Joyce Ikingura, Clarence Kipobota, Aceme Nyika, Wen Kilama
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1. Types of research

This module applies primarily to biomedical research, which covers only a part of the studies involving human beings. However, it is necessary to pay attention to various specific rules, which vary depending upon the type of research. Researchers ought to understand some ethical and legal issues in regard to different kind of experimentation if they are to undertake epidemiologic studies.

There are several types of health studies including those whose primary goal is diagnostic or therapeutic for the patient. These are purely scientific in nature as they include medical research designed to alleviate diseases, research on traditional medical practices, clinical trials, and the like. All types of research should conform to general and specific ethical rules as have been indicated in Module I and other regulations. The law in Tanzania allows a wide range of health research to be carried out. Every individual is free to choose and pursue any research provided that he/she abides by laid down procedures for approving the protocol and carrying out the research.

The Tanzania Commission for Science and Technology (COSTECH) coordinates and monitors all activities on scientific research and technology development and has a manual which indicates priority areas of scientific research.

  • Tanzania Commission for Science and Technology Act, Cap. 226, S. 5 (2)
  • National Institute for Medical Research, Cap. 59, Ss. 4, 9 and 10.

1.1. Biomedical research

Biomedical research can be subdivided into several types, in particular; clinical trials (which imply a direct link between the subject and the investigator), research which involves human biological material and epidemiologic studies (which look for causative factors of an illness or disease).

Apart from the normal diagnostic and therapeutic procedures for patients done by doctors in the normal way in Tanzanian hospitals, the carrying out of all other biomedical research is governed by ethical principles contained in different rules, regulations and laws of the country. Researchers are required to take into account laid-down procedures throughout the process.

The laws and professional ethics guidelines in Tanzania require observance of some core principles of professional codes of ethics, which oblige the health researchers to, among other things; do no harm (non-maleficence); always do good (beneficence) and never divulge secrets (confidentiality). All rights mentioned in Module I must be respected, before, during and after the research.

  • National Institute for Medical Research Act, Cap. 59, Ss. 4 and 10 (1)
  • Tanzania Food, Drugs and Cosmetics Act, 2003, Ss. 61 and 63 (1)
  • Tanzania Commission for AIDS Act, Cap. 379, S. 5 (1) (f)
  • Ocean Road Cancer Institute Act, Cap. 86, S. 4(g)
  • Industrial and Consumer Chemical (Management and Control) Act, 2003, S. 10 (2) (t)
  • Guidelines on Ethics for Health Research in Tanzania of 2004.
  • Standard Operating Procedures (SOPs) of NIMR of 2007.
  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995.

1.1.1. Clinical trials

As a general rule, physicians/researches who are carrying out research in Tanzania are required to abide by Good Clinical Practice (GCP) and international standards as provided by CIOMS, UNESCO, Declaration of Helsinki, and other related instruments.

As a general rule the Investigator must demonstrate that the proposed research is justified scientifically and it must be conducted according to proper procedures. The Investigator must also demonstrate that he or she is experienced and therefore knowledgeable about the said procedures and applicable ethical guidelines and law.

The Code of Conduct and Health Laboratory Safety Rules of Tanzania, G.N Nos. 415/1998 and 101/2001 indicates that persons conducting clinical trials should observe the following:

  • Maintain strict secrecy of patient information and test results;
  • Protect the rights and privacy of patients/participants;
  • Be responsible for the logical process from the possession of the specimens to the production of data and the final report of the test results;
  • Be accountable for the quality and integrity of clinical laboratory services;
  • Exercise professional judgment, skills and care while meeting established ethical standards;
  • Uphold and maintain the dignity and respect of the profession and strive to maintain a reputation of honesty, integrity and reliability; and
  • Strive to improve professional skills and adopt scientific advances that benefit the patient and improve the delivery of test results.

The Code of Conduct and Health Laboratory Safety Rules is embodied in the Health Laboratory Technologists Registration Regulations, G.N Nos. 415/1998 and 101/2001. The said GNs are made pursuant to the provisions of S. 22 of the Health Laboratory Technologists Registration Act, Cap. 48.

It is also vital for researchers to seek participants’ views and valid permission before they undergo research because every person has the right to freedom of opinion, expression and choice.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (b), 5.3.1 and 5.4.1
  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 16
  • Constitution of the United Republic of Tanzania of 1977, Art. 18 (a)
  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996.

1.1.1.1. Clinical drug trials

A lawful and ethical clinical trial of a drug is the one which ensures benefits to and safety of patients or other human participants. The risks and benefits of the proposed trial must be professionally, skilfully and carefully considered (to meet the requirements of reputable standards) and the benefits must outweigh the associated risks. Other ethical requirements are the same as indicated in Modules I and II and elsewhere in this Module.

The characteristics of lawful clinical trials of drugs are well defined under provisions of the Tanzania Food, Drugs and Cosmetics Act, 2003. Section 61 of this law defines a clinical trials of a drugs as an investigation or series of investigations consisting of a particular description by, or under the direction of a medical practitioner, dentist or veterinary surgeon to the patient where there is evidence that drugs, medical devices or herbal drugs of that description have effects which may be beneficial and safe to the patient in question and the administration of the drugs, medical devices or herbal drugs is for the purpose of ascertaining beneficial and harmful effects.

It should be noted that deaths or injury caused bya failure to abide by ethical guidelines are civil and/or criminal offences based on the violation of the duty of care or professional misconduct or assault.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (d)
  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996.
  • Tanzania Food, Drugs and Cosmetics Act, 2003. Section 61
  • Medical Stores Department Act, Cap. 70, S. 4 (1) (c) and (d)
  • Law Reform (Fatal Accidents and Miscellaneous Provisions) Act, Cap. 310, S. 3

1.1.1.2. Other clinical trials

There are a few laws which regulate this field of scientific study. They include laws on radiology; imaging; radiations; chemicals (production, transferring and usage); and other related subjects.

Radioprotection

Any activity involving medical radiology and imaging is to be conducted according to the standards of conduct governing the field of medical radiology. It must further conform to the standards of Imaging Professionals to protect human subjects against the injurious effects of radiation.

Only registered Radiographers, Radiologists, Medical Physicists or Radio-pharmacists with a degree or diploma in radiography or any other qualification accredited by the relevant council are lawfully allowed to perform activities on radiology and imaging in Tanzania.

