Orquidea Massarongo, Teresa Machai, Eusebio Macete, Armindo Tiago, Esperanca Sevene
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1. Type of research

This module focuses primarily on biomedical research, which 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 and on the type of participants. The most relevant types of biomedical research are clinical trials, research with human biological material and epidemiological studies.

There is no specific regulation or guidelines in the country that applies to each of the categories of biomedical research mentioned above. Every individual is free to choose and pursue any research provided that he/she abides by laid down procedures for approving the protocol and carrying out the research and is conducted in respect to the community.

Article 2 (1) of the Science and Technology Ethics Code (2007) establishes that the Code covers all fields where scientific research occurs, and it exceptionally applies to the activities which involve ethical aspects that put human life at risk. The priority areas of scientific health research are dealt at the Scientific Council for Health.

1.1. Biomedical research

Biomedical research broadly covers any research in the field of health. It comprises the study of specific diseases and conditions (mental or physical), including detection, cause, prophylaxis, treatment and rehabilitation of persons; the design of methods, drugs and devices used to diagnose, support and maintain the individual during and after treatment for specific diseases or conditions; the scientific investigation required to understand the underlying life processes which affect disease and human well-being, including such areas as cellular and molecular bases of diseases, genetics, immunology.

Biomedical research carried out in the country by hospitals and research centers, including academic institutions, is governed by ethical principles contained in different laws and documents some of them non-binding, but with persuasive effect.

Researchers are required to take into account laid-down procedures throughout the process, as those provisions from the Helsinki Declaration and Universal Declaration on Bioethics and Human Rights.

The Science and Technology Ethics Code (2007) requires observance of some core principles, obliging the health researchers to, among other things, respect principles of integrity and human dignity, professional dignity, non-maleficence, consent and confidentiality.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4, 6, 7 & 8
  • UNESCO - Universal Declaration on Bioethics and Human Rights (2005), Art. 2, 3, 4, 5 & 6

1.1.1. Clinical trials

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

There is no specific regulation for clinical trials in Mozambique, although they are under preparation at the Ministry of Health. Nevertheless, as per the Science and Technology Ethics Code (2007), the scientific activities must be strictly adhere rules of scientific rigour, and the investigator must demonstrate that the proposed research is justified.

  • ICH Guideline for Good Clinical Practice, 1996, Para 2.2,2.5
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (a)
  • Declaration of Helsinki (2008), Para. 19

1.1.1.1. Clinical drug trials

Current regulations in Mozambique do not include regulations specifically on clinical trials. International regulations, especially ICH-GCP 1996, are applicable to the evaluation of clinical trials.

As per the Code of Medical Professional Ethics, clinical drug trials with new medicines cannot deliberately deprive the patient from a well known efficient and essential treatment to safeguard his life or when the omission may put the patient in disproportional risks.

  • ICH-GCP 1996, Para 5.22; 5.23; 6; 6.3; & 6.4
  • Code of Professional Conduct of Medical Doctors, Art. 62.

1.1.1.2. Other clinical trials

This field of scientific study includes laws on radiology, imaging, radiations, chemicals and other related subjects. One of the most frequent clinical trials in Mozambique is those involving bed nets for prevention of malaria. There is nothing in particular in Mozambique, the reference to regulations are those specified at ICH-GCP 1996, Declaration of Helsinki, as indicated above.

  • ICH-GCP 1996 Para. 6

1.1.2. Research with human biological material

There is not specific regulation that applies to the collection, storage, and transfer of human biological samples for the purpose of biomedical research. International regulations, especially The World Medical Association, Declaration on Ethical Considerations Regarding Health Databases, 2002, are are used for the evaluation of research with human biological material.

  • Declaration of Helsinki (2008), Para. 25
  • Declaration on Ethical Considerations Regarding Health Databases, 2002

1.1.3. Epidemiological studies

Mozambique does not have specific law that applies to epidemiological studies. However, international rules and principles are applicable. For instance the requirement for information to the research subjects in order to obtain a valid consent, protection of privacy and confidentiality during the study. One important element is the responsibility before the community where the study will occur.

As far as Epidemiological research is based on the critical analysis of data, the rules of professional secrecy are very important here. There is a provision on data protection, which establishes that all individual information obtained for statistical purposes may not be disclosed, and may not be inserted in any publication or given any connection that might identify the participants.

  • Constitution of Mozambique (2004), Art. 41.
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (a), (b), (c), (e) & (g); Art. 8
  • Law Nº 7/1996, of 05th July, National Statistics System, Art. 14 nº 1 & 2.
  • CIOMS - International Ethics Guidelines for Epidemiological Studies,
  • UNESCO - Universal Declaration on Bioethics and Human Rights (2005), Art. 9

1.2. Research involving humans other than health research

Despite the fact that this Module focuses on research in the field of human, it must also be considered domestic principles and laws applicable to other fields involving humans that have impact on the well-being of human subjects. The principles do not vary much, rules such us informed consent, confidentiality, protection to participants and analysis risk-benefit must be present.

In Mozambique, as the Law is general, extensive to all areas of scientific research, the Science and Technology Ethics Code applies to all types of research developed in the country and principles like consent, respect to participants, and justice are present. Health and environment studies are regulated by the same law.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 2, 6,7, 8 & 9

2. Ethics review

There is an implicit requirement for submission of a research protocol to the ethics committee, as the law indicates under Article15 (i) of the Science and Technology Ethics Code. The Committee has the duty to provide an opinion on ethical aspects to the research project submitted. At the same time, the Ministerial Order of May 21st 2002 creating the National Ethics Committee for Health, hereinafter referred as CNBS, establishes that the CNBS has to review all research protocols in order to guarantee the ethics and respect for human subjects. The Terms of Reference (ToRs) of the Ministerial Order presents the list of documents required for the application for ethical review and the directives guiding the examination of submitted documents. This regulatory basis is made upon the international regulations on the evaluation of protocols: Operational Guidelines for Ethics Committees that review Biomedical Research (WHO) 2000, Declaration of Helsinki (WMA) 2008, Ethical Guidelines for Biomedical Research (CIOMS), Good Clinical Practices (ICH) 1996, and Others.

