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Journal of the Academy of Hospital Administration

Statement of General Principles in Biomedical Research Involving Human Subjects

Author(s): Editor

Vol. 13, No. 1 (2001-01 - 2001-06)

The recent developments in frontier areas like genome mapping, genetic re-combinant engineering, assisted reproductive biology, stem cell research, have opened up hither to unknown practical applications of these technologies. However, these exciting areas also raise some delicate and sensitive issues regarding ethics in Bio-medical research. Accordingly, as a sequel to the "Policy Statement on ethical consideration involved in research on human subjects" published by ICMR; the Central Ethics Committee on Human Research has come out with comprehensive guidelines. Starting with this issue, we will be publishing these "Ethical guidelines for Biomedical Research on Human Subjects" in six consecutive issues, as the document is not widely available, but is mandatory for institutions carrying out research on human subjects. The first issue covers a statement of general principles in biomedical research.

This statement of Ethical Guidelines for Biomedical Research on Human Subjects shall be known as the ICMR Code and shall consist of the following:

  1. Statement of General Principles on Research using Human Subjects in Biomedical Research
  2. Statement of Specific Principles on Research using Human Subjects in specific areas of Biomedical Research

These Statements of General and Specific Principles may be varied, amended, substituted and added from time to time.


The Second World War (1939-45) in its aftermath, gave rise to an intense concern about the use of human subjects for medical research as revealed by the shocking details of the trial of German medical practitioners accused of conducting experiments on human subjects without their consent and exposing them to grave risk of death or permanent impairment of their faculties. Thus, the first International Statement on the ethics of medical research sing human subjects namely, the Nuremberg Code was formulated in 1947, which emphasised consent and vountariness. In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed concern about human beings being subjected to involuntary maltreatment. In 1966, the International Convenant on Civil and Political Rights specifically stated,

"No one shall be subjected to torture or to cruel, in human or degrading treatment or puishment. In particular, no one shall be subjected without his consent to medical or scientific treatment or punishment. In particular, no one shall be subjected without his consent to mdical or scientific treatment."

Based on the preliminary efforts of the Council for International Organisations of Medical Sciences (CIOMS) in 1964 at Helsinki, the World Medical Association formulated general principles on use of human subjects in medical research in addition to specific guidelines for biomedical research, known as the Helsinki Declaration which was revised from time to time. In February 1980, the Indian Council of Medical Research released a "Policy Statement on Ethical Considerations involved in Research on Human Subjects" for the benefit of all those involved in clinical research in India. In 1982, the World Health Organisation (WHO) and the CIOMS issued the "Proposed International Guidelines for Biomedical Research involving Human Subjects".

Subsequently the CIOMS brought out the "International Guidelines for Ethical Review in Epidemiological studies" in 1991 and "International Ethical Guidelines for Biomedical Research involving Human subjects" in 1993. Over the years, various bodies in national jurisdictions have also laid down general and specific precipices in specific areas of scientific research entailing the use of human beings as subjects in medical research entailing the use of human beings as subjects in medical research. These "national" Codes (drawn from the international codes and the universal principles underlying them) outline "guidelines" to be followed in their respective jurisdictions.

General Statement

Medical and related research using human beings as subjects must necessarily ensure that:

(i) The PURPOSE, of the such research is that it should be directed towards the increase of knowledge about the human condition in relation to its social and natural environment, mindful that the human species is one of the many species in a planet in which the well being of all species is under threat, no less from the human species as any other, and that such research is for the betterment of all, especially the least advantaged.

(ii) Such research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well being, under conditions of professional fair treatment and transparency; and after ensuring that the subject is placed at no greater risk other than such risk commensurate with the well being of all subject in question in the light of the object to the achieved.

(iii) Such research must be subjected to a regime of EVALUATION at all stages of the proposal i.e., research design and experimentation, declaration of results and use of the results thereof, and hat each such evaluation shall bear in mind the objects to be achieved, the means by which they are sought to be achieved, the anticipated benefits and danger, the potential uses and abuses of the experiment and its results, and above all, the premium that civilised society places on saving and ensuring the safety of each human life as an end in itself.

