Ethical Review

A South African-based research ethics committee must review the ethical and academic rigour of all research conducted in South Africa. No research involving human subjects or human biological materials can begin until the ethics committee has granted approval. Researchers must obtain ongoing approval, at least annually, throughout the research activity.

Ethical Requirements for Human Research

In its Code for Research Involving Human Subjects, the University of Limpopo aims to promote high quality research in the interests of South African society and the human condition as a whole. It aims to do research that has:

  • Scholarly integrity and excellence.
  • Social sensitivity and responsibility.
  • Respect for the dignity and self-esteem of the individual and for basic human rights.
  • Reference to clearly specified standards of conduct and procedures ensuring proper accountability.

More specifically, the Human Research Ethics Committee is committed to the following ethical requirements:

Scholarly Merit

The design and methods must be academically sound. Unless research generates reliable and valid data which address the study’s objectives, it will have no social or academic value and participants may be exposed to risk with no compensating benefit. Research undertaken in South Africa should be designed so that the findings will be useful and appropriate to individuals and communities in this country.

What to Check:

  • HDC Checklist ticks
  • Official proposal format
  • Aspects in the TREC’s Standard Review Criteria (usually attached to the agenda)

Social Value

The research must be worth doing. It must be relevant to broad health, well-being and development needs of South Africa and to the individual needs of those who suffer from the conditions under study. Ideally, the findings should translate into mechanisms for improving the status of South Africans.

What to Check:

  • Check and comment on what indicates that the research is relevant to the broad health, well-being and development needs of South Africa? The aspect could be ascertained from the Purpose of the Study and the Significance of the Study sections of the proposal, and from the information under “Description of the advantages that may be expected from the results of the study” in the TREC application forms.

Respect and Dignity and Standard of Care

Respect for persons implies concern for the safety, well-being, value systems, beliefs and customs of individuals and communities taking part in research. As a rule, respect for persons manifests through informed consent which allows individuals and communities to choose if they want to participate in research. Valid consent presumes individuals are given information in a form, language and manner which they understand, and that they are able to choose in circumstances free from undue pressure. Valid informed consent is more than obtaining a signature on a consent form. It is a continuous process of disclosure that involves ongoing communication and trust between researchers and participants. Informed consent must be sensitive to language and the range of contexts in which human research is conducted in South Africa. Standard care means: provision of equal standards of medical care / facilities for all participants, equal respect and dignity for all participants, the same follow-up facilities for all participants after completion of the study and the same access to ongoing care.

Respect and Dignity and Standard of Care

What to check:

  • Appropriate information to participants in a form and language which they can understand. It must be free of spelling and grammatical errors.
  • Completeness
  • Appropriate consent forms including TREC Form Part IV, in a language which participants can understand.
  • In the proposal, under the section Ethical Consideration, there must be clear indication of a fair, humane process by which consent will be obtained.
  • There should be clear evidence in the proposal of the aspects listed under the section Guidelines for Referral of Distress Participants. Standard of care must be the same for all participants.
  • Completion and signature of declaration form (TREC Form A – Part I).
  • Completion of TREC form Part II
  • The type and nature of questions which participants will be required to respond to. You may want to ascertain if the questions are sensitive to the value system, beliefs, customs and traditions of the individuals or communities who will participate in the study. Is there evidence of the researcher’s understanding of the targeted community? Are the questions sensitive to religious, sexual, gender, disease and racial issues?
  • Special checks need to be conducted for vulnerable persons, see below.
  • See other requirements under collaborative partnerships

Privacy and Confidentiality

In its simplest form privacy is concerned with access to personal information or records, while confidentiality refers to the use of personal information once it has been disclosed.

Researchers must put measures in place which protect individuals and communities from harm which might result from access to personal and sensitive information. The harm which results from invasion of privacy or breach of confidentiality is often termed a ‘social harm’ as it may lead to stigmatisation, or loss of insurance or employability.

What to check:

  • Is there a declaration in the information for participants that guarantees protection of the participant’s privacy and confidentiality?
  • Does the researcher explain the nature of confidential information which will be obtained and the processes by which such information will be obtained, stored, used or destroyed in a manner that respect the privacy and confidentiality of participants.
  • Data collected and stored should preferably be de-identified (not re-identifiable, anonymous).
  • Data should be stored with personal identifiers (identified or potentially identified data) only if absolutely necessary and where sound justification is provided.
  • Identifiable personal data should never be stored in computers outside research establishments and the files containing personal identifiers stored in locked cabinets or rooms separately from the data. Personal data must only be sent by secure methods.
  • The researcher must indicate all persons who will have legitimate access to the data and they must sign a promise of secrecy.

