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TOUCH MEMORIAL INSTITUTE FOR MEDICAL RESEARCH (NMI MR) Office Use Only COLLEGE OF HEALTH SCIENCES, UNIVERSITY OF GHANA, LEON Protocol Number: INSTITUTIONAL REVIEW BOARD FORM B CONTINUING REVIEW FORM

How to fill out form b continuing review

How to fill out Form B Continuing Review:

1. Start by carefully reviewing the instructions provided with Form B Continuing Review. Familiarize yourself with the purpose and requirements of the form.
2. Begin filling out the form by providing the necessary identifying information, such as the name of the study, the principal investigator, and the IRB protocol number.
3. In the next section, provide a brief summary of the research study, including the objectives, methodology, and any modifications made since the last review.
4. Indicate whether any adverse events or unanticipated problems have occurred during the course of the study. If yes, provide a detailed explanation of the event and the actions taken in response.
5. Explain if any changes have been made to the study procedures, participants, or informed consent process since the last review. If applicable, attach any revised documents or consent forms.
6. Discuss the progress of the study, including the enrollment status, data collection, and any interim findings. Provide any supporting documentation if necessary.
7. Assess the risks and benefits of continuing the study. Explain how the benefits outweigh the risks or describe any steps taken to minimize risks to participants.
8. If any conflicts of interest exist, disclose them in this section. Provide details about the nature of the conflict and any measures taken to manage or eliminate it.
9. Sign and date the form, indicating your role and responsibility in the study. Make sure to include any additional signatures required by your institution or IRB.
10. Submit the completed Form B Continuing Review to the appropriate authority or committee responsible for the review and approval of research studies.

Who needs Form B Continuing Review:

1. Researchers or principal investigators involved in ongoing research studies that have received prior approval from an Institutional Review Board (IRB) or similar ethical committee.
2. Institutions or organizations that oversee research activities and ensure compliance with ethical guidelines and regulations.
3. Regulatory agencies or bodies that require regular monitoring and review of research studies to protect the rights and welfare of human participants.

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