NHSRC Protocol Forms: Streamlining Ethical Review
The Research Division is pleased to announce the official release of our updated National Health Sciences Research Committee (NHSRC) forms. These revisions are implemented to enhance efficiency, ensure regulatory compliance, and facilitate a smoother ethical review process for all researchers. Please review the summaries below to familiarize yourself with the purpose and required use of each newly released form, effective immediately for all new and ongoing protocols.
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. Proper completion and submission of this form, along with payment of the application fee, are non-negotiable prerequisites for the NHSRC to begin its scientific and ethical evaluation. It ensures the committee has a structured and complete package to assess the project’s merit and adherence to ethical guidelines from the outset.
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 (in English and local language), CVs of all investigators, evidence of funding, and payment of the application fee—are included. Researchers must tick each item present and provide a justification for any absence. Submitting a proposal without completing this checklist or without all required elements will lead to automatic rejection or significant delays in the review process. Its use is critical for preventing administrative back-and-forth and ensuring the committee receives a complete and organized package for ethical and scientific assessment.
Download Form →FORM 701
Reviewer UseProtocol Assessment Form
The NHSRC Protocol Assessment Form is a crucial internal document used by designated reviewers to systematically evaluate research proposals. It provides a structured checklist for assessing the scientific and ethical integrity of a submitted protocol across multiple dimensions. Reviewers utilize this form to rate aspects such as clarity of objectives, methodological soundness, fairness of risk-benefit assessments, and ethical considerations like informed consent and confidentiality provisions. Based on their comprehensive analysis, the reviewer makes a final recommendation, which may range from approval as presented to rejection or requiring minor/major modifications. This form is fundamental to maintaining a standardized, transparent, and rigorous review process across all research submitted to the NHSRC. The detailed feedback section facilitates clear communication of required improvements to the Principal Investigator.
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. Crucially, the form explicitly states that any changes cannot be implemented until official NHSRC approval for the amendment has been formally granted and documented. If the amendment impacts participant interaction, the investigator must also indicate whether changes to the approved informed consent form are required and attach the revised document. This submission ensures all protocol variations are ethically and scientifically vetted, maintaining the integrity of the research as originally approved by the committee. It acts as the gatekeeper for maintaining regulatory compliance throughout the lifespan of the study.
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, preventing any lapse in NHSRC authorization. It requires updated information on recruitment numbers, any changes to the protocol or informed consent documents, and a summary of all adverse events. The NHSRC policy clearly emphasizes that failure to ensure timely submission of this application is a serious violation that can result in the suspension or termination of the research. This mechanism confirms that the entire study, including risk-benefit ratios and subject protections, is continuously monitored and remains acceptable according to ethical standards. For long-term follow-up or data analysis only, specific sections of the form can be completed.
Download Form →FORM 19-01
Site MonitoringInspection Visit Form
This form is utilized by NHSRC representatives to document findings during scheduled or unscheduled site visits to research facilities. It is a comprehensive checklist covering all aspects of research conduct, including study team presence, PMRA/NHSRC approvals, informed consent documentation, drug/product handling (IPs), quality assurance procedures (SOPs, GCP training), and overall facility standards (cleanliness, emergency equipment). The form ensures that the research site is compliant with the approved protocol and all relevant regulations, covering everything from documentation storage and data handling to participant understanding and safety. The NHSRC representative uses this to record observations, issues raised, and recommendations for the study team and the committee.
Download Form →NHSRC Checklist
Site MonitoringSite Inspection Checklist
This detailed checklist accompanies the Inspection Visit Form (19-01) and guides the NHSRC inspector through specific elements to verify during a site visit. It covers compliance areas such as the adequacy of the reception/consulting rooms, proper storage and handling of Investigational Products (IPs) including temperature logs, the availability and calibration of study-specific equipment, and adherence to infection control procedures (e.g., waste disposal). It provides a structured mechanism to ensure the research environment and operational procedures meet ethical, regulatory (PMRA), and Good Clinical Practice (GCP) standards. The checklist acts as the objective reference point for findings reported on the corresponding Inspection Visit Form.
