Introduction

The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission published The Belmont Report articulating the ethical principles that guide the conduct of research involving human subjects and continues to serve as the foundation of the Department of Health and Human Services regulations governing the protection of human subjects (hereafter 45 CFR 46).

In the design, conduct, approval and review of research, Trinity College officials, the IRB members, and investigators adhere to the basic principles set forth in The Belmont Report: respect for persons, beneficence, and justice.

In consideration of RESPECT for persons, Trinity College investigators must seek and obtain voluntary informed consent from potential research participants. Informed consent means that participants are given explicit assurances of the voluntary nature of their involvement in terms that are easy to understand, and that they are not under duress or pressured to serve as participants. The consent process also includes information about the research project that will assist participants in deciding whether to participate in the study. In addition, respect means honoring the privacy of individuals and maintaining confidentiality.

The principle of BENEFICENCE requires that researchers maximize the potential benefits to participants, or to society, while minimizing the potential risks of harm. The extent of protection depends on the risks and benefits of the proposed research. All participants should be treated in an ethical manner. Benefits to participants, or benefits in the form of generalizable knowledge gained from the research, should always outweigh the risks. If there are any risks resulting from participation in the research, then there must be benefits, either to the participants or society.

JUSTICE means that subjects must be selected fairly and that both the risks and benefits of research are distributed evenly. In the language of The Belmont Report: "Who ought to receive the benefits of research and bear its burdens?" Investigators should take precautions not to select participants simply because of convenient availability, manipulability, their compromised positions, or because of social, racial, sexual, economic, or cultural biases institutionalized in society.

Many U.S. government departments and private funding agencies have their own human subjects research policies. PIs should check to see if a funding agency has policies and procedures that go beyond Trinity College IRB policies.

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1.1 Purpose of Trinity College IRB Policies & Procedures Manual

The IRB Policies & Procedures Manual serves as a reference guide describing the policies, procedures, and regulations governing research involving human subjects and the requirements for submitting protocol applications for review by the Institutional Review Board of Trinity College. The intended audience of users includes research administrators, principal investigators (faculty, staff and students), and IRB members. The manual describes and explains the various aspects of the review process and regulatory requirements.

The field of human subjects protection is constantly evolving; some parts of the manual may be updated from time to time. The IRB chair will keep the Trinity research community apprised of revisions or new developments as they occur.

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1.2 Human Subjects Research Defined and Who Must Submit Protocols

Virtually all federally funded research with human subjects is governed by federal regulations patterned on those of DHHS (Department of Health and Human Services,) described at 45 CFR 46, and known as "the Common Rule." These federal regulations define research as: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Systematic investigations are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and reporting research findings.

Human subjects, sometimes called human participants, are defined as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information."

"Intervention" includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction," on the other hand, includes communication or interpersonal contact between the investigator and a subject such as by way of interviews or survey questionnaires.

"Private information" includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

At Trinity College, all faculty and staff research that conforms to these definitions in the Common Rule (45 CFR 46.102) must be submitted for review by the IRB regardless of funding source: federal, state, local, private or unsponsored. The Trinity College IRB reviews protocol applications from all disciplines. In accordance with the Federalwide Assurance (FWA00013955) issued to Trinity College by the Office for Human Research Protections (OHRP), DHHS, all human subjects research funded by the federal government must be performed in accordance with 45 CFR 46. In addition, the actions of Trinity College officials, researchers, and staff must conform to all applicable federal, state and local laws and regulations.

Student research involving human subjects, for example, all honors theses proposals or undergraduate research intended for publication or wide dissemination such as a web page or presentation outside of the classroom (e.g., at a conference or poster session) must be submitted for review by the IRB. Student research involving human subjects must be supervised by a Trinity College faculty advisor who will assume the responsibility for ensuring that all research procedures comply with federal and state laws and regulations and college policies designed to protect human participants. Classroom projects, problems courses, and independent studies that are exclusively for instructional or mentorship purposes and that do not entail greater than minimal risk to human subjects need not undergo review by the IRB.

Faculty advisors and students are encouraged to follow this IRB Policies & Procedures Manual when designing and conducting class exercises, projects or other assignments that involve the use of human volunteers or respondents, even if not submitted for IRB review. All student research that poses GREATER than minimal risk to human subjects must be submitted for IRB review (see definition of minimal risk, section 3.2 of this manual).

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1.3 The Role of the IRB

The IRB is charged with two principal responsibilities:

1.                   Determine and certify that all research protocols conform to the regulations and policies set forth by DHHS regarding the health, welfare, safety, rights, and privileges of human subjects; and

2.                   Assist investigators in conducting ethical research that complies with federal and other regulations in a way that permits the accomplishment of the research activity.

The IRB meets these responsibilities through a review of applications submitted by principal investigators, negotiations between the IRB and investigators for approval of research, and IRB outreach to the research community. The process of review serves to ensure the safe and ethical conduct of research that ultimately will protect the rights and welfare of human subjects. The dignity and welfare of individuals who participate in research must be a central concern of everyone involved with the protection of human subjects. The college and all faculty, staff and student investigators share in the collective responsibility for the ethical conduct of research.

This collaboration of the research community must operate in a culture of trust, mutual assurance, and integrity by upholding the highest ethical principles in the conduct of research and the pursuit of knowledge.

