Do you have any questions pertaining to your rights to participate?

For any questions pertaining to their rights to participate contact the   COMREC Chairperson on 0888118993

1. What format should an investigator follow when preparing a research protocol for COMREC’s approval?

The investigator should follow the COMREC format and the research proposal guidelines which can be downloaded from the website: www.medcol.mw/comrec/

2. Should I contact the secretariat about my proposal before I print copies of it and supporting documents for submission?

If it is a first submission, consult the IRB Administrator, the Compliance Officer, or the Administrative Assistant on COMREC guidelines for proposal submission. Thereafter, submit 1 copy of the proposal and all accompanying documents for administrative screening purposes. If your proposal meets with the COMREC requirements for proposal submission you will be requested to submit 4 hardcopies to the Secretariat office and 1 electronic copy to comrec@medcol.mw

3. Should I submit electronic copies of my proposal and supporting documents?

Yes, once your proposal has been screened, and has complied with the COMREC guidelines for submission.  You are required to submit a single pdf file of not more than 5MB in size.The guidelines can be downloaded from the website: www.medcol.mw/comrec/

4. Why does COMREC need to see the Informed Consent Form (ICF) and data collection tools, and what is the expected structure of the ICF?

English and Chichewa (or other relevant languages) consent forms need to be submitted so that reviewers can ensure that the aims, objectives and methodology of the study are clearly and accurately articulated and that no misleading information is placed or no important information is omitted. In addition, reviewers need to check whether adequate forms of compensation are provided and that individuals are not unduly influenced or coerced into participating in the research. Data collection tools need to be reviewed to ensure that the questions asked are in line with the objectives of the research and those questions are appropriately translated into the local language. A template on how to write up an ICF can be obtained from the website: www.medcol.mw/comrec/downloads

5. How much detail for each CV is needed? Should it be included as an integral part of the proposal?

The CV should be appended to the proposal. The most important aspect which reviewers take note of is the qualification of researcher to conduct this research. Academic qualifications and recent publications assist in demonstrating whether or not a researcher has the necessary skills to conduct this research. The CV (or bio-sketch) should be brief.

6. I need to obtain ethical approval from an overseas Research and Ethics Committee (REC). Should I submit to the two review boards simultaneously or in sequence?

It is preferred that the investigator apply for ethical approval first from an external/overseas REC. Once approval from the external/overseas REC has been provided, an investigator should then apply to COMREC for local ethics approval.

7. What procedures should an investigator follow when communicating with COMREC?

When an investigator wishes to communicate to COMREC on any aspect related to research this should be done using the COMREC secretariat email address and not personal emails of the chair or vice-chairperson of COMREC. The official address for the secretariat is comrec@medcol.mw

8. Under what research conditions can an investigator apply for a waiver/exemption from review?

Exemption from review may be considered under the following conditions: Research involving the collection of existing data, documents, records, program evaluation, pathological specimens, or diagnostic specimens, only if the sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to subjects

9. What information do I need to complete the sample size subsection of the protocol?

For quantitative studies, use a relevant equation to arrive at the sample size. Ensure that the variable of interest is specified. In a descriptive study the variable will normally be the main outcome / parameter to be estimated, whereas for a comparative study it will be the outcome / parameter to be compared. Provide justifications for the point estimates that you have used and specify either the confidence level or the significance level to be used. For comparative studies, including those, which involve the identification of risk factors, the calculation must specify the minimum difference of interest and the power required to detect it. Adjust the sample size to cater for refusals, dropouts or expected missing data. For qualitative studies, provide a minimum number of key informants to be interviewed or focus group discussions (FGDs) to be conducted. Always state the number of people per FGD.

10. When I have been asked to revise the proposal what should the response include and how should I submit it?

A revised proposal should have the revised sections highlighted or in track changes. It should be accompanied with a cover letter that quotes each of the issues raised in the review, with a response below and the reference to the page number of the protocol where the changes have been made. It does not need to include CVs and other appendices, which are unchanged.

11. What does the COMREC processing fee (US $150) cover?

It assists in supporting the administrative costs that the COMREC Secretariat office incurs in processing the protocol and communicating with reviewers and researchers.

12. Who receives and manages the 10% COM Research Administration fee?

It is the College of Medicine. Although, most people refer to it as a COMREC fee, this is a wrong term to use since COMREC does not receive or use this fee. The rationale for the fees is provided in the University of Malawi Policy for Research and Consultancies. The complete details can be found by visiting the website www.medcol.mw/comrec/downloads/

13. Who grants a waiver for the 10% COM Research Administration fees?

COM Research and Consultancy Policy clearly states that only the Dean of Postgraduate Studies and Research can grant waivers for 10% Research and Administration Fees and NOT the COMREC Chairperson.

