Jadesola Lokulo-Sodipe, Oluwatoyin Akintola, Clement Adebamowo
This module was realized with support of Fogarty International Center and West African Bioethics
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1. Types of Research

The different types of researches are being conducted in Nigeria include applied, basic, directed and biomedical. Researchers must however comply with laid down laws, principles, and guidelines to ensure that research is scientifically sound. The Federal Ministry of Science and Technology was saddled with the responsibility of monitoring and co-ordinating research and development issues in Nigeria. However in 1988 witnessed a reorganisation of the civil service by the Federal Government for effective, efficient and productive service. This resulted in the creation of the Department of Planning, Research and Development (DPRS) in all ministries. With regards to research involving children, the Technical Advisory Committee has the function of advising the Federal Ministry of Health on policy formulation, promotion, co-ordination, and monitoring of research programmes. The Federal Ministry of Health may initiate and support research activities relevant to the development of the child together with institutions, Non-governmental organisations and private sector.

  • National Code for Health Research Ethics, 2007
  • NAFDAC GCP Regulations, 2009.
  • Scientific and Industrial Research Act.
  • National Child Health Policy, Para 3.4 and Para. 4.1.6

1.1. Biomedical Research

The National Code for Health Research Ethics provides that Biomedical Research can be divided into two general categories, namely:

* Therapeutic Procedures which are intervention administered with the intent of providing direct benefits to the research participants. * Non-Therapeutic Procedures which are interventions that are not administered with therapeutic intent and are only intended to answer the scientific questions of the study.

Health research must be scientifically sound to be ethical. Before clinical research can be conducted on humans in Nigeria, it must be both scientifically sound and ethical.

The Research Unit within the Department of Health Planning, Research and Statistics is the Department, Federal Ministry of Health, co-ordinates issues concerning health research in Nigeria. Be that as it may, various Institutes co-ordinates different aspects of research.

  • National Code for Health Research Ethics, 2007, Section A,
  • Food, Drugs, and Related Products (Registration, etc) Act
  • Child’s Right Act, Section 5
  • National Agency for the Control of HIV/AIDS Act, 2008, Section 6(1)(e); Section 6(2)(a)
  • Scientific and Industrial Research Act, Section 3(1)
  • National Primary Health Care Development Agency Act
  • National Eye Centre Act

1.1.1. Clinical Trials

A clinical trial is any investigation on participants intended to discover or verify the clinical, pharmacological and /or other pharmacodynamic effects of one or more investigational medicinal products, and /or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.

Clinical trials would be illegal unless the investigators ensure the benefits and safety of participants prior to the commencement of the trial. The investigators must weigh the foreseeable risks and inconveniences against the anticipated benefit for the individual trial participant and other present or future patients. Anticipated benefits must justify the risks.

The investigators are expected to seek participants’ views and consent before commencing the research. This is hinged on the right to freedom of opinion, expression and the right to make choices. Failure to obtain consent may also constitute an actionable wrong in battery law. Battery is the intentional application of force to another person.

Where death and injury is occasioned as a result of failure to comply with ethical guidelines, it is a ground for civil and /or criminal liability which can be founded on the breach of duty of care, professional misconduct or assault.

  • NAFDAC Good Clinical Practice Regulations 2009, Sections 6, 36
  • 1999 Constitution Sections 34, 37,39
  • African Charter on Human and Peoples’ Right (Ratification and Enforcement) Act, Cap A9 Art 4, 5, 9
  • NAFDAC GCP Regulations 2009 Section 4
  • Child’s Rights Act, Section 11

1.1.1.1 Clinical Drug trials

Section 5 of the Food, Drugs and Related Products (Registration, etc) Act, empowers NAFDAC to regulate and control clinical trials in Nigeria. S.5(1) provides that, no person shall in the course of his business:

  • Procure the manufacture or assembly of a drug, drug product, cosmetic or medical doctor.
  • Procure the importation or supply of a drug, drug product, cosmetic or medical device for the purpose of a clinical test unless he is a holder of a valid clinical trial certificate and the trial is to be carried out in accordance with the terms of the certificate and the provisions of any regulation in force.

Application for clinical trial certificates is to be made to NAFDAC in the prescribed manner.

Where there is a contractual agreement between a sponsor and a Principal investigator conducting a clinical trial, such contractual agreement must be approved by the Head of the Institution in which the trial is being conducted or designee appointed for that purpose.

Clinical trials in Nigeria must comply with Good Clinical Practice (GCP), and international standards laid down by Belmont Report, CIOMS, Declaration of Helsinki, UNESCO and other international guidelines. There are also various local Acts and guidelines that govern conducting clinical trials in Nigeria.

  • Food, Drugs and Related Products (Registration, etc) Act, Sections 5
  • National Code of Health Research Ethics, Section E (o)
  • NAFDAC GCP Regulations, 2009;
  • Child’s Right Act, Section 2(2)
  • 1999 Constitution of the Federal Republic of Nigeria
  • National Health Bill, Section 32
  • Code of Medical Ethics in Nigeria, Section 31

1.1.1.2 Other Clinical Trials

1.1.1.2.1 Radioprotection

With regards to Radioprotection, the Radiographers (Registration, etc) Act, the Nuclear Safety and Radiation Protection Act and the Regulations made pursuant to the latter Act, set out standards of conduct governing exposure to radiation, imaging, professional qualification and level of protection to be given to human subjects against injurious radiation.

The Criminal Code Act requires every person who, except in the case of necessity, undertakes to administer surgical or medical treatment or to do any other lawful act which is or may be dangerous to human life or health, to have reasonable skill and to use reasonable care in doing such act. Where a person, whose duty it to do an act, undertakes to do any act the omission to do which is or may be dangerous to human life or health, he will be liable for any resulting consequence by reason of the omission to perform the duty.

  • Radiographers (Registration, etc) Act, Sections. 10, 18-21
  • Nuclear Safety and Radiation Protection Act, Sections 4(1) (b-d); 18;21;25
  • Nigerian Safety and Security of Radioactive Sources Regulations, Sections 4-9, 10, 28, 35(1)(a)
  • Criminal Code Act, Sections. 303; 304; 305

1.1.1.2.2 Transplantation

The National Health Bill 2008 makes provision for laws governing blood, tissue or blood product transplant. This must be done with the informed and written consent of the donor and in accordance with the conditions prescribed by the appropriate authority. Transplantation must be done in a hospital authorised for that purpose and by a medical practitioner. The tissue, blood or blood product removed may be used only for medical or dental purposes. Where a donor has not given consent or where the tissue is one that cannot be replaced by natural process for a person under the age of 18, the tissue may not be removed. A donor may however revoke his consent at any time prior to the removal of the relevant organ. In addition, other ethical guidelines would also apply. It is expected that the risks involved would have been explained to the parties concerned and they are then given the opportunity to voluntarily consent to the procedure. The medical practitioners involved owe a duty of care to the patients in carrying out the transplant. The best interest of the patient given the prevailing circumstances must be considered before the transplant is done.

