General Instructions / Recommendations for Researchers / Principal Investigators
- The research proposals shall be prepared according to format given at Annexure I & Annexure II
- The Principal Investigators should decide the kind of review required i.e. whether proposal requires Exempted, Expedited or Full Review based on Annexure III.
- All Researchers and Principal Investigators involved in Research on Human participants are advised to get Good Clinical Practice (GCP) training course available atgcp.nidatraining.org or any other similar training.
- The PI or researcher should not start the research till the time ethical approval has been granted.
- Conduct the project strictly in accordance with the proposal submitted and granted ethics approval, including any amendments made to the proposal required by the PUIEC
- Provide a 'progress report' for every year of approval. (See Annexure 3)
- Make submission for approval of amendments to the approved project before implementing such changes. (See Annexure 4)
- Inform in writing if the project has been discontinued. (See Annexure 7)
- Provide a 'final report' when the project is complete. (See Annexure 12)
- Inform immediately (Email: firstname.lastname@example.org) of any complaints or other issues in relation to the project which may warrant review of the ethical approval of the project
- All the researchers / PI's are requested to check the status of previously submitted proposals (if any) to PUIEC owing to transition from pervious PUIEC to newly formed PUIEC.
Please note that failure to comply with the conditions of approval and the National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 may result in withdrawal of approval for the project.