The Ministerial Order of May 21st 2002 empowers the CNBS to regulate, control, and review of ethics on health research in Mozambique. All individuals or organisations that intend to develop a research project in the country must seek permission from CNBS, which is granted in the form of an Ethics Approval Document. However, this document does not replace an administrative authorization, which is issued by the Minister of Health.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 15 (i)
  • Order of Ministry of Health (2002), Normative Procedures, Para. 2 (Scope of action).
  • Mozambican Code of Professional Conduct of Medical Doctors, Art. 64
  • WHO Operational Guidelines for Ethics Committees (2000), Para.6
  • Declaration of Helsinki (2008), Para. 15

2.1. Research Ethics Committee

There is a National Health Research Ethics Committee (CNBS), which is the main responsible for research protocols approval on Health in Mozambique. The CNBS started in 2008 to delegate their mandate to authorized Institutional Health Research Review Committee or Boards – IRBs which are given statutory powers and duties to conduct health research review activities. The IRBs can only review institutional Protocols.

There are not very many IRBs. But by the end of year 2010 it is expected there will be at least four (4) IRBs in the country, one from a National Institute of Health, two from academic institutions and one from a Research Centre.

The CNBS is in the process of harmonization the rules of procedure for institutional ethics committees or Boards (IRBs) and of accreditation for the evaluation of research protocols to be implemented in the institution concerned.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 14 n°1
  • Order of Ministry of Health 2002, Normative Procedures, Para. 2 (Scope of action).
  • WHO Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research (2000). Para. 2

2.1.1. Jurisdiction of the REC

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

The scope of competence of the IRBs (Institutional Review Board) is defined in regards to a given type of research. The CNBS defines the jurisdiction of the IRBs as follows: protocols on demographic inquiry; epidemiological studies without invasive measures; Studies on Knowledge, attitudes and practices and Monitory and evaluation Studies.

  • Order of Ministry of Health 2002, Normative Procedures, Para. 2 (Scope of action).

2.1.2. Independence of ethics review

2.1.2.1. Independence of the REC

The RECs must guarantee an independent and competent review of the protocols submitted. As regards composition, procedures and decisions, RECs are obliged to be independent from any politic, institutional, professional or any undue influence in order that the opinion of an ethics review committee has value. The members of the REC/CNBS decide in full freedom, they must be free from all conflicts of interest. The member of CNBS usually declares before the review of protocols whether they have any conflicts of interests.

Another crucial requirement for RECs is to be independent of the researchers, sponsors, as well as of their establishing institution or authority, in this case from the Ministry of Health. The regulatory basis supporting the independence of RECs is: Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research.

  • Order of Ministry of Health of May 21st 2002, Terms of Reference, Section II (Objectives).
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 4, 7
  • Declaration of Helsinki (2008), Para. 15

2.1.2.2. Independence of members

The members of RECs are selected in their personal capacities, objectivity, scientific knowledge and commitment. Their decisions are based on the merits of the protocols and not the institutions they are affiliated to. Members must base their deliberations on the protocol to the relevant professional ethics, national and international legal instruments.

REC members should have a basic understanding of the importance of research and how it can benefit human health and welfare. They must be able to make their own independent judgments when considering the ethical issues involved in the research proposals placed before them.

  • WHO Operational Guidelines for Ethics Committees (2000): Para. 4, 7.1

2.1.3. Composition of the REC

The CNBS consists of 13 members including four women, with a balance of scientific expertise, legal and ethical backgrounds, as follows: a clinical pharmacologist, three specialist doctor (internal medicine and paediatrician), a nurse, one epidemiologist, two public health specialists and four lay members (two representatives of religious groups, one lawyer, one sociologist and one linguist).

It must be noted that the majority of the members are qualified in biomedical sciences, as they have the major role to review the pharmacology and methodology aspects on the protocols submitted.

Other existing committees, namely the IRBs (Institutional Review Board) and those that could be accredited, follow the same directive for their composition, being a minimum of 5 members covering the areas specified previously which at least one must be a lay member. The supporting regulatory basis on which the composition of RECs is based is the Operational Guidelines for Ethics Committees in charge of the evaluation of Biomedical Research.

The mandate of the members is for a period of three (3) years renewable, being the maximum period of tenure in office six (6) years. The continuity of accumulated expertise is guaranteed as some of the members may stay longer period, when there is a difficulty of replacement.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.2
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 4.1; 4.2
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 14 nº 4

2.1.4. Functioning of the REC

The CNBS meets regularly every last Thursday of the month, from 2:00 p.m. based on summon of the month to review research proposals and decide on their ethical acceptability. The documents of the plenary meetings (full protocols) are sent to the members at least fifteen (15) days before the meeting in order the allow the members to review it. Depending on the workload, the CNBS can have an extra meeting in the month where the dates are agreed to by the committee members in accordance with their availability.

The CNBS cannot work in plenary meeting without a valid quorum that should always be greater than half of RECs members.

Every CNBS meeting must have minutes taken, where it is indicated the members present, the protocols reviewed and recommendation or decision for each protocol. At each meeting, the minutes of previous meeting have to be approved after consideration of the members.

When the CNBS considers that it lacks capacity to decide about a certain protocol, it can invite selected expertise, the main researcher or even the promoter to give an opinion about the protocol. The selected expert is bound by the principle of confidentiality, which must be registered at the minutes of the meeting.

Applications should be submitted to the CNBS secretariat at least two (2) weeks before the next upcoming scheduled meeting that the applicants want their applications to be reviewed, in order to allow time for the secretariat to prepare and distribute a tentative agenda based on the applications received and matters arising from the previous meeting

The maximum protocols to be reviewed in each meeting is ten (10), plus 3 to 4 amendments, clarifications or a suspended document from the previous meeting

Every member has a word to say on protocol review; however specific tasks are for medical professionals, lawyers and other lay members on ethics issues.

The WHO guidelines for the functioning of an ethics committee are applied at the CNBS

  • Order of Ministry of Health of May 21st 2002, Normative Procedures, Section 4
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 4.5; 4.6; 6.1

2.1.4.1. Organization of the REC

As per the Order of Ministry of Health of May 21st 2002, the CNBS is an organ under superintendence of the Ministry of Health.

