Jérôme Ateudjieu, Peter Ndumbe
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1. Type of research

Although this module applies primarily to biomedical research, it covers only a portion of all research involving human beings. Therefore attention must be paid to the specific rules that may vary depending on the type of research (for example, epidemiological studies, research in the field of organ transplantation).

Article 2 of the ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 describes the research categories that it covers. Three types of research are involved: interventional research; observational research on data and interactions with human beings; and research on the environment that can affect human life.

  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987, MINSANTE order: Art. 2.

1.1. Biomedical research

Biomedical research is any research in the field of health. It can be divided into several types, in particular, [clinical trials] (which imply a direct relationship between the subject and the investigator), [research with human biological material], and [epidemiological studies]. According to Article 2 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987:

  1. 1) Any research project on human beings that cannot be considered as an element in the routine clinical management of patients and which includes:
    1. An intervention, physical or psychological observation on a patient or a healthy subject;
    2. The collection, preservation and dissemination of information relating to one or many given patients.
  2. The above definition does not apply only to scheduled tests on human beings but also to research in which environmental factors can be altered to the point where people are at risk.
  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987, Art. 2.

1.1.1. Clinical trials

Clinical trials are considered as research involving an intervention on research participants as described in the article 2 of the ministerial decree creating the ethics committee.

1.1.1.1. Clinical drug trials

Particular regulations on clinical trials are not specifically identified in the current regulations. International regulations, especially ICH-GCP 1996, are particularly applicable to the evaluation of clinical trials.
  • ICH-GCP 1996

1.1.1.2. Other clinical trials

In this area, the current regulation in preparation may cover tests on x-ray protection, x-ray diagnostics and therapy, organ transplants, genetic engineering, assisted reproduction, transplantation, biological samples and stem cells.

  • MINSANTE order: Art. 2.
  • ICH-GCP 1996

1.1.2. Research with human biological material

The regulatory bases for the collection, storage, and transfer of human biological samples for the purpose of biomedical research are not specified. International regulations, especially The World Medical Association, Declaration on Ethical Considerations Regarding Health Databases, 2002, are particularly used for the evaluation of research with human biological material.

  • The World Medical Association, Declaration on Ethical Considerations Regarding Health Databases, 2002

1.1.3. Epidemiological studies

In Cameroon epidemiological research is not, in its entirety, the subject of a law. Its features are regulated in relation to professional secrecy by the Code of Medical Ethics (Article 4), by Decree No. 2001/958/PM 1st November 2001 laying down detailed rules for the implementation of the Law No. 2000/10 of 19th December 2000 governing archives (Articles 15-21), by international regulations including particularly the "International Ethical Guidelines for Epidemiological Studies" and by The World Medical Association Declaration on Ethical Considerations Regarding Health Databases, 2002. As far as Epidemiological research is based on the critical analysis of data, the rules of professional secrecy are very important here. See further on this subject the section on protection of privacy and confidentiality.

  • Code of Medical Ethics: Article 4,
  • Law No. 2000/10 of 19th December 2000 governing archives: Articles 15-21
  • International Ethics Guidelines for Epidemiological Studies,
  • World Medical Association Declaration on Ethical Considerations Regarding Health Databases, 2002

1.2. Research involving humans other than health research

Although this module focuses on research in the field of health research involving human beings, to be outside this field is not to be outside of the law. Certainly, in the absence of comprehensive legislation on research involving human beings, the question arises as to what extent existing legislation can be applied by analogy to research in a context other than health. As with any research, priority should be given to the protection of research subjects. Thus, the general principles of law are also applicable here, as are the general standards. This is particularly true in relation to [informed consent] and the [protection of privacy and confidentiality]. Moreover, as in any other research, a project must be relevant and scientifically valid. In the agriculture and environment sectors, we have Decree No. 011 / CAB / PM of 02nd March 2004 creating an ad hoc committee on food safety in Cameroon, Law No. 2003/003 of 21st April 2003 and the law N° 96/12 of August 5th 1996 as the fundamental law on plant protection and environmental management in Cameroon.