Favourable Balance of Benefits and Risks/Harms

Because the purpose of research is to advance the frontiers of knowledge, it unavoidably carries some uncertainty. However to avoid harm, researchers must first learn what is harmful and in the process of obtaining this information persons may be exposed to harm. Harms may be physical, psychological, legal, social and economic. Researchers must aim to maximise benefits and minimise risks/harms to individuals and communities. Where a study offers no direct benefit to individual participants, the social value of the research must be sufficient to justify potential risk/harm or inconvenience.

What to check:

  • The nature of the risks/harm/discomfort must be completed on Part II of the TREC application form.
  • Consent form, Part IV must be completed.
  • Check the risks/harm/discomfort against benefits listed under social value and provide your opinion about the balance of benefits versus risks/harm/discomfort.

Fair Subject and Community Selection

The benefits and burdens of research must be shared fairly among individuals and communities. To achieve a fair balance between access to the benefits of research and protection from its harms, research must be responsive to the needs of vulnerable populations. Inclusion of vulnerable groups such as children requires a compelling scientific justification as to why the research cannot be conducted among less vulnerable populations, a reasonable chance of direct benefit to individual participants and the absence of significant risk or discomfort. Convenience is not an acceptable reason for including vulnerable groups in research. Historically, justice or fairness in research has focussed on which participants are included in research when they should not be. Yet it is also unethical to exclude classes of people who are likely to benefit from taking part in research or in whom the results of a specific kind of research are likely to be applied. Accordingly, research must not systematically exclude a class or type of person who is likely to benefit from research participation or in whom the results of a specific kind of research are likely to be applied.

What to check:

  • In qualitative research involving statistical methodology, a letter must be attached from a statistician that he or she was consulted in drafting the proposal.
  • Check the sections: on Sample / Study population, Data Collection, and Bias to make a judgement regarding the aspects listed under fair subject and community selection.

Collaborative Partnerships

To ensure that research is relevant and acceptable, researchers should engage key stakeholders such as community representatives and policy makers in designing the protocol, conducting the research and distributing the findings. Moreover, community participation could include input into a suitable informed consent process, appropriate risk reduction interventions, and decisions regarding treatment and care linked to the research. Collaborative partnerships should allow community members to become genuine, active partners in the research process. This requires sustainable forums for regular communication and problem solving. Likewise, in international multi-centre research, collaborative partnerships between researchers and sponsors from developed countries and researchers and communities in the host country are likely to reduce exploitation, facilitate the negotiation of fair benefits and show awareness of and respect for cultural differences.

What to check:

  • For collaborative research involving international partners there must be a senior researcher from South Africa.
  • There must be evidence of fair benefit sharing.
  • Is there evidence that key stakeholders such as community representatives and policy makers were involved in the design of the protocol?
  • Where relevant are community members involved in the research not only as participants.
  • Letters seeking permission / permission granted to access premises, to use certain records, to access certain communities, from appropriate authorities, must be attached.

Professional Competence and Sufficient Capacity

Researchers must be technically competent in their specific fields to conduct a study. The principal investigator carries the primary responsibility for securing participants’ safety and well-being during a study. Researchers who perform human research must be suitably qualified by experience and/or training to safeguard participants’ rights in their research, and all others involved in a study share this responsibility in varying degrees. In international, multi-centre research, the local principal investigator must be based in South Africa. In multi-disciplinary research there must be technically competent researchers who cover the range of fields which are involved in the study.

What to check:

  • Check abridged CV of the Main Researcher/Supervisor for appropriate qualifications and experience related to the proposed study.
  • If it is a multi-disciplinary study involving several researchers the full names and details (qualifications and relevant experience to the proposed study) must be listed in the TREC forms and signed letters of consent to participate must be attached.

Coercion, Undue Pressure and Conflict of Interest

Individuals and communities should freely choose if they want to participate in research by giving their consent. A researcher must disclose the source and extent of funding to research participants. Commercial affiliations or financial interests at the time of proposing and reporting the research must be disclosed.

What to check:

  • A researcher must disclose the source and extent of funding to research participants.
  • Commercial affiliations or financial interests at the time of proposing and reporting the research must be disclosed.

Legal and Regulatory Requirements

The researcher must adhere to all national and international laws and regulations.

What to check:

  • TREC application Form A Part I or Form B Part I must be completed and signed.
  • The researcher should demonstrate an awareness of particular laws and regulations applicable to his/er discipline and the proposed.
  • The researcher should demonstrate an awareness of applicable national and international laws, regulations and codes.

Vulnerable Persons and Special types of Research

South African ethics committees are required by legislation to pay additional special attention to protecting the welfare of participants who are classified as vulnerable persons or communities, and persons taking part in certain specified research areas.