  • The National Health Bill, Sections 49, 50(1)&(2), 52, 53, 58
  • National Health Bill 2008.
  • 1999 Constitution, Sections 33 & 34
  • Child’s Right Act, Sections 11&13
  • Code on Medical Ethics, Section8(A)
  • Criminal Code Act, Sections 303-305

1.1.2. Research with human biological material

Transfer of samples and biological materials such as animals, herbs, and plants out of Nigeria requires a Material Transfer Agreement (MTA) detailing the type of materials, anticipated use, location of storage outside Nigeria, duration of such storage, limitations of use, transfer and termination of use of such materials subject to any law, and enactment in Nigeria. The HREC concerned is expected to review the MTA to ensure consistency with the stated objectives of the research, the contents of the informed consent documents and other principles. The HREC grants approval provisional approval pending receipt of acknowledgement from the NHREC. Final approval is granted by the HREC following receipt of the acknowledgement and compliance with all other criteria.

The National Health Bill, 2008 and the Federal Ministry of Health’s Nigerian Blood Policy 2005 make provision for transporting, storing and scientific disposition of human biological materials such as blood, gamete, etc . The Bill prohibits reproductive or therapeutic cloning without the approval of the Minister. Importation and exportation of human zygotes or embryos must be done only with the prior written approval of the Minister and on the recommendation of the National Ethics Research Committee.

The Nigerian National Blood Policy standardizes the methods of collection, transportation, processing, testing, storage, distribution of blood and blood components and derivatives which are safe for transfusion and other medical therapy. National cross-border exchange of blood and blood products may be done under the authority of a registered medical practitioner. All health personnel handling and/or administering blood and blood products are expected to observe the National Blood Service Technical Guidelines for appropriate record keeping and haemovigilance.

  • National Code of Health Research Ethics, Section E(n)(2),(4),(5)
  • National Health Bill, 2008, Sections 51 (a) and (b), 51(2)
  • Nigerian National Blood Policy, 2005, Para 9 & 55

1.1.3. Epidemiological studies

Research protocols for epidemiological studies must protect the welfare and rights of research participants and reflect the basic ethical principles of respect for persons, beneficence and justice. It must be detailed enough for a proposed participant to make a decision as to whether or not he/she would participate in the study.

  • Belmont Report
  • NAFDAC Good Clinical Practice Regulations 2009
  • National Health Bill, Section 32
  • 1999 Constitution, Sections 33 & 34

1.2. Research involving humans other than health research

Other human subject researches include those related to the environment, wildlife, agriculture education and animals. Same ethical principles that apply to biomedical research would also apply to this kind of research.

  • Environmental Impact Assessment Act Cap E12, Section 1, 2&4
  • Animal Disease (Control) Act Cap A17
  • Directorate of Food, Roads and Rural Infrastructure Act, Section 5(h)
  • National Environmental Standards and Regulations Enforcement Agency (Establishment) Act, Section 7(a)-(m)
  • NAFDAC Good Laboratory Practice Regulations, 2008.

2. Ethics Review

Without validity, research cannot generate the intended knowledge, nor can it produce any benefit, and cannot justify exposing subjects to burdens or risks. It is therefore essential and indeed a requirement of the law that the ethical and scientific rigour of all research projects be conducted in Nigeria must be reviewed by a Nigerian based ethical review committee. All research involving human participants conducted in Nigeria must be revised by an ethics committee, and where appropriate by the National Agency for Food, Drug Administration and Control (NAFDAC). The Research Unit within the Department of Health Planning, Research and Statistics is the Department, Federal Ministry of Health, co-ordinates issues concerning health research in Nigeria. Be that as it may, various Institutes co-ordinates different aspects of research.

  • National Code of Health Research Ethics, Sections A, E (d) (i)
  • NAFDAC GCP Regulations, Sections 3(c)
  • National Health Bill, 2008, Section 34 (2)
  • NAFDAC Act, Section 5
  • Scientific and Industrial Research Act, Section 3(1)
  • National Primary Health Care Development Agency Act
  • National Eye Centre Act

2.1 Research ethics committee

In Nigeria, the various institutions have their research ethics committees which are known as the institutional review boards or the ethical review committee. The National Health Research Ethics Committee (NHREC) is however the apex body responsible for the provision of and adherence to guidelines that govern ethical research practice in order to ensure the protection of human research participants.

S. 31 of the National Health Bill establishes the National Health Research Committee (NHREC) to amongst others, determine the extent of health research to be carried out by public and private health authorities in Nigeria.

All RECs must be registered with the NHREC.

  • National Health Bill, 2008 Sections 31(5)(a), (c), (6), 34(1)
  • National Code of Health Research Ethics, Sections A & C

2.1.1. Jurisdiction of the REC

The authority of REC shall be limited to the boundary of the proposing institution or the activities of its permanent members of staff, unless otherwise specified by the NHREC. Where a permanent member of staff is the principal investigator of a study taking place outside the boundaries of the proposing institution, the researcher shall seek ethical oversight only from the institution in which he/she is a permanent member of staff. This provision does not preclude co-investigator(s) from seeking ethical oversight from their institution(s) where there is more than one study site.

  • National Code of Health Research Ethics, 2007, Section C (e)

2.1.2. Independence of ethics review

For research to be ethical, it must undergo independent research. This assures society that reasonable attempts have been made to minimize the potential impacts of these conflicting interests and ensures balanced judgements.

  • National Code of Health Research Ethics, 2007, Section F (e)

2.1.2.1. Independence of the REC

The REC is an independent body which is responsible for its decision. It must be seen to be independent. Any conflict of interest must be disclosed. It is however subject to oversight by the NHREC.

  • National Code for Health Research Ethics, 2007, Sections A and C

2.1.2.2. Independence of members

It is pertinent for the members of the REC to be independent. Consequently, no member of the REC may participate in the REC initial or continuing review of any project in which the member has a conflicting interest.

  • National Code of Health Research Ethics, 2007, Section D(g)
  • UDBHR, 2005, Art 19

2.1.3. Composition of REC

The HREC consists of at least 5 members. Where the members are more than five, must be in odd number. In selecting members, the HREC, should take cognisance of age, gender, socio-cultural backgrounds, religion and sensitivity to issues.