Statement of General Principles

Any research using the human beings as subjects of medical or scientific research or experimentation shall bear in mind the following principles:

I. Principles of essentiality whereby, the research entailing the use of human subjects is considered to be absolutely essential after a due consideration of all alternatives in the light of the existing knowledge in the proposed area of research and after the proposed research has been duly vetted and considered by an appropriate and responsible body of persons who are external to the particular research and who, after careful consideration, come to the conclusion that the said research is necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well being of the planet.

II. Principles of voluntariness, informed consent and community agreement whereby, research subjects are fully research on the research subject and others; and whereby the research subjects retain the right to abstain from further participation in the research irrespective of any legal or other obligation that may have been entered into by such human obligation that may have been entered into by such human subjects or someone on their behalf, subject to only minimal restitutive obligations of any legal or other subjects or someone on their behalf, subject to only minimal restitutive obligations of any advance consideration received and outstanding. Where any such research entails treating any community or group of persons as a research subject, these principles of voluntariness and informed consent shall apply, mutatis mutandis, to the community as a whole and to each individual member who is the subject of the research or experiment. Where the human subject is incapable of giving consent and it is considered essential that research or experimentation be conducted on such a person incompetent to give consent, the principle of voluntariness and informed consent, the principle of voluntariness and informed consent shall continue to apply and such consent and voluntariness shall be obtained and exercised on behalf of such research subjects by someone who is empowered and under a duty to act on their behalf. The principles of informed consent and voluntariness are cardinal principles to be observed throughout the research and experiment, including its aftermath and applied use so that research subjects are continually kept informed of any and all development in so far as they affect them and others. However, without in any way undermining the cardinal importance of obtaining informed consent from any human subject involved in any research, the nature and from any human subject involved in any research, the nature and form of the consent and the evidentiary requirements to prove that such consent was taken, shall depend upon the degree and seriousness of the invasiveness into the concerned human subject's person and privacy, health and life generally, and, the overall purpose and the importance of the research.

III. Principles of non-exploitation whereby as a general rule, research subjects are remunerated for their involvement in the research or experiment; and, irrespective of the social and economic condition or status, or literacy or educational levels attained by the research subjects kept fully apprised of all the dangers arising in and out of the research so that they can appreciate all the physical and psychological risks as well as moral implications of the research whether to themselves or others, including those yet to be born. Such human subjects should be selected so that the burdens and benefits should be selected so that the burdens and benefits of the research are distributed without arbitrariness, discrimination or caprice. Each research shall include an in built mechanism for compensation for the human subjects either through insurance cover or any other appropriate means to cover all foreseeable and unforeseeable risks by providing for remedial action and comprehensive after-care, including treatment during and after the research or experiment, in respect of any effect that the conduct of research or experimentation may have on the human subject and to ensure that immediate recompense and rehabilitative measures are taken in respect of all affected, if and when necessary.

IV. Principles of privacy and confidentiality whereby, the identity and records of the human subjects of the research or experiment are as far as possible kept confidential; and that no details about identity of said human subjects, which would result in the disclosure of their identity, are would result in the disclosure without valid scientific and legal reasons which may be essential for the purposes of therapeutics or other interventions, without the specific consent in writing of the human subject concerned, or someone authorised on their behalf; and after ensuring that the said human subject does not suffer from any form of hardship, discrimination or stigmatisation as a consequence of having participated in the research or experiment.

V. Principles of precaution and risk minimisation whereby due are and caution is taken at all stages of the research and experiment (from its inception as a research idea, its subsequent research design, the conduct of the research or experiment and its applicative use) to ensure that the research subject and those affected by it are put to the minimum risk, suffer from no irreversible adverse effects and, generally, benefit from and by the research or experiment; and that requisite steps are taken to ensure that both professional and ethical reviews of the research are undertaken at appropriate stages so that further and specific guidelines are laid down, and necessary directions given, it respect of the conduct of the research or experiment.