Physicians/researchers are required to maintain competence to practise at all times and must ensure that they never expose patients to unnecessary risks.

Transplantation

Tanzania has no specific law in regard to transplantation of human or animal organs. However, a general ethical principle requires physicians involved in the process to fully explain to potential donors the risks associated with the removal of organs or tissues and possible consequences to their health. Moreover, the decision to donate must be entirely voluntary.

It is unethical to conduct surgical procedures of transplanting organs without informing individuals about the process and the purpose of the surgical operation. Throughout the process physicians are required to take good and reasonable care. The surgical operation upon any person should be for his/her benefit or interest and should consider the patient's state at the time.

  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 5
  • Industrial and Consumer Chemical (Management and Control) Act, 2003, Ss. 11 to 41
  • Constitution of the United Republic of Tanzania of 1977 Art. 16 (1) and 18
  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 15
  • Penal Code, Cap. 16, Ss. 222A and 230

1.1.2. Research with human biological material

Tanzania does not have a law specifically meant to deal with biological materials such as transporting, storing or any kind of scientific disposition. However, NIMR has designed the samples of the Material Transfer Agreements (MTA) of 2008, which are made pursuant to the provisions of Section 4 (1) of the National Institute for Medical Research Act, Cap. 59.

  • Material Transfer Agreements (MTA) of 2008
  • National Institute for Medical Research Act, Cap. 59, Section 4 (1)

1.1.3. Epidemiological studies

It is generally required that in epidemiological studies, the research proposals should provide adequate information to ensure that individuals or the community can give valid consent and that there is consideration of respect for persons as well as beneficence and that the study will cause no harm (non-maleficence) and there will be justice in sharing the benefits and risks. In addition, the interests of research subjects (and not of the researchers) must be given priority throughout.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 6.1.5.4 and 6.6.4.
  • Constitution of Tanzania of the United Republic of Tanzania of 1977, Arts. 16 and 18.
  • HIV and AIDS (Prevention and Control) Act, 2008, S. 6 (4)

1.2. Research involving humans other than health research

Despite the fact that this Module focuses on research in the field of human health, it is important to consider other related fields of research which, in one way or the other, may be relevant and have an impact on the well-being of human subjects.

It is vital to study ethical issues pertaining to research on humans outside this field because of the same significance; that is, to consider how the interests of human subjects taking part in research can be legally and ethically protected or given priority. The same general principles of health research such as non-maleficence, confidentiality, beneficence and validity of the research apply to all research on human subjects.

Some of the relevant areas of study in this group are those related to the environment, wildlife, forestry, agriculture, animals, plants, insects and the like.

  • The Environmental Management Act, 2004;
  • The Mosquitoes (Control) Act, Cap. 99;
  • The Tsetse Fly (Control) Act, Cap. 100;
  • The Plant Protection Act, Cap. 133;
  • The Seeds Act, 2003;
  • The Animal Welfare Act, 2008.

Studies in these scientific fields have a direct bearing on the well-being of human subjects and it is with that in mind that researchers are obliged under those laws to abide by the same ethical principles.

2. Ethics review

It is required under the law that every research protocol should be submitted to a Research Ethics Committee (REC) for review, evaluation and consideration of ethical merit with the goal being to ensure and guarantee the rights, dignity, safety and protection of individuals and communities who take part in research activities.

The National Institute for Medical Research, Cap. 59 empowers NIMR to control, coordinate, conduct and promote the conduct of health research and disseminate the research results in Tanzania. Permission must be sought from NIMR in order to conduct health research in Tanzania and under no circumstances can such a process take part in the country without a mandate from the said institution. The said permit is granted in the form of an Ethics Clearance Certificate.

COSTECH approves and monitors all scientific research in Tanzania (regardless of the field of study). NIMR issues the Ethical Clearance Certificate and submits its copy to the Director General of COSTECH to enable researchers/investigators to apply for a Research Clearance Permit once it is satisfied with the scientific and ethical integrity of the protocol.

The Permit will then allow researchers to proceed to the immigration department to obtain a visa and a work permit. The Chief Medical Officer, Ministry of Health and Social Welfare will then sign the Ethics Clearance Certificate. The whole review process takes about 60 days for the research protocol to be granted ethical approval. Well documented applications tend to reduce the review time as they take less time and fewer movements between reviewers, researchers and the REC.

  • National Institute for Medical Research, Cap. 59, Ss. 4, 9.
  • Tanzania Commission for Science and Technology Act, Cap. 226, S. 5 (2) (b).

2.1. Research ethics committee

There are number of institutions in Tanzania (the Institutional Health Research Review Committee or Boards – IRBs) which are given statutory powers and duties to conduct health research review activities.

As for studies on human subjects, the National Institute for Medical Research, Cap. 59 empowers NIMR’s council to appoint such committees and subcommittees as it determines necessary for the control and co-ordination of medical research carried out by or on behalf of the Institute. In this case, there is the National Health Research Ethics Review [Sub-] Committee (NHRERC).

The crucial role of the NHRERC is to analyze and asses the risks and benefits of research for the protection of research participants. Normally, the NHRERC considers ethical issues like the scientific validity of the proposal; social value; methodology; investigator’s potential; data ownership; authorship and material transfer; budget issues; justification for local contact researchers and institutions in case the research involves external collaboration. It should also be noted that the Chairman, Medical Research Coordinating Committee (MRCC) is the one who signs the Ethical Clearance Certificate. MRCC is one of the three functional Committees of the NIMR Council. The Chairman of MRCC is also the Director General of NIMR.

  • National Institute for Medical Research Cap. 59, S. 9.

2.1.1. Jurisdiction of the REC

The NHRERC of NIMR operates countrywide in terms of geographical jurisdiction. Its powers and responsibility to review, analyze and approve scientific protocols are limited to those on health research on human subjects.

  • National Institute for Medical Research Cap. 59, S. 4

2.1.2.1. Independence of the REC

Independence of RECs and their members during the review and evaluation of the protocol is vital. Members of the RECs are supposed to be free from any influence or conflict of interest; that is why members of the NHRERC of NIMR sign a form to declare no conflict of interest, as well as a secrecy form, before they review any proposal.

The National Institute for Medical Research Cap. 59 guarantees the freedom of NIMR’s committees (RECs). Its provisions state, “NIMR is a body corporate and has perpetual succession.” Its function is thus free from influence by any other authority unless it is for furtherance of its mandate.