  • National Code of Health Research Ethics, 2007, Section D (b) & (c)

2.1.4. Function of HREC

The main functions of the Ethics Committee include: * Reviewing research proposals and protocols to ensure that research conducted will be in the spirit of endeavouring to promote health, and/or prevent disease and/or disability and cure disease; * Ensuring that humans involved in research are treated with dignity and that their well-being is not compromised and that animals involved in research are treated compassionately; a) Ensuring that informed consent is obtained in the case of human subjects; and b) Granting approval in instances where research proposals and protocols meet ethical standards; c) Monitoring the process and evaluating the outcome of research it approves to ensure that the guiding ethical principles are adhered to throughout the research process.
  • National Health Bill, 2008, Section 34(2)
  • National Code of Health Research Ethics, 2007, Section E

2.1.4.1. Organization of the REC

Each HREC shall have at least 5 members and if more, then the total membership must always be an odd number. The members shall be sufficiently qualified. Members should have varying academic and professional backgrounds to promote complete and adequate review of health research. It also expected that a lawyer be a member, at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. Each REC shall include at least one member who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

  • National Code of Health Research Ethics, 2007, Section D

2.1.4.2. Decision making process within the REC

REC shall review prescribed application materials and have authority to approve, require modifications in (to secure approval) or disapprove all health research activities covered by this code.

In order for research to be approved, the decision shall ordinarily be arrived at by discussion and consensus or it shall receive the support of a simple majority of those members present at the meeting.

REC may, at its own discretion, invite representations from the applicant(s), sponsor(s), institution(s) or any other person(s) that it may consider relevant to provide information pertinent to the research during the review process.

2.1.4.3. Transmission of the REC decision

HREC shall notify investigator(s) in writing of its decision to approve, disapprove or requirement for modifications of the research activity. Where the REC fails to conclude review within the stipulated time and the application has not been referred to the NHREC, the applicant has a right to complain to the NHREC with the possibility of re-allocation of the proposal to another REC and sanction of the concerned REC.

  • National Code of Health Research Ethics, 2007, Section E (d)

2.1.5 Ongoing review of research

It is the responsibility of the REC to conduct continuing oversight of research at intervals adjudged by REC as being appropriate to degree of risk involved in participation in the research. REC has authority to examine all aspects and documents including consent forms, questionnaires, case report forms etc. that are related to the research and necessary for the REC to conduct its oversight function. This shall be done at least once a year or at least once during the lifetime of the research where the duration of the research is less than a year.

REC may observe or cause to be observed on its behalf, the research and its consent process to ensure compliance with the highest scientific and ethical standards.

REC may initiate process of oversight of research in the event of receipt of complaints, information or data relevant to the research from any source.

  • National Code of Health Research Ethics, 2007, Section E (e) (1-5)

2.1.6. Responsibility of the REC

The REC is to provide ethical advice to researchers in order to assist decision-making on the adequacy of proposed research projects regarding the protection of potential and actual human subjects. It must ensure that the study protocol is scientifically sound in purpose and design, methodologically rigorous, valid and feasible. It is the responsibility of the REC to ensure human protection in all studies involving human subjects.

  • National Code for Health Research Ethics, 2007, Section E

2.2. Ethics review criteria

In carrying out its duty of ethical review, the RECs have criteria for approval and rejection of protocols. These are in addition to the guidelines for ascertaining scientific and ethical issues relevant to the proposed study. Nigeria is multicultural having over 100 tribes with over 400 languages. It is therefore pertinent for the REC to take into account the culture and religious beliefs of the host community. It should, familiarize itself with requirements and conditions of the various localities in which the research is taking place.

The impact of the research on the participants must be clear from the onset. Also to be considered in arriving at a decision are the numerous national and international legal documents guiding the conduct of research on humans.

  • UDBHR, 2005, Art 12
  • NAFDAC GCP Regulations, 2009, Section 11 (b)
  • National Code of Health Research Ethics, 2007, Section F
  • Declaration of Helsinki, 2008
  • Belmont Report
  • CIOMS
  • International Convention on Civil and Political Right of 1966 (ICCPR)
  • Universal Declaration of Human Right (UDHR) 1948

2.2.1. Social value of the research project

The research must have social value to either participants, the population they represent, the local community, the host country or the world, in order to justify the use of finite resources and risk exposure of some participants to harm. It should evaluate issues that lead to improvements in health and contribute to knowledge, contribute to capacity building, technology transfer and health care delivery strategies that address significant local health problems and add value to local participants of research, including researchers, institutions, communities and the country.

  • National Code of Health Research Ethics, 2007, Section F (a)
  • 1999 Constitution of the Federal Republic of Nigeria, Section 17 (1), (2)(a-d), (3)(c),(d),(l)
  • UDBHR, 2005, Art 14

2.2.1.1. Medical relevance of the research project

The research must be relevant to both the broad health and development needs of the country and to the real needs of those who are affected by the diseases and concerns under the study. The findings of the research must be translatable into mechanisms for improving health status of Nigeria.

  • National Code of Health Research Ethics, 2007, Section F
  • NAFDAC GCP regulations, 2009, Section 11(b)(i)
  • UDBHR, 2005, Art 14

2.2.1.1.1. Relevance for the target population

The research proposal should provide sufficient justification for the reasonable likelihood that the population on whom research is to be carried out stand the benefit from the research project and its results. With regards to children, research must be in their best interest.

  • National Code of Health Research Ethics, 2007, Section F
  • NAFDAC GCP regulations, 2009, Section 11(b)(i)
  • UDBHR, 2005, Art 14

2.2.1.1.2. Relevance for public health

The research project must be relevant to the broad health needs of the country and to the real needs of those who are affected by the diseases and concerns of the study.

  • National Code of Research Ethics, 2007, Section F (a)
  • UDBHR, 2005, Art 14

2.2.1.2. Safeguard intellectual property rights

Nigerian law upholds and protects intellectual property rights. In order for researchers to enjoy the benefit of their work, it is important that the intellectual property rights in their work be protected, especially with respect to unpublished data, methods or results. With regards research, the relevant intellectual property rights are in the area of copyright and patent. It illegal to infringe the intellectual property rights of others.[MH3]

  • Sections 1, 10, 12, 21 Copyright Act, Cap 28 LFN 2004
  • Sections 1, 2, 3, 6, 13, 17,19 Patents and Design Act, Cap P2 LFN 2004
  • Sections 2-6, 22 Trade Marks Act, Cap T13 LFN 2004
  • Sections 491-493 Criminal Code Act, Cap C38 LFN, 2004.

2.2.2. Scientific validity of the research project

The research must have sound methodology and high probability for providing answers to the specific research question posed. The research protocol must show knowledge of the relevant literature, derived where possible from systematic review of that literature. The research methods and result should be open to peer-review and scrutiny.

