General Guidelines for the Protection of Human Research Participants

The University of the District of Columbia (UDC) is guided by the ethical principles regarding all research activities involving humans as participants as set forth in the report of the National Commission for the Protection of Human Subjects of BioMedical and Behavior Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research known as the Belmont Report.  The investigator who proposes to use human participants in research is strongly recommended to become familiar with this report.   It is the responsibility of the investigator to fully comply with federal regulations and protection of human participants, codified as Title 45 Part 46 of the Code of Federal Regulations (45CRF 46)

The University of the District of Columbia has established an Institutional Review Board (IRB) to ensure compliance with the protection and welfare of human participants set forth in 45 CRF 46.  The IRB is charged to review all research conducted by faculty, staff, and students of the University in connection with institutional responsibilities, or research involving the use of the University’s non-public information to identify or contact human research participants or prospective participants, or research using any property or facilities or employees or students of the University.  The IRB shall review and have authority to approve, require modification in (to secure approval), or disapprove all research activities involving human participants. The involvement of human participants in research covered by this policy will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained in accord with and to the extent required by 45 CFR 46.116. The IRB shall also have the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.

The IRB Chairperson in consultation with a designated IRB member will determine if the research is Exempt or non-exempt from IRB review beyond the Chair. If the research is non-exempt, the Chair will determine whether the review qualifies for Expedited Review procedures using two board members or whether it requires a Full Review by the Board. Any research in which participants will be exposed to greater than minimal risk must be reviewed at a convened meeting of the full IRB.

Minimal Risk is defined by the DHHS Office for Human Research Protections as: “The probability and magnitude of harm or discomfort [physical, psychological, social, legal, or other] anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life, or during the performance of a routine physical or psychological examination or tests.

Federal regulations exempt some types of research projects involving human participants from the regular review process of the IRB. Research activities that (1) present no more than minimum risk to human participants, and (2) involve only procedures in one or more of the attached Exempt Categories are exempt, UNLESS the research involves vulnerable populations:  fetuses, pregnant women, children, human in vitro fertilization, or prisoners. Briefly, the exempt categories are:

(a) Research involving normal educational practices

(b) Research involving the use of educational tests, survey, interview, or observation of public behavior, unless:  (i) information can be linked to the participants; and (ii) disclosure of information will place participants at some risk.

(c) Research involving the use of educational tests, survey, interview, or observation of public behavior that is not exempt under (b) above, if participants are elected or appointed public officials or candidates for public office.

(d) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information cannot be linked to the participants.

(e) Research and demonstration projects conducted by or subject to the approval of US Government Agencies, and designed to study, evaluate, or otherwise examine public benefit or service programs.

(f) Taste and food quality evaluation and consumer acceptance studies that meet safety requirements set forth by government agencies or local laws.

 

Federal regulations permit the principal investigator to make the preliminary determination of whether their project qualifies for exemption; however the IRB Chair makes the final determination. An application for exemption must be submitted to the IRB for this purpose.

Prepared by the University of the District of Columbia Institutional Review Board (UDC IRB) with reference to the Institutional Review Board Guidebook (http://www.hhs.gov/ohrp/irb/irb_guidebook.htm).  The UDC IRB acknowledges the assis tance of the College of Charleston, which shared its web materials, on which UDC’s materials are based.  The UDC IRB is also indebted to many other fine university web sites which it has visited in the course of preparing these ma terials, and in particular commends the design and content of the University of Maryland Baltimore Campus website.