The CNBS has the following structure a president, one vice-president, Executive secretary, administrative secretary, a treasurer and ordinary members.

The responsibilities and tasks of the CNBS President, vice-president and secretary are clearly specified at the Normative Procedures Works section 3.2 at the Ministry of Health Order of May 21st 2002.

The founder’s members of CNBS were nominated by the Minister of Health in 2002. Nowadays, with the Science and Technology Ethics Code, only the president will be nominated by the Minister of Health under proposal of the CNBS after internal elections.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.2

2.1.4.2. Decision-making process within the REC

For decision making, the quorum of CNBS should always be greater than half of total membership. Thus the minimum quorum is half of CNBS members plus one, including at least one lay member.

When making decisions the CNBS considers the following aspects:

  • Scientific design and conduct of the study;
  • Recruitment and Protection of research participants;
  • Confidentiality;
  • Informed Consent Form;
  • Community Considerations
  • Data collection and storage.

Normally, the decisions are arrived by a consensus, when it is not possible to reach consensus, the decision is taken by the majority, but with acceptable grounds.

The CNBS may decide to postpone its decision in case more details or reflection is required, where the principal investigator may be invited into the next meeting room to clarify some aspects that arise from the protocol.

Some protocols are approved with recommendations, which are not binding. When there is a negative decision is always followed by a clearly stated reason, which must also be stated at the minutes of the meeting.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1, 7
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 4.5; 7

2.1.4.3. Transmission of the REC decisions

The Committee responds in writing and gives the approval or the rejection of the research proposal, and if the protocol is rejected the reasons for that decision must be stated. The communication of decision is made within two weeks after the meeting at which the decision was made.

When the CNBS proposes or requires amendments on the protocol, the applicant investigator has a period of 30 days to send the amendments to the Committee, after that period the protocol is filed.

Nothings is specified in regards to the right to appeal a decision of the Committee. However the CNBS does not put any barriers and, according to their records, there were few appeals of their decisions. According to the Science and Technology Ethics Code, on art. 13 e) the CEAIC ( Ethics Council of Scientific Investigation Activities) has the power to settle any dispute that might arise at RECs, thus implying that there is a chance to appeal to that organ.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 13 e) Order of -Ministry of Health 2002, Normative Procedures, Section 7
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 8

2.1.5. Ongoing review of research

One of the tasks of CNBS is to monitor the implementation of approved protocols and developments occurring in the context of biomedical research. This involves the obligation for the research team to inform the Committee about any adverse or unexpected effect. Any significant change in the research protocol modifies the research and requires a new assessment by the Committee. The investigators are always required to inform the CNBS regularly about the course of study. The selection of the study for follow up is done at random among all protocols approved.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 f), S. 5
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 9

2.1.6. Responsibility of the REC

The CNBS has the responsibility to ensure participants’ rights to dignity, safety and protection in the review or evaluation of the ethical merits of research protocols. The Committee must also ensure the scientific merit of research and the qualification of the investigator or team of investigators.

Another responsibility is to verify whether any compensation proposed is fair, if any damage or injury sustained in the course of the clinical trial or any other research is properly addressed.

It is also important to evaluate whether the information of the study is going to be given to research participants and whether help them to give a proper consent.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 a) to e)
  • WHO Operational Guidelines for Ethics Committees (2000) Para. 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 and cultural considerations.

On the evaluation of the protocols the CNBS considers criteria defined in general by the national law, Science and Technology Ethics Code and Code of Medical Professional Ethics and other international instruments.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art.4, 7, 8 & 9
  • Code of Professional Conduct of Medical Doctors, Art. 60, 61, 62,
  • WHO Operational Guidelines for Ethics Committees (2000) Para. 6.2
  • Declaration of Helsinki, Para. 15,16,17,18
  • CIOMS International Ethical Guidelines 2002

2.2.1. Social value of the research project

The social value of a research project is evaluated taking into account the importance of the study for the community. One of the principles of the Science and Technology Ethics Code is that scientific activities must be carried out in respect of well-being of the community, cultural and environment aspects, meaning that the community should be privileged from the results of the study. There might be some benefits, direct or indirect, to the research subject or community bearing the risk they are exposed at the study.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art.4 (c) & (e), Art. 9 (d).
  • Universal Declaration of Human Rights, Art. I
  • International Covenant on Civil and Political Rights (ICCPR), Art. I
  • WMA Declaration of Helsinki; Para.7; 17 and 21
  • CIOMS International Ethical Guidelines 2002: GL 2

2.2.1.1. Medical relevance of the research project

The medical relevance of the research has to do with a study which is aimed at easing a condition or disease. There is medical relevance when the research is going to result in medical progress; however the interest in medical progress must not come before well being of the research participant. In any diagnosis or therapeutic experiment the ethics guarantees must be present and reviewed by the National Ethics Committee (CNBS).

2.2.1.1.1 Relevance for the target population

The studies conducted in Mozambique must be relevant to the population, in relation to their culture, environment and diseases pattern.

The population targeted for the study should be the one which will use the results, as beneficiaries, this is a guarantee given by law on Science and Technology Ethics Code.

2.2.1.1.2. Relevance for public health

Medical research should focus on the improvement of public health. There is a duty of the citizens to promote and protect public health. However this may not undermine the well-being of the individual research participant which takes precedence among other interests.

2.2.1.2. Safeguard the intellectual property rights

The Mozambican Ethics Code establishes as a principle that intellectual property rights must be protected during the development of scientific research activities plus a particular duty for the investigator to respect those rights.

The protection of intellectual property rights in medical research is generally done through the Industrial Property Code which incorporates the principles of the Paris Convention of 1883 and its subsequent amendments.

As regards the exclusion of patentability, only products, substances or compositions used in methods of surgical treatment, therapy or diagnosis applicable to the human body can be patented. Are excluded from the patent protection all that is contrary to morals, usages and morality, public health, as well as all or part of human body. However, microbiological processes are patentable.