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, approval date, and the final number of participants enrolled in the study. The Principal Investigator must provide a concise summary of the study’s results at the time of termination, or the specific reasons if the study was stopped prematurely. This submission ensures proper closure of the research file and provides the NHSRC with final accountability for the human subjects involved. It serves as an essential regulatory step for investigators to fulfill their oversight obligations once the study activity has concluded. The NHSRC reserves the right to request additional supporting information to validate the notification.
Download Form →FORM 15-01
Final ReportingStudy Report Submission Form
The NHSRC Study Report Submission Form is used by the Principal Investigator to submit comprehensive information regarding the completed research project. It collects critical details about the study, including the number of subjects treated, the specific study articles used, dosage information, and the overall duration of the research. Most importantly, the form requires the Principal Investigator to clearly state the study’s objectives and provide 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 for the ethical approval granted. The form ensures that the committee is properly informed of the entire research lifecycle, from initial approval to final reporting of results. Investigators are permitted to use extra pages if the designated space for results proves insufficient.
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 approved by the NHSRC. It collects critical, time-sensitive information, including sender details, site awareness and report dates, and key participant and protocol information. The form is structured to gather specific details on the adverse event, including causality assessment related to the study intervention, the outcome for the participant, and the severity of the event. It acts as the official notification mechanism to ensure the prompt ethical oversight and review of any unexpected harm to human participants. Investigators must certify the accuracy and completeness of the data and attach all relevant supporting medical documentation, such as progress notes or lab reports. Prompt reporting is essential for participant safety and regulatory compliance throughout the study’s duration.
Download Form →FORM 02-01
Ethical ComplianceConfidentiality Agreement Form
The Confidentiality Agreement Form is a foundational ethical requirement for all NHSRC members and external visitors attending committee meetings. By signing this form, the individual acknowledges that confidential, proprietary or sensitive information may be discussed or distributed during their service or attendance. The signatory formally affirms their commitment to holding all such information in the strictest confidence, except where disclosure is legally mandated by applicable law. This agreement is a non-negotiable legal and ethical document that protects the privacy of research protocols, participant data, and proprietary committee discussions. It is essential for maintaining trust and ensuring the integrity of the entire NHSRC review process and its associated documentation. The completed form is kept on file as a record of the individual’s commitment to data security and ethical conduct.
Download Form →FORM 20-01
Ethical ComplianceConflict of Interest Form
This form outlines the essential policy for managing actual or potential conflicts of interest among NHSRC members to protect the integrity of human subjects research. It establishes that no member may participate in the review or approval of an activity where a conflicting interest exists, reinforcing the policy’s impartiality mandate. The form requires the immediate disclosure of any conflicts and mandates abstinence from related discussions or recommendations, even if the conflict is only potential. Common examples of conflicts, such as involvement in competing research or biases that interfere with judgment, are explicitly listed to guide disclosure. Members with a conflict of interest are not counted toward the quorum or vote for a decision on the relevant protocol. Signing this form signifies acceptance of these terms, ensuring that all review outcomes prioritize ethical protection over personal or financial gain.
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 and scientific justification for the transfer, including the duration of storage and the samples’ eventual disposition after testing. Key ethical and legal considerations are addressed, such as appropriate informed consent for exportation and importation, ownership, and accessibility of the stored samples. The form explicitly governs who will be the controlling officers for the samples and strictly prohibits the sale of samples collected in Malawi without prior approval from the collaborating institutions and the NHSRC. This rigorous documentation ensures full accountability, proper governance, and ethical use of valuable human biological materials in line with national and international regulations. The agreement must be signed by the Principal Investigator, Co-PI, and receive formal NHSRC approval.
Download Form →Need Further Assistance?
For any questions regarding the correct usage or submission requirements of these new NHSRC forms, please contact the Research Division Secretariat directly. Ensuring compliance is a shared responsibility, and our team is ready to provide the necessary guidance to support your ethical research endeavors. All forms are available for download via the links above.