Documentation of research proposals are needed to meet legal requirements, they can be used to show and prove that the proposed work has been done in the correct way, acts as a base for patents and is invaluable when trouble shooting or back tracing has to be done. Proper documentation also helps researchers avoid such transgressions as plagiarism and theft of intellectual property. Research proposals need to communicate what the researcher is proposing to do, why they feel it is important to do and how this issue will be addressed.
These will be encompassed briefly within the inbuilt initial application form on ABHATH and in detail on the supporting study documents which are to be uploaded as part of the submission process. The additional supporting study documents are available within the download center on ABHATH. Study documents that are to be submitted (uploaded) as part of the application submission but not inbuilt in ABHATH are:
- Research Protocol
- Informed Consent Form
- Assent Form
- Research Info Sheet
- Data Share Agreement
- Material Transfer Agreement
- Photographic Consent
- Progress/Continuing Review Report Form
- Final Report form
The PI of a study is responsible for preparing and submitting the above mentioned forms along with the application at MRC. Apart from this, PI is also responsible for completing and providing the below listed supporting documents and agreements/ contracts as and when required or requested by MRC or IRB.
- Data Collection Tools
- Documentation of IRB Approval (If additional IRB review being sought at another institution apart from HMC-IRB)
- Telephone Script (if applicable)
- Radiation and Biosafety Committee Approval (if applicable)
- Data Safety Monitoring Plan (DSMP) or Data and Safety Monitoring Board (DSMB), if applicable for more than minimal risk research
- Investigator Brochure, or device specifications (if applicable)
- Financial Disclosure Statement (FDA) (if applicable)
- FDA Form 1572 (drug study) or signed Investigator Agreement (device study) (if applicable)
- Grant or contract of funding agency (if applicable)
The documentation should be done according to MRC and HMC guidelines, national and international rules and is one of the most important parts when doing research. Documentation that is done in the best possible way will facilitate the PIs as well as MRC and IRB.