One relevant aspect of medical research, has to do with the compulsory license, defined as defence mechanism against possible abuses committed by the patentee, and which is issued by the government that grants the privilege. Through licensing, the government authorizes a third party to explore the subject of a patent without consent of the holder.

For Mozambique, the invention can be exploited with the authorization of the supervising Minister, currently the Minister of Industry and Commerce, but without the consent of the patent holder on grounds of public interest, particularly when the invention is of prime importance for public health, national defence and economic and technological development.

The code also indicates the acts that constitute infringement of industrial property rights and the situations that constitute violation of exclusive rights to patent, which is based on the requirement of holders authorization/consent.

  • Constitution of the Republic of Mozambique (2004), art. 89
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art.4 (d) (e), Art. 6 (f) & Art. 9 (b) (d)
  • Code of Professional Conduct of Medical Doctors, Art. 60; 64.
  • WMA Declaration of Helsinki, Para.5, 6, 7, 17, 21

2.2.2. Scientific validity of the research project

The evaluation of the scientific quality of a research project is an important task of the CNBS. The Committee must review whether, based on the objectives, the study will produce valid results. A scientifically non-valid research project cannot be ethically acceptable.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (f)
  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 (a)
  • Code of Professional Conduct of Medical Doctors, Art. 64
  • WMA Declaration of Helsinki, Para. 12, 14 and 16.
  • CIOMS International Ethical Guidelines 2002: Guideline 2

2.2.2.1. Method / design of the research project

There is no specific rule under Mozambican legislation regarding the design of health research project; nevertheless the design of research study involving humans must be clearly described in a research protocol. The Protocol must contain the objectives well defined in regards to the title of the study, all procedures and methodology to be used, risks involved, data safety, report of the results, etc.

The CNBS on its review process considers those aspects as indicated previously at point 2.1.4.2, as per the international instruments such as ICH-GCP; WMA Declaration of Helsinki and WHO Operational Guidelines for Ethics Committees

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 9 (a)
  • WMA Declaration of Helsinki, Para. 14
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.1
  • ICH-GCP (1996). Para. 2.4; 5.12; 6.2.7

2.2.2.1.1. Pre-clinical data

As a general rule, medical research involving human subjects must be preceded by animal experimentation, where the welfare of animals used on the research must be respected.

The law specifies that trial in human beings relating to new drugs or techniques for treatment can only be conducted after a various animal experiments which demonstrate a reasonable probability of success and therapeutic security and guarantee all necessary conditions of medical vigilance. Once again the consent and integrity of the patient must be in place.

The Ethics Code in Mozambique it is too vague. It only indicates that, when using animals, the investigator must take all considerations to prevent any harm on health and must also consider the well being of the animals, part of the study which will later benefit the individuals.

  • Code of Professional Conduct of Medical Doctors, Art. 60
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art.6 n°2
  • WMA Declaration of Helsinki (2008), Para. 12

2.2.2.1.2. Scientific literature review

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

  • ICH-GCP (1996), Para. 6.2.7
  • WMA Declaration of Helsinki (2008), Para. 12

2.2.2.1.3. Research design

The design of research study must be clearly described in a research protocol.The research design must emphasize the procedures and the increase of the scientific knowledge that the research will bring. According to the law, this must incorporated as an essential part of the research design.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 9 (a)
  • ICH-GCP (1996), Para. 5.4 / 6.4
  • WMA Declaration of Helsinki (2008), Para. 14

2.2.2.2. Investigator’s brochure

There is no specific provision relating to investigator’s brochure in Mozambique. The REC follows what is specified in international instruments with no legal binding effect, but generally accepted as an international standard. The rules of ICH- Good Clinical Practices (1996) are one of the examples.

  • ICH-GCP (1996), Para. 7 (7.1 to 7.3)

2.2.3. Investigator’s qualification

The investigator needs to be capable of conducting such a study. When submitting a research proposal, a Curriculum Vitae or any other relevant documentation where the research experience is summarized must be attached as one of the pre-requirements for protocol approval. The investigator should indicate that he has all the qualifications specified by the applicable regulatory requirements/laws.

The Declaration of Helsinki indicates clearly that “medical research involving human subjects must be conducted only by individuals with the appropriate scientific training and qualifications”. These qualifications are certified by a Local Medical Association.

  • Law n˚ 3/2006 of 3rd May establishing the Mozambican Medical Association, organization and practice of medicine, Art. 82
  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 (b) & 6
  • WMA Declaration of Helsinki, Para.16
  • WHO Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research (2000). Para. 6.2.3.1

2.2.4. Compensation for damages

The order of Ministry of Health relating to CNBS and its normative procedures requires that the research protocol be submitted with an insurance certificate, notwithstanding this is not always the practice, which serves for compensation in case the participating subject is injured. The compensation for the damage or injury aims at restoring the subject to the state which would have been if the damage or injury had not occurred.

The compensation is regulated under the provision of the Civil Code art. 493 (2), under the principle of risk responsibility (art. 499), whereas whoever causes harm to anybody is obliged to compensate, there is a requirement of causal link for this provision to be valid.

On the other hand, investigator should make treatment available to research subjects in the event of a trial-related injury or when during the study they find out that the participant is infected, they must referred them to clinic or Medical Unit.

  • Order of Ministry of Health 2002, Normative Procedures, Section 6
  • Civil Code, art. 493 (2) as referred by art. 499; art. 562 & 563.
  • Penal Code, Art. 368 & 369.
  • WMA Declaration of Helsinki (2008), Para 14
  • ICH-GCP (1996) 5.8.2

2.2.4.1. Coverage of the damage

Cover for losses during the implementation of a research project falls under civil responsibility rules provided in Section V (Art. 493 to 564) of the Mozambican Civil Code, where it is regulated all situation in regards to compensation and damage.

The compensation covers the damage caused plus the benefits that the participant was prevented to obtain as a result of the injury and also future predictable damages. Normally the amount is determined by a court decision, taking into account the economic situation of the participant injured and all other relevant circumstances.