14. Does COMREC have a role to play in the granting of waiver for 10% COM Research Administration fees?

No. COMREC does not have a role to play. What COMREC requires is that all protocols should include the minimum of 8-10% Research Administration fees in their budgets for the execution of the work. It only checks whether a research scientist has complied with the administrative requirements for submitting a protocol.

15. Under what conditions does one need clinical trial insurance?

According to the Policy Guideline issued by the National Commission for Science and Technology (NCST), the following clinical trials shall always require insurance coverage;
Vaccine or drug trials where safety issues remain fully unknown. This also includes all clinical trials for candidate vaccines and drugs at all phases of development.
Vaccine or drug trials involving vulnerable populations (e.g. pregnant women, neonates, children) and non vulnerable populations where such trials are of drug(s) already registered but proposing new usage, dosage, combinations, and/or formulations other than the therapeutic usage, dosage, combinations and/or formulations for which the drug/vaccine was originally prequalified by WHO and registered by a drug regulatory authority such as the Pharmacy Medicines and Poisons Board.
Trial involving investigational/pharmaceutical product(s) which was already prequalified by WHO and registered by a drug regulatory authority for therapeutic usage and dosage in a specified route of administration but the trial proposes changes to its originally approved route of therapeutic administration, dosage or usage.
Any trial involving an investigational/pharmaceutical product in the formulation, combination, usage, dosage and with route of administration not prequalified by WHO and registered by a Drug Regulatory Authority.
Any trial involving any form of investigational product including a medical device that has not been prequalified by WHO and approved for usage.
Any gene therapy trials/studies aimed at introducing a genetic material into patients to treat a genetically inherited or acquired disorder.
Complete details of the policy can be accessed from the College of Medicine Research and Ethics website (www.medcol.mw/comrec/) by clicking on downloads on the left hand side of the screen.

16. Under what conditions does one need a Data Safety Monitory Board (DSMB) for the study?

All intervention studies involving human participants where the; Investigation of a research question has direct implications for clinical care or public health (including all Phase III trials),  The population is classified as highly vulnerable  The clinical trials involve a high risk intervention For large multicentre clinical trials

17. Under what conditions does COMREC approve the transfer outside of Malawi of biological samples obtained from Malawian study participants?

When reviewing the application for exportation of samples, the request to transfer the samples outside of Malawi need to clearly demonstrate that currently no local capacity is available to analyze the samples. The other critical elements that are considered are provided in the Material Transfer Agreement (MTA) form found on website www.medcol.mw/comrec/downloads/

18. I am planning to modify the study or add another component for data collection, how should I proceed?

When should I submit a proposal amendment and when should it be a new proposal? If the researcher plans to modify the study or add another component for data collection then s/he ought to apply for an amendment to an approved protocol. Request/complete a protocol amendment form from the COMREC secretariat. In addition, attach a cover letter addressed to the committee that refers the reviewers to the specific sections and pages w here the changes/modifications to the originally approved protocol have been made. Submit 4 hard copies of the amended protocol with the amended sections highlighted or presented in track changes. Submit 4 clean copies of the amended protocol as well. For guidance purposes, amendments can be classified as minor or major amendment. A minor amendment is defined as a change that does not materially affect the balance of risks and benefits in a study or does not substantially change the specific aims or design of the study. A major amendment is defined as a change that involves significantly increased risk to participants and often reflects changes in the direction of a study that may substantially change its purpose or goal. Please note: Changes that alter the overall purpose or objective of a study may require a new protocol submission.

19. What will happen if I don’t submit an annual progress report?

Your annual ethics approval will lapse thus making it unethical to continue your research.

20. When is a study monitored? What does it involve?

COMREC monitors research through the following mechanisms: Annual Progress Reports, Data Safety Reports and Study Site Inspections. Inspections involve reviewing all the study site and study documents and study staff to ensure that sites to assess how well the investigators and the sites are complying to the approved protocol, are complying with (International Conference on Harmonization on Good Clinical Practice (ICH-GCP guidelines), Human Subjects Protection (HSP), Good Clinical Laboratory Practices (GCLP) guidelines GCP and the applicable regulatory requirements. Normally inspection visits will be arranged in advance with the Principal Investigators but COMREC may also conduct unannounced visits.

21. What are COMREC’s requirements on the submission of Serious Adverse Events/Adverse events reports?

It is the responsibility of an investigator to submit Serious Adverse Events/Adverse Events reports within 24 hours of their occurrence to COMREC. An electronic copy can be emailed to the secretariat email address: comrec@medcol.mw Hard copies should follow thereafter.

22. What is an investigator required to do at the end of implementation of his/her study ?

At the end of the implementation of the study, an investigator is required to comply with the conditions of the ethical approval and among them; these include the dissemination of findings to COMREC. This can be in the form of journal articles etc. In addition, an investigator should complete and submit a COMREC close-out form which can be access from the COMREC secretariat.