods, recruitment and retention of participants, interpretation and publication of data and the ethical review of research. It is, therefore, necessary to develop and implement policies and procedures to identify, mitigate and manage such COI which can be at the level of researcher, ethics committee or at the level of institution. Research institutions, researchers and research ECs must follow the steps given in Box 3.1.

Box 3.1 Identifying, mitigating and managing COI

The broad responsibilities of those involved in research, with respect to COI, are given below:

  1. Research institutions must:
    • develop policies and SOPs to address COI issues that are dynamic, transparent and actively communicated;
    • implement policies and procedures to address COI and conflicts of commitment, and educate their staff about such policies;
    • monitor the research or check research results for accuracy and objectivity; and
    • not interfere in the functioning and decision making of the
  2. Researchers must:
    • ensure that documents submitted to the EC include disclosure of COI (financial or non-financial) that may affect their research;
    • guard against conflicts of commitment that may arise from situations that place competing demands on researchers’ time and loyalties; and
    • prevent intellectual and personal conflicts by ensuring they do not serve as reviewers for grants and publications submitted by close colleagues, relatives and/or students.
  3. ECs must:
    • evaluate each study in light of any disclosed COI and ensure appropriate action is taken to mitigate this; and
    • require their members to disclose their own COI and take appropriate measures to recuse
    • themselves from reviewing or decision making on protocols related to their COI; and
    • make appropriate suggestions for management, if COI is detected at the institutional or researchers level. 

3.3.2      DATA ACQUISITION, MANAGEMENT, SHARING AND OWNERSHIP

  • There is no single best way to collect data. Different collection techniques are needed for different types of research. Researchers should be sensitive to participants and use best practices for data
  • Data collection involves physical process of recording data in hard copy, soft or electronic copy, or other permanent forms. The physical formats for recording data vary considerably, from measurements or observations to photographs or interview recordings. To be valuable, research data must be properly
  • Institutes receiving research funds have responsibilities for budgets, regulatory compliance and management of collected data with funded This means that researchers should obtain appropriate permissions/approvals to take their data and funding with them if they move to another institution.
  • Ownership issues and responsibilities need to be carefully worked out well before data are collected and researchers should ensure clarity about data ownership, publication rights and obligations following data MoUs vetted by the institution and/or EC should be in place.
  • For biological samples, donors (participants) maintain the ownership of the sample. She/he could withdraw both the biological material and the related data unless the latter is required for outcome measurement and is so mentioned in the initial informed consent
  • Institutes hosting/implementing the research are the custodians of the data/
  • Research must be conducted using appropriate and reliable methods to provide reliable data. The use of inappropriate methods in research compromises the integrity of research data and should be
  • Quality research requires attention to detail at every Proper protocols need to be established and the results accurately recorded, interpreted and published. Implementation of poorly designed research wastes resources and should be avoided.

In some cases, authorization is needed prior to data collection. Researchers are responsible for knowing when permission is needed to collect or use specific data in their research.

See Box 3.2 for further details.

Box 3.2 Research requiring authorization prior to data collection

Data for the following types of research cannot be collected without getting prior authorization:

  1. human participants and animals in research;
  2. information posted on some websites;
  3. hazardous materials and biological agents;
  4. biological sample storage and future testing;
  5. information from some libraries, databases and archives;
  6. published photographs and other published information; and
  7. other copyrighted or patented processes or materials.

Data protection and storage is important and once collected, data must be properly protected, as it may be needed at a later stage to confirm research findings, establish priority, or be re-analysed by other Responsible data handling begins with proper storage and protection from accidental damage, loss or theft. Care should be taken to reduce the risk of fire, flood and other catastrophic events. Computer files should be backed-up and the back-up data saved in a secure place at a site that is different from the original data storage site.