  • Civil Code, Art. 493, 494, 495,496, 499, 562, 563 & 564.
  • ICH-GCP 5.8

2.2.4.2. Persons responsible under the coverage of the damage

The main person responsible would be the physicians who participate in medical research, as the Declaration of Helsinki indicates that it is their duty to protect the life, health, dignity, integrity, privacy (...) of research subjects.

The person responsible can also be the sponsor, in those cases where the investigator, physician is contracted to perform one or more of a sponsor/s trial duties and functions. In these cases the investigator, acting on behalf of an organization, being the one having a legal duty of care to protect others against their acts. As indicated in art. 500 of Civil Code, those who put somebody in charge of something, are responsible for any damages caused by that person, when there is an obligation of compensation.

  • Civil Code, Art. 493 nº 2, 500 & 507.
  • WMA Declaration of Helsinki (2008), Para 11

2.2.4.3. Extent of damage

This covers all the damage which results from the act or mistake of the researcher. The nature of the damage must be vividly perceived or seen fully and need not be limited to damage to health. It can be very diverse in such a way that it goes beyond attacks on health. For instance, damage resulting from a surgical operation can also lead to lack of capacity to work because of impairment or psychological trauma. It can also be extended to those who assisted the injured

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.

  • Civil Code, Art. 495, 496, 563 & 564.

2.2.4.4. Nature of damage

In general terms, damage consists of material or moral prejudice to one person caused by a third party. To have compensation the injury must be certain. Damage may involve an involuntary reduction of a heritage that can be expressed in many ways but must be linked with research. It may be physical and psychological damage. In the context of clinical trials, the damage consists of all losses suffered, in particular injuries, burial expenses, 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 and will imply on the compensation value where the last decision is left to the judge.

  • Civil Code, Art.496 & 564.

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 an equitable selection, without unnecessarily burden the weight of research on a particular population.

  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.2

2.2.5.1. Selection criteria

Mozambican law do not specifically provide criteria for the selection of research subjects. The CNBS on its review takes into consideration the principles and rules provided international instruments, such as WMA Declaration of Helsinki, WHO Operational Guidelines for Ethics Committees, etc. Researchers generally use the “consent” factor after deciding who has to be involved in the research. However, factors and reasons for inclusion or exclusion of subjects must be specified and justified by scientific standards.

  • WHO Operational Guidelines for Ethics Committees (2000).Para. 6.2.2

2.2.5.1.1. Inclusion criteria

The main inclusion criteria is the consent given based on the information provided by the investigator. The other criteria’s must be clearly stated on the Protocol.

  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.2.4
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (g)

2.2.5.1.2. Exclusion criteria

When it comes to exclusion criteria, this must be well explained, and the reasons for exclusion must be clear, and based on scientific standards.

  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.2.5

2.2.5.2. Vulnerable participants

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

Particular attention must be paid to vulnerable people, whose participation in a research project must always be justified specifically. When they are selected, the means of protecting their rights and welfare must be strictly applied.

The Mozambican Science and Technology Ethics Code, indicates that participants must give their consent based on “intelligible” information on the research project, this persons normally are not in capacity to give that type of consent. Researchers should also be aware of the special needs of these groups and ensure greater privacy to enable them to communicate directly with the researchers.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (g)
  • CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects, 13-16
  • WMA Declaration of Helsinki, Para. 17

2.2.5.2.1. Populations or communities with limited resources

In this regard, the law only makes reference to the principle that the communities must be privileged beneficiaries of the results of the study and the study must produce knowledge to benefit the community as a whole, without disregard the freely and intelligible consent, they might not be induced to participate in the study only because they have limited resources.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (e) & 9 (d)
  • 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

The protection of the rights and welfare of research participants in Mozambique is guaranteed by the Science and Technology Ethics Code, the Constitution of the Republic as the constitutional principles in respect of fundamental rights shall be interpreted and integrated in harmony with Universal Declaration of Human Rights and with African Charter of Human and Peoples Rights. Although this is not sufficient but the basic protection is guaranteed.

  • Constitution of the Republic of Mozambique (2004), Art. 43
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4, 6, 7, 8 & 9
  • CIOMS. Guideline 12
  • WMA Declaration of Helsinki (2008), Para. 9 and 17

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

In Mozambique these individuals are incompetent persons such as minors, mentally disabled and incapacitate persons, and almost fall under the same regime: they need a special authorization or guardian to consent on their behalf. The first are limited by age, as per Mozambican Law below 21 years, the second and third do not have the ability to appreciate the meaning and effect of a specific act and the ability to act freely according to this assessment.

  • Civil Code, Art.122; 123; 124; 130; 138; 139; 152 & 153
  • Familiy Law, Art. 283, 287, 337 to 341
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (h)
  • WMA Declaration of Helsinki, Para. 27; 28; 29
  • CIOMS: Guideline 13 & 15

2.2.5.2.4. Junior or subordinate members of a hierarchical group

We can consider that this group might have limited capacity and freedom to consent as per their position in the group. For this group to participate in the study it must be guaranteed that their consent was given based on open, clear, intelligible information about the research project.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 7 nº 2
  • CIOMS: Guideline 13

2.2.5.2.5. Persons who have serious diseases

Persons who have serious diseases or who are severely ill or unconscious are vulnerable subjects because they do not have the capacity to understand or their freedom to refuse is limited. New medical therapeutic trials or surgery techniques must have a reasonable probability to be worthwhile and taking into account the physical and psychological well being of the patient, without unnecessary burden balanced with the benefits.

In all cases, the ethical guarantees needs to be evaluated by the National Research Ethics Committee (CNBS).

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 7 nº 2
  • Code of Professional Conduct of Medical Doctors, Art. 64 & 65
  • CIOMS: Guideline 13

2.2.5.3. Recruitment process

The information on the recruitment of subjects should be included in the application to the CNBS, in order to verify whether the participants are induced, or not, or if there was any discrimination in the process. The process of recruitment is aligned with the inclusion and exclusion criteria of the research study.

2.2.5.3.1. Recruitment process in general

In general the recruitment of research subject is done in hospitals, health facilities or at community level. The legal capacity of the participant is a basis for recruitment plus the consent to be included on the study.

