Mandatory Training Regarding Principal Investigators with Expired Studies ▾
Communication from IRB Chair to Principal Investigators with expired studies about required training on their responsibilities for maintaining study approval and the consequences for allowing IRB approval to expire. Expand to Register

Upcoming Training Sessions (all via Zoom):

April 2nd, 2024 at 8:30 to 9:00 am
April 12th, 2024 at 9:00 to 9:30 am
April 18th, 2024 at 4:30 to 5:00 pm
April 29th, 2024 at 3:30 to 4:00 pm
May 7th, 2024 at 11:00 to 11:30 am

To register for session email asadzewicz@umaryland.edu with desired date.

This resource helps investigators design, write, and organize research protocols; maintain compliance with UMB, IRB, and federal policies, procedures, and regulations; create and submit IRB applications via CICERO; and ensure the protection of human research participants

For Researchers Sections

HRPP Plan 

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

 

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 Form Templates

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

 

Study Conduct

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

 

CT.GOV Information

Contains information, resources, and contacts for investigators conducting human subjects research that requires registration with clinicaltrials.gov.

 

Investigational New Drug Application

Includes requirements for IND submissions and FDA contact information for pre-IND consultation program for sponsor-investigators.

 

General Tools and Links

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

 

Instructional Videos and Recorded Lectures

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

 

Reseacher News

UMB Research Computing - Secure Research Environment Guidebook ▾
The Secure Research Environment (SRE) is a new University virtual environment designed to protect sensitive and restricted research data from misuse and unauthorized access.

The SRE is different from the current UMB research computing environment in that the computing resources, data storage and software are not located on a local desktop or laptop computer but are available in a secure Cloud infrastructure. The SRE minimizes risk to the institution and to the principal investigator of an unlawful exposure of sensitive data.

See Guidebook

Recorded Webinar UMB Research Compliance Education - Research with Prisoners ▾
Held March 2, 2023 1:00 - 2:00 PM, A Review of the Federal Regulations Pertaining to Research with Prisoners presented by Julia Gorey, JD, Department of Health and Human Services (HHS).

Title: A Review of the Federal Regulations Pertaining to Research with Prisoners.

Speaker: Julia Gorey, JD

Julia Gorey serves as a Policy Analyst in the Office for Human Research Protections, Division of Policy, Department of Health and Human Services (HHS), and is charged with writing and interpreting guidance and policy for 45 CFR part 46, the HHS regulations for the protection of human subjects in research. In addition to general responsibilities, she oversees the administration of subpart C and the review and authorization of human subject research involving prisoners; she also serves as Executive Director of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which provides expert advice and recommendations to the Secretary, HHS, on issues relevant to research involving human subjects with a particular emphasis on vulnerable populations. She is a University of Maryland Francis King Carey School of Law alumnus.

Recorded Webinar Link: https://umaryland.webex.com/umaryland/ldr.php?RCID=b6625c743e2521293c0e43600ad584ab 

UMMS / UMB Quarterly Research Fact Sheet  ▾
Research Community, Please see the attached quarterly Research Fact Sheet from the UMMS Human Protections Administrator/ Office of Corporate Research Compliance.

FY2021 Q3 Fact Sheet: FY2021-Q3 UMMS.UMB Research Fact Sheet
OHRP - New Lecture Video on e-Consent

OHRP Newsletter February 2020. OHRP is excited to announce that a new informative video on e-Consent is now available to the research community!

HHS Announcement, Single IRB and Cooperative Research

HHS Announcement Nov. 21st, 2019 - Determination of Exception to the Required Use of a Single IRB for Certain HHS Cooperative Research that is Subject to the 2018 Requirements.

Researcher Information:

 Recorded OHRP webinars:

OHRP Information:

 

Required Training

Contains training requirements information for researchers conducting human subjects research:

  • CITI training
  • GCP training
  • HIPAA training

 

Clinical Research Training Mentoring Program

Program Director: James Campbell, MD, MS
Associate Program Director: Robert Rosenthal, MD
Contact the HRPO (send email)

The program provides the following support services:

  • Assist investigators in designing, submitting, and/or revising IRB protocols.
  • Assist investigators with scientific and regulatory issues unique to their research protocols.
  • Meet personally with investigators and research team to provide instruction to facilitate the submission of protocols through CICERO.
  • Advise how to strengthen the design and conduct of their studies.
  • Attempt to identify other faculty and staff experienced in clinical research that can help the investigator.
  • Provide assistance until protocols are approved or withdrawn.

Click to Request CRTMP Support