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1.4 Jurisdiction and Authority of the IRB

The Federalwide Assurance with OHRP/DHHS details the relationship of Trinity College and the Office for Human Research Protections within DHHS. This agreement and other DHHS policies empower the IRB with the authority to review, approve, require modification of, or disapprove research activities involving human subjects conducted by Trinity College investigators, including jurisdiction over proposed changes in previously approved human subjects research. For approved research, the IRB also determines which activities require continuing review more frequently than the maximum interval of twelve months.

The IRB must insure that voluntary informed consent will be obtained by research investigators and their staff in a manner that meets the requirements of Title 45 Code of Federal Regulations Part 46, sections 116 and 117. (See section 5.0 of this manual, Informed Consent: Process and Documentation.) The IRB holds the authority to observe or have a third party observe the consent process when deemed necessary.

IRB decisions and requirements for revisions, if any, are conveyed to investigators in writing, with the provision of an opportunity for appeal to the IRB by the investigator in the case of disapproval. No committee or official can approve an investigator to conduct any human subjects research that the IRB has not approved. [See 45 CFR 46.112.]

IRB approval means that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.

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1.5 Responsibilities of the Investigator and Departments

Federal DHHS regulations, policies, and guidance documents describe the role of investigators, illustrating further the principles of mutual trust, collective responsibility and the nature of decentralized accountability in human subjects research. Researchers must acknowledge and accept their own responsibilities for protecting the rights, privacy and welfare of the human subjects.

The application submitted to the IRB for review must demonstrate full compliance with federal, state, and college regulations and with all components of the Trinity College Federalwide Assurance for the protection of human subjects in research.

Once IRB approval has been obtained, investigators (PIs) must maintain updated records to include the initial application, approval letter(s) from the IRB, modifications requested and approved, continuation or re-approval progress reports, instruments completed, consent forms administered and signed, correspondence related to the study, adverse event reports, if any, etc. These records must be maintained for review or audit by the IRB for a minimum period of three years after official closure of the study. In the case of student PI's, the sponsoring faculty member, or department or program should maintain the records. (The IRB must also maintain certain records, as described in section 8.0 of this manual.)

If the research is approved by the IRB, investigators must obtain documented and legal informed consent from all research participants involved in each protocol, unless the IRB has granted a waiver, exception or alteration as provided for in the federal regulations and described in section 5.3 of this manual. Research investigators must also promptly report any injuries, unanticipated problems or adverse events to the IRB.

All amendments and modifications to a study need IRB approval before they are implemented. If the investigator wants to change anything in the research that would impact the subjects, such as recruitment procedures, key personnel, inclusion/exclusion criteria, research procedures, the informed consent document / process, or data elements collected, the investigator must obtain IRB review and approval prior to implementation of the changes. The only exception are changes necessary to eliminate apprent immediate hazards to a subject. If an investigator is unsure about reporting changes to the IRB, he/she should call the IRB office and ask for guidance. The IRB office can also provide investigators with instructions for submitting a request to modify an IRB-approved research protocol.

Progress reports and any proposed modifications to previously approved research activities must be submitted in writing in the manner prescribed in this manual.

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1.6 IRB Membership, Infrastructure and Resources

The Trinity College IRB consists of the Chair (who is normally a tenured member of the faculty in an appropriate department), and as required by 45 CFR 46.107, at least five  members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by Trinity College. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall include persons knowledgeable in these areas.

Every nondiscriminatory effort will be made to ensure that the IRB does not consist entirely of men or women, including the consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB may not consist entirely of members of one profession. The IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. The IRB shall include at least one member who is not otherwise affiliated with Trinity College and who is not part of the immediate family of a person who is affiliated with Trinity College.

Members of the IRB are appointed by the Dean of the Faculty with input from the IRB Chair and the IRB Administrator (Associate Academic Dean), as well as from chairs of departments and programs. To ensure an element of continuity in the work of the IRB, faculty members will normally serve a two-year term. Terms of appointment will be staggered to maximize continuity. The IRB must include at least one member of each sex, whenever the composition of the faculty makes it possible.

The members of the Trinity College IRB are:

Chair
IRB Administrator (Associate Academic Dean)
One member from the Psychology Department
One member from the Social Sciences Division other than Psychology
One non-scientist member
One member from the community
One appointed administrator to assist the work of the committee (non-voting)


 The Trinity College IRB is supported by an IRB Administrator and other administrative staff assigned by the Associate Academic Dean.

The role of the staff is to:

  • receive and log all protocol applications submitted by investigators

  • conduct a preliminary screen of applications for the necessary forms and attachments,

  • maintain all records on a computerized database,

  • document actions taken at IRB meetings by way of written minutes, and

  • maintain the IRB web site.

The IRB Chair provides leadership for the development and implementation of policies and procedures for the protection of human subject participants in research. The Chair is also responsible for scheduling timely reviews of the process, conducting training and outreach programs, and submitting reports required by Trinity College and federal agencies.

The IRB Chair presides at the IRB meetings and reports to the Dean of the Faculty. The Dean of the Faculty serves as the Institutional Signatory Official. According to current OHRP instructions for the Federalwide Assurance, the Institutional Signatory Official cannot be the IRB Chair or a member of the IRB.

Trinity College legal counsel and the Office of the Dean of the Faculty provide technical and/or administrative support as needed.