UNIVERSITY OF MARYLAND UNIVERSITY COLLEGE

POLICY MANUAL

POLICY 130.25

SUBJECT: Conducting Research Involving Human Subjects

I. Purpose

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)*, UMUC faculty, staff, and students, and individuals external to UMUC, who wish to conduct research involving human subjects must adhere to this policy before conducting any research. The purpose of this research 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 of data collection.

II. Definitions

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.

1) 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.

2) 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.

III. Institutional Review Board (IRB)

    1. IRB Membership - UMUC has established an Institutional Review Board (IRB) to review all applications for research involving human subjects. The IRB may approve, require modification as a condition of approval, or reject proposed research activities that are covered by this policy. The IRB consists of seven members: the Provost who will serve as the Committee's Chair, the Director of the Office of Institutional Accountability, Planning, and Research, the Director of the Institute for Research and Assessment in Higher Education (IRAHE), the Dean of Undergraduate Programs (UGP), the Dean of Graduate Studies (GSMT), one representative each from the UMUC-Maryland in Asia and UMUC-Maryland in Europe. The Provost, Deans, and Directors may each designate a representative to serve in their place. At least two of the seven representatives will be individuals whose primary role is teaching. The Office of Institutional Accountability, Planning, and Research will assist the Chair by providing technical support and research review when requested.
    2. The IRB will hold an annual meeting to review this policy and the procedures for conducting research involving human subjects.

IV. Responsibilities of Individuals Conducting Research Involving Human Subjects

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. The research form and procedures are available in both the IRAHE Office and the Office of Institutional Accountability, Planning, and Research, and on the UMUC web site and the UMUC Intranet web site.

    1. UMUC Students - Students who wish to conduct research that involves human subjects in fulfillment of course requirements must complete the research form and submit it to their course instructor for approval. If the instructor determines that the research involves only the student's class and that there is minimal risk to the human subjects, the research activity may be approved. If the instructor determines that there may be a risk to human subjects or involves the research involves human subjects outside of the student's immediate class, the instructor will forward the application form to the appropriate unit IRB representative. The IRB representative may decide on behalf of the IRB that the human subjects are not exposed to more than minimal risk and may approve the proposed research activity. If the proposal involves more than minimal risk, the proposal will be brought to the IRB for a full review, as described in section V.
    2. UMUC Students, Faculty, and Staff - UMUC students (conducting research not in fulfillment of course requirements), faculty, and staff who wish to conduct research involving human subjects must complete the research form and submit their application to their unit's IRB representative. If the student, faculty, or staff's unit is not represented on the IRB, copies of their application must be sent to the IRB Chair or designee and a copy must go to their unit's senior vice president. The IRB representative, or the IRB Chair or IRB Chair designee, may decide on behalf of the IRB that the human subjects are not exposed to more than minimal risk and may approve the proposed research activity. If the proposal involves more than minimal risk, the proposal will be brought to the IRB for a full review, as described in section V.
    3. Individuals External to UMUC - Individuals external to UMUC who wish to conduct research involving UMUC faculty, staff, and/or students must complete the research form and submit the application to the IRB Chair or IRB Chair designee. All applications for individuals external to UMUC will be brought to the IRB for a full review, as described in section V.

V. IRB Review

For proposals that are determined to be minimal risk and/or are required as part of regular state, federal, and USM data collection that maintains confidentiality, reviews may be completed by a single IRB representative, or in the case of UMUC students in IV.1., the course instructor. Reviews will be generally completed within five (5) working days from receipt of the completed form.

For proposals that are determined to involve more than minimal risk and/or are from individuals external to UMUC, the IRB will convene a full review meeting consisting of at least five members by any mode of communication. 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 ten (10) working days from receipt of the completed form.

VI. UMUC Data Library and Archives

Abstracts of all proposals will be kept for two years on the UMUC Intranet web site, in the Office of Information and Library Services, and in the IRAHE Office. All completed research forms, electronic research files, proposals, research reports and data collection instruments must be stored in the Office of Institutional Accountability, Planning, and Research for two years so that the data will be available to future UMUC researchers.

VII. Assuring Quality Control in UMUC Research

Efforts to avoid excessive surveying of UMUC students, faculty, and staff, which could result in the degradation of response rates to state, federal, and USM mandated surveys, will be enforced.

*A 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 is available in the IRAHE office.