  • Data sharing is important as research data is valuable and needs to be shared, but deciding when and with whom to share may raise difficult Once a researcher has published the results of an experiment, it is generally expected that all the information about that experiment, including the final data, should be freely available for other researchers to check and use. Data should be shared or placed in a public domain in a de-identified/anonymized form, unless required otherwise, for which applicable permissions/re-consent should be sought unless obtained beforehand.

3.4            REVIEWING AND REPORTING RESEARCH

The public’s trust in published research is an essential component of ethical and responsible research.

3.4.1 The basic premise of all reviewers and editors evaluating research is that the work has been performed honestly, its reporting is transparent and truthful and the researchers’ integrity is beyond

3.4.2 Transparency pertains to both the research site and the researcher(s). This would require disclosure of the location of the research as well as the collaborating sites/institutions and the authors of that

3.4.3 Research that is completed, irrespective of results, must be published, since it would be unethical to expose another set of participant/patients/volunteers to the same risks to obtain the same

3.4.4 Researchers should provide results of study in the public database of the Clinical Trial Registry-India (CTRI).

3.5            RESPONSIBLE AUTHORSHIP AND PUBLICATION

  • Authorship – The researchers should follow the guidance of International Committee of Medical Journal Editors (ICMJE) on authorship which is largely accepted as a standard and is endorsed by the World Association of Medical Editors (WAME). See Box 3 for further details.
    Box 3.3 Criteria for authorship (ICMJE)
    According to the ICMJE, authorship entails the following criteria:
    1. substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work;
    2. drafting the work or revising it for important intellectual content;
    3. final approval of the version to be published;
    4. agreement to be accountable for all aspects of the work and ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
     
  • Institutions and departments should have authorship Editors of journals do not adjudicate on authorship disputes and would almost always refer these to the institution/researchers themselves to resolve.
  • Authorship should never be gifted and ‘ghost’ authors are not acceptable. The authorship of research should be considered at the time of its initiation.
  • The primary author should be the person who has done most of the research work related to the manuscript being submitted for publication. Research performed as part of a mandatory requirement of a course/fellowship/training programme including student research should have the candidate as the primary author. All efforts must be made to provide the candidate with an opportunity to fulfil the second, third and fourth criteria of the ICMJE guidelines.

3.5.2      PEER REVIEW

Scientific disclosure and progress has been dependent largely on peers evaluating research and judging the quality and utility of conducting and publishing research.

  • The present peer review system depends on fairness, honesty and transparency of all stakeholders – editors, reviewers and researchers. It can involve one or more reviewers and should be completed within a reasonable period of
  • Researchers must avoid mentioning friends, well-wishers and mentors as reviewers and must decline to review research of close associates, friends and students.
  • Funding agencies and journals must ask reviewers and researchers to inform them of COI, if any.
  • Reviewers must maintain the confidentiality of manuscripts sent to them for review.
  • If reviewers feel they are not competent to review papers, then they should inform editors immediately and should not pass on the manuscripts to friends and colleagues without seeking the consent of the
  • Reviewers who are researchers must not misguide editors in an attempt to self evaluate their research (using another email ID and profile).

3.6 RESEARCH MISCONDUCT AND POLICIES FOR HANDLING MISCONDUCT

Research misconduct involves fabrication, falsification and plagiarism of data, which are serious issues both nationally and internationally. See Box 3.4 for further details.

3.6.1 Institutions should develop policies to address scientific/research

3.6.2 Research misconduct, if suspected, needs to be An institution must investigate all allegations of misconduct as present or future participants’ lives may be endangered if facts are not presented accurately. Such investigations must be done in a timely, fair and transparent manner and the results should be made available in the public domain.

3.6.3 It is important to establish institutional mechanisms for protection of both the whistle- blower and the person accused of research misconduct. This information must be kept confidential until the enquiry is complete.

