All documentation for submission is available on  https://www.dut.ac.za/research/institutional_research_ethics or can be obtained from the IREC Administrator.

The following will need to be submitted:

1)  Completed DUT approved format for proposal submission ensuring the following are addressed:

• Participant recruitment procedures
• Safety information
• Any payment or compensation to participants
• Ethical checklist

2)  Letter of information and consent (Appendix B)

3)  Conflict of interest form (appendix C)

4)  Other information being supplied to participants

5)  Other documentation necessary for the IREC to make an informed decision regarding the research.

The IREC Administrator will accept applications from the FRC’s/ FREC’s and principal investigators for ethical clearance on a rolling basis. The IREC Administrator in conjunction with the Chairperson will determine whether the application requires expedited or full review. The IREC Administrator will check the application ensuring that all relevant documentation has been submitted, should documentation be missing it will be requested.

All research approved by the IREC on human participants must have a letter of information and consent compiled according to the guidelines in Appendix B. Each participant or, where necessary, the participant’s legally authorised representative, must be given sufficient time to read the letter of information and consent and have the opportunity to ask questions. There should be no coercion or undue influence. The letter of information and consent should be in a language understandable to the participant or representative, allowing them to make an informed decision to participate in the research. Only then may the participant or representative sign the letter of information and consent. In the case where the participant is illiterate, verbal consent may be given in the presence of a literate witness who will verify and sign the letter of information and consent on behalf of the participant, indicating that informed verbal consent was given.

The letter of information and consent must include the following:

• The qualification/s and contact details of the researcher/s
• Participants’ responsibilities
• Purpose of the research
• Any risks and benefits to participants
• Outline study procedure e.g. placebo or control groups if necessary
• Duration of study
• Alternative procedures or treatments
• Confidentiality
• A statement that participation is voluntary and that non-participation will not result in any penalty
• A statement that ethical approval for the study was obtained
• A statement that sponsors or the ethics committee may inspect research records
• Compensation for research related injury
• Contact details of the IREC
• Contact details of the person to contact should there be research related injury

The letter of information and consent must be written in simple language.

APPENDIX B Letter of information and consent

Gatekeeper permission is required when a researcher proposes to collect data from an institution/ organisation. A letter requesting gatekeeper permission is required to be included in the PG 2a. 

APPENDIX C Template for Gatekeeper Permission

The IREC when reviewing a proposal must protect the rights, safety and well-being of the research participants and their communities. It will do this by evaluating all factors that may influence the scientific validity and ethical acceptability of the proposal by applying the various ethical benchmarks mentioned below:

Collaborative partnership:

• Develop partnerships with researchers, makers of health policies and the community and other relevant stakeholders
• Involve partners in sharing responsibilities for determining the importance of a research problem, assessing the value of research, planning, conducting and overseeing research, and integrating research into the health-care system.
• Respect the community’s values, culture, traditions and social practices.
• Develop the capacity for researchers, makers of health policies and the community to become full and equal partners in the research enterprise.
• Ensure the recruited participants and communities receive benefits from the conduct and results of research.
• Share fairly financial and other rewards of the research.

Social value:

• Specify the beneficiaries of the research, i.e, who?
• Assess the importance of the research problems being investigated and the prospective value of the research for each of the beneficiaries, i.e, what?
• Enhance the value of the research for each of the beneficiaries through dissemination of knowledge, product development, long – term research collaboration and/or  other system improvements.
• Ensure that the study is relevant to the community involved or the greater South African population.

Scientific validity:

• Ensure that the scientific design realizes the scientific objectives while guaranteeing research participants the interventions to which they are entitled.
• Ensure that the research study is feasible within the social, political and cultural context.
• Researchers should have the appropriate qualifications and expertise to conduct the proposed research.
• Researchers must be registered with their relevant statutory council where applicable.
• In studies where there is a large clinical component and the principal investigator is not a clinician, a co-investigator who is a clinician must be appointed.
• All international collaborative research must have a local principal investigator/supervisor.

Fair selection of the study population:

• Select the study population to ensure scientific validity of the research.
• Select the study population to minimize the risks of the research and enhance other principles, especially collaborative partnership and social value.
• Select the study population fairly and without coercion.
• Identify and protect vulnerable populations.

Favourable risk-benefit ratio:

• Assess the potential risks and benefits of the research to the study population in the context of its health risks.
• Assess the risk-benefit ratio by comparing the net risks of the research project with the potential benefits derived from collaborative partnership, social value, and respect for study populations.
• Risk to participants and/or the environment must be minimized.