  • Decree No. 011 / CAB / PM of 02nd March 2004 creating an ad hoc committee on food safety in Cameroon
  • Law No. 2003/003 of 21st April 2003 relating to plant protection
  • Law N° 96/12 of August 5th 1996 as the fundamental law on plant protection and environmental management in Cameroon

2. Ethics review

The submission of a research protocol to the ethics committee is an obligation under Articles 7-11 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the ethics committee. This Decree presents the list of documents required for the application for ethical clearance and the directives guiding the examination of submitted documents. This regulatory basis is supplemented by international regulations on the evaluation of protocols.

  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987r: Art. 7-11.
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 6

2.1. Research ethics committee

  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987: Art. 1; 3; 4
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 2

2.1.1. Jurisdiction of the REC

The scope of competence (jurisdiction) can be defined geographically depending on whether it relates to an institution (Institutional Review Board (IRB) in the USA), covers a geographic area or a given type of research. The provisions of Article 3 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987establishing the ethics committee gives it a national responsibility. Accredited institutional ethics committees evaluate research protocols to be implemented within these institutions.

  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987: Art. 3

2.1.2. Independence of ethics review

2.1.2.1. Independence of the REC

In order that the opinion of an ethics review committee may have value and is not simply the performance of a procedural task, it is necessary that members of the REC decide in full freedom. This means that they must be free from all [conflicts of interest] and all other forms of influence that could hamper their freedom. Item 2 of paragraph 6 of Article 8 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the Ethics Committee specifies the conduct of a member of a REC when facing a possible conflict of interest. Globally, the regulation does not provide a guideline for the preservation of the independence of ethics committees and members in relation to the sponsor, the investigator, the research institutions and administrative and political authorities when evaluating research protocols.
  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987: Art. 8
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 4, 7

2.1.2.2. Independence of members

In order that the opinion of an ethics review committee may have value and is not simply the performance of a procedural task, it is necessary that members of the REC decide in full freedom. This means that they must be free from all [conflicts of interest] and all other forms of influence that could hamper their freedom. Item 2 of paragraph 6 of Article 8 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the Ethics Committee specifies the conduct of a member of a REC when facing a possible conflict of interest. Globally, the regulation does not provide a guideline for the preservation of the independence of ethics committees and members in relation to the sponsor, the investigator, the research institutions and administrative and political authorities when evaluating research protocols.
  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987: Art. 8
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 4, 7

2.1.3. Composition of the REC

Article 4 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the ethics committee specifies the composition of the ethics committee. This article states that the committee consists of 14 members including at least two women, a president, a vice-president, a deputy secretary, a treasurer and members of which at least half must be well qualified in biomedical sciences. Members are representative of a number of ministries and research institutions. Article 1 of the Minister of Health Decision concerning the CIRCB Ethics Committee specifies the composition of its ethics committee stating that it consist of: a representative of the scientific committee, a community representative, two representatives of associations defending rights of persons leaving with HIV/AIDS, three representatives of religious groups, one jurist and one philosopher. For other existing committees and those that could be created/accredited, there is as yet no directive guiding their composition.
  • MINSANTE Order: Art. 8
  • Decision of the Minister of Public Health Noticing the Composition of the Ethics Committee of the Chantal BIYA International Centre for Research (CIRCB) on HIV/AIDS prevention Art.1
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 4

2.1.4. Functioning of the REC

Article 7 to 13 of the Ministerial Order creating the ethics committee states the functioning of REC created by the MINSANTE in 1987. Globally, the guidelines for the functioning of an ethics committee existing in Cameroon are not described in any of the current regulations.

  • MINSANTE Order: Art. 7 to 13
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 2

2.1.4.1. Organization of the REC

Articles 4, 5, 6 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the ethics committee present the organisation of a REC. There are currently no guidelines for all existing committees in Cameroon.

  • MINSANTE Order: 4; 5; 6
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 2

2.1.4.2. Decision-making process within the REC

Article 8 of the Ministerial Order creating the ethics committee specifies the process for submitting an application for ethical clearance to the REC created by the Ministry of Public Health in 1987.

