Submission Process – Problems How do I report unanticipated problems that arise during the study?
Submission Process – Continuing Review Form What should I submit in order to renew my project? Can I submit my Continuing Review Form and an amendment request at the same time? My study is closed to enrollment. Do I still need to recertify? Once my study is complete, is there anything else that I need to submit to the HSC? Informed Consent & Subject Recruitment How do I draft a legally effective informed consent document? My study involves a vulnerable population (e.g., minors, pregnant women, prisoners, mentally disabled, etc.). Do I need to do anything extra? How do I consent children, and when is a child assent form necessary? How do I enroll a subject who does not speak English? What is a waiver of consent and what criteria must my study meet in order to request one? May informed consent be obtained by telephone from a legally authorized representative? When is it necessary to inform subjects of changes in the study and/or re-consent subjects?
Related Questions
- If anybody encounters problems during the submission process, please consult the Student Instructions or the Faculty Instructions. Really stuck beyond all hope?
- When there are problems in the registration in eRA Commons and/or in the grants.gov submission process, where can one get help?
- Submission Process - Problems How do I report unanticipated problems that arise during the study?