  • National Institute for Medical Research Cap. 59, S. 3

2.1.2.2. Independence of members

The independence of members of this committee is two fold. Firstly, members are selected in their personal capacities based on their interest, objectivity, impartiality, ethics, scientific knowledge and commitment. Their decisions are based on the merits of the protocols and not the institutions they are affiliated to. Secondly, deliberations on the protocol are based on the requirements of the SOPs, relevant professional ethics and other national and international legal instruments. Their decisions are therefore free from any other external influence apart from procedures and conditions provided in the standards or codes.

  • Standard Operating Procedures of NIMR of 2007. SOP # 1
  • National Institute for Medical Research Cap. 59, S. 3

2.1.3. Composition of the REC

The NHRERC consists of the following member institutions (appointing authorities), which are represented in the committee meetings:

  1. The National Institute for Medical Research (NIMR).
  2. The Tanzania Commission for Science and Technology (COSTECH).
  3. The Muhimbili University of Health and Allied Sciences (MUHAS).
  4. The Christian Social Services Commission (CSSC).
  5. The Muslim Council of Tanzania (BAKWATA).
  6. The Economic and Social Research Foundation (ESRF).
  7. The Tanzania Gender Networking Programme (TGNP).
  8. The Legal and Human Rights Centre (LHRC).
  9. The University of Dar-es-Salaam (UDSM).
  10. The Ministry of Health and Social Welfare (MoH &SW).
  11. The Ministry of Education and Vocational Training (MoE &VTC).

Members are appointed for a period of 4 years and may be renewed for two consecutive terms. They may resign from the committee by declaring their intention to the Chairperson.

REC Membership

The NHRERC requires that if a clinical trial is conducted in Tanzania, one member of the REC should be from Tanzania.

2.1.4. Functioning of the REC

The Standard Operating Procedures of NIMR of 2007 lists responsibilities of REC which are to:

  1. Review, discuss and consider research protocols submitted for evaluation to safeguard the rights and well-being of study participants.
  2. Review progress reports and monitor ongoing studies as appropriate;
  3. Evaluate final reports and outcomes;
  4. Support the executive in the discharge of their duties when called upon;
  5. Maintain secrecy of documents and deliberations of committee meetings;
  6. Declare conflicts of interest;
  7. Take part in ongoing education activities in biomedical ethics and research;
  8. Undertake duties assigned to them by the Chairperson;
  9. Attend meetings regularly and contribute actively during deliberation.
  • Standard Operating Procedures of NIMR of 2007. SOP # 3
  • National Institute for Medical Research Cap. 59, S. 4

2.1.4.1. Organization of the REC

The NHRERC is an organ (sub-committee) of the Medical Research Coordinating Committee (MRCC) of NIMR. It is the National Research Clearance body responsible for receiving and clearing protocols in Tanzania. The said sub-committee meets once every month to work for and on behalf of the MRCC.

Copies of Ethical Clearances once issued are sent to the Director of COSTECH and to the Regional Medical Officers (RMO) and District Medical Offices (DMO) for information.

2.1.4.2. Decision-making process within the REC

The decision making process inside the REC is outlined under the Standard Operating Procedures of NIMR of 2007.

  1. The proposals are received from the Principal Investigator (PI) and registered at NIMR by the Secretariat.
  2. Each proposal is sent to three identified reviewers;
  3. The status of the review process is conveyed monthly to Sub-committee meetings which consider the ethical issues based on the reviewers’ comments;
  4. The received comments are sent to Principal Investigators (PIs) for revision of their proposals;
  5. The proposal is re-submitted to NIMR for re-evaluation. It is supposed to be resubmitted within a month. The PIs who do not respond within three months are subjected to deletion from the register;
  6. The resubmitted proposals are reconsidered and resent to reviewers for recommendations and if reviewers are satisfied,
  7. Members of the Sub-committee will then endorse it.
  8. The approved proposals are thereby recommended to MRCC for ethical Research Clearance Certificate (RCC); and;
  9. Copies of RCC are sent to the Director of COSTECH and to the Chief Medical Officer of Tanzania for signing.
  10. Finally, the PIs are informed of the eventual/definitive decision of the REC.

The PI may also be invited into the meeting room during consideration of his or her protocol. He or she may make a 15-20 minute presentation on his/her protocol. After reflection, each committee member shall vote/have a say for or against a protocol or abstain. An absentee member is allowed to send in his/her comments but cannot vote. A majority of members present at a meeting is required to approve a protocol. The committee may also decide to postpone its decision in case more details or reflection is required.

  • Standard Operating Procedures of NIMR of 2007. SOP # 6 (1) to (9)

2.1.4.3. Transmission of the REC decisions

The committee will give the investigator an opportunity to respond in person or in writing in case it decides to disapprove (reject) a research proposal/protocol. It shall also include in its written notification to the investigator a statement of the reasons for its refusal.

A displeased investigator has the right to appeal against the decision of the committee to the MRCC which sits as a negotiation board once appeals are lodged to it. There is no duration or limitation of time within which appeals can be lodged and determined by the MRCC. In the absence of time limits, this could be done at any reasonable time or as soon as it would be practical. MRCC should make its decisions with all convenient speed and as often as necessary.

The format of appeal is also not mentioned. Therefore, an Appellant can just write a letter/statement which discloses his/her grounds (reasons) of dissatisfaction with the REC’s decision.

  • Standard Operating Procedures of NIMR of 2007, SOP # 6 (8) and (9)
  • Interpretation of Laws Act, Cap. 1, S. 62

2.1.6. Responsibility of the REC

It is essential for the REC to ensure that it guarantees participants’ rights to dignity, safety and protection in the review or evaluation of the ethical merit of research protocols. The REC must also ensure the scientific merit of research and the rights of the researchers.

However, this task will be different from other duties such as those on fair compensation of any damage or injury sustained in the course of the clinical trial or any other research. The latter are usually dealt with through legal processes and not by the RECs.

2.2. Ethics review criteria

It is necessary for the REC to devise criteria to be used as guidelines for approval or rejection of protocols apart from consideration of the scientific and ethical issues relevant to the proposed study.