VI. Principles of professional competence whereby, the research is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, the ethical considerations to be borne in mind in respect of such research or experiment.

VII. Principles of accountability and transparency whereby, the research or experiment will be conducted in a fair, hones, impartial and transparent manner after full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist; and whereby, subject to the principles of privacy and confidentiality and the rights of the researcher, full and complete records of the research inclusive of data and notes are retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further research (whether by the initial researcher or otherwise) and in order to make such records available for scrutiny by the appropriate legal and administrative authority, if necessary.

VIII. Principles of the maximisation of the public interest and of distributive justice whereby, the research or experiment and its subsequent applicative use are conducted and used to benefit all human kind and not just those who are socially better off but also the least advantages; and in particular, the research subject themselves.

IX. Principles of institutional arrangements whereby, there shall be a duty on all persons connected with the research to ensure that all the procedures required to be complied with and all institutional arrangements required to be made in respect of the research and its subsequent use or application are duly made in a bonafide and transparent manner; and to take all appropriate steps to ensure that research reports, materials and data connected with the research are duly preserved and archived.

X. Principles of public domain whereby, the research and any further research, experimentation or evaluation in response to, and emanating from such research is brought into the public domain so that its results are generally made known through scientific and other publications subject to such rights as are available to the researcher and those associated with the research under the law in force at that time.

XI. Principles of totality of responsibility whereby the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research or experiment in question, devolves on all those directly or indirectly connected with the research or experiment including the researchers, those responsible for funding or contributing to the funding of the research, the institution or institutions where the research is conducted and the various persons, groups or undertakings who sponsor, use or derive benefit from the research, market the product (if any) or prescribe its use so that, inter alia, the effect of the research or experiment is duly monitored and constantly subject to review and remedial action at all stages of the research and experiment and its future use.

XII. Principles of compliance whereby, there is a general and positive duty on all persons, conducting, associated or connected with any research entailing the use of a human subject to ensure that both the letter and the spirit of these guidelines, as well as any other norms, directions and guidelines which have been specifically laid down or prescribed and which are applicable for that area of research or experimentation, are scrupulously observed and duly complied with.

These 12 principles laid down under Statement on General Principles are common to all areas of biomedical research. The specific issues are mentioned under relevant topics.

Ethical Review Procedures

The need for evaluation of research proposals has been emphasized under the Statement of General Principles at item no. 5 pertaining to precaution and risk minimisation. It is mandatory that all proposals on biomedical research involving human subjects should be cleared by an appropriately constituted Institutional Ethics Committee (IEC), also referred to as Institutional Review Board (IRB) in many countries, to safeguard the welfare and the rights of the participants. The Ethics Committees are entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the ethics of the approved programmes till the same are completed. Such an ongoing review is in accordance with the Declaration of Helsinki and all the international guidelines for biomedical research.

Basic Responsibilities

The basic responsibility of an IEC is to ensure a competent review of all ethical aspects of the project proposals received and execute the same free from any bias and influence that could affect their objectivity. IECs should provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research through appropriate Scientific Review Committees. In smaller institutions the Ethics Committee amy take up the dual responsibility of Scientific and Ethical Review. It is advisable to have separate Committees for each taking care that the scientific review preceeds the ethical scrutiny. The scientific evaluation should ensure technical excellence of the proposed study.

The IECs should specify in writing the authority under which the Committee is established, membership requirements, the terms of reference, the conditions of appointment, the offices and the quorum requirements. The responsibilities of an IEC can be defined as follows:

  1. To protect the dignity, rights and well being of the potential research participants.
  2. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs
  3. To assist in the development and the education of a research community responsive to local health care requirements.


IECs should be multidisciplinary and multisectorial in composition. Independence and competence are the two hallmarks of an IEC.

