Frequently Asked Questions
(1) What is the turn around period if a research proposal is submitted to the Medical Research Council of Zimbabwe for review?
It takes 4-6 weeks before a researcher gets a response from the committee. When five copies of a new research proposal are submitted for review to the Medical Research Council of Zimbabwe, one copy becomes the MRCZ copy, the other four copies are sent to external reviewers depending on their area of speciality and the title of the proposal. These are expected to send back comments to the Medical Research Council of Zimbabwe before the proposal is tabled during MRCZ monthly review meetings.
(2) What are the submission requirements for a new study?
The researcher is supposed to submit to the Medical Research Council of Zimbabwe the following documents:
- Five copies of duly completed MRCZ form 101, the form can be down loaded from our website: http://mrcz.org.zw
- Five copies of protocol summary less than 3 pages in length.
- Five copies of complete research protocol.
- Five copies of consent forms in English and local language of the study population in MRCZ template (include parental consent and assent forms where relevant).
- Five copies of questionnaire being administered during the study in English and local language of participant.
- If it is a drug trial five copies of drug brochure and same application package to be submitted to Medicine Control Authority of Zimbabwe (MCAZ).
- 5 copies of CVs for PI and Co-PI
The researcher is required to pay processing fee of:
- 10 USD for students doing first degree
- 50 USD for a masters level dissertation
- 200 USD for PhD Students
- 500 USD for researchers or 1000 USD for expedited review.
NB: STUDENTS SHOULD PRODUCE PROOF OF REGISTRATION WITH THEIR RESPECTIVE UNIVERSITIES AND APPROVAL FROM STUDY SITES WHERE DATA COLLECTION WILL TAKE PLACE
(3) What are investigators’ responsibilities during the conduct of an approved research study?
Investigators play a crucial role in protecting the rights and welfare of human participants and are responsible for carrying out sound ethical research consistent with research plans approved by the Medical Research Council of Zimbabwe. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:
• obtaining and documenting informed consent of participants or participants’ legally authorized representatives prior to the participants’ participation in the research, unless these requirements have been waived by the Medical Research Council of Zimbabwe
• obtaining prior approval from the MRCZ for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to participants and
• ensuring that progress reports and requests for continuing review and approval are timely submitted to the Medical research council of Zimbabwe
• providing to the MRCZ prompt reports of any unanticipated problems involving risks to participants or others,
• providing to the MRCZ prompt reports of serious or continuing non compliance with the regulations or the requirements or determinations of the committee.
(4) What should investigators do if they want to amend / modify an MRCZ approved research study?
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.
(5) What are researchers’ responsibilities once a study is completed?
If all research-related interventions or interactions with researcher participants have been completed, and all data collection and analysis of identifiable private information described in the MRCZ-approved research plan have been finished, then the research study has been completed. When research study has been completed, the researcher no longer requires to obtain continuing review and approval of that study by the MRCZ. The researcher notifies MRCZ through a completely filled in MRCZ FORM 105 (study termination form) and final report should be attached. Researcher may keep the data they collected, including identifiable private data, consistent with the MRCZ-approved research plan. Researcher should continue to honour any confidentiality protections of the data. Researcher should also honour any other commitments that were agreed to as part of the approved research, for example, providing information about the study results to research participants, or honouring commitments for compensation to research participants for research participation.
(6) What happens if a research participant becomes a prisoner during the course of a research study?
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.
(7) What is child assent, and how do the requirements vary with the age of the research participants?
“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.”
(8) Is child assent always required when research involves children?
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.
(9) How is child assent documented?
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.
(10) What happens if a child reaches the legal age of consent while enrolled in a study?
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.