Independent Review:

• Ensure public accountability through reviews mandated by laws and regulations.
• Ensure public accountability through transparency and reviews by other international and non – governmental bodies, as appropriate.
• Ensure independence and competence of the reviews.

Informed Consent:

• Involve the community in establishing recruitment procedures and incentives.
• Disclose information in culturally and linguistically appropriate formats.
• Implement supplementary community and familial consent procedures where culturally appropriate.
• Obtain consent in culturally and linguistically appropriate formats.
• Ensure the freedom to refuse or withdraw.
• The method utilised must be ethically and legally acceptable (Appendix B).

Respect for Recruited Participants and Study Communities:

• Develop and implement procedures to protect the confidentiality of recruited and enrolled participants.
• Ensure the participants know they can withdraw without penalty.
• Provide enrolled participants with information that arises in the course of the research study.
• Monitor and develop interventions for medical conditions, including research-related injuries, for enrolled participant’s at least as good as existing local norms.
• Inform participants and the study community of the results of the research.

(Emanuel et al., 2004)

Researchers have the right to appeal decisions made by the committee or may have concerns regarding IREC administration process. The appeal must be submitted by the principal investigator to the Chairperson of the IREC through the IREC Administrator. There must be a clear motivation for the appeal which should be supported by a subject specialist other than the principal investigator. The IREC Chairperson or delegated member may then seek outside consultation about the research. This will then be reported back to the IREC members along with recommendations regarding the appeal. The IREC committee will then reconsider the entire protocol with the new motivations and a decision will be made. The decision after the appeals process is final.

The IREC approves the study protocol ensuring that the research will be conducted using sound ethical principles. All amendments must be submitted to the IREC utilising the “Application for approval of amendment” form (Appendix D) prior to being implemented. The Chairperson will decide if the amendment has minor or major implications for the study and its participants. If the change is minor it may be seen through expedited review; if the change is major it will serve at a full committee meeting.

• Minor amendment – does not change the risk – benefit profile of the study, e.g. change of title1, administrative changes, adding an investigator, changes that do not affect study design and outcomes, small changes to letter of information and consent such as editorial changes.
• Major amendment – does change the risk-benefit profile of the study, e.g. change in study aims and objectives, alterations to study procedure, changing inclusion criteria to make study more accessible, changes to letter of information and consent.

1Application for change of title: The approved PG 4c: Notification of Research Proposal Title Change by the Higher
Degrees Committee document must be forwarded to the IREC by the relevant Faculty Research Committee for noting.

In the case of protocol deviations, defined as a “once off” instance where the research protocol is not followed either deliberately or by mistake, the deviation will fall into one of two categories: major or minor as outlined above. If minor, the deviation must be reported to the IREC in the annual progress report. If the deviation is major, it will need to be reported to the IREC within 15 days. The Chairperson will then decide the action to be taken.

APPENDIX E Application for Approval of Amendment

All adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), serious adverse drug reactions (serious ADR) and serious adverse experiences (SAEx) which occur during a study must be reported to the IREC.

• Adverse event (AE) is defined as ‘any untoward occurrence affecting participants in a research investigation or clinical investigation participant administered a pharmaceutical product or other intervention/ investigation, which does not necessarily have a causal relationship with this treatment/Investigation.’ An AE can therefore be any unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational) product, or other intervention/ investigation, whether or not related to the medicine or investigational product or intervention.
• Adverse drug reaction (ADR) is defined as ‘any noxious and unintended response associated with the use of a drug in humans or animals’.
• Serious adverse event (SAE) or serious adverse drug reaction (serious ADR) is ‘any untoward medical occurrence that at any dose/ intervention: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.’
• Serious adverse experience (SAEx) is ‘any experience that suggests a significant hazard, contraindication, side effect or precaution’.

APPENDIX F Adverse Event Reporting

Continual review and recertification

All research approved by the IREC will be subject to substantive, meaningful and focused continuing review to determine that the risks and benefits of the study have not changed, that there are no unanticipated findings involving risks to participants and/or others, and that any new information regarding risks and benefits are provided to the participants. The review will occur every two years, unless the level of risk requires more frequent review. The IREC may withdraw approval of a protocol previously approved.

All applications will be reviewed by the full committee. However the final decision rests with the Chairperson or a person delegated with this responsibility. At least one member of the IREC will receive a copy of the full protocol including any modifications that have been previously approved by the IREC, with the full committee having access to the complete IREC protocol file and relevant IREC minutes at the convened meeting. All studies will require continual review until the IREC receives the final study report and the completion of study form (appendix G).