The number of persons in an ethical committee be kept fairly small (5-7 members). It is generally accepted that a minimum of five persons is required to compose a quorum. There is no specific recommendation for a widely acceptable maximum number of persons but it should be kept in mind that too large a Committee will make it difficult in reaching consensus opinion. 12 to 15 is the maximum recommended number.

The Chairperson of the Committee should preferably be from outside the Institution and not head of the same Institution to maintain the independence of the Committee. The Member Secretary who generally belongs to the same Institution should conduct the business of the Committee. Other members should be a mix of medical/non-medical, scientific and non-scientific persons including lay public to reflect the differed viewpoints. The composition may be as follows:

  1. Chairperson
  2. 1-2 basic medical scientists.
  3. 1-2 clinicians from various institutes
  4. One legal expert or retired judge
  5. One social scientist/representative of non-governmental voluntary agency
  6. One philosopher/ethicist/theologian
  7. On lay person from the community
  8. Member Secretary

The ethical committee at any institution can have as its members, individuals from other institutions or communities if required. There should be adequate representation of age, gender, community; etc. in the Committee to safeguard the interests and welfare of local, social and cultural norms, as this is the most important social control mechanism. If required subject experts could be invited to offer their views, for example for drug trials a pharmacologist, preferably a clinical pharmacologist, should be included. Similarly, based on the requirement of research area, for example HIV, genetic disorders etc., specific patient groups may also be represented in the Committee.

Terms of Reference

The IEC members should be made aware of their role and responsibilities as committee members. Any change in the regulatory requirements should be brought to their attention and they should be kept abreast of all national and international developments in this regard. The Terms of References should also include a statement on Terms of Appointment with reference to the duration of the term of membership, the policy for removal, replacement and resignation procedure etc. Each Committee should have its own operating procedures available with each member.

Review Procedures

The Ethics Committee should review every research proposal on human subjects. It should ensure that a scientific evaluation has been completed before ethical review is taken up. The Committee should evaluate the possible risks to the subjects with proper justification, the expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice issues. The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals.

Submission of Application

The researcher should submit an appropriate application in a prescribed format along with the study protocol at least three weeks in advance. The protocol should include the following:

  1. Clear research objectives and rationale for undertaking the investigation in human subjects in the light of existing knowledge.
  2. Recent curriculum vitae of the Investigators indicating qualification and experience.
  3. Subject recruitment procedures.
  4. Inclusion and exclusion criteria for entry of subjects in the study.
  5. Precise description of methodology of the proposed research, including intended dosages of drugs, planned duration of treatment and details of invasive procedures if any.
  6. A description of plans to withdraw or withhold standard therapies in the course of research.
  7. The plans for statistical analysis of the study.
  8. Procedure for seeking and obtaining informed consent with sample of patient information sheet and informed consent forms in English and vernacular languages.
  9. Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory and animal research.
  10. For research carrying more than minimal risk, an account of plans to provide medical therapy for such risk or injury or toxicity due to overdosage should be included.
  11. Proposed compensation and reimbursement of incidental expenses.
  12. Storage and maintenance of all data collected during the trial.
  13. Plans for publication of results - positive or negative - while maintaining the privacy and confidentiality of the study participants
  14. A statement on probable ethical issues and steps taken to tackle the same.
  15. All other relevant documents related to the study protocol including regulatory clearances.
  16. Agreement to comply with national and international GCP protocols for clinical trials.
  17. Details of Funding agency / Sponsors and fund allocation for the proposed work.

Decision Making Process

The IEC should be able to provide complete and adequate review of the research proposals submitted to them. It should meet periodically at frequent intervals to review new proposals, evaluate annual progress of ongoing ones and assess final reports of all research activities involving human beings through a previously scheduled agenda, amended wherever appropriate.