2.2.5.3.2. Recruitment process by advertisement

There is no experience in the country for that kind of recruitment.

2.2.5.4. Community consent

The community consent, of which mention is made in paragraph 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 makes it much easier and acceptable as all research activities must be developed in respect to the cultural values of the communities. In Mozambique the traditional authorities, particularly in rural areas, has a special role and are well recognized by the population.

  • Constitution of the Republic of Mozambique, art. 118 nº1
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (c) & 7 nº1
  • WMA Declaration of Helsinki (2008), Para. 22.

2.2.6. Informed consent

The free and informed consent of participants is a legal obligation. The potential research participant must be provided with appropriate, accurate and understandable information about the research project before he gives his consent. The consent should be given based on open, clear and intelligible information on what the study is about

Any medical experimentation in a healthy person or patient can only be admitted if the person has given his consent freely and informed about the level of the risks and possible effects of the intervention.

  • Constitution of the Republic of Mozambique, Art. 48 nº 1
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 7 nº2
  • Code of Professional Conduct of Medical Doctors, Art. 61 nº 1, 62 nº1.
  • WMA Declaration of Helsinki, Para. 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 is regulated in general under the Civil Code.

The potential research subjects must be in position to give the consent, in words they must have capacity and when they do not have capacity this must be given by a legal guardian.

  • Civil Code; Art. 122,123, 124, 125, 130, 138, 139, 152, 153, & 156
  • - Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (h) & 7 nº2

2.2.6.1.1. Adult

According to Mozambican law, any person who attains 21 years of age acquires full capacity to exercise his rights, to govern its own life and to have use of his own goods or patrimony that is when he is considered an adult. However, the person below the age of 21 can be considered adult if he has attained 18 years of age by means of emancipation by marriage, court decision or parental authorization, in those cases his acts are considered made by adults.

  • Civil Code, Art. 130, 132, 133

2.2.6.1.2. Capable adult

The Mozambican law considers that every adult is capable of discernment, unless he is incapacitated, such as by mental illness or weakness of mind which makes them incapable to govern their own life.

As a principle, any medical experimentation can only be admitted on adults, and is exceptionally accepted in minors when there is a direct benefit to them and the legal representative has given a proper consent.

  • Civil Code, Art. 138 & 152
  • Family Law, Art. 332
  • Code of Professional Conduct for Medical Doctors, Art. 61 nº 1 & nº3.

2.2.6.1.3. Incapable adult

A person who lacks legal capacity to consent usually cannot understand the information given about the proposed research intervention. The inability to consent may be partial or total, and may be fluctuating or permanent. For these incapable adults the figure of guardianship or legal representative is called to give consent.

  • Civil Code, Art. 138, 139,124, 152, 153 & 257
  • - Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (h)
  • WMA Declaration of Helsinki, Para. 29

2.2.6.1.4. Legal representative

The legal representative is the person designated by law to safeguard the interests of the minor or incompetent adult who are unable to consent. For minors it is usually parents and when it is not possible by a guardian indicated by a court decision. The guardian can be a person indicated by the parents, the spouse for an incapable adult, the elder son or any person indicated by court upon hearing the family council.

The legal representative must receive all relevant information about the research proposal in order to give consent.

2.2.6.1.5. Minor

Anyone who has not attained the age of majority, namely 21 years, is a minor, and cannot make any rational decisions, including consent to research.

  • Civil Code, Art. 122, 124, 139, 143, 144 & 154
  • Law nº 7/2008 of 9 July, Promotion and Protection of Children’s Rights, Art. 36 nº 1
  • WMA Declaration of Helsinki, Para. 27, 28

2.2.6.1.6. Capable minor

The emancipated minor is a minor who has attained 18 years of age and was given that condition. The emancipated minor has a full capacity to exercise rights and govern his life as an adult.

The minor can be emancipated by marriage, court decision or parental authorization, in those cases his acts are considered made by adults. There the emancipated minor has a legal capacity to consent.

There are other situations where a minor is consider capable, as far as he has attained 18 years of age, such as marriage, elections and to work. For that reason, there is a common understanding that the minors who have attained 18 years has enough discernment. Therefore his consent is considered valid for a simple research study which does not include any major intervention on the minor between the age o 18 to 21 years of age.

2.2.6.1.7. Incapable minor

As per what was stated previously about minors, all those below the age of 18, are incapable minors, they cannot in any case give a valid consent for any research project.

2.2.6.1.8. Legal representative

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

  • Civil Code, Art. 132-137
  • Family Law, Art. 283,284,287, 337 to 341
  • Law nº7/2008 of 9 July, Promotion and Protection of Children’s Rights, Art. 36 nº 1
  • WMA Declaration of Helsinki, Para. 27, 28

2.2.6.2. Participants’ Right to information

Respect for autonomy acknowledges a person’s capacity to make personal choices. A potential research participant must therefore be provided with appropriate, accurate and understandable information about the research project. The right to information is provided in general in Mozambican Constitution.

In regards to biomedical research, the potential participant must be clearly informed about the aims and procedures of the research, including any risks that might arise.

  • Constitution of Mozambique, Art. 48 nº1
  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (g) & 7 nº 2
  • Code of Professional Conduct for Medical Doctors, Art. 61 nº 1; 62
  • CIOMS: Guideline 5
  • WMA Declaration of Helsinki (2008), Para. 24

2.2.6.2.1. Form of the information

Nothing is specified in the laws referring to biomedical research, about the form of the information. Nevertheless, in order to give evidence that the information was given, the information must be in writing. The other reason is for CNBS review purposes as it has to take into account the document to verify whether the appropriate information is being delivered to the potential participants. The form is an extra precaution to ensure the protection of research subjects.

The document must be in a language that the potential participant can understand. For studies at the rural areas the CNBS requires that the information must also be available in a local language. This might not be enough, as in many situations, the potential participant is unable to read or/and to sign, in those cases as a general practice even on the courts, it is required two witness/interpreters who will read, and explain to the participant and they confirmation of acceptance with a finger print.