  • MINSANTE Order: Art. 8
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 5

2.1.4.3. Transmission of the REC decisions

When asked for an ethics review of a protocol, the REC must render an opinion. There are also other cases in which it must render an opinion, particularly in its monitoring activity of ongoing research. Article 11 of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the ethics committee specifies the process of transmission of the opinion by the REC.

  • MINSANTE Order: Art. 11
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 8

2.1.5. Ongoing review of research

The REC is required to monitor the implementation of approved protocols and developments occurring in the context of biomedical research (changes in the protocol, discontinuation of a clinical trial, etc.) In such circumstances, there is as a corollary to this awareness, the obligation for the research team to inform the REC. Any significant change in the research protocol modifies the research and requires a new assessment by the REC. The notion of monitoring the implementation of a protocol is not specified in the regulations currently applicable.

  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 9

2.1.6. Responsibility of the REC

  • MINSANTE Order: Art. 3
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 2

2.2. Ethics review criteria

During the process of evaluation of protocols, in order to determine its ethical acceptability, the REC must make use of a number of criteria. Among these, mention should be made of : the social value of the research, its scientific validity, the qualification of the investigator, the compensation of damage, the selection of research subjects, informed consent, the risk-benefit ratio, conflicts of interests, privacy and confidentiality in relation to research subjects, care and following up of research subjects. The present regulation in Cameroon does not provide criteria for the evaluation of protocols by ethics committees. Ethics committees refer to several texts, both national and international, covering several areas of health: human rights, the civil and penal codes, the code of professional ethics, and the Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 6.
  • Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research: Art. 6

2.2.1. Social value of the research project

  • Law n° 96-06 of 18t January 1996 to amend the Constitution of 2 June 1972, Preamble
  • The Preamble and Article I of the Universal Declaration of Human Rights
  • Article I of the International Covenant on civil and political Rights
  • Declaration of Helsinki; Principles 7; 17 and 21
  • CIOMS International Ethical Guidelines 2002: GL 2

2.2.1.1. Medical relevance of the research project

2.2.1.1.1 Relevance for the target population

2.2.1.1.2. Relevance for public health

  • Declaration of Helsinki, Principles 7, 17 ,21

2.2.2. Scientific validity of the research project

The evaluation of the scientific quality of a research is an important task of the REC, [which is the responsibility of the REC]. A scientifically non-valid research project cannot be ethically acceptable. The evaluation of the scientific validity of a research project at the National Ethics Committee of Cameroon is in the light of:

  • Declaration of Helsinki, Principles 12; 14 and 16.
  • CIOMS International Ethical Guidelines 2002: GL 2

2.2.2.1. Method / design of the research project

  • Declaration of Helsinki, Principles 12
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.1

2.2.2.1.1. Pre-clinical data

  • ICH-GCP 2.4 / 5.12 / 6.2.7

2.2.2.1.2. Scientific literature review

  • ICH-GCP 6.2.7

2.2.2.1.3. Research design

  • ICH-GCP 5.4 / 6.4

2.2.2.2. Investigator’s brochure

  • ICH-GCP 2.5 / 4.4.2 / 4.4.3 /7

2.2.3. Investigator’s qualification

  • Law N ° 90-36 of August 10th 1990 relating to the organization and practice of medicine, Articles 2 and 35
  • Declaration of Helsinki, Principle 16
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.3.1

2.2.4. Compensation for damages

  • ICH-GCP 4.8.10 j)

2.2.4.1. Coverage of the damage

Cover for losses during the implementation of a research project is considered by articles 1382 to 1386 of the Cameroonian Civil Code.
  • Cameroon Civil Code, Art. 1382 to 1386
  • Declaration of Helsinki, Principle 15
  • ICH-GCP 5.8

2.2.4.2. Persons responsible under the coverage of the damage

The person responsible here is the person responsible for taking measures to prevent any damage as well as the person who will be called upon in case of damage occurring to provide compensation.

  • Cameroon Civil Code, Art. 1382 to 1386
  • Declaration of Helsinki, principle 11 and 13.

