Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Link directly to a passage with its anchor — for example #office-render-page-1 — to open it highlighted. This reference version is generated from the authority’s publication and does not replace it. Language: English.
NATIONAL HEALTH SCIENCES RESEARCH COMMITTEE
APPLICATION FOR CONTINUING REVIEW: FORM 11-01
STATEMENT OF POLICY
It is the policy of the National Research Council of Malawi (NRCM) and affiliated Institutional
Ethical Review Committees (IERCs) that in the continuing review of ongoing research, the
entire study will be reviewed to ensure the continued protection of the rights and welfare of the
human participants. The NHSRC follows, at minimum, the regulations set forth in the
Helsinki Declaration and CIOMS Guidelines as the criteria for continuing review. The
Continuing Review process must be no less stringent than the initial review.
The Principal Investigator is responsible for timely submission of a continuing review
application to prevent any lapse in NHSRC approval. NHSRC regulations do not provide for
exceptions to the requirement for continuing review. Therefore, failure by the Principal
Investigator to ensure timely review is a serious matter that may lead to suspension or
termination of the study. NO EXTENSIONS CAN BE GRANTED.
If applying for re-approval for long-term follow-up or data analysis only, complete sections
A, C,D,E, F, and H only.
A. STUDY INFORMATION
NHSRC Protocol # Expiration date of
current approval
period:
Project Title:
Principal Investigator
:
Institution:
Phone: Email:
Contact Person:
Promoting Scientific and Ethical 1
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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(If applicable)
Role on Project:
Phone: Email:
B. PROJECT FUNDING
Funding: ☐ Unfunded
☐ Funded
Agency/Company
Name:
Payment of 10% fee to ☐ Pending ☐ Paid ☐ Planned
NHSRC:
C. PERFORMANCE SITE(S)
List all performance sites for this study (including names of foreign countries with sites).
D. STATUS OF STUDY (check one)
Active study
☐ Recruitment/enrolment continues
☐ Accrual complete, research intervention continues
☐ Long-term follow-up
☐ Data analysis only, data collection complete
E. INTERVENTION INFORMATION
Intervention:
Promoting Scientific and Ethical 2
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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☐ Drug ☐ Device ☐ Genetic study ☐ Tissues
☐ Radiation Use ☐ Medical Record
☐ Survey/Questionnaire Review
☐ Other, Briefly
explain
Drug/Device
name:
F. PROGRESS REPORT
1. Enrolment and demographic information: LEAVE NO LINE BLANK
Total number of participants requested in original NHSRC
application:
Number of participants enrolled since last progress report:
Total number of participants enrolled since the start of the
study
Please report the number of participants in Malawi in the following categories: (Numbers must add
up and make sense. Please check before submitting form)
Currently active in study Withdrawn from study
Follow-up data collection only Deaths related to study
Completed intervention and any follow- Deaths unrelated to study
up
Lost to follow-up
Promoting Scientific and Ethical 3
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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2. Adverse Events, Complications, Study Withdrawals:
In the past approval period, did any participants suffer an unanticipated or serious adverse event or
death? ☐ Yes ☐ No
If yes, please attach the Adverse Event Report(s) if adverse events not already reported to
NHSRC.
Adverse events/overall risk: Answer every question.
Based on your knowledge of the adverse events for this study, do you feel that there is a significant
increase in risks to participants? Has anything occurred since the last NHSRC & IERC review that
may have altered the risk/benefit relationship? Explain.
Did you withdraw any participant(s) from your study because of a problem or complication?
Explain.
Did any participant (s) withdraw themselves from your study? Explain .
Did any problems occur in obtaining or documenting informed consent (i.e., problems with subject
understanding, high refusal rate, etc.) Explain.
NOTE: Attach a report of the Data Safety Monitoring Board if available. If not available,
indicate when it is going to be available
3. Progress Report:
Please attach a brief summary of findings (preliminary or final) obtained in the study, a summary of
recent literature or relevant information, especially information about risks associated with the study.
Begin with a 1-2 sentence description of the purpose of the study. If there are no findings at this
time, this should be stated and explained.
NOTE : Attach a report of the Data Safety Monitoring Board if available. If not available,
indicate when it is going to be available
Promoting Scientific and Ethical 4
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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G. AMENDMENT / REVISION REQUEST Complete ONLY if Amendments or Revisions were
requested.
HIGHLIGHT CHANGES TO THE REVISED CONSENT FORM WITH A BRIGHT COLOURED
HIGHLIGHTER.
Approved Amendment(s): List the approved Amendments and briefly describe the nature of the
approved changes and their rationale. Please attach an amended version of the protocol and/or the
Informed Consent if applicable.
Human Participant Population: Has the human subject population changed? If yes, explain.
Indicate if there are new performance sites or any changes in selection criteria.
Risks/Benefits: Describe if and how the risks/benefits have changed.
Principal Investigator's Assurance Statement:
I understand NCST 's policy concerning research involving human participants and I
agree:
1. to accept responsibility for the scientific and ethical conduct of this research study,
2. to obtain prior approval from the NHSRC before amending or altering the research
protocol or implementing changes in the approved consent form,
3. to immediately report to the NHSRC any serious adverse reactions and/or
unanticipated effects on participants which may occur as a result of this study,
4. to train study personnel in the proper conduct of human participants research,
5. to complete the Continuing Review and Final Report Forms.
Signature of Principal Investigator Date
Write/Typed Name of Principal Investigator
Promoting Scientific and Ethical 5
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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H. APPLICATION ENCLOSURES CHECKLIST
Check all that are included in your submission for continuing review.
The following must be included in the submission for continuing review:
☐ Continuing Review Application, complete with signature of PI
☐ Progress Report, attached to application
☐ Current copy of Consent Form(s)
☐ Copy of previous approval letter
Include the following only if applicable:
☐ Clean copy of Consent Form(s) with revisions if necessary (for new approval stamp)
☐ Informational letters used in place of consent form (cover memo)
☐ Adverse Event Summary Table
☐ Current Approval letters from other foreign sites with IERC
☐ Complete protocol including modifications previously approved by the IERC (if submitting an
amendment or
modification to original protocol)
☐ Recruitment Information (Ads, Web postings, letters etc., if modified from originally approved
recruitment materials)
☐ Additional information PI considers important for review by NHSRC
This section is for NHSRC Use only
Comments :
Decision:
Chairperson’s Signature: _____________________________________________
Date-------------------------------------------------------------------------------------------------------------
Promoting Scientific and Ethical 6
Conduct of Health Research in Malawi
Executive Committee: Dr M. Joshua (Chairperson), Dr F. Namboya (Vice-Chairperson)
Registered with the USA Office for Human Research Protections (OHRP) as an International IRB
IRB Number 00003905 FWA00005976
Email: research@health.gov.mw/mohdoccentre@gmail.com
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