  1. The decision must be taken by a broad consensus after the quorun requirements are fulfilled to recommend/reject/ sugges modification for a repeat review or advice appropriate steps. The Member Secretary should communicate the decision in writing.
  2. A member must voluntarily withdraw from the IEC while making a decision on an application which evokes a conflict of interest which should be indicated in writhing to the chairperson prior to the review and should be recorded so in the minutes.
  3. If one of the members has her/his own proposal for review, then the member should not participate when the project is discussed.
  4. A negative decision should always be supported by clearly defined reasons.
  5. An IEC may decide to reverse its positive decision on a study in the even to receiving information that may adversely affect the benefit/risk ratio.
  6. The discontinuation of a trial should be ordered if the IEC finds that the goals of the trial have already been achieved midway or unequivocal results are obtained.
  7. In case of premature termination of study, notification should include the reasons for termination along with the summary of results conducted till date.
  8. The following circumstances require the matter to be brought to the attention of IEC:
    1. any amendment to the protocol from the originally approved protocol with proper justification;
    2. serious and unexpected adverse events and remedial steps taken to tackle them;
    3. any new information that may influence the conduct of the study.
  9. If necessary, the applicant/investigator may be invited to present the protocol or offer clarifications in the meeting. Representative of the patient groups or interest groups can be invited during deliberations to offer their viewpoint.
  10. Subject experts may be invited to offer their views, but should not take part in the decision making process. However, her/his opinion must be recorded.
  11. Meetings are to be minuted which should be approved and signed by the Chairpersons.

Interim Review

Each IEC should decide the special circumstances and the mechanism when an interim review can be resorted to instead of waiting for the scheduled time of the meeting. However, decisions taken should be brought to the notice of the main committee. This can be done for the following reasons:

  1. re-examination of a proposal already examined by the IEC;
  2. research study of a minor nature such as examination of case records etc.;
  3. an urgent proposal of national interest.

Record Keeping

All documentation and communication of an IEC are to be dated, filed and preserved according to written procedures. Strict confidentiality is to be maintained during access and retrieval procedures. Records should be maintained for the following:

  1. the Constitution and composition of the IEC;
  2. the curriculum vitae of all the IEC members;
  3. standing operating procedures of the IEC;
  4. national and International guidelines;
  5. copies of protocols submitted for review;
  6. all correspondence with IEC members and investigators regarding application, decision and follow up;
  7. agenda of all IEC meetings;
  8. minutes of all IEC meetings with signature of the Chairperson;
  9. copies of decisions communicated to the applicants;
  10. record of all notification issued for premature termination of a study with a summary of the reasons;
  11. final report of the study including miscrofilms, CDs and Video-recordings.

It is recommended that all records must be safely maintained after the completion/termination of the study for at least a period of 15 years if it is possible to maintain the same persmanenetly.

Special Considerations

While all the above requirements are applicable to biomedical research as a whole irrespective of the specialty of research, there are certain specific concerns pertaining to specialised areas of research which require additional safe guard/protection and specific concerns pertaining to specialised areas of research which require additional safe guards/protection and specific considerations for the IEC to take note of. Examples of such instances are research involving children, pregnant and lactating women, vulnerable subjects and those with diminished autonomy besides issues pertaining to commercialisation of research and international collaboration. The observations and suggestions of IEC should be given in writing in unambiguous terms in such instances.

General Ethical Issues

All the research involving human subjects should be conducted in accordance with the four basic ethical principles, namely autonomy (respect for person/subject) beneficence, non maleficence (do no harm) and justice. The guidelines laid down are directed at application of these basic principal Investigator is the person responsible for not only undertaking research but also for observance of the rights, health and welfare of the subjects recruited for the study. She/he should have qualification and competence in biomedical research methods for proper conduct of the study and should be aware of an comply with the scientific, legal and ethical requirements of the study protocol.

I. Informed Consent Process

1. Informed Consent of Subject: For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject or in the case of an individual who is not capable of giving informed consent, the consent of a legal guardian. Informed consent is based on the principle that competent individuals are entitled to choose freely consent protects the individual's freedom of choice and respect for individual's autonomy.