  • National Code of Health Research Ethics, 2007, Section F (b)
  • NAFDAC GCP Regulations, 2009, Section 6 (e)
  • Code of Medical Ethics in Nigeria, Section 31 (A)(1)

2.2.2.1 Method/design of the research project

The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol.

  • National Code of Health Research Ethics, 2007, Section F (b)
  • Code of Medical Ethics in Nigeria, Section 31 (A)(iii)

2.2.2.1.1. Pre-clinical data

With regards pre-clinical data, the Copyright Act provides that literary work will be eligible for copyright if it can be shown that sufficient effort has been expended on making the work original character and fixed on any medium of expression either directly or with the aid of any machine or device.

  • Section 2 (a-b) Copyright Act, Cap C28, LFN 2004.

2.2.2.1.2 Scientific literature review

There must be a thorough knowledge of the scientific literature, other relevant sources of information.

  • Helsinki Declaration, 2008, Para. 11

2.2.2.1.3. Research design

The research must be designed is such a way as to answer the research question and must be justifiable.

  • National Code of Health Research Ethics, Section F
  • Code of Medical Ethics in Nigeria, Section 31(A) (iii)
  • Helsinki Declaration, Para. 13

2.2.2.2. Investigator’s brochure

The investigator’s brochure is a compilation of clinical and non-clinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects’ research. A medical person should participate in the editing of the investigator’s brochure and its content should be approved by the disciplines that generated the data. The investigator’s brochure is one of the documents that guide the HREC in its decision to grant approval.

  • CIOMS Guideline 1.36
  • CIOMS Guideline 7.1
  • NAFDAC GCP Regulations, 2009, Section 11(b)(v)

2.2.3. Investigator’s qualification

The researcher is expected to have the requisite qualification. The different legislations relating to health research set out varying qualification it expects researchers in the relevant field to have.

Different laws set out different qualifications for health researchers. These include:

  • NAFDAC GCP Regulations, 2009, Section 6(h)
  • ICH GCP Guideline 4.1.1 [E6(R1)],1966
  • Helsinki Declaration, Section 15
  • Optometrists and Dispensing Optician (Registration, etc) Act, Sections 2(a), 10
  • Pharmacists Council of Nigerian Act, Section 1(a), 11, 12
  • Radiographers Act, Section 1(a), 10
  • Nigerian Institute of Science Laboratory Technician Act, Sections 2(b), 12(1)
  • Nigerian Radiation Safety in Radiotherapy Regulation, 2006, Section 10

2.2.4. Compensation for damages

The researcher(s), their institution and/or sponsors must be prepared to take care of side effects and dangers to participants and remunerate them or their estates in event of death or incapacitation. The essence of compensation is to restore the victim as far as possible in the position he would have been in had the incidence not occurred. A research participant will only be entitled to compensation if the damage suffered is, in the eyes of the law, not too remote from the original wrong. If the damage is too remote, it follows that the defendant will not be liable for such damage.

This must however be distinguished from that due for transportation expenses or loss of income resulting from participating in the research.

  • ICH Guidelines for Good Clinical Practice [E6(R1)], 1996, Para 5.8.1
  • Insurance Act Cap I17 LFN, Section 2(3)(b)
  • Fatal Accidents Law, Part 2 Torts Law Cap 161 Laws of Oyo State, Nigeria. Sections 3(1) and 6(1)
  • National Code of Health Research Ethics, 2007, Sections S1(iii),(iv) and 6(vi)
  • NAFDAC GCP Regulations, 2009, Section 6 (q)
  • 1999 Constitution, Section 17(2)(a)

2.2.4.1. Coverage of damage

It is expected that provision be made for insurance and indemnity to cover the liability of the investigator and sponsor which may arise in relation to the research or trial. Injuries arising from misconduct, malpractice or negligence will however not be covered by insurance and relief must be sought in either the criminal or civil courts.

S.72 of the Insurance Act provides that a foreign insurer may transact insurance/reinsurance business in respect of life only where that foreign insurer is registered under the Act.

  • Insurance Act, Sections 2(3)(b), 72
  • ICH Guidelines for Good Clinical Practice [E6(R1)], 1996, Para 5.8.1.
  • Fatal Accidents Laws of Oyo State, Cap 161, Section 3(1)

2.2.4.2 Persons responsible under the coverage of the damage

A person whose responsibility it is to supervise a research activity stands in a fiduciary position to all who can be harmed by a breach of that duty. He therefore owes a duty of care to the latter.

A duty of care is owed wherever in the circumstances it is foreseeable that, if the defendant does not exercise due care, the Plaintiff will be harmed.

For a cause of action to be founded in negligence, there must be a duty of care owed by the defendant to the plaintiff, a breach of that duty must have occurred and damages accruing to the plaintiff as a result of that breach.

The standard of care expected to be exercised by the defendant is that of a reasonable man placed in the defendant’s position.

  • ICH Guidelines for Good Clinical Practice [E6(R1)], 1996, Para 5.8.1.
  • Criminal Code Act, Cap C38 LFN, Sections 303-305

2.2.4.3. Extent of damage

Under the case law, this will cover all the damages resulting from the act, omission or mistake of the researcher. The nature of the damage must be foreseeable. It would include incapacitation, loss of earnings, emotional/psychological trauma. The greater the likelihood that the defendant‘s conduct will cause harm, the greater the amount of caution required by him. Be that as it may, the seriousness of the risk created by the defendant’s activity must be weighed against the importance or utility of such activity, and where the defendant’s conduct has great social value, he may be justified in exposing others to risk which would not otherwise be justifiable Defences available are, contributory negligence – negligence of a person which while not being the primary cause of a tort, nevertheless combined with the act or omission of the primary defendant to cause the tort and without which the tort would not have occurred and volenti non fit injuria - no injury is done to one who consents. The implication of this is that no one can enforce a right which he has voluntarily waived or abandoned.

2.2.4.4. Nature of damage

The nature of damage depends on how it arises. It may be as a result of data and specimen collection, storage, utilization of the results, economic loss, and interference with privacy. It could be physical or psychological damage, it could be a minor or major damage having multiple effects such as burial expenses, loss of earnings, moral wrong, indignity and damage to property.

  • Fatal Accidents Law, Cap 61, Laws of Oyo State, Sections 3 and 6

2.2.5. Selection of research participants

All citizens are entitled to equal rights and opportunities before the law and have a right to freedom from discrimination. Consequently, the selection, recruitment, exclusion and inclusion of research participants in a research project must be just and fair, based on sound scientific and ethical principles. No person must be inappropriately or unjustly excluded on the basis of race, age, sexual orientation, disability, education, religious beliefs, pregnancy, marital status, ethnic or social origin, conscience, belief and language.

