NHSRC Protocol Forms: Streamlining Ethical Review
The Research Division has updated its official National Health Sciences Research Committee (NHSRC) forms. Below, find the documents required for researchers to download, submit, and manage protocols, followed by the internal forms used for NHSRC oversight.
1. Researcher Action Forms (Downloadable)
These forms are mandatory for researchers to initiate, modify, renew, or close a study protocol. Click to download the official template.
FORM 101
Initial SubmissionApplication to Conduct Health Research
This is the mandatory initial application form required for all researchers intending to conduct human health research under the NHSRC’s jurisdiction. It serves as the comprehensive formal submission that officially initiates the ethical review process by providing all necessary preliminary data. Researchers must include essential protocol information, institutional endorsements, and a complete checklist of supporting documents such as the full proposal, informed consent forms, and investigator CVs.
Download Form →Checklist Form
Pre-SubmissionProtocol Submission Checklist
This essential document must be completed by the Principal Investigator prior to submitting the study proposal to the NHSRC. It serves as a comprehensive self-audit tool, ensuring that all mandatory components—including the main proposal, Form 101, informed consent documents, CVs, evidence of funding, and payment—are included. Submitting a proposal without completing this checklist or without all required elements will lead to automatic rejection or significant delays in the review process.
Download Form →FORM 10-01
Post-ApprovalRequest for Amendment/Modification
This form is strictly required when a Principal Investigator needs to request any changes to a study protocol that has already received NHSRC approval. Researchers must clearly detail the proposed modifications, providing the specific reasons necessitating the amendment to the ongoing project. Any changes cannot be implemented until official NHSRC approval for the amendment has been formally granted and documented.
Download Form →FORM 11-01
Annual OversightApplication for Continuing Review
The Continuing Review form is mandatory for all ongoing research protocols to ensure continued ethical compliance and participant welfare past the initial approval period. This process mandates the Principal Investigator to provide a detailed progress report and certify the ongoing ethical conduct of the study. Failure to submit this application in time can result in the suspension or termination of the research.
Download Form →FORM 14-01
Closing StudyProtocol Termination Notification
This form must be submitted to the NHSRC to formally notify the committee of the conclusion or early termination of an approved research protocol. It requires key administrative details, including the protocol number and the final number of participants enrolled, as well as a concise summary of the study’s results at the time of termination. This ensures proper closure of the research file and provides final accountability for human subjects.
Download Form →FORM 15-01
Final ReportingStudy Report Submission Form
This form is used by the Principal Investigator to submit comprehensive information regarding the completed research project. It collects critical details about the study, the number of subjects treated, and dosage information. Most importantly, it requires a detailed summary of the final results and findings. This submission is vital for the NHSRC’s record-keeping and for demonstrating the research outcomes and accountability.
Download Form →SAE Form
Safety AlertSerious Adverse Event Reporting Form
This specialized form is designed for the urgent, mandatory reporting of any Serious Adverse Event (SAE) that occurs during a study. It collects critical, time-sensitive information, including causality assessment related to the study intervention, the outcome for the participant, and the severity of the event. Prompt reporting is essential for participant safety and regulatory compliance throughout the study’s duration.
Download Form →MTA Form
Material/SampleMaterial Transfer Agreement Form
The Material Transfer Agreement (MTA) Form is mandatory for research protocols involving the transfer or export of materials, such as biological samples, to institutions outside the collection site. It requires detailed documentation of the intention, scientific justification for the transfer, duration of storage, and strict prohibitions against the sale of samples collected in Malawi without prior approval.
Download Form →2. NHSRC Internal Oversight Forms
These documents are used internally by the NHSRC, its reviewers, and its monitors. The summaries below outline the standards and compliance metrics researchers should be aware of, but the forms themselves are not available for public download.
FORM 701
Reviewer Use OnlyProtocol Assessment Form
This is the crucial internal instrument used by designated NHSRC reviewers to systematically evaluate research protocols. It provides a structured checklist for assessing scientific and ethical integrity, focusing on clarity of objectives, methodological soundness, fairness of risk-benefit assessments, and ethical considerations like informed consent and confidentiality provisions. This form standardizes the review process and is the basis for the committee’s decision (e.g., approval, minor/major modifications, or rejection). Researchers should ensure their submissions address all these core areas comprehensively.
FORM 19-01
Site MonitoringInspection Visit Form
This form is utilized by NHSRC representatives or appointed monitors when conducting an on-site visit to a research location. It documents the purpose and outcomes of the inspection, covering administrative details, study status, and protocol compliance. The form serves as a structured report to the committee, ensuring that research sites adhere to the approved protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements throughout the study’s lifespan. Researchers should expect this level of oversight during the life of the study.
Inspection Checklist
Site Monitoring ToolSite Inspection Checklist
This checklist is used in conjunction with the Inspection Visit Form (19-01) to systematically audit specific elements of a research site’s operation. Areas covered include: informed consent processes, drug accountability, data management, Quality Assurance (QA) systems, staff training records (GCP/Ethics), and appropriate waste disposal procedures. It ensures a standardized, thorough assessment of compliance across all participating sites. Knowing the categories on this checklist can help investigators proactively prepare for monitoring visits.
FORM 02-01
Ethical ComplianceConfidentiality Agreement Form
This is a foundational ethical requirement for all NHSRC members and external visitors attending committee meetings. The individual formally affirms their commitment to holding all confidential, proprietary, or sensitive protocol and participant information in the strictest confidence, except where disclosure is legally mandated. This agreement protects the privacy of research protocols and data during the ethical review process.
FORM 20-01
Ethical ComplianceConflict of Interest Form
This document is completed by NHSRC members and staff to outline and manage any actual or potential conflicts of interest. It enforces the policy that no member may participate in the review or approval of an activity where a conflict exists, thus ensuring that all review outcomes prioritize ethical protection of human subjects over personal or financial gain. This mechanism is crucial for maintaining the impartiality and integrity of the review process.
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Promoting Scientific and Ethical 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: IRB00003905
FWA Number: FWA00005976