FAQs

What is the turn around period if a research proposal is submitted to the Medical Research Council of Zimbabwe for review?

Researchers should allow 4-6 weeks for studies undergoing normal review. Applications eligible for expedited review are processed within 10 working days, while undergraduate and Master's student research projects are reviewed within 5 working days. Turnaround times are calculated from the date a complete application package is received and accepted for review.

Investigators are responsible for conducting research in accordance with the approved protocol, ethical principles, and applicable regulatory requirements. This includes obtaining and documenting informed consent, seeking prior approval for protocol amendments, submitting required progress and continuing review reports, promptly reporting adverse events and unanticipated risks, and ensuring compliance with all conditions of approval throughout the study. Failure to meet these obligations may result in corrective actions by the Medical Research Council of Zimbabwe.

If investigators wish to amend / modify an ongoing MRCZ-approved research study, they must submit a request to the MRCZ and receive MRCZ approval before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to participants. If a researcher changes the research in order to eliminate apparent immediate hazards to participants without prior MRCZ approval, he or she should report those changes promptly to the MRCZ. 

Once a study is completed, researchers must notify the Medical Research Council of Zimbabwe (MRCZ) by submitting a completed Study Termination Form (MRCZ Form 105) together with a final study report. Researchers are required to continue safeguarding the confidentiality and security of research data, comply with all commitments made to participants, and ensure that any agreed dissemination of study findings or participant-related obligations are fulfilled in accordance with the approved research protocol.

If a participant involved in ongoing research that was approved by the MRCZ becomes a prisoner during the course of the study, the researcher must promptly notify the MRCZ for re-review of protocol. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-participant must be suspended. In special circumstances in which the investigator asserts that it is in the best interests of the participant to remain in the research study while incarcerated, the participant may continue to participate in the research. 

“Assent” is defined by the regulations as follows: 
“Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. When judging whether children are capable of assent, the MRCZ is charged with taking into account the ages, maturity, and psychological state of the children involved. MRCZ has the discretion to judge children’s capacity to assent for all of the children to be involved in a proposed research activity, or on an individual basis. MRCZ takes into account the nature of the proposed research activity and the ages, maturity, and psychological state of the children involved when reviewing the proposed assent procedure and the form and content of the information conveyed to the prospective subjects. For research activities involving adolescents whose capacity to understand resembles that of adults, the assent procedure should likewise include information similar to what would be provided for informed consent by adults or for parental permission. For children whose age and maturity level limits their ability to fully comprehend the nature of the research activity but who are still capable of being consulted about participation in research, it may be appropriate to focus on conveying an accurate picture of what the actual experience of participation in research is likely to be (for example, what the experience will be, how long it will take, whether it might involve any pain or discomfort). The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve.” 

No. Assent means a child’s affirmative agreement to participate in research. The Medical Research Council of Zimbabwe is the one responsible for deciding whether child assent is required or not in proposed research activities. Mere failure to object should not be construed as assent. Child assent is required, except in the following three circumstances. 
1. The capability of some or all of the children is so limited that they cannot reasonably be consulted; 
2. The intervention or procedure involved in the research holds out the prospect of direct benefit to the health or well-being of the children and is available only in the context of the research; 
3. The research meets the same conditions as those for waiver or alteration of informed consent in research involving adults. 

The Medical Research Council of Zimbabwe has the discretion to determine the appropriate manner, of documenting child assent. Based on such considerations as the child’s age, maturity, and degree of literacy, the committee decides what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the participants were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent. 
If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The Medical Research Council of Zimbabwe may also decide that documentation of assent is not warranted. 

The Medical Research Council of Zimbabwe notes that informed consent is an ongoing process throughout the duration of a research. When a child who was enrolled in research with parental or guardian permission subsequently reaches the legal age of consent to the procedures involved in ongoing research, the participant’s participation in the research is no longer regulated by the requirements regarding parental or guardian permission and child assent. 
Unless the Medical Research Council of Zimbabwe determines that the requirements for obtaining informed consent can be waived, the investigator should seek and obtain the legally effective informed consent, for the now-adult participant for any ongoing interactions or interventions with the participant. This is because the prior parental permission and child assent are not equivalent to legally effective informed consent for the now-adult participant. 

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