  • Civil Procedure Code, Art. 139, 141, 232
  • Code of Professional Conduct for Medical Doctors, Art. 61 nº 1 & 4; 62
  • WMA Declaration of Helsinki (2008), Para. 24 & 26
  • WHO Operational Guidelines for Ethics Committees responsible for the evaluation of biomedical research (2000), Para. 6.2.2.5 and 6.2.6

2.2.6.2.2. Scope of the information

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

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (g) & 7 nº 2
  • WMA Declaration of Helsinki, Para. 24

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 or not to participate in research 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.

  • Constitution of the Republic, Art. 48 nº 1, 2 & 6
  • Civil Code, Art. 246; 247; 253; 254 & 255.
  • Article I of the Universal Declaration of Human Rights
  • WMA Declaration of Helsinki, Para. 24

2.2.6.3.1. Compensation to subjects

Compensation to research participants must not be likely to influence their decision to participate to the detriment of their health. Any payment and rewards provided to participants must be appropriate to the burden and inconvenience of the research but not at the level that might encourage them to accept a risk that would otherwise not accepted.

  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.3.10
  • CIOMS Ethics Guideline, Guideline 7.

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. It is common practice, though, that consent is in written form and its contents approved by the RECs, in our case by the CNBS.

  • WMA Declaration of Helsinki, Para. 24
  • ICH- GCP 1996, Para. 4.8
  • Code of Professional Conduct for Medical Doctors, Art. 61 nº 1 & 4; 62.

2.2.7. Risk to benefit ratio

For any biomedical research involving human beings, the researchers must ensure that the risks and burdens of research participation are not disproportionate to any potential benefits. Risks and burden should always be minimised. 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 and the ethical principles of beneficence and non-maleficence.

  • CIOMS, Guideline 8
  • The Declaration of Helsinki, Para. 6; 18; 20; 21

2.2.7.1. Risks of the research

Scientific research, especially epidemiology and clinical trials, are prone to potential physical and psychological damage because they involve human beings at different levels. Therefore, a researcher has to oversee and take into account all potential risks – consider whether there is a probability that damage will occur in the process of investigation. The important question is whether measures are in place to mitigate the risks.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (b); 6 nº 1 b)
  • CIOMS, Guideline 8
  • WMA Declaration of Helsinki, Para. 6; 18; 20; 21

2.2.7.1.1. Harm

The harm is a bad outcome which includes loss of life, personal, physical or physiological injury. The harm must be minimised in research projects. The research on human beings may only be undertaken when there is no alternative method which could provide comparable results

2.2.7.1.2. Nature of harm

The harm may be physical, psychological or social from one side, and can also be temporary or permanent. When there is a risk of permanent harm the study must not be accepted because of the potential high risk. The Code of Professional Conduct for Medical Doctors prohibits any research that may be an attempt to psychic life, moral conscience, dignity and integrity of the individual.

2.2.7.1.3. Extent of harm

2.2.7.1.4. Measure to minimize risks

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

- Establishment of a mechanism to protect research subjects from potential harm;
- Make treatment available to research subjects in the event of a trial-related injury
- Careful monitoring of research subjects.
  • Code of Professional Conduct for Medical Doctors, Art. 60, 62 nº2; art. 67.
  • CIOMS, Guideline 8 and 9

2.2.7.1.5. Monitoring

The CNBS (REC) is entitled to monitor and evaluate safety and adverse events at any time during the research. The main aim is to verify if the rights and well-being of human subjects are protected.

The CNBS is allowed to conduct onsite monitoring visits at random, especially for researchers who do not submit progress reports or researchers who are suspected of having changed their objectives and conduct as approved.

The monitoring occurs 3 times during the study, and the calendar can be agreed between CNBS and the investigator.

  • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 (f)
  • ICH-GCP (1996), Para. 5.18.1
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 9

2.2.7.1.6. Quality assurance

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

  • ICH-GCP (1996), Para. 5.1.1; 5.1.3 & 5.19
  • WHO Operational Guidelines for Ethics Committees (2000). Para. 6.2.1.6

2.2.7.1.7. Appropriate resources

The resources and infrastructure must be appropriated to the research enterprise. The investigator should be able to demonstrate potential for recruiting or acquiring the most appropriate resources and should have an adequate number of qualified staff and adequate facilities for the intended investigation, so that he can act with responsibility.

  • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 6 (b)
  • ICH-GCP (1996), Para. 4.2.1 & 4.2.3
  • 2.2.7.1.8. Competent personnel

    Medical research involving human subjects must be conducted only by individuals with appropriate scientific training and qualifications. Thus, the personnel must have sufficient competence to be able to carry out the tasks which are entrusted to them. At no time should health research be left in the hands of incompetent personnel.

    • Declaration of Helsinki (2008), Para.16
    • ICH-GCP (1996), Para. 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.

    According to the Mozambican Law, all research projects must be done based on the principle of participants or sources benefit. For instance it must increase the knowledge of the area of the study in benefit to the participants either direct or indirect, and this must be expressly indicated at research design. When it is a community study, it must result is direct benefit to the community in collective.

    In order to assure the benefit, the result of the scientific research must be lodged to the research participants and other sources.

    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 9 (a), (b), (d);
    • CIOMS, Guideline 1
    • WMA Declaration of Helsinki (2008), Para.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 he belongs.

    The laws does not specify the type of benefit, direct or indirect. It only indicates that the participants should be privileged with the results of the study, and specific requirements apply to community studies, where it must generate a result in benefit of the community.

    In regards to children and incapable, medical experimentation is only allowed when there is a direct benefit to them.

    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (e), 9;
    • Code of Professional Conduct for Medical Doctors, Art. 61 nº3
    • WMA Declaration of Helsinki (2008), Para.33

    2.2.7.2.2. Indirect benefits

    The indirect benefits do not directly profit the targeted population or the subject. It is a kind of benefit of the research to science or society, as it does not produce results of direct benefit or the health of the person concerned.

    • Convention on Human Rights and Biomedicine, (Additional Protocol), art. 6

    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 he faces in his daily life or in normal standard treatment.

    The risk must not exceed those related with routine medical or psychological examination of such person, where there is no requirement for special protective measures.

