Joint Research Ethics Committee for the University of Zimbabwe

Faculty of Medicine and Health Sciences and Parirenyatwa Group

of Hospitals
Research Ethics Committee

APPLICATION FORM
Details of Research Team

Name of Principal Investigator (P.I) Chipara Gerald

Existing Qualifications Undergrad
Academic Title Student Radiographer
Institution & Dept. University of Zimbabwe Medical physics and imaging Sciences
Postal address HH04 Nyandoro street rugare kambuzuma harare
E-mail address [email protected]
Telephone No. 0785 989 200
Is this research expected to lead to the award of a Yes
higher degree? (Yes/No)
University/Institution where registered University of Zimbabwe
Departmental Supervisor Qualifications Institution/Department
Vutsvene Zephania Bsc hon rad University of Zimbabwe Medical physics and imaging
Sciences

Details of the Proposed Research

Title of proposed research. Evaluation of the measure being used by radiographers to prevent equipment
breakdown in Harare

Proposed starting date 01 April

Proposed ending date 31 April
Performance site Parirenyatwa Group of Hospitals, Sally Mugabe Central Hospital, 24HR
Kensington medical health clinic
Total number of study personnel 3
Budget (state currency) 30 000 rtgs
Name and address of Funding agency: Self
Status of funding : Funded
 STUDY IMPACT: Does the study impact on other hospital departments such as (Nursing,
Pharmacy, Labs, Imaging, no

Pathology, Medical Records, etc) or need specialized committee approval?

If YES, have appropriate approvals been obtained from affected departments?
YES - NO
(List departmental approvals and obtain appropriate signatures)

Departments/Committees Impact Departmental/Divisional

Approval Signature

Pharmacy Yes- No-

Pathology Yes -No

Nursing Services Yes-No

Diagnostic Imaging Yes-No

Public Health laboratory Yes -No

Other Yes –No

Has this proposal received prior scientific peer review? yes

Has this proposal received prior ethical review by another Research Ethics Board? no

Population : Proposed inclusion criteria Type of study (check all that applies)
(Check all that apply)
Males :y Survey :
Females :y Secondary data :
Adolescents (12 – 17 years) : Program Project :y
Children (Under 12 years of age) : Clinical community trial :
Pregnant women : Case control :
Foetuses : Longitudinal study :
Elderly (over 65 years) : Record review :
Prisoners : Course activity :
Cognitively impaired : Other (specify) : …………………………………..
Hospital inpatients :

Consent Process (Check all that applies)

Written : y Oral : English : y Local Language : None :
 Proposed sample size :……
33………………………………………………………………………

Reading level of consent document : Below Grade 3 Below Grade 6 Below Form 2
Below Form 4 Above O level Graduate level

Determination of Risk (Check all that applies)

Does the research involve any of the following YES NO

Human exposure to ionizing radiation n
Fetal tissue or abortus n
Investigational new drug n
Investigational new device n
Existing data available via public archives/sources n
Existing data not available via public archives y
Observation of public behavior y
Is the information going to be recorded in such a way that subjects can be identified n
Does the research deal with sensitive aspects of the subjects behaviour, sexual behavior, alcohol use or illegal n
conduct such as drug use
Could the information recorded about the individual if it became known outside of the research, place the subject n
at risk of criminal prosecution or civil liability
Could the information recorded about the individual if it became known outside of the research, damage the y
subjects financial standing, reputation and employability?

STUDY LOCATION: Where will this research take place?

__y_Parirenyatwa Hospital ___Mbuya

Nehanda Hospital___Sekuru Kaguvi Hospital Other ___radiology and radiotherapy___________

___Inpatient _______ Outpatient ______________

Ward clinic

Do you consider the proposed research

A) greater than minimal risk
B) minimal risk
C) no risk yes

Minimal risk is a risk where the probability and magnitude of harm or discomfort anticipated in
the proposed research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical, psychological examinations or tests. For
example the risk of drawing a small amount of blood from a healthy individual for research
purposes is no greater than the risk of doing so as part of routine physical examinations.

EXECUTIVE SUMMARY

the Institutional Review Board (IRB) includes individuals with varied backgrounds
and education. Investigators are therefore required to attach a 2-3 page (maximum 4
pages) Research Proposal Summary using the headings provided below in terminology
that is understandable across disciplines.
 1. TITLE
2. RESEARCH QUESTION TO BE ADDRESSED BY THIS PROPOSAL
3. RATIONALE FOR RESEARCH
Describe briefly the background of the study, and state reasons for conducting it.
State objectives of study.
3. METHODS
Study design and rationale for that design. Explain how the study will be performed.
Population : Sample size, outline criteria for selection and exclusion of subjects, gender, ethnic group,
performance sites (provide justification for single gender or group). For larger sample sizes on greater
than minimal risk studies, provide justification of the sample size.
Subject's state of physical health. Indicate if healthy, ill, seriously ill or terminally ill.
Special populations, such as, minors, foetuses, abortuses, pregnant women, prisoners, mentally retarded,
mentally disabled.
If subjects are from one of the above special populations explain the necessity for including them.
Specify source of participating subjects, e.g. hospitals, clinics, institutions, prisons, industry, unions, schools,
general population, etc. NOTE: If you plan to advertise for patients, the ad must be submitted to the
IRB, for review and approval prior to its publication and/or posting.
List all research procedures and/or interventions involving human subjects (when applicable) including tests
to be conducted and the analysis of samples (where applicable including where the analysis is to be
done – if outside the country please justify including how the samples are to be shipped).
Distinguish procedures which are part of routine care from those that are part of the study
Questionnaire/interview instrument (when applicable)
If the study includes either of these, a copy of the instrument is to be appended to this application.
If the instrument is in development stages, provide an outline of the types of questions to be asked
and the expected date of completion and submission to the IRB.
Methods of intervention Will any new drugs or biologic agents be administered to the subjects,
or will previously used agents be used in a new manner? If yes, please note that you are also
required to file a separate application with the Medicines Control Authority of Zimbabwe
(MCAZ) and may not conduct your study without the approval of the MCAZ . Methods for
dealing with adverse events
Methods for dealing with illegal, reportable activities (e.g child abuse)