2.2.4.3. Extent of damage

Any damages that are directly linked to the test are covered. The coverage of the damage should be full and total. The [nature of the] damage may be very diverse and not limited only to damage to health. Compensation for damages arising out of the test involves a reduction of the burden. The subject must make plausible that there is a sufficient causal link between the test and the harm suffered. Causation is adequate if, in the ordinary course of things and life experience, the fact was considered proper to have an effect like what happened; the occurrence of this result appears in general favoured by such a circumstance. The person responsible for the damage can free himself by demonstrating that there is properly no such causal link. The assessment of the extent of damage is left to the appreciation of the judge in relation to the damage experienced.

2.2.4.4. Nature of damage

Damage involves an involuntary reduction of a heritage that can be expressed in many ways but must be linked with research. In the context of clinical trials of drugs, the damage consists of all losses suffered under the Code of Obligations, in particular, injuries (treatment and rehabilitation), burial expenses, damage to property (e.g., damage to clothes), loss of earnings, loss of support and moral harm. The evaluation of the nature of the damage is done in the light of the medical diagnosis (moral or physical) or left to the decision of the judge consulted.

2.2.5. Selection of research participants

The process of selection of participants includes the selection criteria, [inclusion] and [exclusion] as well as the situation of subjects, that is, whether they are vulnerable or not. The purpose is to achieve a fair selection, without unnecessarily burdening the weight of research on a particular population.

  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2

2.2.5.1. Selection criteria

Cameroonian regulations do not deal specifically with selection criteria except in order to emphasize the protection of vulnerable subjects. The [inclusion] or [exclusion] of subjects must be justified scientifically.
  • Declaration of Helsinki, principle 12
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2

2.2.5.1.1. Inclusion criteria

  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2.4

2.2.5.1.2. Exclusion criteria

  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2.5

2.2.5.2. Vulnerable participants

The concept of vulnerable subject covers many different circumstances. The CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects give many categories of vulnerable subjects.

  • CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects

2.2.5.2.1. Populations or communities with limited resources

  • CIOMS: Guideline 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

There may be cases in which the groups in question are socio-economically disadvantaged or belong to a minority.

  • CIOMS. GL 12
  • Declaration of Helsinki, principles 9 and 17

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

Discernment involves two aspects: the ability to appreciate the meaning and effect of a specific act and the ability to act freely according to this assessment. Thus, a person has the ability to discern if she has the ability to act reasonably according to the assessment she has made for a specific act and to offer normal resistance to people trying to influence her. These include, for example, incompetent persons, prisoners, etc. The appreciation of the nature of freedom of consent is in the light of Articles 488, 449, 1123 of the Cameroonian Civil Code. The ethics committee may also refer to international regulations:

  • Cameroon Civil Code; Art. 488, 449, 1123.
  • Declaration of Helsinki, principles 27, 28, 29
  • CIOMS: GL 13,

2.2.5.2.4. Junior or subordinate members of a hierarchical group

These include, for example, medical students, military personnel, employees of the Promoter, etc...

  • CIOMS: GL 13,

2.2.5.2.5. Persons who have serious diseases

  • CIOMS: GL 13,

2.2.5.3. Recruitment process

The recruitment of subjects differs from selection in that it focuses on the method used. The information on the recruitment of subjects should be included in the application to the REC.

2.2.5.3.1. Recruitment process in general

2.2.5.3.2. Recruitment process by advertisement

This is a special case that requires additional regulatory precautions.

  • Code of Medical Ethics, Art. 7

2.2.5.4. Community consent

The community consent, of which mention is made in principle 22 of the Declaration of Helsinki, is conceived as a means of approaching representatives or leaders of opinion in the targeted population to obtain their permission to implement the study in the community. It does not replace individual consent, but is used in cases where research involves populations or vulnerable subjects.

  • Declaration of Helsinki, 22.