  • 1999 Constitution Sections 17(2)(a), 42
  • UDBHR, 2005, Art 11
  • National Code of Health Research Ethics, 2007, Section F(c)
  • ICH Guidelines for GCP [E6(R1)], 1996, Art. 6.5

2.2.5.1. Selection criteria

Ethical research must ensure fair selection of participants based on the scientific objective(s) of the research while minimizing risk. This requirement refers to both who is included and who is excluded from recruitment and the strategies employed for participants’ recruitment (including choice of research sites and communities). Regardless of this requirement, participants who are at excessively increased risk of harm should be excluded. Children, pregnant women, socially, culturally, economically, politically, educationally, physically and psychologically disadvantaged groups, groups with constrained autonomy and other vulnerable populations should not be excluded from research without explicit reasons for doing so; particularly from studies that can advance their health and well being. However specific safeguards should be included to protect the vulnerable, appropriate to degree of risk. Groups, communities, participants and researchers who bear the burden of research should share in the benefits.

  • National Code of Health Research Ethics, 2007, Section F (c)
  • ICH GCP [E6(R1)1996 Art. 6.5 (1) and (2)
  • 1999 Constitution Sections 17(2) & 42

2.2.5.1.1. Inclusion criteria

This must be stated in the protocol and justified by the study.

  • CIOMS, Item 10, Appendix 1

2.2.5.1.2 Exclusion criteria

This must be stated in the protocol and justified by the study.

  • CIOMS, Item 10, Appendix 1,

2.2.5.2 Vulnerable participants

Research with vulnerable populations should only be undertaken when it is directly related to their own health and these studies cannot be done with other groups. Consequently their inclusion must be justified. The researcher is also under an obligation to protect their rights and welfare.

Vulnerable participants include children, women, prisoners, the illiterate and people with limited resources, refugee population and internally displaced persons.

  • National Code of Health Research Ethics, 2007, Section F (c)
  • CIOMS Ethical Guidelines 13-16
  • UDBHR, 2005, Art 8
  • Child’s Right Act, Cap C50 LFN, Section 16
  • Illiterate Protection Law, Cap 61 Laws of Oyo State
  • National code for Health Research Ethics, Section F(c)

2.2.5.2.1. Population or communities with limited resources

Research involving low income communities, must be geared at their health needs and the priorities of the population or community in which it is to be carried out. The benefits of the outcome of the study must be available for the population or community.

  • CIOMS Ethical Guidelines, 2002, Art 10
  • Belmont Report.

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

As with study participants in developing countries, most human subjects in Nigeria are unaware of their rights, thereby making them vulnerable. It is therefore pertinent for researchers and sponsors to ensure adequate and comprehensive consent documents. This will give the subject the opportunity of understanding the essence of the study and their rights, duties and obligations with respect to the study among other things.

  • National Code of Health Research Ethics, 2007, Section F (5) (f)
  • NAFDAC GCP Regulations, 2009, Section (6)(i)
  • CIOMS Ethical Guidelines, Art. 10
  • 1999 Constitution, Sections 17(2)(a)&(d), 38 & 39

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

With regards to the above mentioned group of people, and certain groups of married women who have limited capacity due to religious and cultural reasons, strict adherence to ethical principles must is required. The means of protecting their rights must be apparent and complied with. Additional safeguards must be put in place so as to reduce potential for exploitation.

  • NAFDAC GCP Regulations, 2009, Section 10
  • CIOMS Ethical Guidelines, Sections 13 & 15
  • UDBHR, 2005, Art 7

2.2.5.2.4. Junior or subordinate members of a hierarchical group

For research on medical students, soldiers, employees of the sponsor to be ethical, they must have given a valid informed consent. Failure to do this gives an impression of the existence of undue influence. The effect of undue influence on a contract is that it renders it illegal and therefore null and void. Consequently, the informed consent should be obtained by a well-informed physician who is not engaged in the study and completely independent.

  • National Code of Health Research Ethics, 2007, Section F(c)
  • CIOMS Guideline No. 13
  • Helsinki Declaration, Para 23

2.2.5.2.5. Persons who have serious diseases

Recruiting persons with serious diseases or illness or who is unconscious come within the class of people who are vulnerable. In view of the fact that they are incapacitated and unable to give informed legal consent, care must therefore be taken in recruiting them for research.

  • NAFDAC GCP Regulations, 2009, Section 10
  • CIOMS Guideline No. 13
  • Belmont Report

2.2.5.3. Recruitment process

The law provides that the researcher must state in the protocol his/her proposed method of recruiting research participants, showing justification for his proposed choice.

  • NAFDAC GCP Regulations, 2009, sec.11 (b)(xi)

2.2.5.3.1. Recruitment process in recruitment process in general

The researcher must be a suitably qualified individual. The investigator’s competence is assessed by technical competence. Technical competence, which includes research competence, is assessed by education, knowledge, certification and experience. There must be no evidence of inducement and pressure.

  • NAFDAC GCP Regulations, 2009, Section 11 (b) (iv)

2.2.5.3.2. Recruitment process by advertisement

There are no provisions of law in Nigeria prohibiting recruitment through advertisement per se. However the Tobacco Smoking (Control) Act, Cap T6 which was enacted pursuant to the WHO Tobacco Treaty places a restriction on advertising tobacco products in a bid to encourage smoking. It is presumed that advertising for tobacco research will fall under this provision. It is expected that the potential researcher will have the requisite qualification.

  • Tobacco Smoking (Control) Act, Cap T6, LFN 2004

2.2.5.4. Community assent

In certain instances, community consultation or assent may have to precede research activities in order to engender community buy-in and to respect the socio-cultural values of the community and its institutions. It may also be necessary to inform the community from time to time about the progress of the research, pertinent findings that may influence their health and well being, and the outcome of the research. This however does not preclude obtaining individual consent.

The definition of community varies with research and is based on application of the best scientific principles.

  • Section F (f) (13)(g) National Code of Health Research Ethics, 2007
  • Art. 22 Helsinki Declaration, Section 11 (b) (iv)
  • National Code of Health Research Ethics, 2007, Section E (s)(4)(iv)

2.2.6. Informed consent

No investigator should conduct a research involving humans unless he has obtained the informed consent of the participants or their legal/authorized representative. Informed consent must be obtained under circumstances that provide the prospective participant or their representative sufficient opportunity to consider whether or not to participate and the circumstances shall minimize the possibility of coercion or undue influence. The legal justification for informed consent in Nigeria is founded on three areas of the law, namely, torts, contract and the Constitution.