When research design involves not more than minimal risk (for example, where the research involves only collecting data from subject's records) the Institutional Ethics Committee may waive off some of the elements of informed consent.

Waiver of informed consent could also be considered during conditions of emergency. However, this would be permissible only if Ethical Committee has already approved the study or use of drug.

However, the patient or the legal guardian should be informed after she/he regains consciousness or is able to understand the study.

2. Obligations of investigators regarding informed consent : The investigator has the duty to:

  1. Communicate to prospective subjects all the information necessary for informed consent. There should not be any restriction on subject's right to ask any questions related to the study as any restriction on this undermines the validity of informed consent.
  2. Exclude the possibility of unjustified deception, undue influence and intimidation. Deception of the subject is not permissible. However, sometimes information can be withheld till the completion of study, if such information would jeopardize the validity of research.
  3. Seek consent only after the prospective subject is adequately informed. Investigator should not give any unjustifiable assurances to prospective subject, which may influence the subject's decision to participate in the study.
  4. As a general rule obtain from each prospective subject a signed form as an evidence of informed consent (written informed consent) preferably witnessed by a person not related to the trial, and in case of incompetence to do so, a legal guardian or other duly authorised representative.
  5. Renew the informed consent of each subject, if there are material changes in the conditions or procedures of the research or new information becomes available during the ongoing trial.
  6. Not use intimidation in any form which invalidates informed consent. The investigator must assure prospective subjects that their decision to participate or not will not affect the patient-clinician relationship or any other benefits to which they are entitled.

3. Essential information for prospective research subjects: Before requesting an individual's consent to participate in research, the investigator must provide the individual with the following information in the language he or she is able to understand which should not only be scientifically accurate but should also be sensitive to their social and cultural context:

  1. the aims and methods of the research;
  2. the expected duration of the subject participation;
  3. the benefits that might reasonably be expected as an outcome of research to the subject or to others;
  4. any alternative procedures or courses of treatment that might be as advantageous to the subject as the procedure or treatment to which she/he is being subjected;
  5. any foreseeable risk or discomfort to the subject resulting from participation in the study;
  6. right to prevent use of his/her biological sample (DNA, cell-line, etc.) at any time during the conduct of the research;
  7. the extent to which confidentiality of records could be maintained i.e.., the limits to which the investigator would be able to safeguard confidentiality and the anticipated consequences of breach of confidentiality;
  8. responsibility of investigators;
  9. free treatment for research related injury by the investigator/institutions;
  10. compensation of subjects for disability or death resulting from such injury;
  11. freedom of individual/family to participate and to withdraw from research any time without penalty or loss of benefits which the subject would otherwise be entitle to;
  12. the identity of the research teams and contact persons with address and phone numbers;
  13. foreseeable extent of information on possible current and future uses of the biological material and of the data to be generated from the research and if the material is likely to be used for secondary purposes or would be shared with others, clear mention of the same;
  14. risk of discovery of biologically sensitive information;
  15. publication, if any, including photographs and pedigree charts.

The quality of the consent of certain social groups requires careful consideration as their agreement to volunteer may be unduly influenced by the Investigator.

II. Compensation for Participation

Subjects may be paid for the inconvenience and time spent, and should be reimbursed for expenses incurred, in connection with their participation in research. They may also receive free medical services. However, payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in research against their better judgement (inducement). All payments, reimbursement and medical services to be provided to research subjects should be approved by the IEC. Care should be taken:

  1. when a guardian is asked to give consent on behalf of an incompetent person, no remuneration should be offered except a refund of out of pocket expenses;
  2. when a subject is withdrawn from research for medical reasons related to the study the subject should get the benefit for full participation;
  3. when a subject withdraws for any other reasons he/she should be paid in proportion to the amount of participation