The Standard Operating Procedures of NIMR of 2007 lists some of the criteria. It states that, in evaluating protocols and ethical issues, the REC should;

  1. Take account of the diversity of relevant laws, cultures and practices governing research and medical practices in various communities/localities in Tanzania. It should be noted here that Tanzania has more than 120 ethnic groups (such as Sukuma, Hehe, Chagga, Hadzabe, Ndorobo, Haya, Gogo, Maasai, and Nyakyusa), of which each one has its own cultural norms.
  2. The REC should therefore attempt to inform itself where possible of the requirements and conditions of the various localities where proposed research is proposed;
  3. The REC should be informed, as appropriate, by institutional/community committees and researchers of the impact of the research it has approved;
  4. The committee should also be guided in its reflection, advice and decisions by the ethical principles specified in various internal legal instruments such as the Declaration of Helsinki of 2008, CIOMS, Universal Declaration of Human Rights of 1948, International Convention on Civil and Political Rights of 1966 and other legal instruments.
  • Standard Operating Procedures of NIMR of 2007
  • Declaration of Helsinki of 2008
  • CIOMS
  • Universal Declaration of Human Rights of 1948
  • International Convention on Civil and Political Rights of 1966

2.2.1. Social value of the research

The social value of research is the importance of the project to the study community. A study with no social value will not leave the research participants better off.

  • Standard Operating Procedures of NIMR of 2007, SOP # 1 and 7
  • Guiding Principle on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 6.4 and 11
  • National Institute for Medical Research, Cap. 59, S. 4 (1) (d)
  • Constitution of the United Republic of Tanzania of 1977, Arts. 8 (1) (b), 9 (a), 9 (f) and 21 (2).

2.2.1.1. Medical relevance of the research project

The medical relevance of the research means a particular study, which is aimed at (among other aspects) easing a condition or disease. It can be, for instance, studying the treatment schedules for a drug for which the dose has already been established or a drug that is no longer used for treatment - to determine whether there is a new and better drug for treatment.

  • Guideline on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (a)
  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (2)
  • National Institute for Medical Research, Cap. 59, S. 4 (1) and (2)

2.2.1.1.1. Relevance for the target population

The population targeted for the study should be the one which will use the results, as beneficiaries.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (2)
  • Constitution of the United Republic of Tanzania of 1977, Art. 21 (2)
  • Tanzania Commission of Science and Technology Act, Cap. 226, S. 5 (2) (d)

2.2.1.1.2. Relevance for the public health

Any research should focus on the improvement of public health and not only of individual beneficiaries (participants) of the research.

  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 11

2.2.1.2. Safeguard the intellectual property rights

Respect for copyrights, patents, inventions, trademarks and other related forms of intellectual property is important in order to safeguard the rights of the researchers especially in respect of unpublished data, methods or results. Likewise, it is illegal and unethical to copyright or patent (and commercialize) the data/information or work done as a result of the research for one’s sole benefit without notifying other local or international collaborators who took part in the research process.

  • Trade and Service Marks Act, Cap. 326, Ss. 14, 16, 32, etc.
  • Copyright and Neighbouring Rights Act, Cap. 218, Ss. 2, 5, 6, 7, 10, 36, 37, etc.
  • Patents (Registration) Act, Cap. 217, Ss. 8, 9, 10, 11, 14, 17, 18, 21, etc

2.2.2. Scientific validity of the research

The evaluation of the scientific validity/quality of research is an important task of the REC because research which is not scientifically valid based on the criteria discussed in this and other Modules is unacceptable.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7
  • National Institute for Medical Research Cap. 59, S. 4
  • Tanzania Commission of Science and Technology Act, Cap. 226, S. 5

2.2.2.1. Method/ design of the research project

A health research project must be described in a well thought out protocol giving details of the experimental procedures. The protocol must be submitted to qualified independent reviewers for consideration, comments and guidance before implementation.

  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 2.3 (b)

2.2.2.1.2. Scientific literature review

The proposal needs to briefly mention what has been done on the subject and what is the gap to be researched in the study. Scientific literature review in a summary shows what is known, leaving the unknown to future studies.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7
  • Declaration of Helsinki of 2008, Principles 11.

2.2.3. Investigator’s qualification

The investigator need to be capable of conducting such a study, and this is reflected in his/her Curriculum Vitae or any other relevant documentation where the research experience is summarized. The investigator should indicate that he/she has all the qualifications specified by the applicable regulatory requirements/laws.

Different laws set out different qualifications for health researches. For instance: -

  • S. 61 of the Tanzania Food, Drugs and Cosmetics Act, 2003.
  • S. 4 of the National Institute for Medical Research Cap. 59.
  • S. 6 and 14 of the Health Laboratory Practitioners Act, 2007.
  • S. 5 (2)(d)(vii) of the Tanzania Commission for Science and Technology Act, Cap. 226.
  • S. 14 of the Medical Radiology and Imaging Professionals Act, 2007.
  • S. 14 of the Protection From Radiation Act, Cap. 188.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 4.1.1
  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (3)
  • Declaration of Helsinki of 2008, Principles 15
  • Tanzania Food, Drugs and Cosmetics Act, 2003, S. 61
  • National Institute for Medical Research Cap. 59, S. 4
  • Tanzania Commission for Science and Technology Act, Cap. 226, S. 5 (2)(d)(vii)

2.2.4. Compensation for damages

The sponsor and/investigator should include in their research protocols insurance for compensation in case the participating subject is injured. The compensation for the damage or injury aims at restoring the subject to the state which would have been his/her had the damage or injury not occurred.

It must be separate from compensation to subjects for the expenses resulting from their involvement such as transport and loss of earnings because of absence of work while taking part in the test.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.8.2.
  • Law Reform (Fatal Accidents and Miscellaneous Provisions) Act, Cap. 310, Ss. 2 and 3
  • Insurance Act, Cap. 394, S. 110
  • Constitution of the United Republic of Tanzania of 1977, Art. 13 (3)

2.2.4.1. Coverage of the damage

It is the duty of the sponsor to provide insurance and/or indemnify (legal and financial coverage) the investigator against claims arising from the trial or research because the participating subjects are entitled to compensation should they get injured in the process of investigation. However, claims which arise from malpractice, misconduct or negligence are not covered by the insurance. Those claims can be pursued through other civil or criminal procedures.

