Policy Statement: Institutional Review Board

Trinity in Washington lives by a mission whose core values embrace the dignity and worth of all people. Trinity’s history as a Catholic institution of higher learning, with a profound commitment to justice and equity, and its ongoing tradition of excellence and rigor in all of its teaching and learning endeavors, compels the creation of policies and practices that actively safeguard the rights and welfare of individuals associated with Trinity’s academic enterprise.

In the realm of human subject research, Trinity has always expected faculty and students to observe good professional and ethical practice. In adopting this written policy statement for human subject research, and the creation of the Institutional Review Board (IRB), Trinity is formalizing its longstanding expectations and practices to conform with contemporary norms throughout higher education, and the public as well as private research community.

Trinity’s strategic plan anticipates many new programs and growth in graduate as well as undergraduate programs. With the expansion of graduate programs, in particular, and the addition of new faculty will come the need for increased ethical oversight of research projects. Institutional review boards (IRBs) are important in protecting research subjects. The purposes of IRBs are: to review initial research proposals to ensure that the researchers’ plans provide subjects with adequate opportunity to provide informed consent for procedures and to ensure that subjects are not exposed to unreasonable risks. IRBs also conduct continuing review of approved long term projects to make certain that subject protections remain in place. These purposes also support Trinity’s mission values and curricular goals.

Nothing in this statement can substitute for the researcher’s own sound professional judgment and careful attention to the ethics of conducting research. This statement describes commonly accepted considerations for such research, and a standard review process. Beyond this baseline, individual cases and projects may well require particular safeguards. For that reason, the IRB and Trinity College have broad discretion in the management of individual cases, and from time to time the IRB and Trinity may choose to issue additional guidelines for human subject research.

This statement also incorporates by reference the research guidelines of the U.S. Department of Health and Human Services.

A. Applicability

This policy statement and the IRB process applies to research projects conducted by faculty or students of Trinity that involves human subjects. Such research is typically in the behavioral sciences and education, e.g., Psychology, Counseling, Education, Sociology, Political Science, Economics, Communication, and but may involve almost any other discipline as well. The kind of research conducted under this policy usually involves testing a hypothesis, drawing conclusions, and using the results to contribute to the body of knowledge. Because the researcher may derive a benefit from conducting such research (e.g., a grade, a promotion, a book published, tenure, etc.), safeguards are necessary to be sure that the research is free from bias, and that the subjects involved are truly engaged voluntarily.

This policy applies to research that faculty and students of Trinity College conduct on its own premises as well as with or through other institutions or any external locations.

Certain forms of research are exempt from review under this policy. Following the guidelines established by the Department of Health and Human Services’ Office for Protection from Research Risks (OPRR), research that is exempt from review by an IRB includes: research conducted in established educational settings that involves usual educational practices; research involving educational tests which are part of an accepted curriculum; surveys, interviews or observations of public behavior where the subject cannot be identified by the collected data; archival research studying existing data, documents or specimens. In addition, some research will be eligible for expedited review, if it involves minimal risk to human subjects and is covered under the list of categories of minimal risk published by OPRR. On the other hand, any research that involves children, or research that probes into sensitive private information (e.g., medical or criminal records) calls for review.

One of the important functions that the IRB can fulfill is to advise members of the faculty on their research questions, and when in doubt about whether a particular project falls under this policy, the researcher should consult with the IRB.

This policy statement does not apply to questionnaires or other forms of informational research that Trinity conducts to discover information and data about its student, faculty, staff, alumnae or other publics, by way of improving services, complying with regulatory expectations, or other non-academic purposes.

B. Ethical Principles

The HHS guidelines (IRB Guidebook, pp. 2-5) outline three major principles that undergird the human subject research guidelines: respect for persons; beneficence, and justice. The following discussion summarizes the expectations embodied in these principles:

Respect for persons includes, most importantly, the idea that the subjects of the research will have sufficient information to give informed consent to participate in the project, and that such consent is based on a good understanding of what the project is all about, and voluntarily given.

Beneficence means that the researcher demonstrates clear effort to minimize any potential harms that may arise in the research, and considers the benefits for both the individual subject and society, and can justify the research in a risk/benefit assessment.

Justice means that the subjects of the research are selected and treated fairly, without bias, not simply for convenience, and that the selection reflects acceptable distribution of the selection across individual characteristics to safeguard against discrimination.

Other important principles include the desirability of protecting the privacy of individual subjects, including data about individuals; careful attention to the maintenance of data and information throughout the study, and mechanisms for ongoing review of the study.

C. The Institutional Review Board

In order to implement this policy and create a climate to promote good research practices, Trinity has created the Institutional Review Board in order to: (a) contribute to the scholarly life and recognition of Trinity College, (b) provide encouragement for faculty members to do original research, (c) meet the research needs of those graduate programs that require student research, (d) enhance individual faculty members’ opportunities for seeking and securing funding, (e) benefit undergraduates, especially in the social sciences, by providing opportunities for collaborative research with faculty, (f) permit undergraduate and graduate students to enhance their research experience.

