Policy 130.25 Research Involving Human Subjects

1. It is the policy of UMGC to respect and protect the rights and welfare of individuals in accordance with USM Policy on Human Subjects of Research (IV - 2.10) and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979), UMGC employees and students who wish to conduct research involving human subjects must adhere to this Policy before conducting any research. Individuals external to UMGC who wish to conduct research involving UMGC faculty, staff, and/or students, or who wish to conduct research on human subjects on the premises of UMGC, must also adhere to this Policy before conducting any research. For an electronic copy of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research, email irb@umgc.edu. The purpose of this Policy is:
   1. to institute procedures that protect the rights and welfare of human subjects used in research, and
   2. to establish clear guidelines that support the integrity and privacy of data collection.
2. Any inquiries regarding UMGC data collection and surveying should be directed to irb@umgc.edu.

Roles & Responsibilities

The Chief Academic Officer has designated the Chair of the Institutional Review Board (IRB) to administer this policy and to develop procedures as necessary to implement this policy.

1. Research involving human subjects can be classified into two groups, 1) research that involves minimal risk and 2) research that involves more than minimal risk.
2. An individual is considered to be at minimal risk if the risks of harm anticipated are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests, and that any information taken from the individual is recorded in such a manner that the individual cannot be identified.
3. An individual is considered to be at more than minimal risk if exposed to the possibility of harm—physical, psychological, social, legal, or other—in the proposed research which departs from the performance of routine physical or psychological examinations and tests, or which departs from established and accepted procedures necessary to meet the individual's needs, or which increases the probability or magnitude of risks ordinarily encountered in daily life.

1. Should any eligible proposal require a full review, a full Institutional Review Board will be convened. The IRB may approve, require modification as a condition of approval, or reject proposed research activities that are covered by this Policy. The Senior Vice President and Chief Academic Officer (CAO) or a designee of the CAO will serve as the Committee's Chair. Information about IRB membership is available on the University’s intranet site or by emailing irb@umgc.edu.
2. The IRB consists of a chair designated by the CAO and four representatives from at least three different units within Academic Affairs. At least three members must have training and experience as a primary investigator in primary research on human subjects.
3. The IRB will hold meetings once every two years and in years when federal regulations have changed to review this Policy and the procedures for conducting research involving human subjects.

1. Researchers proposing to include UMGC students, staff, and/or faculty as participants are limited to UMGC employees conducting institutional studies and UMGC graduate students fulfilling degree requirements. Outside researchers and adjunct faculty members are not eligible for approval.
2. All researchers much complete the Research Project Notification and Human Subjects Protection Form (or the "research form") and receive proper approval prior to initiating research. To request a copy of the form and to confirm eligibility, email irb@umgc.edu.
3. UMGC Students - Students who wish to conduct research that involves human subjects in fulfillment of a thesis or dissertation as part of degree requirements must complete the research form and submit it to the IRB for approval.  To request a copy of the form and to confirm eligibility, email irb@umgc.edu.
4. Research Assigned as Coursework – Faculty teaching courses in which students are assigned to conduct research involving human participants are required to complete brief research ethics tutorials designated for the type or types of assignments students will complete prior to the session start date of any relevant course. Information on research training requirements is available through the University’s Intranet system. Direct supervisors may determine which faculty members are exempted from the training requirement through prior training and/or professional research experience or activities.
5. All Categories - If the research proposal receives UMGC approval, the IRB shall forward the approved and completed form to the office designated by the CAO to verify quality control in IRB research. Once all approval signatures are obtained on the research form, the proposer may undertake the approved research.

1. For proposals that are determined to be minimal risk and/or are regularly required as part of state and federal law and in which the proposed data collection maintains confidentiality, reviews may be completed by a single IRB representative. IRB reviews will be generally completed and returned within ten (10) business days from receipt of the completed form.
2. For eligible proposals that are determined to involve more than minimal risk, the IRB will conduct a full review. Full review requires the completed research form to be circulated to all IRB members for review and comment. Issues of clarification and issues related to the adequacy of scientific design and appropriate controls may emerge during review. Full IRB reviews will be generally completed within fifteen (15) business days from receipt of the completed form.
3. The President and Executive Committee of UMGC always retain the discretion to disapprove research that has been approved by the IRB.  

Assuring Quality Control in IRB Research

Efforts to avoid excessive surveying of UMGC students, faculty, and staff, which could result in the degradation of response rates to state, federal, and UMGC mandated surveys, quality control will be enforced worldwide by the office designated by the CAO. Quality control reviews will be generally completed and returned to the UMGC within ten (10) business days from receipt of the completed form. Please refer any inquiries regarding surveying to the appropriate office.

Past Proposals

Past proposals are available upon request by emailing irb@umgc.edu.  The IRB may limit disclosure of proposals containing confidential or other information protected from disclosure under Maryland’s Public Information Act. All proposals will be stored electronically within the CAO’s office for three years.