The insurer can be a local or international company (operating from outside Tanzania). The best practice is to use a local insurance company as an agent for the foreign insurance company. This is allowed under the Insurance Act, Cap. 394 of Tanzania. It is imperative for the REC to consider insurance cover in assessing the soundness of the protocol.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.8.1.
  • Insurance Act, Cap. 394, S. 110
  • Law Reform (Fatal Accidents and Miscellaneous Provisions) Act, Cap. 310, S. 3, 4 and 7

2.2.4.2. Persons responsible under the coverage of the damage

The responsible person for taking precautions against any danger by his/her act or omission is the one who is actually in charge of the mission, that is, the one who is supervising a particular activity or who has a legal or fiduciary duty to another person. The responsible person has a legal duty of care to protect others against his/her acts.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.8.1
  • Penal Code, Cap. 16, Ss. 227 to 234

2.2.4.3. Extent of damage

This covers all the damage which results from the act or mistake of the researcher. The nature of the damage must be vividly perceived or seen fully [must be adequate]. It can be very diverse in such a way that it goes beyond attacks on health. For instance, damage resulting from a surgical operation can also lead to lack of capacity to work because of impairment or psychological trauma.

The burden of proof and level of compensation also differ. They depend on the extent of the damage. Moreover, there must be a bond of adequate causality between the test/ research done and the damage undergone. Causality is adequate if it is specific and involve direct effect(s) resulted from the same research work. The person in charge when the damage occurred can defend him/herself by showing that there was not such a bond of adequate causality.

  • Penal Code, Cap. 16, Ss. 230 to 234

2.2.4.4. Nature of damage

The nature of the damage may depend on the way it arises. It may arise from data and specimen collection, storage, utilization of the results, economic loss, and even by interfering with the privacy of the human subject participating in research. It may be physical and psychological damage; it can as well be minor or serious and one damage can have multiple effects such as body lesions (treatment and readjustment), expenses of burial, attacks against property (e.g. damage caused to clothes), loss of profit, loss of support, moral wrong, indignity, psychological trauma and the like.

  • Law Reform (Fatal Accidents and Miscellaneous Provisions) Act, Cap. 310, Ss. 2, 3, 7 and 8

2.2.5. Selection of research participants

The method of selection of the subjects for research includes the criteria [factors/ justification] of selection as well. It applies to inclusion and exclusion tests as well as consideration of the situation of the subjects, for example, whether they are vulnerable or not. The goal is to arrive at an equitable selection, without loading unnecessary burden on a particular population.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 6.5

2.2.5.1. Selection criteria

The Tanzanian laws do not specifically provide criteria for the selection of research subjects. Researchers generally use the “consent” factor after deciding who has to be involved in the research. However, factors and reasons for inclusion or exclusion [plus withdrawal criteria and procedures] of subjects must be specified and justified in a scientific way – based on internationally accepted standards for health related issues.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 6.5 (1) and (2)

2.2.5.1.1. Inclusion criteria

The protocol has to state inclusion and exclusion criteria of subjects and justify the same in a scientific way.

2.2.5.1.2. Exclusion criteria

The protocol has to state inclusion and exclusion criteria of subjects and justify the same in a scientific way.

2.2.5.2. Vulnerable participants

There are circumstances whereby prospective research subjects are unable to freely consent to research procedures for one reason or another. They include children, mentally handicapped persons, prisoners, detainees, refugees, severely ill or unconscious patients and some elderly persons – who are in generically terms called vulnerable subjects.

Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied. Physicians and/or researchers should also be aware of the special needs of these groups and ensure greater privacy to enable them to communicate directly with the physicians and/or researchers.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3.6, 7 and 8
  • CIOMS Ethical Guidelines # 13 to 16

2.2.5.2.1. Populations or communities with limited resources

Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.

  • CIOMS Ethical Guidelines # 10

2.2.5.2.2. Countries or communities with insufficiently well-developed systems for the protection of the rights and welfare of research participants

Most human research subjects in Tanzania are unaware of their legal and human rights. This situation makes them vulnerable. Therefore, the sponsor and the investigator must ensure adequate informed consent so that the said human research subjects understand the rationale and their rights in respect of the proposed research. The explanation must include reasons for the study, procedures, techniques, advantages, disadvantages and the right for research subjects to decline participation or discontinue from study without consequences.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (f)
  • CIOMS Ethical Guidelines # 10 [and 12]
  • Constitution of the United Republic of Tanzania of 1977, Arts. 18 and 21

2.2.5.2.3. Individuals with limited capacity or freedom to consent or to decline to consent

Special justification is required for inviting vulnerable individuals [with limited capacity and freedom to consent] to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3.6, 7 and 8
  • CIOMS Ethical Guidelines # 13 and 15
  • Mental Health Act, 2008, S. 4.

2.2.5.2.4. Junior or subordinate members of a hierarchical Group

It is not unethical to conduct research on medical students, soldiers, employees of the sponsor, and other such groups as long as they have been informed about the research and have given a valid consent. An impression should not be created that acceptance to take part in the study will benefit any member of the group such as a student passing examinations, an employee receiving a promotion or financial inducements for soldiers. The consent must be freely and voluntarily given.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3.8.
  • CIOMS 2002, Guidelines # 13

2.2.5.2.5. Persons who have serious diseases

Persons who have serious diseases or who are severely ill or unconscious are vulnerable subjects because they do not have the capacity to understand or their freedom to refuse is limited. (see for instance S. 13 of the Infectious Diseases Act, Cap. 96 and S.12 of the Internationally Notifiable Diseases (Prevention) Act, Cap. 53)

They are therefore exposed to a danger of maltreatment and injuries. Researchers should deal with them in an exceptional way according to relevant principles.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3.6, 7 and 8
  • CIOMS Ethical Guidelines # 13

2.2.5.3. Recruitment process

The recruitment of subjects is different from the selection of the subjects. Note that information on the recruitment of subjects must be included in the request for research approval by the REC.

The research protocol should indicate a provision which shows the justification for the selected subjects and how will they be recruited. As a general rule a person to be recruited should be one who has attained the age of majority [18 years] and is of sound mind.

  • Law of Contract Act, Cap. 345, S. 11

2.2.5.3.1. Recruitment process in general

Concerning the recruitment of researchers in Tanzania there is the Procurement and Supplies Professionals and Technicians Board Act, 2007 which generally regulates practice and procurement (which includes recruitment) of professionals in scientific work. The general requirement is the relevance of a profession to carry out a specific field of science. Moreover, inducement and pressure during recruitment of subjects should be avoided. Moreover, the person to be recruited as a researcher should be the one who has attained the age of majority and is of sound mind.