The contractual relationship/right is between the researcher and participants. For a contractual relationship to exist, the elements of contract such as offer, acceptance, consideration and intention to enter into a legal relationship must be present.

With regards to the law of Torts, the law of battery and negligence apply.

Battery involves touching without the consent of the victim, consequently, treatment of the victim without his consent is an actionable wrong. It protects the individual’s bodily integrity. In addition, good faith of the part of the offender is not relevant.

Negligence on its part requires a legally established duty from the defendant to the plaintiff, which the former must have breached. The plaintiff must experience an injury which is measurable in monetary terms called damages. Such injury must be causally related to the defendant’s breach of duty. Lastly, the causal relationship between the act or omission and the injury must be proximate.

  • 1999 Constitution, Sections 17(2), 34, 38,
  • Child’s Right Act, Cap C50 LFN, Section 7(1)
  • National Code of Health Research Ethics, 2007, Sections. E(s)(1)(i) , F(f)(1-13)
  • NAFDAC GCP Regulations, 2009, Sections 4, 6(i)
  • Belmont Report, Part C (1)
  • UDBHR, Art. 6
  • ICCPR, Art. 18
  • ICH GCP Guideline 6.5(1)&(2)
  • CIOMS Guidelines 5, 6 & 9

2.2.6.1. Capacity

For informed consent to be legal and acceptable, study participants must possess the ability to comprehend information provided concerning the research. Consequently, participants must be legally capable of granting consent.

2.2.6.1.1. Adult

Under Nigerian law, a child is anyone under the age of 18years. We can safely assume that all persons 18years and above are adults and prima facie capable of granting a legally enforceable consent to research. In some cultures however, families and groups participate in decision making. In certain situations, others such as the family head or husband actually take decisions instead of the adult participants.

  • 1999 Constitution
  • Child’s Right Act, Cap C50 LFN 2004

2.2.6.1.2 Capable adult

Once a person is considered an adult and of sane mind, he is capable of granting a legal binding consent. In some cultures however, families and groups participate in decision making. In certain situations, others such as the family head or husband actually take decisions instead of the adult participants.

With regards to illiterates, the fact that an individual is an illiterate does not preclude him from being legally capable of granting consent. The Nigeria law requires that the consent be first read over and explained to illiterate person prior to document being signed with the signature or mark of the illiterate person, and a statement that the signature or mark was made by such person. This is known as the Illiterate Jurat. Where such document does not contain the illiterate jurat or it content is false, the writer of the document shall be guilty of an offence and liable on conviction to a fine of one hundred naira or to imprisonment for six months.

  • Nuremberg Code.
  • Illiterate Protection Law; Cap 61 Laws of Oyo State of Nigeria, Sections 3(b), 4

2.2.6.1.3. Incapable adult

A person who has attained the age of majority may be incapable of making rational decision due to illness, insanity, incarceration or intimidation. Such an individual will not be able to give valid consent and a legal representative would be required to grant consent on his behalf. This would usually be the husband or the family head as the case may be.

  • NAFDAC GCP Regulations, 2009, Section 10
  • UDBHR, Art 5 and Art 7(a)
  • CIOMS Guidelines 9 & 13

2.2.6.1.4. Legal representative/proxy

A legal representative is any person vested with such powers by the law to protect the interest of people who may be vulnerable for various reasons. These may be parents or guardians. They may be family members, lawyers, social workers or respected community or religious leaders, who are appointed by the incapable adult, or other members of the family or the government/court, known as the guardian ad litem. In granting such consent, the best interest of the person being represented must be the basis of granting consent.

  • 1999 Constitution Section 17(2)
  • NAFDAC GCP Regulations, 2009, Section 10(a)
  • Child’s Right Act, Cap C50 LFN, Section 2
  • Helsinki Declaration, Para 26

2.2.6.1.5. Minors

The Child’s Right Act defines a minor as any person who has not attained the age of 18 years. A minor is regarded as not having the capability to make rational decisions and consequently vulnerable. In Nigeria, various laws governing issues involving minors. These include the Child’s Right Act, Criminal Procedure Act, Criminal Code Act, and the African Charter on Human and Peoples’ Right (Ratification and Enforcement) Act.

  • Child’s Right Act, Cap C50 LFN, Section 27(7)
  • UDBHR, Art 5&7
  • Helsinki Declaration, Para 25
  • NAFDAC GCP Guidelines, 2009, Section 9

2.2.6.1.6. Capable minor

A capable minor is anyone who has not attained the age of 18 years, but is capable of testifying, making rational decisions, and doing things for the purposes of enhancing his/her welfare.

To ascertain the mental stability of a minor, it would be necessary to assess his/her socio-psychological well-being. To determine this, the minor’s ability to understand the information given at the material time, giving him/her the ability to decide whether or not to participate is crucial. Where however, there is a doubt as to the minor’s ability to make an independent judgment, consent from a legal representative would be advisable.

  • NAFDAC GCP Regulations, 2009, Section 9 (d)
  • Child’s Right Act, Cap C50 LFN
  • 1999 Constitution Section 17(2)
  • CIOMS Guidelines 13 and 14

2.2.6.1.7. Incapable minor

A minor will be regarded as being incapable of giving valid consent where factors such as infancy, illness, mental incapacity and socio-cultural and religious norms arise. In such instances, the HREC would be expected to critically review the research protocol so as to guarantee the presents of safeguards for the best interest of the child to be served. In addition, the best interest of the minor should be considered in requesting for granting consent by parents or guardian of the minor.

  • NAFDAC GCP Regulations, 2009, Section 9(9)
  • Child’s Right Act, Sections 19&20
  • UDBHR, Art 12
  • CIOMS Guidelines 9, 13, 14
  • Helsinki Declaration, Paras. 27 &28

2.2.6.1.8. Legal representative

A legal representative is a person appointed by law to safeguard the protection of anyone regarded as being vulnerable and therefore incapable of taking reasonable decisions. This may be a parent or guardian of the latter.

  • Child’s Right Act, Sections 7 (2-4), 14

2.2.6.2 Participants’ right to information

An individual’s right to information is a fundamental human right guaranteed under sections 38 and 39(1) of the 1999 Constitution of the Federal Republic of Nigeria. With regards to obtaining informed consent for human research purposes, the information given must contain material information necessary for the prospective research participant to decide whether or not he will participate in the study. The right to receive information concerning the study is continuous and extends even to the period after the study has been concluded.

  • National Code of Health Research Ethics, 2007, Section F (f)(7)
  • NAFDAC GCP Regulations, 2009, Section 6(d)
  • Code of Medical Ethics in Nigeria, Section 19(b)

2.2.6.2.1. Form of the information

The consent document should be written in lay language, that is, at the educational level not higher than that of individuals with at most 9 years of education in Nigeria. Where the research participants do not understand English language, the consent document must be translated to the relevant language of the participants. The informed consent document may not include any exculpatory language through which the participant or their representative is made to waive or appear to waive any of their legal rights, or release or appear to release the investigator, sponsor, institution or its agents from liability of negligence.