2.2.6. Informed consent

The free, express and informed consent of participants is a legal obligation not only in research legislation but also under the general rules for the protection of the personality in civil, criminal and constitutional law. The evaluation of informed consent is based on the following legislation:

  • Law n° 96-06 of 18t January 1996 to amend the Constitution of 2 June 1972, Preamble
  • The Preamble and Article I of the Universal Declaration of Human Rights
  • The Cameroon Civil Code, Articles 1108
  • The Declaration of Helsinki, principles 24-26

2.2.6.1. Capacity

Discernment involves two aspects: the ability to appreciate the meaning and effect of a specific act and the ability to act freely according to this assessment. Thus, a person has the ability to discern if she has the ability to act reasonably according to the assessment she has made of a specific act and to offer normal resistance to people trying to influence her. The assessment of capacity to consent is in the light of Articles 1108, 1109, 1110, 1111, 1116, and 488 of the Cameroonian Civil Code.

  • Cameroon Civil Code; Art. 1108, 1109, 1110, 1111, 1116 and 488

2.2.6.1.1. Adult

An adult is a person who has attained 21 years of age.

  • Cameroon Civil Code, Art. 388

2.2.6.1.2. Capable adult

The Cameroonian law has the presumption that every person is capable of discernment, unless she is incapacitated, such as by minority, mental illness or weakness of mind.

  • Cameroon Civil Code, Art. 1123

2.2.6.1.3. Incapable adult

Without exception, persons incapable of discernment cannot validly give consent. Nevertheless, we must take into account the expressed wishes of their representative.

  • Cameroon Civil Code, Art. 1108-122

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 incompetent adult. For minors it is usually parents and when there is joint parental authority, the parent acting alone is presumed to act with the agreement of the other.

2.2.6.1.5. Minor

Anyone who has not attained the age of majority, namely 21 years, is a minor.

  • Cameroon Civil Code, Art. 388

2.2.6.1.6. Capable minor

The emancipated minor is presumed capable of discerning if she is not a victim of disability, her young age or weakness of mind.

2.2.6.1.7. Incapable minor

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 incompetent adult. For minors it is usually parents and when there is joint parental authority, the parent acting alone is presumed to act with the agreement of the other.

2.2.6.2. Participants’ Right to information

Consent must be informed. To do this, the subjects have the right to be informed, in so far as a person can only consent about what she knows. This implies that the information is complete and understandable. This right is supported in Cameroon by:

  • CIOMS: Guideline 5
  • The Declaration of Helsinki, principle 24

2.2.6.2.1. Form of the information

The prescription of a particular form of information does not aim at providing a simple means of proof. The form is an extra precaution to ensure the protection of research subjects. Information must be adapted to the personality of the subject to enable her to understand it. It is given in writing and orally in the language of the person concerned. If she is unable to read, other means must be employed to make information accessible and understandable. It can also be done through an interpreter.

  • The Declaration of Helsinki, principle 24-26
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2.5 and 6.2.6

2.2.6.2.2. Scope of the information

The extent of information should be as broad as possible. The subject must be given all the subjectively and objectively essential information which might influence her decision.

  • The Declaration of Helsinki, principle 24-26
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.2

2.2.6.3. Freedom of consent

Consent is the exercise of a constitutional right and personal freedom. It can be restricted only under very strict conditions. The choice whether to participate in research or not should not be unduly influenced. In research, freedom of consent permits no exception. No one may be compelled to participate in research against her will. Freedom of consent also covers the freedom to withdraw consent. This principle is also enshrined in the law. The subject may at any time withdraw from the research without suffering any harm.

  • The Cameroonian Civil Code Article 1108-23.
  • Preamble and Article I of the Universal Declaration of Human Rights
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.5
  • The Declaration of Helsinki, principle 24

2.2.6.3.1. Compensation to subjects

Compensation to research participants must not be likely to influence their decision to participate at the expense of protecting their health. It can be the source of [conflict of interest]. In practice, the committee should not permit compensation exceeding the shortfall resulting from participating in the research project.

  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.3

2.2.6.4. Form of consent

The international texts require that consent be written or evidenced in writing. It must be expressed and given by the subject herself or her representative.