All applications for continual review must be submitted by the primary investigator to the IREC on the IREC safety monitoring and annual recertification report form (appendix F) along with any other supporting documentation. This documentation will need to be sent to the IREC Administrator at least 14 days before the meeting to be added to the IREC meeting agenda and will be distributed to members for review. The IREC should receive this application at least three months before the ethics approval for the study expires; this will ensure that re-approval takes place before the studies ethical approval expires. No study may continue without valid ethical approval and re-certification.

Once the IREC has assessed the continual review application the study may:

• Continue as originally approved
• Have some modifications
• Request a site visit by the safety monitoring committee
• Be suspended
• Be terminated

The IREC Administrator will inform the principal investigator in writing of the outcome of their application and any reasons for its decision. All conditions required by the IREC must be met before continual approval will be granted. If the principal investigator appeals the decision, the IREC must ensure there is a fair hearing of the query.

Safety monitoring

The IREC will monitor compliance with respect to the approved research protocol ensuring the protection of the research participants. Such continued monitoring allows for early intervention should proceedings deviate intentionally or unintentionally from the approved sequence of events.

A Safety Monitoring Committee (SMC) will be formulated by the IREC and function as a sub-committee thereof.

The role of the SMC is to perform the following functions:

1. Investigate and report on the following:

• Ascertain if an approved study is being conducted according to its approved protocol.
• Ascertain whether an approved study is being conducted according to the conditions of approval by the IREC
• Ascertain whether amendments to the original protocol are necessary.

2. Monitor and report on the following:

• Progress made in an approved study in respect of the anticipated timeframe as indicated in the proposal
• Outcomes and findings of such approved studies upon completion thereof

3. Review and investigate if required:

• All adverse events should they arise and advise the IREC accordingly
• Report to the IREC the findings of the SMC with respect to each adverse event.

Composition of the SMC:

The SMC will comprise, at minimum, a member of the IREC and at least 2 additional people who meet the following criteria:

• Suitable expertise and experience in the field of study to be reviewed
• Neutrality with regard to the site, to the principal investigator, and to other relevant parties involved.

In the absence of suitable expertise necessary, the IREC may source such expertise from other academic institutions or from industry.

Monitoring procedure:

Safety monitoring reports

The principal investigator will submit a safety monitoring and recertification report form every two years (appendix F), along with any other supporting documentation, to the IREC, a minimum of three months before ethical approval of the study lapses. In situations where the IREC deems fit, additional safety monitoring reports may be requested. Such situations may include:

• Studies involving vulnerable population groups
• Studies graded as Level 3 (possible risk/ risk to humans, animals, environment or sensitive/ highly sensitive research)
• Studies in which additional factors warrant more stringent monitoring e.g. sample size, complexity of design, location and number of trial sites, degree of financial outlay, number of investigators, degree of experience of the site and staff, degree of manpower involved OR other factors deemed to justify such additional monitoring by the IREC
• Studies with sites from which complaints have been received
• Studies suspected to be not complying with approved protocol

Site inspection

In order to perform the first function, the SMC may conduct site inspections/audits on behalf of the IREC. Such site inspections may include inspections of the following:

• The presence and suitability of all trial documentation and essential documents (appendix F)
• Appropriateness and suitability of facilities and infrastructure at the trial site
• Suitability of expertise and staff recruited to participate in or facilitate the research process
• Investigational equipment for monitoring and interventions made
• Investigational products and interventions with respect to storage, labelling, dispensing, counselling of participants, administration, stock control, and disposal thereof
• Administration and storage of all trial documentation
• Evidence of recruitment strategy and practice applied (including informed consent)
• Evidence of provisions made for patient/ participant confidentiality
• General evidence to support the degree of compliance with the approved research protocol.

All studies categorised as Level 3 as defined in the proposal document, will be subject to a minimum of one annual, compulsory site inspection by the SMC. All other studies will be subject to site inspections as deemed fit by the IREC based on random selection or based on the factors warranting greater than one annual safety monitoring report.

Progress monitoring

In order to perform the site inspection, the SMC may request progress reports from the principal investigator; such reports if necessary may be required to be substantiated by the submission of additional evidence or by undertaking site inspections. Studies which do not meet the anticipated progress targets set in the approved protocol will be reported to the IREC for review and intervention.

