Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Appendix C 4.3 Submission of Application for Ethical Review and Approval All applications for ethical review of research should be submitted to the ERC secretariat. 4.4 Application for Ethical Review of Research Protocols An application for ethical review of a proposed health related research shall be submitted by a Principal Investigator (PI) qualified to undertake the particular study. The PI is directly responsible for the ethical and scientific conduct of the research. Student applications shall be submitted under the responsibility of a supervisor involved in the oversight of the student’s work or in the student’s name, co-signed by the supervisor. The applicant should submit all documents required for ethical review of the proposed research. These may include but is not limited to: Principal Investigator’s Application for submission. Cover letter from head of the PI’s Institutions i.e. (Institutional Support letter for the study Confirmation letter from participating/collaborative institution involved in the study A statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines. Material Transfer Agreement (MTA) for shipment of specimen/biological materials (where applicable) Administrative Information on sponsors of the study Completed GHS-ERC administrative information form Completed GHS-ERC checklist Full Protocol with executive summary with the following attachments: Signed agreement between sponsor and PI (where applicable)
Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Appendix C 4.3 Submission of Application for Ethical Review and Approval All applications for ethical review of research should be submitted to the ERC secretariat. 4.4 Application for Ethical Review of Research Protocols An application for ethical review of a proposed health related research shall be submitted by a Principal Investigator (PI) qualified to undertake the particular study. The PI is directly responsible for the ethical and scientific conduct of the research. Student applications shall be submitted under the responsibility of a supervisor involved in the oversight of the student’s work or in the student’s name, co-signed by the supervisor. The applicant should submit all documents required for ethical review of the proposed research. These may include but is not limited to: Principal Investigator’s Application for submission. Cover letter from head of the PI’s Institutions i.e. (Institutional Support letter for the study Confirmation letter from participating/collaborative institution involved in the study A statement that the researcher(s) agree to comply with ethical principles set out in relevant guidelines. Material Transfer Agreement (MTA) for shipment of specimen/biological materials (where applicable) Administrative Information on sponsors of the study Completed GHS-ERC administrative information form Completed GHS-ERC checklist Full Protocol with executive summary with the following attachments: Signed agreement between sponsor and PI (where applicable)
STANDARD%20OPERATING%20PROCEDURES%20FOR%20GHS-ERC%20ACTIVITIES-%20EDITED%2028th%20July%202015%20%20-%20-final.docx