  • Standard Operation Procedures of NIMR of 2007, SOP # 7 (3)
  • Law of Contract Act, Cap. 345, S. 11

2.2.5.3.2. Recruitment process by advertisement

Recruitment can be done through an advertisement provided that it specifies relevant qualifications and that the best qualified applicants are chosen. This method, however, is uncommon in Tanzania.

2.2.5.4. Community consent

There are circumstances where it may not be feasible to obtain informed consent from individual subjects for epidemiologic and other studies. In such situations; agreement of a community representative may have to be obtained in the community where the planned study is to take place; selection of the representative should be carried out in a manner that conforms with the traditions and culture of the community; approval given by the community has to be assessed and must conform with ethical norms; and there may be a need to establish the authenticity of the community approval.

It should be noted that an individual refusal (refusal of one person) to take part in the study must be respected regardless of the community consent.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 6.2 and 6.3
  • Law of Contract Act, Cap. 345, Ss. 13 and 14
  • Declaration of Helsinki of 2008, Principle 22.

2.2.6. Informed consent

The free and enlightened consent of the research subject is a legal obligation not only in the legislation as regards research, but also under the terms of the general rules aimed at the protection of the personality in civil, penal and constitutional law.

The Constitution of Tanzania states that everyone has the right and freedom to participate fully in the process leading to a decision on matters affecting him/her, his/her well-being or the nation. If a person is not well informed about a procedure, she/he will not fully participate in the process and this will be a breach of his/her right.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 6.5 (1) and (2)
  • Constitution of the United Republic of Tanzania of 1977 Arts. 18 and 21 (2)
  • CIOMS Ethical Guidelines # 5, 6 and 9

2.2.6.1. Capacity

Participating subjects must have the ability to understand and appreciate the nature of the research in order for them to give informed consent. Therefore, any person whose mind is not adversely influenced by any factor such as illness or insanity is deemed to be capable of giving lawful consent and to participate in research.

2.2.6.1.1. Adult

In Tanzania a person is presumed to be an adult if he or she has attained 18 years; according to the Age of Majority Act, Cap. 43, “[E]very person domiciled in Tanzania shall attain full age and cease to be under any disability of minority at the beginning of the eighteenth (18th) anniversary of the day on which he or she was born.”

  • Age of Majority Act, Cap. 43, S. 2

2.2.6.1.2. Capable adult

According to Tanzanian law a person is deemed to be a capable adult if he has attained the age of majority (18 years) as said above and that person is of sane mind and therefore capable of making sensible decisions by his or her own choice; that is, that person is said to have legal capacity to consent – according to the wording of the Nuremberg Code.

However, in some tribes in Tanzania such as the Maasai, Sukuma and Kurya, an unmarried girl, even if she is of the age of majority, is regarded as incapable of giving her consent. Equally in some of the Islamic communities an adult wife cannot give her consent without the permission of the husband. All these are important hints for a researcher to take into account. But those cultural norms do not invalidate the legality of scientific research if the consent of these people does not follow the said cultural norms.

  • Nuremberg Code

2.2.6.1.3. Incapable adult

Any person who has attained the age of majority (18 years) but because of serious illness, incarceration, insanity or intimidation is said to be an incapable adult because that person cannot make a rational decision or give valid consent.

  • CIOMS Ethics Guidelines # 9 and 13

2.2.6.1.4. Legal representative

The Legal Representative is the person designated by the law to safeguard the interests of the minor or adults who are incapable of acting on their own because of various factors. Legal Representatives for minors are generally parents or guardians.

For incapable adults, Legal Representatives can be family members, lawyers, social workers, and other members of the community duly appointed by the incapable adult or appointed by other members of the family/community because of their relationship to that incapable adult. In law, Legal Representatives cannot consent to any procedure which is contrary to the interests of those whom they represent.

  • Civil Procedure Act, Cap. 33, S. 91
  • Civil Procedure Act, Cap. 33, O. III, r. 1 to 6
  • Constitution of the United Republic of Tanzania of 1977, Art. 13
  • Children and Young Persons Act, Cap. 13, Various Provisions

2.2.6.1.5. Minor

A person who has not attained the age of majority (18 years) is termed a minor who can not make any rational decisions, including consent to research, which involve his/her wellbeing.

There are various laws governing minors/ children in Tanzania. The laws include the Children and Young Persons Act, Cap. 13; the Criminal Procedure Act, Cap. 20; the Civil Procedure Act, Cap. 33; the Penal Code, Cap. 16 and the Constitution of the United Republic of Tanzania of 1977.

  • Children and Young Persons Act, Cap. 13
  • Criminal Procedure Act, Cap. 20
  • Civil Procedure Act, Cap. 33
  • Penal Code, Cap. 16
  • Constitution of the United Republic of Tanzania of 1977
  • Declaration of Helsinki of 2008, Principles 27 and 28
  • CIOMS Ethics Guidelines # 9, 13 and 14

2.2.6.1.6. Capable minor

A capable minor is any person under the age of eighteen (18) years who is capable of testifying, making rational decisions, and doing anything for the purposes of enhancing his or her well-being.

However, the disability of minority in Tanzania is a subjective term. That is, it depends on the mental capacity of individual minors. Therefore, practically, one has to assess [for instance, using a socio-psychological test] the mental capacity of minors in order to ascertain if they know what they have to decide about health research involving them. A guiding question to ascertain this can be “whether the minor has capacity to understand” or “whether that minor can exercise his/her freedom to refuse.”

Where the minor’s capacity to understand is doubtful it may be a matter of good practice to seek the child’s permission to explain the research proposal to parents/guardians, and if the minor objects, the objection should be given weight.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3. 6 and 3.7
  • Age of Majority Act, Cap. 43, S. 2.
  • Constitution of the United Republic of Tanzania of 1977, Art. 21 (2)
  • CIOMS Ethics Guidelines # 13 and 14

2.2.6.1.7. Incapable minor

An incapable minor is any person under 18 years who is incapable of giving valid consent because of factors such as infancy, illness, mental handicap, and socio-cultural norms of some tribes in Tanzania, which prohibit children and young persons, especially girls, to talk to or discuss anything with elders or strangers, especially men.

In order to avoid all those legal issues, any consent from minors should be governed by safeguards including critical review by an REC, observance of the interests of the minor and seeking parents’ or guardians’ consent to any treatment or research.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 3. 6 and 3.7
  • Age of Majority Act, Cap. 43, S. 2
  • Customary Laws Declaration Order, G.N 276 of 1963
  • CIOMS Ethics Guidelines # 9, 13 and 14
  • Declaration of Helsinki of 2008, Principles 27 and 28

2.2.6.1.8. Legal representative

The Legal Representative is the person designated by the law to safeguard the interests of the minor or adults who are incapable of acting on their own because of various factors. Legal Representatives for minors are generally parents or guardians.