Investigation of adverse events

In order to perform progress monitoring, all Adverse Event Reports submitted to the IREC will be delegated to the SMC for investigation, corroboration and reporting. The SMC may request additional supporting evidence and documentation from the principal investigator, conduct an appropriate site inspection, or interview involved parties and stakeholders should it be warranted. Upon concluding its investigation, a report of the findings will be submitted to the IREC for review.

Independent site/trial audit

The IREC may request an independent site audit should it be warranted; such an audit may be instituted in the following situations:

• Studies/sites in which significant evidence of non-compliance or transgression of research protocol exists
• Studies/sites from which serious or multiple complaints have been received
• Studies/sites from which serious adverse events or serious adverse drug reactions are reported
• Studies/sites suspected of committing fraudulent acts
• Studies/sites suspected serious of breach of confidentiality and or poor handling of participants
• Any additional situations in which the IREC deems an independent audit necessary.

In such situations an independent suitably qualified auditor will be appointed by the IREC to act on its behalf and conduct the audit, the aim being to determine if the research is being conducted according to and in keeping with the approved research protocol; that participants are protected and treated fairly and ethical standards are maintained.

APPENIDX G Safety Monitoring and Annual Recertification Report

Suspension or termination by IREC:

Where the IREC is satisfied that such circumstances have arisen that a research project is not being conducted in accordance with the approved protocol and that, as a result, the welfare and rights of participants are not or will not be protected, the IREC may withdraw approval. The IREC shall also inform the researcher and the institution or organisation of its action, and shall recommend that the research project be discontinued or suspended, or that other appropriate steps be taken.

Where ethical approval has been withdrawn, a researcher must discontinue the research and comply with any special conditions required by the IREC. A report to this effect has to be submitted to the IREC within 2 weeks of suspension/ discontinuation of the project.

When the safety of participants is at risk, the Chairperson of the IREC in consultation with an IREC subcommittee and/or other co-opted parties will call a meeting as soon as possible but not more than seven days after receipt of such information. The outcome of such a meeting will be reported to IREC at the next quorate meeting. IREC will give a detailed written reason for suspending or terminating the study to the relevant parties e.g. the principal investigator, the relevant DVC, the study sponsor or agency, the investigator’s departmental head, the South African National Health Research Ethics Council and the South African Medicines Control Council (if applicable).

Suspension or termination by researcher: 

In the case where a research project is prematurely suspended/ terminated the principal investigator/researcher must notify the IREC in writing of the reasons for suspension/termination and give a summary of the results obtained in a study thus far (Appendix H).

APPENDIX I Interruption of Study

A study is considered active or on-going until all data is collected, follow up at all research sites is complete and participant participation is no longer needed. The principal investigator/researcher must submit a letter to the IREC informing them that the study is completed (appendix G) along with the final study report or a copy of the study abstract (in the case of student research). This should be done after the comments from the examiner’s report have been addressed successfully. If a study is not closed but is allowed to expire (a lapse in approval) an administrative suspension letter may be sent to the principal investigator.

APPENDIX H Completion – Termination of Study

For purposes of the SOP, the following definitions apply: 

• ‘Adolescent’ means a child between the ages of 12 and 17 years of age. 
• ‘Minor’ means a person (child) less than 18 years (s17, Children’s Act 38 of 2005) 
• ‘Assent’ means a minor’s affirmative agreement to participate in research. Mere failure to object should not be interpreted as assent. 

The participation of both minors and adolescents requires: 

• Permission in writing from parents or legal guardian for the minor to be approached and invited to participate (in accordance with s 10 of the Children’s Act 38 of 2005); 
• Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate (Appendix J). 
• Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate; the parent may not override this decision. 

 During the assent process: 

• The research team explains the trial to the child in language the child can understand, including what it means to take part and what the child can expect. 
• The research team may use written forms, videos, graphics, and other visual aids to help explain the trial. 
• Free of scientific jargon and unexplained acronyms. 

The child is encouraged to ask questions.

APPENDIX K Assent

The IREC will pay special attention to research involving certain participants and certain types of research. It may be necessary in these instances for the IREC to impose additional measures to protect the well-being of the research participants. Conducting post-research investigations may also be necessary to ensure that the additional measures were implemented. Where compliance is defective, ethical approval may be withdrawn. The IREC will follow the National Health Act section 71(3) (a), where research on children for non- therapeutic interventions must fulfil the following criteria: permission from the Minister, permission from the minors parent/s or guardian and, where the minor is capable of understanding and consenting, from the minor.

