Human Subjects Research

• IRB Process Synopsis
• Exempt Research
• Protection of Human Subjects in Research Policy
• Protection of Human Subjects in Research Procedures
• CITI Training Program - The CITI Human Subjects Research (HSR) course is the required training for all researchers involved in human subjects research. Researchers may select the HSR course most appropriate for their research area or "Learner Group" (e.g., Biomedical, Social Behavioral Education (SBE), etc.). All researchers are also strongly encouraged to complete the following CITI Courses: Responsible Conduct of Research (RCR) to promote research ethics and avoid research misconduct (fabrication, falsification, and plagiarism), AND Conflict of Interest (COI) to promote timely disclosure of financial and other conflicts of interest.
• FAQ's

Anyone involved in human subjects research must complete CITI Training before beginning any research activities. The CITI Training should be completed before submitting an application for IRB review when initiating a new study, or prior to engaging in research activities, including access and analysis of private identifiable data, when joining an active research project.

 This includes:

• Principal Investigators (PIs)
• Co-Principal Investigators
• Research staff listed in the research personnel list
• Individuals obtaining informed consent
• Individuals listed as contact persons in recruitment materials
• Faculty Advisors

PIs, Co-PIs, and Faculty Advisors are always considered engaged in research due to their oversight responsibilities. The PI is responsible for ensuring all research personnel have completed the required training at https://citiprogram.org/.

• Human Subjects Research Approval Request Form
• Human Subjects Research Approval Renewal Form
• Human Subjects Research Protocol Amendment/Modification Form
• Human Subjects Research Reportable Events Form
• Human Subjects Research Informed Consent Sample Template

• Human Research Closure Form
  STUDY CLOSURE AND FINAL REPORT FOR RESEARCH INVOLVING HUMAN PARTICIPANTS
  This form is used to formally document the completion of IRB-approved human subjects research at Morgan State University. It enables the Principal Investigator to confirm that all study activities, including participant interaction and identifiable data collection, have ended so the protocol can be administratively closed. This process ensures IRB records remain accurate and compliant with 45 CFR 46.

External (Non-Affiliated) Investigators – Recruitment of Morgan State University Participants

Non-affiliated investigators seeking to recruit Morgan State University (MSU) students, faculty, or staff must contact the Office of Research Compliance at irb.research@morgan.edu before initiating any recruitment activities.

Requests must include:

• A memorandum describing the recruitment plan and justification for selecting the MSU population.
• A copy of all home IRB-approved materials, including the IRB approval/determination letter and protocol number.

Supporting documents, as applicable, should include the IRB application, consent forms, recruitment materials, instruments, and any relevant attachments.

Recruitment or research activities involving the MSU community may not begin until written site authorization is granted by the University’s Authorized Institutional Official.

Abstracted from & courtesy of University of Maryland, Baltimore County – Division of Research and Creative Achievement – Recruitment From Outside of Campus 

https://research.umbc.edu/recruitment-from-outside-of-campus/

Under the revised Common Rule (45 CFR Part 46), many minimal-risk studies no longer require annual continuing review. However, the IRB may require continuing review for certain studies, including greater-than-minimal-risk research or when additional oversight is necessary.

If your study requires continuing review, the Office of Research Compliance will notify you 60–90 days before the review due date. Your submission should include the following:

• a brief study progress update
• current enrollment status
• any protocol modifications
• reportable events (if applicable)
• and any revised study documents

The IRB will review the submission to determine whether the study continues to meet the criteria for approval and will issue a written determination. To avoid a lapse in IRB approval, please submit all required materials by the requested deadline. If approval expires, all human subjects research activities must stop unless continuation is necessary to eliminate an immediate hazard to participants.

If you have questions about whether your study requires continuing review, please contact: irb.research@morgan.edu

For more details see 45 CFR 46.109.

Committee Composition

Federal regulations 45 CFR 46 require that the IRB shall have at least five members, and membership include at a minimum, one member whose primary concerns are in scientific areas, one member whose primary concerns are in nonscientific areas, numerous members representing more than a single profession, and at least one individual not affiliated with the institution.

Morgan's IRB membership is drawn from faculty in several disciplines, from the social, behavioral and biological sciences to the liberal arts and business. The current IRB membership includes the following voting members:

IRB Members

• Benjamin Welsh, Ph.D., Chairperson, Associate Professor, Education
• Justin Bonny, Ph.D., Vice IRB Chair, Assistant Professor, Psychology
• Timothy Meeker Ph.D., Vice IRB Chair, Assistant Professor, Biology
• Mian Hossain, Ph.D., Professor, Community Health and Policy
• Asha Layne, Ph.D., Associate Professor, Sociology
• Karen Watkins-Lewis, Ph.D., Assistant Professor, Psychology
• Mona Addison, MA, Non-affiliated Community Member
• Samia Kirchner, Ph.D., Associate Professor, Architecture
• Emelia Asamoah, Ph.D., Assistant Professor, Nursing
• Lujie Peng, Ph.D., Assistant Professor, Social Work
• Raymond Adams, Ph.D., Associate Professor, Social Work
• Robin Butler, Ph.D., Assistant Professor, Community Health & Policy
• Naja Mack, Ph.D., Assistant Professor, Computer, Mathematical & Natural Sciences
• Thomas Noel Jr., Ph.D., Assistant Professor, Education
• Cristina Murphy, Alternate IRB Member, Ph.D. Candidate, Architecture

Administration

• Willie May, Ph.D., Institutional Official
• Keyshawn Moncrieffe, Ph.D, MBA, CCEP, CRA, Acting Director, Research Compliance
• Olatunde Aladesote, Research Compliance Assistant
  

Note:  A quorum will be a majority (greater than 50%) of the voting members of the IRB. For reasons other than conflict of interest, abstentions do not alter the quorum, or change the number of votes required.