Provost

I. Overview

Muhlenberg College is committed to protecting the safety, welfare, rights, and privacy of all persons who participate as subjects in research projects conducted under its auspices by faculty, staff, and students.  It is also committed to ensuring that the subjects of such research are fully aware of their rights and the protections available to them.  In addition, the College is obligated by law to assure the federal government that such safeguards are being provided and implemented.  These safeguards are derived from the following ethical principles, first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979:

Respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy or particular vulnerabilities, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons.  Human subjects should enter into research voluntarily and with adequate information.

Beneficence: the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks.  Possible risks to human subjects should be weighed against possible benefits to the subjects, as well as against the possible improvement of knowledge.

Justice: fairness in the distribution of research benefits and burdens. In selecting human subjects for research, researchers should ensure that no group of participants is either consistently selected to participate in research, or consistently deprived of the opportunity to do so.  When research participation is a course requirement or opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.

 

Research in which human beings participate as subjects conducted under the auspices of Muhlenberg College, by its faculty, students, and staff, is subject to review by the College’s Institutional Review Board (IRB).  The IRB is the body charged with reviewing, prior to its commencement, all research and experimental activities in which human beings participate as subjects, as well as research by external researchers seeking to use Muhlenberg College students or personnel as research subjects.  "Research" is defined as "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge" (45 CFR 46.102d).  Research subject to review thus includes, but is not limited to, pilot studies, class projects to be published or presented beyond class, independent research, and senior theses, whether such research takes place on or off the Muhlenberg campus, including work done outside of the United States.  Researchers should remember that research conducted outside the United States may also be submit to foreign law.  Section VI includes a discussion of activities that are beyond the scope of IRB; however, note that exemption from IRB review does not imply that ethical considerations do not exist in conducting research involving human subjects.  The ethical and legal standards appropriate to one’s discipline always apply, as discussed below.

Muhlenberg College’s IRB procedures for review adhere to the regulations of the Department of Health and Human Services (45 CFR 46, as revised and published in the Federal Register on June 23, 2005), and to the Federalwide Assurances filed with the HHS.  In addition, the IRB has consulted Protecting Human Subjects: Institutional Review Guidebook (1993), prepared by the Office for Protection from Research Risks of the National Institutes of Health, and has adopted sections from the policies of other liberal arts institutions, all of which are based on the same federal standards.

This policy affirms Muhlenberg College’s commitment to academic freedom.  It will not be used to discourage or disapprove innovative research. The IRB at Muhlenberg College understands and is sensitive to enduring debates about the appropriate reach of IRBs and the tensions that may emerge in applying review policies originally designed for the experimental sciences to research in the social sciences and humanities. Furthermore, in promoting the establishment of Departmental Coordinators of Human Subjects Research and supporting Departmental Coordinators through ongoing training and education, the IRB recognizes that different disciplines have their own professional codes of ethics that are most appropriate to their fields of research.  Most academic professional associations have codified and published ethical guidelines that researchers should consult. 

Beyond fulfilling its obligations to the federal government as summarized below, as an institution focused on undergraduate learning, Muhlenberg’s IRB has an educational role to play in helping members of the College community think about the ethical implications of their research projects and supporting faculty in the development and training of students as ethical researchers.  Rather than an elaborate process, the IRB hopes to be viewed as a resource for support and education in the best liberal arts tradition.  Faculty supervisors of independent research and instructors of research methods courses, or similar courses in which students conduct research with human subjects, are responsible for oversight of student projects.  Instructors should consult with their Departmental Coordinator or the IRB to determine appropriate procedures for assuring that student projects meet ethical guidelines.

The College's policy places the primary responsibility for the protection of the welfare and the right of privacy of the individual subject on the principal investigator. The responsibility is shared by the College as an institution, by the sponsoring agency where outside support is provided, and by the faculty advisor in the case of student-conducted research.

See a statement on IRBs and academic freedom by the AAUP at http://www.aauup.org/AAUP/comm/rep/A/humansubs.htm