Classes of participants that require special attention include:

• Minors – those under 18 years of age
• Pregnant women
• Prisoners
• People with intellectual or mental impairment
• People for whom English is not a first language
• People from vulnerable communities
• Or any other group deemed to be applicable

Types of research requiring special attention:

• Indigenous medical systems
• Emergency medical care
• Innovative therapy/interventions
• Research requiring ambiguity of information for participants

The IREC will follow the guidelines from the Department of Health, Ethics in Health Research: Principles, structures and processes, available at http://www.nhrec.org.za/?page_id=14

The Institutional Research Ethics Committee considers internal and external applications for ethics clearance for research for non-degree purposes/ independent research.

All documentation for submission is available on  https://www.dut.ac.za/research/institutional_research_ethics or can be obtained from the IREC Administrator.

The following will need to be submitted:

1)  Completed  DUT  Independent  Research  Proposal  (Appendix  A)  ensuring  the  following  are addressed:

• Participant recruitment procedures
• Safety information
• Any payment or compensation to participants

2)  Letter of information and consent (Appendix B)

3)  Conflict of interest form (appendix C)

4)  Other information being supplied to participants

5)  Other documentation necessary for the IREC to make an informed decision regarding the research.

The IREC Administrator will accept applications directly from principal investigators for ethical clearance on a rolling basis. For applications internal to DUT, the proposal need not serve at the respective Faculty Research Committee. Applications external to DUT will be charged a fee for review and consideration of the application. The IREC Administrator in conjunction with the Chairperson will determine whether the application requires expedited or full review. The IREC Administrator will check the application ensuring that all relevant documentation has been submitted, should documentation be missing it will be requested.

APPENDIX A Independent Research Proposal Template

The IREC may receive complaints about researchers, the conduct of research, or about the conduct of the IREC. Complaints may be made by participants, researchers, staff of the institution, or others. All complaints should be handled promptly and sensitively.

Possible complaints cover a broad spectrum from ‘inadvertent technical deviations’ from established protocols to allegations of scientific misconduct or fraud. The primary concern in response to any complaint is the extent to which research participants are endangered. There may also be concerns about the degree to which researchers are fulfilling their responsibilities, questions around culpability for misconduct and misleading reports being published by a researcher accused of misconduct or fraud. Often the IREC will be the most appropriate body to consider complaints in the first instance, although ultimately, the responsibility lies with DUT.

The Chairperson of the IREC will receive the complaints; he/she may delegate this responsibility to a member of the IREC. All complaints will be dealt with and may require the assistance of other persons (not necessarily members of the IREC). The letter of information and consent (appendix B) provided to study participants will provide the contact details of IREC Administrator should participants wish to lodge a complaint. The IREC Administrator will forward the complaint on to the Chairperson/complaints officer.

Procedure for complaint:

• complaint referred to the Chairperson of the IREC
• the Chairperson would consider the complaint – including, where necessary, reference to original protocol, contact with researchers, contact with complainant
• action would be taken including, if warranted, implementing an investigation with the complainant being advised accordingly
• a report will appear at the next IREC meeting.

Where the complainant is not satisfied with the actions taken, the complaint would be referred to the relevant DVC.

Conflict of interest arises when the individual’s private or personal interests and professional obligations are divergent to such an extent that an independent observer may have doubt as to whether or not the individual’s  professional  actions  are  influenced  by personal  considerations,  financial  or  otherwise.  Any conflict of interests should be avoided, and all researchers must make known any potential conflict of interests. Interference by clients or funders that could compromise the integrity of the research is unacceptable.

Possible conflict of interests:

• Financial relationships of any kind by the researcher e.g. equity, stock
• Proprietary interests e.g. patents, intellectual property
• Sponsorship/donations e.g. conferences, equipment
• Funding e.g. for additional staff or facilities, payments to departments
• Co-authorship of articles
• Positions on various boards e.g. Pharmaceutical Advisory board
• Grants and retainers.

Conflict of interests that are not disclosed may have a negative impact on the well-being of the research participants; therefore the IREC must be duly informed in order to protect the participants. All principal investigators are required to sign a conflict of interest form (appendix C).

Appendix D Conflict of Interest

The IREC, with the approval of the relevant DVC and Senate, will levy a schedule of fees for review of external proposals. The schedule of fees must be approved by the relevant DVC from time to time as required. The fees received may be used for expenses related to the operation of the IREC, for continuous professional development or specific ethics training. All staff and students registered at DUT will be exempt from paying fees. Students from other academic institutions will pay a nominal fee.