Box 3.4 Types of research misconduct

Research misconduct includes the following:

  • Fabrication is the intentional act of making-up data or results and recording or reporting them.
  • Falsification is manipulating research materials, equipment or processes, or changing or omitting/suppressing data or results without scientific or statistical justification, such that the research is not accurately represented in the research
  • Plagiarism is the “wrongful appropriation” and “stealing and publication” of another paper or another author’s “language, thoughts, ideas, or expressions” and the representation of them as one’s own original work or duplicating one’s own publication (self plagiarism).

3.6.4 Simultaneous submission of the same grant application to different funding agencies or submitting papers/overlapping publications to journals is not acceptable, as this could lead to unnecessary duplication in review process or in meta .

3.6.5 All clinical research involving human participants including any intervention such as drugs, surgical procedures, devices, biomedical, educational or behavioural research, public health intervention studies, observational studies, implementation research and preclinical studies of experimental therapeutics and preventives or AYUSH studies may be registered prospectively with the

3.6.6 Trial registration involves providing information regarding the study, investigators, sites, sponsor, ethics committees, regulatory clearances, disease/condition, types of study, methodologies, outcomes,

3.6.7 Registration of research in CTRI ensures that more complete, authenticated, readily available data on research is available publicly. This improves transparency, accountability and

3.7   COLLABORATIVE RESEARCH

Researchers are increasingly collaborating with colleagues who have the expertise and/or for resources needed to carry out particular research. This could be inter-departmental/ inter-institutional or international and also multicentre involving public and/or private research centres and agencies. The main ethical issues surrounding collaborations pertain to sharing techniques, ownership of materials and data, IPRs, joint publications, managing research findings, managing COI and commercializing research outcomes. Researchers should familiarize themselves with all aspects including local, national and international requirements for research collaboration including necessary approvals, memorandums of understanding (MoUs) and material transfer agreements (MTA) and EC approval of collaborating institutes.

3.7.1      ETHICAL CONSIDERATIONS IN COLLABORATIVE RESEARCH

Collaborative studies should take into account the values/benefits expected from the research as compared to the risks involving the persons/population being studied.

  • The participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of ownership of samples and data, analysis, dissemination, publication and IPR as There must be free flow of knowledge and capacity at bilateral/multilateral levels.
  • Careful consideration should be given to protecting the dignity, rights, safety and well-being of the participants in cases where the social contexts of the proposed research can create foreseeable conditions for their exploitation or increase their vulnerability to
  • The nature, magnitude and probability of all foreseeable harm resulting from participation in a collaborative research programme should be specified in the research protocol and well explained to the
  • The benefits and burdens should be equally distributed amongst participants recruited by all collaborating institutions.
  • All participants in collaborative research should have access to the best nationally available standard of care.
  • If there is exchange of biological material involved between collaborating sites, the EC may require appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance while addressing issues related to confidentiality, sharing of data, joint publications, benefit sharing,

3.7.2 RESPONSIBILITIES OF ETHICS COMMITTEES, RESEARCHERS AND INSTITUTIONS

The review, conduct and monitoring of collaborative research should be overseen and stakeholders must be aware of the requirements of various regulatory and funding agencies.

  • An EC should review the protocols in the local social and cultural context and ensure respect for sensitivities and values of participants and communities at collaborative
  • A mechanism for communication between the ECs of different participating centres should be In case of any conflict, the decision of the local EC based on relevant facts/guidelines/law of the land shall prevail.
  • An EC should examine whether the researcher has the required expertise and training in the area of collaboration.
  • An EC should protect the interests and rights of the collaborating researcher(s) and ensure that they are not treated as mere collectors of samples or data.
  • Participating researchers from collaborating sites should be adequately represented when designing the research proposal.
  • Institutions are responsible for fair contract negotiation in collaborative research partnerships (including benefit sharing and avoiding unauthorized use of their expertise, biological samples and data) to safeguard the interests of participants, researchers and
  • Institutions should provide opportunities for collaboration to build capacity and engage in research which is mutually beneficial.