The IRB is an administrative body of Trinity College, and it reports directly to the provost, who is the Authorized Institutional Official required by HHS guidelines to oversee the work of the IRB. The provost reports to the president of the College, who has the final jurisdiction in any question arising concerning the work of the IRB, subject to the HHS guidelines.

The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within the definition of ‘research’ in this policy. In accord with the HHS guidelines, research that has been approved by Trinity’s IRB may still be subject to review and disapproval by the vice president and president of the university, but those officials may not approve research that the IRB has disapproved.

D. Membership on the Institutional Review Board

The HHS guidelines require the IRB to have five members. These members must be “sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of racial and cultural heritage and their sensitivity to issues such as community attitudes…” (IRB Guidebook) The guidelines further require the IRB members to include:

a. at least one member whose primary concerns are in scientific areas;

b. at least one member whose primary concerns are in non-scientific areas;

c. one member who is not otherwise affiliated with the institution.

The guidelines also expect the IRB to reflect expertise about the kinds of research that would be the most likely, most frequent cases; also, diversity of membership is important.

The guidelines also state, “No IRB member may participate in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.”

In consideration of these guidelines, membership on Trinity’s IRB will be appointed by the president of the College in consultation with the vice president for academic affairs, and the faculty generally will be invited to submit nominations and applications for membership according to the requirements. Service on the IRB will be for a period of three years, but the first terms may be staggered to promote rotation each year.

The IRB will elect a chair annually, and the chair is responsible, with the vice president for academic affairs, to oversee the compliance with all other aspects of the HHS regulations.

The IRB may also invite experts to participate as necessary in the deliberation on individual cases, but these experts may not vote.

E. Institutional Procedures and Guidelines for IRB Decisions

The IRB will promulgate the application guidelines and methods for reviewing the applications. A sample application and set of instructions is attached to this statement; the IRB may choose to revise these materials at any time.

Upon receiving an application for research under this policy, the IRB will review the proposal according to these general questions (but not only these questions; additional guidance is in the IRB Guidebook):

1. Is this “research” that is subject to IRB review?

2. What kind of human subjects does this research involve, and do their characteristics (e.g., children, persons of all one gender or class, etc.) raise any particular issues at the outset? Is the population validly identified? Is there any particularly vulnerable subject population?

3. Does the principal investigator have the appropriate qualifications, experience and facilities to ensure that all aspects of the project and follow-up will be conducted rigorously and with due regard for the safety and well-being of the subjects?

4. Are adequate procedures in place through which the researcher will monitor the project and report problems to the IRB?

5. What is the investigator’s past record with regard to approved research?

6. Have the subjects of the research given informed consent in a truly voluntary way? When was that consent given? Is it still applicable?

7. What are the risks and benefits of the proposed research? Has the researcher appropriately identified and minimized the risks? Are the risks reasonable in relation to the benefits?

8. Do the subjects have full knowledge of the risks and benefits?

9. What is the process for ongoing evaluation of the project?

10. If the research involves a therapeutic procedure, have the risks and benefits of the research been separately evaluated from those of the therapy?

11. What are the privacy issues for the subjects, and what provisions have been made to protect the confidentiality needs and expectations of the subjects?

12. How will the research data be maintained and recorded? Is the plan adequate?

13. Are there sufficient resources to conduct this study effectively?

14. Does this study require the IRB to engage an expert to review the proposal?

F. Enforcement

All faculty and students of Trinity College who are engaging in the kinds of research described in this policy must comply with this policy and the processes described herein. Faculty members are responsible for supervising student research as well as for implementing their own research plans, and so faculty members have the most serious responsibilities under this policy. Failure to comply with the policy could incur disciplinary action ranging from termination of the research project through suspension and dismissal.

In all cases, faculty and students who are not in compliance with this policy will receive a fair opportunity to come into compliance. The IRB itself may inquire into research that has not appeared on its docket if the research appears to fall within this policy. The academic deans and vice president for academic affairs may also refer research projects to the IRB that appear to be out of compliance.

G. Effective Date and Policy Review

This policy is effective for all research projects that begin after July 1, 2001.  Thereafter, the policy will be reviewed on a periodic basis.

A note about research projects and assignments in which Trinity is the topic:

Trinity does not usually consent to being a topic for student class assignments or research papers. This includes Trinity personnel, students, alumnae and other persons associated with Trinity, as well as Trinity data and information, and Trinity assets and property. This exclusion does not apply to information that is publicly accessible through the website, internet resources, or other public data sources.

Faculty who wish to conduct their own research using Trinity as a topic, including its personnel, students, alumnae or other persons, or Trinity data and information, should request permission in writing to the president, and if the research involves human subjects, the project will also require IRB approval.