Academic institutions conducting research in alliance with industries/commercial companies require a strong review to probe possible conflicts of interest between scientific responsibilities of researchers and business interests (e.g. ownership or part-ownership of a company developing a new product). In cases where the review board/committee determines that a conflict of interest may damage the scientific integrity of a project or cause harm to research participants, the board should advice accordingly. Institutions need self-regulatory processes to monitor, prevent and resolve such conflicts of interest. Prospective participants in research should also be informed of the sponsorship of research, so that they canbe aware of the potential for conflicts of interest and commercial aspects of the research. Undue inducement through compensation for individual participants, families and populations should be prohibited. This prohibition however, does not include agreements with individuals, families, groups, communities or populations that foresee technology transfer, local training, joint ventures, provision of health care reimbursement, costs of travel and loss of wages and the possible use of a percentage of any royalties for humanitarian purposes.

III. Selection of Special Groups as Research Subjects

i. Pregnant or nursing women: Pregnant or nursing women should in no circumstances by the subject of any research unless the research carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new knowledge about the foetus, pregnancy and lactation. As a general rule, pregnant or nursing women should not be subjects of any clinical trial except such trials as are designed to protect or advance the health of pregnant or nursing women or foetuses or nursing infants, and for which women who are not pregnant or nursing would not be suitable subjects.

ii. Children: Before undertaking trial in children the investigator must ensure that:

  1. children will not be involved in research that could be carried out equally well with adults;
  2. the purpose of the research is to obtain knowledge relevant to health needs of children. For clinical evaluation of a new drug the study in children should always be carried out after the phase III clinical trials in adults. It can be studied earlier only if the drug has a therapeutic value in a primary disease of the children;
  3. a parent or legal guardian of each child has given proxy consent;
  4. the assent of the child should be obtained to the extent of the child's capabilities such as in the case of mature minors, adolescents etc.;
  5. research should be conducted in settings in which the child and parent can obtain adequate medical and psychological support;
  6. interventions intended to provide direct diagnostic, therapeutic or preventive benefit for the individual child subject must be justified in relation to anticipated risks involved in the study and anticipated benefits to society;
  7. the child's refusal to participate in research must always be respected unless there is no medically acceptable alternative to the therapy provided/tested, provided the consent has been obtained from parents/guardian;
  8. interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child subject as any available alternative interventions;
  9. the risk presented by interventions not intended to benefit the individual child subject is low when compared to the importance of the knowledge that is to be gained.

iii. Vulnerable groups: Effort may be made to ensure that individuals or communities invited for research be selected in such a way that the burdens and benefits of the research are equally distributed.

  1. research on genetics should not lead to racial inequalities;
  2. persons who are economically or socially disadvantaged should not be used to benefit those who are better off than them;
  3. rights and welfare of mentally challenged and mentally differently able persons who are incapable of giving informed consent or those with behavioral disorders must be protected;
  4. adequate justification is required for the involvement of subjects such as prisoners, students, subordinates, employees, service personnel etc. who have reduced autonomy as research subjects.

IV. Essential Information on Confidentiality for Prospective Research Subjects

Safeguarding confidentiality - The investigator must safeguard the confidentiality of research data, which might lead to the identification of the individual subjects. Data of individual subjects can be disclosed only in a court of law under the orders of the presiding judge or in some cases may be required to communicate to drug registration authority or to health authority. Therefore, the limitations in maintaining the confidentiality of data should be anticipated and assessed.

V. Compensation for Accidental Injury

Research subjects who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, their dependents are entitled to material compensation.

Obligation of the sponsor to pay : The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research beings, to provide compensation for any physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.

VI. International Collaboration / Assistance in Bio-Medical / Health Research

Research in biomedical and health areas have been subjects of international interaction over the centuries. However, it was only in the second half of the 20th Century, especially since 1960s, that the scope of co-operation and collaboration assumed such proportions as to have exploitative connotations with commercial and human dimensions. On the one hand, collaboration in medical research suggest an interest in humane and civil society, while on the other it could give the impression of experimentation on the population of one country by another. Different levels of development in terms of infrastructure, expertise, social and cultural perceptions, laws relating to intellectual property rights etc., necessitate an ethical framework to guide such collaboration. The same concerns are applicable even if and when there is no formal collaboration between countries, but the research is undertaken with assistance from sponsors in the form of international organisations (Governmental, non-Governmental or other for example, WHO, UNICEF, UNAIDS etc.).