  • The Declaration of Helsinki, principle 24

2.2.7. Risk to benefit ratio

Here it is a question of evaluating the foreseeable risks and benefits. If this ratio is favourable, the research is acceptable, provided that other conditions are met.

The balance between risks and benefits is based on the principle of proportionality. This implies that the proposed research is likely to achieve its objectives, these objectives are justified from the point of view of science and medicine and foreseeable risks are reasonable in terms of the benefits expected.

  • CIOMS, GL 8
  • The Declaration of Helsinki, principle 18; 20; 21

2.2.7.1. Risks of the research

A risk is defined as the probability that an injury will occur. This involves taking into account all potential injuries.

  • CIOMS, GL 8
  • The Declaration of Helsinki, principle 18; 20; 21

2.2.7.1.1. Harm

Damage may be defined by its nature and scope. During the analysis, we should take into account the following two factors in judging the seriousness of the damage.

2.2.7.1.2. Nature of harm

Harm is an involuntary reduction of heritage that can be expressed in many ways but must be linked with research. The damage consists of all injuries, in particular: corporal injuries (treatment and rehabilitation), burial expenses, damage to property (e.g., damage to clothes), loss of earnings and support and moral damage.

2.2.7.1.3. Extent of harm

The damages covered should be those in connection with the test, but too strict a limitation of the extent of damage would be detrimental to subjects.

2.2.7.1.4. Measure to minimize risks

What are the ways to reduce either the probability of occurrence of damage or its severity? The ethics committee conditions the issuance of ethics clearance on the minimization of risks in either the inclusion criteria or the choice of procedures and interventions known to be tolerated or the choice of the most competent investigators.

  • CIOMS, GL 8 and 9

2.2.7.1.5. Monitoring

Ethics Committees should establish a follow-up procedure for following the progress of implementation of all approved protocols.

  • ICH-GCP 5.1.2/5.5.1/5.5.2/5.16/5.18
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 9

2.2.7.1.6. Quality assurance

Quality assurance is an internal system of the research institution and its team which aims at ensuring the quality of the conduct of research and hence the quality of results. The effectiveness of the measure would depend on the standards used.

  • ICH-GCP 2.13/5.1.1/5.1.3/5.2.1/5.19
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.1.6

2.2.7.1.7. Appropriate resources

The resources and infrastructure must be adapted to the research enterprise. This allows, when used wisely, a better control of risks and ensures the validity and reliability of results.

  • ICH-GCP 4.2

2.2.7.1.8. Competent personnel

Like the investigator (see [qualification of the investigator]), the staff must have sufficient knowledge and be able to perform the tasks entrusted to it.

  • ICH-GCP 2.8 / 4.1.5 / 4.2.3

2.2.7.2. Benefits of research

The benefit of a research project can be calculated in many ways, for example, improvement of the quality of life. The National Ethics Committee considers the expected benefits of a research project on the basis of the expected gains from research results.

  • CIOMS, GL 1
  • Declaration of Helsinki, principle 7

2.2.7.2.1. Direct benefits

The direct benefits are those which directly benefit the research subject or the targeted population to which she belongs.

  • ICH-GCP 4.8.12
  • The Declaration of Helsinki, principle 33

2.2.7.2.2. Indirect benefits

The indirect benefits do not directly profit the targeted population or the subject. In these cases, the level of acceptable risk differs from that allowed for direct benefits. These include capacity building of the care team or the technical condition of local health structures.

  • ICH-GCP 4.8.13

2.2.7.2.3. Minimal risks

In the absence of direct benefits to the health of the minor research subject or incompetent adult, participation in research must not expose him to risks beyond those she faces in her daily life or in normal standard treatment.

  • CIOMS, GL 9

2.2.7.2.4. Upper threshold of risk

All research without direct therapeutic benefit which presents risks of serious or irreversible damage to human health or life is prohibited. Similarly, all research in which the risks outweigh the expected benefits is prohibited.