  • Children and Young Persons Act, Cap. 13

2.2.6.2. Participants’ Right to information

The right to information [and expression] is one of the fundamental human rights to everyone. In Tanzania, it is guaranteed under the Constitution of Tanzania. When it comes to heath research the right to information is the basis for informed consent. That is, a person cannot be validly informed of the research procedures if that person is denied the right to information and expression. This right to information has to be observed during the study in case there is new information that need to be communicated to the participants, such as a change in protocol procedures.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (4)
  • Constitution of the United Republic of Tanzania of 1977, Art. 18

2.2.6.2.1. Form of the information

The information must be translated in a local language of the participant. In Tanzania it should be in Kiswahili and can be clarified further in vernacular languages.

The language used should be plain and easy to understand by the general public. Privacy and confidentiality should also be assured. It should be noted that refusal to impart information, when requested, diminishes the trust which is fundamental to the researcher-participant relationship. The form of the information should be developed in a good way in order to enhance good communication and link with the participants in the research. Researchers should not withhold information other than on a temporary basis in order that suitable time can be found to provide a full explanation of the facts. Physicians/researchers must always inform the patient/participant promptly of any significant error that may have occurred in the course of investigation or treatment.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (4)
  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 2
  • Constitution of the United Republic of Tanzania of 1977, Art. 18 (d)

2.2.6.2.2. Scope of the information

The extent of information must be as broad as possible. The subject must have all the elements that are subjectively and objectively likely to influence their decision, including the reasons for the study, procedures, techniques. advantages, disadvantages and the right for research subjects to decline participation or withdraw from the study without consequences.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (f)
  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 2
  • Constitution of the United Republic of Tanzania of 1977, Art. 18 and 21 (2)

2.2.6.3. Freedom of consent

Consent is the exercise of a constitutional right to personal freedom. This can be restricted only under very strict conditions. The choice to take part or not in research should not be influenced in an undue way. As regards research, freedom to agree does not suffer from any exception. No one should be forced or pressured to take part in research against his/her will. The freedom to consent also covers freedom to withdraw consent at anytime.

2.2.6.3.1. Compensation to subjects

The compensation to subjects should not be likely to influence their decision to take part to the detriment of their health. Therefore, a promise of compensation should not unduly entice the subjects to take part in the research.

  • CIOMS Ethics Guideline # 7

2.2.6.4. Form of consent

In Tanzania, legal consent can be given in written form or orally. It can as well be given by the Legal Representative on behalf of another person if that person is a minor or an incompetent adult. It is common practice, though, that consent is in written form and its contents approved by the RECs.

  • Standard Operating Procedures of NIMR of 2007, SOP # 7 (4)
  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 4.8

2.2.7. Risk to benefit ratio

Each research protocol must contain an evaluation of the foreseeable risks and anticipated benefits. If the benefit/risk ratio is favourable, research is acceptable, insofar as the other conditions are met. The balance of risks and benefits is determined according to the principle of proportionality.

Therefore, the researcher must establish that the benefits of the research outweigh the associated risks. The researcher must, therefore, establish safeguards for the protection of research subjects from potential harm and the research must be carefully monitored, and wherever there are observable harms to research subjects; researchers should immediately discontinue the experiments.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (d)
  • Declaration of Helsinki of 2008, Principles 18 and 20
  • CIOMS Ethics Guidelines # 8 and 12

2.2.7.1. Risks of the research

Scientific research, especially epidemiology and clinical trials, are prone to potential physical and psychological damage because they involve human beings at different levels. Therefore, a researcher has to oversee and take into account all potential risks – consider whether there is a probability that damage will occur in the process of investigation. The important question is whether measures are in place to mitigate/curb the risks and not to prove that they are or are not harmful.

Special consideration should be given to the rights of individual participants, communities and the researchers as well to ensure that their dignity and other human rights are respected throughout the research process.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 6.1.4.1
  • Constitution of the United Republic of Tanzania of 1977, Art. 9 (a), 9 (f) and 13 (6) (e)

2.2.7.1.1. Harm

The damage [harm], which includes loss of life or personal physical or physiological injury, can be defined by its nature and extent. During the analysis, it is necessary to take into account these two factors to judge the gravity of the damage. Any extent of damage cannot, however, be neglected if it occurs.

For research protocols which carry high risks because they involve invasive procedures, the question whether there is or is not professional negligence does not arise. Likewise, even if the issue of professional negligence is advanced to determine the nature and extent of the damage, the consideration of justice to research subjects should be taken into account because a researcher is bound by the core principle of non-maleficence [“the study will do no harm”].

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 6.1.4.2; 6.1.5.4; 7.4.2.1; 7.4.2.2
  • Law Reform (Fatal Accidents and Miscellaneous Provisions) Act, Cap. 310, S. 2
  • Constitution of the United Republic of Tanzania of 1977, Art. 9 (a), 9 (f) and 13 (6) (e)

2.2.7.1.4. Measure to minimize risks

There are a number of ways to scale down the seriousness of harm such as:

- Establishment of a mechanism to protect research subjects from potential harm;
- Careful monitoring of research subjects.
  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (d)

2.2.7.1.5. Monitoring

In Tanzania, the NHRERC (REC) is allowed to monitor and evaluate safety and adverse events at any time during the research. The main aim is to verify that the rights and well-being of human subjects are protected.

The REC is allowed to conduct onsite monitoring visits at random, especially for researchers who do not submit progress reports as per regulations after two reminders; or who prolong completion of their research beyond the approved time frame; or researchers who are suspected of having changed their objectives and conduct as approved.

During the monitoring visits, the REC will review informed consent documents to make sure that the site is using the most relevant version; it will review 25% of the participants’ files to ensure that participants have signed the approved consent form.