  • National Code of Health Research Ethics, 2007, Section F (5)(f)(1)
  • NAFDAC GCP Guidelines, 2009, Section 4

2.2.6.2.2. Scope of the information

The information given should contain all facts material for the participant to arrive at an informed decision. It should state details of the purpose and nature of the study; identity of the researchers, duration, estimated risks and benefits and appropriate alternatives, possible benefits to participants, researchers and others, funding, mechanisms to protect confidentiality within the confines of what is possible and the law, what would be done with the results, who to contact if there are questions.

  • National Code of Health Research Ethics, 2007, Section F (f)
  • NAFDAC GCP Regulations, 2009, Section 4
  • 1999 Constitution, Sections 17 (2)(a) and 39(1)

2.2.6.3. Freedom of consent

Consent should not be obtained under duress and coercion. The participants must be made to realize that consent should be freely given and may be withdrawn at any time during before the study is concluded.

  • NAFDAC GCP Regulations, 2009, Sections 4 and 6(1)

2.2.6.3.1. Compensation to subjects

Incentives given should not constitute coercion by being too tempting for the people to risk the study without appropriately considering the risks and the benefits of the study.

  • NAFDAC GCP Regulations, 2009, Sections 9 (c), 10 (d)
  • CIOMS Guideline 7

2.2.6.4. Form of consent

Informed consent, whether granted by the participants themselves or by their representatives, may be written or oral in certain circumstances. The contents of the informed consent document must be approved by the HREC.

  • National Code of Health Research Ethics, 2007, Section F(f)
  • NAFDAC GCP Guidelines, 2009, Section 4
  • ICH GCP Guidelines 4&8 [E6(R1)]

2.2.7 Risk to benefit ratio

Before the trial is initiated, foreseeable risks and inconveniences must be weighed against the anticipated benefit for the individual trial participant and other present and future patients. A trial will be continued only if anticipated benefits justify the risks. The risks and benefits should be considered at the level of individual research participants and at the community, whenever appropriate.

  • NAFDAC GCP Regulations, 2009, Section 6(b)
  • National Code of Health Research Ethics, 2007, Section F (d)(3)
  • Belmont Report, Part B (2) and Part C (2)
  • CIOMS Guidelines 8 and 12
  • Declaration of Helsinki, Paras 16,17,20, 22 and 23
  • UDBHR, Art 4

2.2.7.1. Risks of the research

All bio-medical researches involve risks. There must be valid attempts to minimize risks and maximize health related benefits. 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 through the research process.

  • National Code of Health Research Ethics, 2007, Section F(d)
  • NAFDAC GCP Regulations, 2009, Section 6 (c)
  • 1999 Constitution, Section 17(2)

2.2.7.1.1 Harm

Harm associated with research can include loss of life, physical injury or psychological injury. These can be ascertained by their nature and their extent. In planning the research these must be taken to account. The assessment of risks requires a careful array of relevant data, including alternative ways of obtaining the benefits sought in the research. Adequate provisions must be made to compensate participants in case harm occurs. The risk-knowledge calculus must be applied to ensure that risks are reasonably compared to the knowledge to be gained.

  • National Code of Health Research Ethics, 2007, Section F (d
  • Fatal Accidents Law, Cap 61 Laws of Oyo State, Nigeria, Sections 3 and 6
  • National Code of Health Research Ethics, 2007, Section F (d)
  • Belmont Report, Part B(2)

2.2.7.1.2. Nature of harm

The requirement that research be justified on the basis of a favourable risk/benefit assessment bears a close relation to the principle of beneficience, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. The term “risk” refers to a possibility that harm may occur. Risk whether small or high, refer both to the probability of experiencing a harm and the severity of the envisioned harm.

  • Belmont Report, Part C (2)

2.2.7.1.3 Extent of harm

Risk of research may affect the individual subjects, their families, and the society at large.

  • Belmont Report, Part C (2)

2.2.7.1.4. Measure to minimise risks

The researcher must take necessary steps to minimize the risks associated with the research. These include monitoring the subjects and provision of medical care delivered by qualified health care providers. The researcher must also ensure that the study site is safe for the participants.

  • NAFDAC GCP Regulations, 2009, Section 6(g)
  • National Code of Health Research Ethics, 2007, Section E (s) (6) (iii)
  • Fatal Accidents Law, Torts Law, Cap 161 Laws of Oyo State, Sections 9 and 10
  • NAFDAC Good Laboratory Practice Regulations of 1993 as amended, Sections 5-8

2.2.7.1.5 Monitoring

HREC shall conduct continuing oversight of research covered by this code at intervals adjudged by HREC as being appropriate to degree of risk involved in participation in the research.

HREC has authority to examine all aspects and documents including consent forms, questionnaires, case report forms etc. that are related to the research and necessary for the HREC to conduct its oversight function. This should be at least once a year or at least once during the lifetime of the research where the duration of the research is less than a year.

HREC has the authority to observe or cause to be observed on its behalf, the research and its consent process to ensure compliance with the highest scientific and ethical standards. HREC may initiate process of oversight of research in the event of receipt of complaints, information or data relevant to the research from any source.

  • National Code of Health Research Ethics, 2007, Section E (e) (1-5)
  • ICH GCP Guidelines 5.18.1(a) &(c)

2.2.7.1.6. Quality assurance

The investigator and sponsor are responsible for implementing and maintaining quality assurance and quality control systems in line with the requirements of the law.

The investigator is responsible for the documentation of all steps in data management to allow step-by-step retrospective assessment of the quality of the data and the performance of the research. Data must be retained by the HREC for 10 years, following the completion of the research.

An investigator should retain records required to be maintained under this section for a period of 5 years following the date a marketing application is approved for the medicinal product for the application is not approved for such indication, until 5 years after the investigation is discontinued and NAFDAC is notified.

  • National Code of Health Research Ethics, 2007, Section E (s) (6)(vii)
  • NAFDAC GCP Regulations, 2009, Sections 6(m) and 16, Section 23
  • ICH GCP Guidelines 5.1.1 and 5.1.3 [E6(R1)].
  • National Code of Health Research Ethics, 2007, Section E (d) (10)

2.2.7.1.7. Appropriate resources

The researcher must provide suitable infrastructure and means for the study to be carried out. His ability to undertake the study must be obvious and the must be evidence that the research team is adequate and competent.