Researchers must be especially sensitive towards persons whose autonomy is in some way compromised due, for example, to cognitive or other deficits or who are relatively disempowered due to situational factors such as poverty and limited access to health services. Often it is difficult to decide if vulnerable persons should be excluded from research. Yet, preventing persons from making decisions to take part in research conflicts with the principle of respect for persons and may be viewed as paternalistic. In such situations, a balance must be sought between respect for persons and potential harms and benefits for specific participants.

Research involving minors (person younger than 21 years of age)

What to check:

  • The researcher needs to acknowledge s/he is conversant with the Child Care Act 74 of 1983; Children’s Bill of 2003; and S71 of the Health Act 2003 effect from 1 March 2012.
  • The research, including observational research (non-invasive research that involves no interference with the bodily or psychological integrity of the child), should place the child at no more than minimal risk (that is, the risk commensurate with the daily life or routine medical or psychological examinations).
  • Where the research involves minimal risks, the researcher must justify the potential benefit of the research to child participant and the benefits must override the risk.
  • Where the research (known as ‘non-therapeutic’) involves more than minimal risks (the risks must present no more than a minor increase over minimal risk), with no prospect of direct benefit to the child participant, the research mush have a high probability of providing significant generalised knowledge.
  • Proof of Minister’s permission to conduct non-therapeutic research.
  • Consent (in a form and language which s/he can understand) of parents or legal guardian in all research except in exceptional circumstances (such as emergencies).
  • Assent/Consent, in a form and language which s/he can understand, from a minor where s/he is competent to make a decision. Where the minor is not competent, permission from the parent(s) or legal guardian must be sought. No other caregiver can act on behalf of a child in providing consent to participate.
  • Consent/Permission from any organisation or person required by law, eg. the National Health Act 61 of 2003.
  • Adequate steps must be outlined in the proposal to obtain the child’s assent.
  • If TREC approves of the assent, it must indicate how such assent must be documented.

Research involving persons in dependent relationships or comparable situation

It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate positions in hierarchically structured groups and may include relationships between:

  • Older persons and their caregivers;
  • Persons with chronic conditions or disabilities and their caregivers;
  • Patients and health-care professionals;
  • Students and teachers;
  • Prisoners and prison authorities;
  • Persons with life-threatening illness;
  • Employees and employers.

What to check for

  • Are such persons involved in the proposed research as participants, if yes then check for:
  • Is the proposal clear on how such consent will be obtained to protect such persons
  • Their consent will be adequately informed and will be voluntary.
  • Favourable balance of benefit versus harm/risks.

Emergency care research

Researchon temporary incapacitated persons and who are experiencing medical emergencies.

This research can only be approved by a hospital research ethics committee.

Research involving pregnant women and foetuses

What to check

  • Adequate justification is presented in the proposal to involve pregnant women as participants in the research.
  • No research studies involving pregnant women and foetus may be undertaken unless:
  • Appropriate studies on animals and non-pregnant individuals have been completed.
  • The research meets the health needs of the mother of the particular foetus or the particular foetus and the risk is minimal.
  • The research on the foetus is minimal and the purpose is the development of important biomedical knowledge which cannot be obtained by other means.
  • The mother and father must be legally competent and must give informed consent.
  • The father’s informed consent need not be secured if:
  • The purpose of the research is to meet the health needs of the mother;
  • His identity or whereabouts cannot be reasonably ascertained;
  • He is not reasonably available;
  • The pregnancy resulted from rape.

Research involving prisoners

Can only be approved by the National Health Research Ethics Council.

Research Involving medical Indigenous Knowledge Systems (IKS)

What to check for:

  • The researcher’s familiarity with the National Environmental Management: Biodiversity Act, 2004: Regulations on Bio-prospecting, Access and Benefit Sharing.
  • Any substance that is used on participants must be subjected to stringent toxicology testing.
  • There must be sufficient proof of safety.

Research involving innovative therapy or intervention

What to check:

  • Appropriate provision for long-term care and observation of a participant.
  • Adequate proof for the maintenance and security of records.

Research involving vulnerable communities

Vulnerable Communities are communities with some or all of the following characteristics:

  • Relatively disempowered due to situational factors such as poverty and limited access to health care and treatment services.
  • Limited economic development.
  • Inadequate knowledge and means to protect their human rights.
  • Inadequate community/cultural experience with the understanding of research.
  • Limited ability of individuals in the community to provide informed consent.

What to check:

  • Whether this research could not be carried out in non-vulnerable communities.
  • The research is relevant to the health needs and priorities of the particular community.
  • Informed consent (in appropriate content, form and language) of each participant must be obtained.
  • The proposal must outline in detail the procedures that will be followed to obtain consent.
  • The Committee must make sure that the consent and procedures which will be followed are appropriate for individuals in the targeted community.

Research Involving Collectivities