RISKS / BENEFITS TO SUBJECTS

Describe in detail any potential risks - physical, psychological, social, legal, ethical (e.g. confidentiality), or other
and assess the likelihood and seriousness of such risks (none, low, moderate, and high). Include the
incidence of complications if known. You may use a narrative description if more appropriate or a table with
3 columns (Potential adverse effects, seriousness and likelihood of complications (Incidence if known.)
Describe procedures for protecting against or minimizing potential risks.
If the activity involves women who could become pregnant and is potentially harmful to a fetus, describe steps
that will be taken to prevent pregnancy or exclude pregnant women.
Assess potential benefits to be gained by the individual subject and explain why the benefits outweigh the risks.
Assess benefits which may accrue to society in general as a result of the planned work.

COSTS AND COMPENSATION

Will subjects receive any compensation, monetary or other? If monetary, how much? Will subjects be asked to
assume any out-of-pocket costs for participating in the research? If yes, what? Identify expenses such as
additional transportation, laboratory tests, supplies, cost of study drug if it becomes commercially available,
etc.

INFORMED CONSENT
Any kind of contact with human subjects requires a disclosure/consent process.
Attach a copy of the consent form. Indicate how (verbal or written) informed consent will be obtained If subjects
are minors or mentally disabled, describe how and by whom permission will be granted.
Where will the record of consent be stored? (Consent forms must be kept for three years after the completion of
the investigation, unless otherwise stipulated by the MRCZ).

CONFIDENTIALITY ASSURANCES
Describe any means by which the subject's personal privacy is to be protected and confidentiality of data maintained.
Include information on the following:
 Any sensitive information that will be gathered.
Plans for record keeping
Location of the data
Data security
Person responsible and telephone number
Who will have access to the data
Plans for disposal of the data upon completion of the study

CONFLICT OF INTEREST (real or apparent)

Other than the normal scholarly gains, are there any other gains you might receive from taking part in
this study?

COLLABORATIVE AGREEMENTS
Provide letters of approval from collaborating institutions’ IRBs and from other local IRBs from other
sites.

INTENDED USE OF RESULTS

Include plans for dissemination and utilization of study results

Please note : Attach 2 COPIES of the full research proposal, as paper and electronic
versions. The full proposal should include the following: Title, objectives, background and
literature review, methodology (to include research design, subjects and methods, ethical
considerations, timetables etc. references, budget etc . Investigators may submit the full proposal
in a funding agency format as long as it covers the above headings.
Please also attach copies of curriculum vitae for the Principal Investigators and all Co-
investigators. The CVs should include the following : Name, Postal address, Employers name
and address, Qualifications, Present Position, Past research experience (relevant) and Published
Papers (relevant). Principal Investigators or co-investigators who would have already submitted
their CVs during the current year are exempted from this requirement.

STUDIES INVOLVING THE TESTING OF DRUGS AND DEVICES

DRUG / DEVICE INFORMATION FORM

Please note that you are required to submit a separate application to the Medicines
Control Authority of Zimbabwe for authorization to test a drug or medical device.
1. Which of the following will be used?
a) investigational drug(s)
b) new therapeutic applications for MCAZ approved drug (s)
c) new combination of any of the above
d) medical device

2. Briefly describe how this drug or device is a part of the proposed investigation.

3. For each drug or device to be used, please provide the following information:

Generic Name Trade or Brand

Name Manufacturer
4. Please give the risks, hazards, known contraindications.

5. Please give reasons for choice of drug(s) for this study. Include pertinent animal
clinical tests or appropriate citations.

6. Please provide dose schedule, route of administration, and duration of therapy.

7. Please describe assessment of patient while receiving therapy including clinical

observations and laboratory tests.
 SIGNATURE ASSURANCE SHEET

Principal Investigator's Assurance Statement:

I certify that the information given by me is correct to the best of my knowledge and
I agree:

(Please check all that applies)

1. to accept responsibility for the scientific and ethical conduct of this research
study;

2. to obtain prior approval from the IRB before amending or altering the research
protocol or implementing changes in the approved consent form;
3. to immediately report to the IRB any serious adverse reactions and/or
unanticipated effects on subjects which may occur as a result of this study;
4. to complete and submit the Continuing annual Review Form annually (when
due) as well as the Final/Study termination form at the end of the proposed
study.

Signature Date 24-03-2023

Print name Chipara Gerald

Signature of Supervisor Date 24-03-2023

Print Name Vutsvene Zephania

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