2.2.8. Conflicts of interest

Those involved in research involving human beings should not have conflicting interests. The safety of research subjects and research integrity depend on this. There is a conflict when the different interests of one person leave a doubt about her ability to maintain the focus of her concern on the ethical and scientific quality of research and the protection of research subjects. Any potential conflict of interest must be reported to the REC. A conflict of interest may take different forms. It may be of a pecuniary nature, attached to the structure of the institution or the personality of the actor involved, particularly because of her personal or professional commitments. Article 8 (6) of the Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987 creating the ethics committee states that during the evaluation of protocols submitted, any member of the ethics committee with a direct interest in the study project should leave the meeting during discussions.

Situations of conflict of interest may apply to the following factors: The investigator (this is the case, for example, of an investigator who is a member of the REC which has to take the decision or an investigator who receives a disproportionate reward for undertaking a research); The Sponsor (for example, the situation of a sponsor who is a member of the REC which has to decide whether its project should be approved); Institution ; Member of a REC; Competent authorities.
  • Ministerial order n° 079/A/MSP/DS of MINSANTE of October 22nd 1987: Art. 8
  • The Code of Medical Ethics, Art. 13
  • Declaration of Helsinki, Principles 14, 15
  • CIOMS: Guideline 2
  • Hippocratic Oath
  • ICH-GCP 3.2.1 / 4.1.4 / 4.9.6 / 5.1.2

2.2.9. Protection of privacy & confidentiality

The right to privacy and confidentiality of one’s data is a right guaranteed by the Constitution, the Civil Code and the Penal Code. A research that does not respect this right would be illegal and therefore unacceptable, even though it is scientifically valid. The fundamental standard is always the protection of research subjects, both in their physical integrity and in their private life or in the use of their personal data.

  • Law n° 96-06 of 18t January 1996 to amend the Constitution of 2 June 1972, Preamble
  • The Code of Medical Ethics, Art. 4
  • The Hippocratic Oath
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.4
  • CIOMS: Guideline 18

2.2.9.1. Privacy

  • Law n° 96-06 of 18t January 1996 to amend the Constitution of 2 June 1972, Preamble
  • The Code of Medical Ethics, Art. 4
  • The Hippocratic Oath

2.2.9.2. Professional secrecy

Respect for professional secrecy is not only a legal obligation but also a standard of professional ethics for doctors.

  • The Code of Medical Ethics, Art. 4
  • The Hippocratic Oath
  • The Penal Code of Cameroon, Art. 310.

2.2.9.3. Data protection

Data protection is an important element of individual freedom. In research, the nature of the data that can be communicated renders data protection very important.

  • The Decree laying down the procedures for implementing the Law No. 2000/10 of 19 December 2000 governing the archives
  • The Declaration of the World Medical Association on ethical considerations regarding the databases of health
  • International Ethics Guidelines for Epidemiological Studies
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.4

2.2.9.4. Right of access to data

It must be guaranteed at any time for the person who participated in the research. Other people have to justify their interest in accessing the data. The investigator must respect this right. At most, he can transmit to the person the data related to his health through a doctor that she had designated. With regard to medical records, the data still belong to the patient.

  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.4

2.2.10. Ongoing respect for research participants

Research subjects cannot be regarded as mere means. Their care must be ensured during the [research] and after [the research]. A monitoring process should also be established to determine the long-term effects of research.

  • CIOMS: Guideline 8, 19
  • Declaration of Helsinki, Principle 34, 35
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.4

2.2.10.1. During the research

As long as the research lasts, the sponsor and the investigator and the competent ethics committee must ensure the welfare of research subjects. That is part of the measures for minimizing risks.

  • CIOMS: Guideline 8, 19
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.4
  • Declaration of Helsinki, Principle 31, 35

2.2.10.2. After the research

The very nature of research leaves some doubt about the follow up of its research participants after its implementation. It is therefore important to ensure that even after the research, the health and welfare of research participants will not be altered as a result of their participation. When the subject is responding positively to the treatment tested, measures should be taken so that she can continue to benefit after the end of the research.

  • CIOMS: Guideline 8, 19
  • Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research, art. 6.2.3
  • Declaration of Helsinki, Principle 14, 15