  • Standard Operating Procedures of NIMR of 2007, SOP # 13 and 17
  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.18.1 (a) and (c)

2.2.7.1.6. Quality assurance

The sponsor and investigator are responsible for implementing and maintaining quality assurance and quality control systems according to the regulations/laws in order to ensure that research is conducted and data are generated, documented (recorded) and reported in compliance with the protocol and applicable regulations/laws. Quality assurance should be applied at each stage of data handling in order to ensure that data are reliable and have been processed correctly.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.1.1 and 5.1.3
  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (a) and (g)
  • Penal Code, Cap. 16, S. 342

2.2.7.1.7. Appropriate resources

The means and infrastructure must be suitable for the research to be undertaken. The investigator should be able to demonstrate potential for recruiting or acquiring the most appropriate resources [assistants, subjects and financial resources]. The investigator needs to have an adequate number of qualified staff and relevant materials for the intended investigation.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 4.2.1 and 4.2.3

2.2.7.1.8. Competent personnel

Just like the investigator [see qualification of the investigator above], the personnel must have sufficient knowledge/competence to be able to carry out the tasks which are entrusted to them. At no time should health research be left in the hands of incompetent persons/personnel. The investigator should inform the personnel about the contents of the protocol.

In dealing with vulnerable research subjects such as children, patients, elderly persons and the like, attention must be directed at ensuring that health research involving those people rests in the hands of competent personnel.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 2.3 (c)

2.2.7.2. Benefits of research

The benefits of research can be calculated in multiple ways. Research should focus on improvement of the quality of life, contributions to the development of local capacity for research and treatment and benefits to local communities and availability of study results.

All these should be taken into consideration while examining the adequacy and legality of the protocol. That is, the protocol should include aspects of imparting benefits to the local personnel/community.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ# 6.5.1 and 7 (5)

2.2.7.2.1. Direct benefits

The direct benefits are especially of knowledge, which directly benefit subjects who participated in the research process. For instance, research studies which are proposed or which have already been done in a community should provide an opportunity to train local health personnel in skills which can be used after the study has come to an end.

  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ# 6.5.2

2.2.7.2.2. Indirect benefits

This is the opposite of the “direct benefits.” It means returns which indirectly benefit subjects who participated or did not participate in the research process. In these cases, the acceptable level of the risks is lower than that allowed for direct benefit.

2.2.8. Conflicts of interest

This has to do with avoiding undue influence from a member or members of an REC with respect to the protocol submitted for review. For conflict of interests to be an issue of concern, one has to prove that the reviewer or investigator or sponsor or institution is affiliated with the member(s) of the REC and therefore by reason of that situation, the member(s) of the REC will not make an independent decision.

The governing rules of conduct of the NHRERC of NIMR require every member of the REC to sign a form declaring that s/he has not any interest in the protocols or decision to be made. It is in jurisprudence of law and (natural) justice that a person should not be part of the decision process in matters in which s/he has a direct or indirect interest. The aim, as said, is to safeguard the capacity of the REC to make an independent decision.

Conflicts of interests can apply to the following actors: Investigator: For example, an investigator who is a member of the REC has a conflict of interests if his/her pending protocol is being examined by that REC; Sponsor: For example, a sponsor who is a member of the REC has a conflict of interests if the protocol which it is sponsoring is being examined by that REC; Institutions: For instance, one of the members of the REC is a PI and that person is an employee of the institution which hosts or coordinates the REC.

2.2.9. Protection of privacy & confidentiality

The right to privacy is one of the very basic human rights guaranteed under the Constitution of Tanzania of 1977. The right to privacy permits an individual (based on his/her own discretion) to decide the manner and extent to which information concerning him/her should be shared with others. Confidentiality is a central issue in fiduciary relationships such as between doctor and patient, researcher and participants or lawyer and clients. The information obtained in this kind of relationship must be, ethically and legally, regarded as strictly confidential unless the subject consents otherwise.

  • Guideline on Ethics for Health Research in Tanzania of 2004, Princ. # 4.1.1
  • Constitution of the United Republic of Tanzania of 1977, Arts. 16 (1) and 19 (1)

2.2.9.3. Data protection

The sponsor or investigator should utilize appropriately qualified individuals to handle and verify the data.

  • ICH Guideline for Good Clinical Practice [E6(R1)], 1996, Princ. # 5.5

2.2.9.4. Right of access to data

The individual subject must be guaranteed the right to access his or her own data. The right of access to data must be guaranteed at any time for the person who participates in research because every person in Tanzania has a constitutional right to be informed at all times of various important issues to him/her and to the society.

Apart from a person who takes part in research, any interested person or institution [such NIMR] can actually have access to data because of certain legal requirements as long as privacy and confidentiality are safeguarded.

  • Standard Operation Procedures of NIMR of 2007, SOP # 11
  • National Institute for Medical Research, Cap. 59, Ss. 10 (1) and 12
  • Constitution of the United Republic of Tanzania of 1977, Art. 18 (b) and (d)

2.2.10. Ongoing respect for research participants

As said earlier, the general code of medical ethics as indicated in this Module targets the protection of research subjects. Three core ethical principles are non-maleficence (never do harm); beneficence (always do good) and confidentiality (never reveal secrets). There are some of the ethical pillars, which once breached, could result in negligence (breach of duty of care) or professional misconduct.

Unanticipated risks are sometimes discovered during the course of a study. It is a responsibility of a researcher to keep close supervision of his/her research. The researcher’s assumption of responsibility must thus be as much assured during research as after research. A process of continuous follow-up must also be set up in order to be aware of the long-term effects of research.

  • Standard Operation Procedures of NIMR of 2007, SOP # 13 and 17

2.2.10.1. During the research

The researcher must ensure the wellbeing and observance of all human rights during the investigation. There must be in place a mechanism for minimizing the risks that occur in the process of investigation.

  • Standard Operation Procedures of NIMR of 2007, SOP # 11

2.2.10.2. After the research

The fear of the risks associated with research can persist even after the researcher has left. This fear is genuine, especially in remote rural areas where there are no health facilities which could mitigate harms resulting from the research. This is why it is important to ensure that after the end of the research, the well-being of the subjects will not be affected by ending their participation. When the subject reacts positively to the treatment tested, they should continue to profit from it at the end from research.

As a general rule post-study access to treatment should be ensured by the researcher. The protocol has to indicate what strategies are in place to guarantee sustainability of the health of the research subjects. As for research (such as clinical trials) which involve patients, the researcher should provide patients with the necessary information to enable them to improve their health and prevent further illness.

  • Guiding Principles on Medical Ethics and Human Rights in Tanzania of 1995, Princ. # 11
  • Guidelines on Ethics for Health Research in Tanzania of 2004, Princ. # 8.3.4