Special Concerns

1. Given the magnitude and severity of the health problems in different countries, capacity building to address ethical issues that arise out of collaborative research must be promoted on a priority basis.

2. Strategies should be implemented to build capacity in various countries and communities so that they can practise meaningful self-determination in health development, can ensure the scientific and ethical conduct of research, and can function as equal partners with sponsors and others in a collaborative process. Community representatives should be involved in an early and sustained manner in the design, development, implementation, and distribution of results of research.

3. Careful consideration should be given to protect the dignity, safety and welfare of the participants when the social contexts of the proposed research can create foreseeable conditions for exploitation of the participants or increase their vulnerability to harm and the steps to be taken to overcome these should be described.

4. As different kinds of research (epidemiological studies, clinical trails, product development, behavioural and social science oriented research, etc. have their own particular scientific requirements and specific ethical challenges, the choice of study populations for each type of study should be justified in advance in scientific and ethical terms in all cases, regardless of where the study population is found. Generally, early clinical phases of research, particularly of drugs, vaccines and devices, should be conducted in communities that are less vulnerable to harm or exploitation. However, for valid scientific and public health reasons, if sufficient scientific and ethical safeguards are ensured it may be considered to conduct research in any phase.

5. The nature, magnitude, and probability of all foreseeable harms resulting from participation in a collaborative research programme should be specified in the research protocol and explained to the participants as fully as can be reasonably done. Moreover, the modalities by which to address these, including provision for the best possible nationally available care to participants who experience adverse reactions to a vaccine or drug under study, compensation for injury related to the research, and referral for psychosocial and legal support if necessary, need to be described.

6. The research protocol should outline the benefits that persons/communities/countries participating in such research should experience as a result of their participation. Care should be taken so that these are not presented in a way that unduly influences freedom of choice in participation. The burden and the benefit should be equally borne by the collaborating countries.

7. Guidelines, rules, regulations and laws of all countries participating in collaborative research projects should be respected, especially by researchers in the host country and the sponsor country. These could be with reference to intellectual property rights, exchange of biological materials (human, animal, plant or microbial), data transfer, security issues, and issues of socially or politically sensitive nature. In this context, it is essential for researchers to follow the GOI notification on "Exchange of Human Biological Material for Biomedical Research" issued on 19.11.97.

VII. Researcher's Relations with the Media and Publication Practices

Researchers have a responsibility to make sure that the public is accurately informed about results without raising false hopes or expectations. It should also not unnecessarily scare the people. Researchers should take care to avoid talking with journalists or reporters about preliminary findings as seemingly promising research that subsequently cannot be validated could lead to misconcepts if reported prematurely. Or, the results of experimental research may be reported in such a way that it would seem that the human application is round the corner only to be told by the researchers later that considerable time has to pass before these findings can be translated into human use. In such circumstances, retractions most often do not appear in the media. Therefore, it is important to avoid premature reports and publicity stunts.

The best safeguard against inaccurate reporting is for the researcher to talk to media on condition that the reporter submit a full written, rather than oral version, of what will be reported, so that it enables the researcher to make necessary corrections, if needed, prior to publication.

Investigator's publication plans should not threaten the privacy or confidentiality of subjects, for example publication of pedigrees in the report on research in genetics can result in identification of study participants. It is recommended that a clear consent for publication shall be obtained besides the consent for participation in research or treatment and such a consent should preferably be obtained on two different occasions and not at the commencement of the study. Maintenance of confidentiality while publishing data should be taken care of. In case there is need for publication/presentation of photographs/slides/videos of subject (s), prior consent to do so should be obtained.

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