  • NAFDAC GCP Regulations, 2009, Sections 6 (m) and 8(b) & (c)
  • ICH GCP Guidelines 4.2.1 and 4.2.3 [E6(R1)].

2.2.7.1.8. Competent personnel

The study must be conducted by suitably qualified individuals. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

  • NAFDAC GCP Regulations, 2009, Section 6(h)

2.2.7.2 Benefits of research

The study should impact positively on the life style of the participants. Research should evaluate issues that lead to improvements in health and contribute to meaningful knowledge. Such knowledge should be disseminated to all relevant stakeholders during and after the conduct of research. In certain instances, for example in some international collaborative studies, research should be integrated with comprehensive capacity building, technology transfer and health care delivery strategies that address significant local health problems and add value to local participants of research, including researchers, institutions, communities and the country.

  • National Code of Health Research Ethics, 2007, Section F (a)

2.2.7.2.1. Direct benefits

These are benefits which directly benefit the participants. These include capacity building, access to scientific and technological knowledge, special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research.

  • National Code of Health Research Ethics, 2007, Section F (a)
  • UDBHR, Art 15

2.2.7.2.2. Indirect benefits

These are those benefits which are not directly enjoyed by the participants but benefit him, his community or posterity. An example is the provision of new diagnostic and therapeutic modalities or product stemming from the research.

2.2.7.2.3. Minimal risks

This refers to the probability of experiencing harm and the severity of the envisaged harm.

  • Belmont Report, Part C(2)

2.2.7.2.4. Upper threshold of risk

This also refers to the chances of the risk occurring and its magnitude.

  • Belmont Report, Part C (2)

2.2.8 Conflict of interest

A researcher must disclose the sources and extent of funding for the research to the research participants and the ethics committee and where appropriate the regulatory, authority, and must declare any affiliation or financial interest at the time of proposing and reporting the research.

Any employment or any other relationships (including stock ownership, receipt of grants, honorariums or support from potential research sponsors) that may be construed as conflict of interest within the context of membership of the HREC.

  • National Code of Health Research Ethics, 2007, Section C (b)(1)(v)

2.2.9 Protection of privacy and confidentiality

Participants’ right to privacy and confidentiality must be protected. The researcher must ensure that where personal information about research participants or a community collected, stored, used or destroyed, it should be done in ways that respect the privacy or confidentiality of the participants or the community and any agreements made with the participants or community. Except in situations when information is available in public domain, all information and records provided by participants and/or obtained indirectly, on the participants/patients must be kept confidential.

Release of any identifying information may only be done as required by law and/or with the expressed permission of the participants/patients.

  • 1999 Constitution, Section 37
  • National Code of Health Research Ethics. 2007, Section F (f) (13) (g)
  • NAFDAC GCP Regulations, 2009, Sections 6(l) & 7 (p)
  • CIOMS Ethical Guideline 18
  • UDBHR, Art 9
  • Helsinki Declaration, Para 21
  • Child’s Right Act, Cap C50 LFN, Sections 8 & 205(2)

2.2.9.1 Privacy

Privacy is concerned with access to personal records. The right to privacy is a right guaranteed by the Constitution of the Federal Republic of Nigeria.

  • 1999 Constitution, Section 37

2.2.9.2. Professional secrecy

The Code of Medical Ethics in Nigeria places the physician in a fiduciary position with the patient. The same is the case for researchers and participants. It therefore expected that the researcher would ensure that strict confidentiality of participants/patients private information is maintained.

  • Code of Medical Ethics in Nigeria

2.2.9.3. Data protection

There are no specific data protection laws in Nigeria. Be that as it may, ethical principles put the onus on the researcher to engage qualified staff to handle and verify data.

  • National Code of Health Research Ethics, 2007, Section E (s) (6) (vii)
  • ICH GCP Guideline 5 [E6(R1)].

2.2.9.4 Right of access to data

The study participants have a right to access any data collected on them pursuant to the study. Other individuals may by virtue of provisions of law have rights of access to data on research participants. These rights are however subject to provision on privacy and confidentiality.

  • 1999 Constitution, Section 39

2.2.10. Ongoing respect for research participants

For research to be ethical there must be respect for potential and enrolled participants. This implies that potential participants be treated with respect from the moment that they are approached to the conclusion of the research should they choose to participate. Their right to privacy may not be needlessly compromised. Participants must know that their involvement is voluntary and that they can withdraw at any time without penalties. However, data, samples, etc. already contributed to the research up to that point may not needlessly be withdrawn as this may jeopardise the scientific validity of the research, unjust to those who remain in the study and all or part of their sample or data may have been used or modified into different form(s), including presentation at meetings or publications by the researchers. Respect entails that participants must be treated as partners in the research enterprise with every opportunity taken to inform them of the progress of the research and any new finding that may have potential impact on their health and well being, and on their continued participation in the research. It also entails protection of the welfare of research participants. This means that the process of research must be carefully monitored to ensure that participants are not exposed to excessive risk and all adverse events are examined in detail and promptly. Such adverse events must also be reported to HREC and efforts made to prevent future occurrences. Full medical care must be provided to participants who have suffered such adverse events and where warranted compensations paid. The requirement to respect both enrolled and potential participants means that researchers should engage with communities where research is being conducted whenever this is appropriate. In certain instances, community consultation or assent may have to precede research activities in order to engender community buy-in and to respect the socio-cultural values of the community and its institutions. It may also be necessary to inform the community from time to time about the progress of the research, pertinent findings that may influence their health and well being, and the outcome of the research.

  • National Code of Health Research Ethics, 2007, Section F (f)(13)(g)

2.2.10.1. During the research

It is the researcher’s duty to monitor research participants while the research is on-going. This includes promptly reporting adverse events; the appropriate management of such events and post-trial follow up. This includes pre and post trial counselling.

  • National Code of Health Research Ethics, 2007, Section E (s) (ii)
  • NAFDAC GCP Regulations, 2009, Sections 6 (g), 32, 33

2.2.10.2. After the research

It important to ensure that participants’ well- being are not affected by ending their participation. They have the right to protection against any harm they would suffer as result of participating in the study. This could be medical or even socio-political retaliation.

The investigator must provide adequate and safe medical or dental care, where appropriate, to participants during the research, within the expertise of the investigator, and must ensure that appropriate medical care and follow-up procedures are maintained after the research for a period of time that is dependent upon the nature of the disease, the research, and the intervention(s). The investigator must provide assurances that reasonable efforts shall be made to ensure that the benefits of research is made available to the community where the research was conducted. Details of any arrangement to ensure this shall be worked out by the researchers, sponsors, HREC, community leaders and Community Advisory Committees.

  • National Code of Health Research Ethics, 2007, Section E (s) (iii-iv)