The UMB Human Research Protection Program Plan is a short document that describes the roles and responsibilities of key individuals, organizations, and committees within UMB's HRP.
* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual
This document will guide investigators through:
- Policies, procedures, and resources related to the conduct of Human Research that are specific to UMB.
- Information regarding human research protections.
- Relevant federal regulations and guidance.
The manual will answer questions such as:
- Can I be a principal investigator for a study?
- When am I engaged in research?
- What is UMB's Institutional Review Board (IRB)?
* All individuals involved in research are expected to be knowledgeable of and follow the guidance outlined in the Investigator Manual.
Consent and Assent Form Templates used by UMB (Only the UMB IRB approved consent/assent templates [with the UMB logo] will be accepted when UMB IRB is the IRB of record):
- Consent Form Template
- Assent Form Template
- HIPAA Authorization Form
Contains information and documents for investigators conducting human subjects research, such as:
- Continuing Review Table to Report SAEs
- Reportable New Information (RNI) bulletin
- Investigator Quality Improvement Assessment
Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.
Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators.
Contains links, documents, and general tools covering regulations, policies, and guidance, such as:
- DHHS Regulations and Information
- FDA Regulations and Information
- VA-Maryland Research and Development
These short videos will deal with common researcher issues, such as:
- NEW! - Common Rule Revisions - Courses for the Jan 2019 Changes
- Accessing and navigating the CICERO system
- Creating and submitting an IRB application
- What is non-human subject research?
- Recorded research seminars