3.7.3      INTERNATIONAL COLLABORATION

The scope of international collaboration in biomedical and health research has gained such momentum in recent years that it could have potentially exploitative commercial and human dimensions. While on one hand collaboration in medical research could be seen as a humane interest in the health of civil society, on the other hand it could create the impression of exploitation by one country experimenting on the population of another

poorer one. Due to different levels of development in terms of infrastructure, expertise, social and cultural perceptions, laws relating to IPR, ethical review procedures, etc., an ethical framework based on equality and equity is required to guide such collaborations. The same is applicable to research undertaken with assistance and/or collaboration from international organizations (public or private). The collaboration may involve either implementation of multiple components of the research or even a single component like laboratory testing. To undertake a collaborative research in India, our country’s ethical guidelines and relevant regulatory requirements should be followed and understood before the sponsor agency/country initiates collaboration.

  • Indian participating centres should function as partners with the collaborator(s) and sponsor(s) in terms of ownership of samples and data, analysis, dissemination, publication and IPR related to research in India, as may be considered
  • There should be good communication between international participating centres and in case of any conflict, the decision of the EC of the Indian participating centre(s), based on relevant facts/guidelines/law of the land, shall
  • The institution should protect against imposition of moral or ethical standards of the sponsoring country (ethical imperialism) which may not be in agreement with India’s ethical and regulatory
  • The institution/EC should not accept international proposals which cannot be conducted in the country of origin.
  • Researchers and EC members should be trained to understand and recognize ethical perspectives that reflect India’s best interests.

The types of international collaborations are mentioned in Box 3.5

Box 3.5 Types of international collaboration

International collaboration can include all or any of the following elements:

  • funding by international agencies, such as UN Agencies, NIH, WHO, Wellcome Trust, World Bank and others;
  • academic collaborations with foreign institutions, universities, organizations, foundations with or without external funding; and
  • formal government  inter-country  bilateral/multilateral  collaborative  arrangements between Indian research bodies/institutions and similar bodies/institutions of other countries.
  • All biomedical and health research proposals involving foreign assistance and/or collaboration should be submitted to the Health Ministry’s Screening Committee (HMSC) for consideration and approval before initiation.19 The secretariat for HMSC is located at the ICMR Headquarters, New As per the requirements of HMSC, all research involving international collaboration – either technical, financial, laboratory or data management must be submitted to HMSC.
  • The exchange of material envisaged as part of a collaborative research proposal must be routed through appropriate authorities. While ethical review and approvals are subject to the national regulatory framework, international collaborations are subject to appropriate considerations of universal ethical principles. The finer specifics recommended in the Indian context may vary from other countries and agencies with respect to socio-cultural norms and needs of the
  • Export of all biological materials will be covered under the existing Government of India (GOI) guidelines for transfer of human biological Research proposals requiring biological material transfer may be considered by the EC on a case-to-case basis. Collaborators should obtain applicable regulatory clearances as mandated by laws such as the Environmental Protection Act, 1986, the Biological Diversity Act, 2002, of Ministry of Environment and Forests, Drugs and Cosmetics Act, 1940, and Rules, 1945, and the relevant amendments. Such exchange of material from and to WHO Collaborating Centres/reference centres for specific purposes, and for individual cases of diagnosis or therapeutic purposes, may not require permission.
  • Indian participating centre(s) must have appropriate regulatory approval and registration to receive foreign funds for research.
  • Any research involving exchange of biological material/specimens with collaborating institution(s) outside India must sign an MTA justifying the purpose and quantity of the sample being collected and addressing issues related to confidentiality, sharing of data, joint publication policy, IPR and benefit sharing, post analysis handling of the leftover biological materials, safety norms,
  • The guidelines, regulations and cultural sensitivities of all countries participating in collaborative research proposals should be respected by researchers in India and the sponsor country. An appropriate MoU should be in place to safeguard mutual interests and ensure