    2.2.7.2.4. Upper threshold of risk

    All research upper the threshold risk are prohibited as it presents risks of serious or irreversible damage to human health or life. The exercise of a scientific activity must respect the life, health, privacy, integrity and dignity of a human being.

    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 4 (b)
    • Code of Professional Conduct for Medical Doctors, Art. 61 (3); 66
    • CIOMS, Guideline 9

    2.2.8. Conflicts of interest

    Those involved in research involving human beings should not have conflicts of interest. As per the Mozambican Science Ethics Code, the investigator should act with independence, autonomy and responsibility, without any undue influence.

    Any potential conflict of interest, involving the member of REC, investigator, institution or sponsor must be reported to the REC, to safeguard the capacity of the REC to make an independent decision.

    The physician responsible for a experimentation or clinical trial must act and be independent of any economic influence from an entity with commercial interest on promotion of new treatment or techniques.

    The rule at CNBS requires that the members decide in full freedom, free from all conflicts of interest. The member of CNBS usually declares before the review of protocols whether they have any conflicts of interests and this is recorded at the minutes of the meeting. A member should not be part of the decision process in matters in which he has a direct interest

    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 6 (b).
    • Code of Professional Conduct for Medical Doctors, Art. 66
    • WMA Declaration of Helsinki, 2008, Para.14 & 15
    • CIOMS: Guideline 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, Penal Code and the Science and Technology Ethics Code. The fundamental standard is always the protection of research subjects, both in their physical integrity, in their private life or in the use of their personal data. Confidentiality is a very important in biomedical research, between doctor and patient or researcher and patient and the information obtained must be regarded as strictly confidential and may not be disclosed.

    • Constitution of Mozambique, Art,.41
    • Civil Code, Art. 79 & 80
    • Penal Code, Art. 290 & 461
    • Science and Technology Ethics Code
    • CIOMS: Guideline 18

    2.2.9.1. Privacy

    All citizens have the right to defend their public image and to protect their privacy, and all individuals must respect the private life of other. All individual information must be treated with confidentiality. When it comes to research projecs, participants’ identifty must be kept anonymous by omitting information that might lead to the identification of research subject. In the case that confidentiality and anonymity may not be guaranteed, the participants must be aware of that fact and of the possible consequences, before they are enrolled in the research.

    The privacy must be considered in the perspective of the participant and its culture.

    • Constitution of Mozambique, Art. 41
    • Civil Code, Art. 80
    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 8
    • Law Nº 7/1996, of 05th July, National Statistics System, Art. 14 nº 1 & 2

    2.2.9.2. Professional secrecy

    One of the duties of scientific researchers provided in the Mozambican Ethics Code is a professional secrecy including the protection of sources, this is a legal obligation.

    There is also a standard of professional ethics to physicians, where the professional secrecy is an obligation to all of them and constitutes a matter of social and moral interest. The scope of professional secrecy covers all facts that came to knowledge of the physician on exercise of his profession and shall include facts disclosed by the patient or accompany during consultation, facts discovered by the physician or transmitted by other physician on the course of medical assistance.

    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 6 (g)
    • Code of Professional Conduct for Medical Doctors, Art. 68; 69 nº 1

    2.2.9.3. Data protection

    The law regulates the protection of personal data, the conditions of access to data banks, the creation and use of such data banks. Access to data bases or computerised archives, files or records for obtaining personal data of third parties is not allowed; the same rule applies to transfer of personal data from one institution to another that belongs to a distinct service, except when there is a court order.

    For statistics purpose, the law establishes an obligation to protect personal data, obtain during statistics production in view to protect the private life and to guarantee that participants trust on the process.

    The chief on duty and physician on health institutions are obliged to guarantee the protection of clinical information contained at patient personal file, and this may not be disclose except for professional use by other peer. The archives must be protected by a password with restricted access.

    • Constitution of Mozambique, Art. 71 nº 2 & 3
    • Science and Technology Ethics Code, Decree n° 71/2007, of 24 December, Art. 8
    • Law Nº 7/1996, of 05th July, National Statistics System, Art. 7
    • Code of Professional Conduct for Medical Doctors, Art. 70 nº 1, 3, 5 & 6.
    • WHO Operational Guidelines for Ethics Committees (2000), Para. 6.2.4

    2.2.9.4. Right of access to data

    The individual subject must be guaranteed the right to access his or her own data. The right of access to data must be guaranteed at any time for the person who participates in research.

    All the information regarded as professional secrecy has the access restricted and the investigator must respect that. In a case that the investigator is a physician, the duty of professional secrecy can be waived upon consent of the patient and when there is a necessity to protect the dignity, honour and legitimate interests of the doctor and patient.

    • Constitution of Mozambique, Art. 71 nº 4
    • Code of Professional Conduct for Medical Doctors, Art. 70 nº 3; 71 & 78 nº3.

    2.2.10. Ongoing respect for research participants

    The respect to research participants must be regarded as permanent, not only considered at the time of research approval. The care of participants must be ensured during and after the research. A monitoring process should also be established to determine the long-term effects of research.

    • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 (f)
    • WMA Declaration of Helsinki (2008), Para. 15; 31; 35.

    2.2.10.1. During the research

    As stated earlier in Section 2.2.7.1.5 the researcher must inform the CNBS about developments of the research and monitoring may occur three (3) times during the study. This means that the researcher must ensure the wellbeing and observance of all human rights during the investigation.

    The CNBS besides the review and approval of protocols, has a also a duty of tracking the study implementation and make decisions before any adverse or unlikely events occurring during the study.

    • Order of Ministry of Health 2002, Normative Procedures, Section 3.1 (f); Sec.5
    • WHO Operational Guidelines for Ethics Committees Para. 6.2.3.3; 6.2.3.4
    • WMA Declaration of Helsinki (2008), Para. 15.

    2.2.10.2. After the research

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

    Nothing is specified about this in national laws, however this is the practice followed by the CNBS.

    • WHO Operational Guidelines for Ethics Committees (2000), Para.6.2.3.3; 6.2.3.4; 6.2.3.8; 6.2.3.11
    • WMA Declaration of Helsinki (2008), Para. 14