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The IRB Policies & Procedures Manual serves as a reference guide describing the policies, procedures, and regulations governing research with human subjects and the requirements for submitting protocol applications for review by the Institutional Review Board of La Roche 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.
At La Roche College, all faculty and staff research must be submitted for review by the IRB regardless of funding source: federal, state, local, private, or unsponsored. The La Roche College IRB reviews protocol applications from all disciplines.
Student research intended to result in generalizable knowledge must also be submitted for review. 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 (i.e., at a conference or poster session). Student research involving human subjects must be supervised by a La Roche College faculty advisor who will assume the responsibility for ensuring that all research procedures comply with federal, state, and college policies designed to protect human participants.
Classroom projects and independent studies that are exclusively for instructional or mentorship purposes need not undergo review by the IRB if the risks are NOT GREATER than minimal. Faculty advisors and students are encouraged to follow the 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 review. All student research that poses GREATER than minimal risk must be submitted for IRB review.
Prior to submitting applications to the IRB for review, researchers must present the complete application to their department chair or administrative head to verify that the proposed study has
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undergone rigorous academic merit review. The department chair, administrative division head, or other appointed college official must read the IRB application and certify with signature that:
• the study's purposes, rationale, design and methods are clearly stated and meet discipline specific guidelines;
• the protocol conforms to the norms, ethical standards, and methods of procedure of the scholarly discipline;
• the proposed study involves no known risks to human subjects other than those specified;
• the principal investigator and other researchers are qualified to conduct the proposed study;
• the study facilities and resources are adequate for the safe conduct of the research;
• and the subject population, sampling procedures, and data to be collected are justified and adequate to meet study objectives.
Role of the IRB
The La Roche College IRB reviews all research proposals involving human subjects in order to ensure that the “protocol,” or procedures of the research, adequately protects the subjects. The Board consists of the Associate Vice President for Academic Affairs, who chairs the committee, and at least five members, both men and women from varied professions representing academic division/programs. They should have diverse backgrounds with some experience in the types of research being reviewed and be sensitive to community attitudes and vulnerable populations.
The IRB reviews applications submitted by principal investigators to determine and certify that all research protocols conform to the regulations and policies set forth by the IRB regarding the health, welfare, safety, rights, and privileges of human subjects. 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 college, and all faculty, staff, and student investigators share in the collective responsibility for the ethical conduct of research.
IRB decisions and requirements for revision, 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. Although research may receive IRB approval, the department chair or other administrative officials may conclude that the research project does not meet the policies and goals of the college and may disapprove, suspend, or terminate a project. However, IRB decisions to require modifications in,
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disapprove as submitted, suspend, or terminate a project are final. Further, no committee or official can approve an investigator to conduct any human subject research that the IRB has not approved.
To a limited extent, the IRB will consider the academic merit of the study design, since it would be unethical to place human subjects at risk with a study where methodological procedures are flawed such that little or no reliable information will be obtained. Primary responsibility for the review of academic merit rests with the department or administrative division sponsoring the research.
Review Process
Research projects are reviewed at one of three levels, depending upon the investigator(s) and IRB’s understanding of the target population to be sampled and the risk to participants posed by the recruitment, procedures, data retention, and dissemination plans. These reviews are done on a continual basis.
The federal definition of minimal risk provides the benchmark for considering the degree of risk a protocol poses. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The IRB must also be assured that, when participants could be vulnerable to coercion or undue influence (e.g., college students in a classroom setting), additional safeguards be in place to protect the rights and welfare of these participants. While the investigator indicates the initial determination regarding the appropriate category of review, the primary reviewer (IRB chairperson) will make the final determination. Any irresolvable matter or dispute between an investigator and the IRB chairperson is brought before the full Board. The categories for review are summarized below:
Exempt Review
Exempt review involves research presenting less than minimal risk to human participants.
Expedited Review
To qualify for expedited review, the research must present no more than minimal risk to participants and correspond to a category appropriate for expedited review or represent a minor change in previously full board approved research that involves no additional risks to research participants.
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Full Review
Any research that does not fit as an exempt or expedited review is to be submitted for full review. Any feature of a research project could prompt a full review; these include recruitment, sampling, participation characteristics, method/procedure, measures, storage plan, or dissemination. Examples of full review research include:
 Research which may put research participants at risk greater than minimal risk;
 Research involving psychological or physiological intervention or non-curricular, interactive research in departments;
 Research involving deception;
 Interviews or surveys relating to topics the La Roche community would define as being sensitive (e.g., sexual activity, alcohol or drug use, illegal behavior), particularly if identifiers are used or confidentiality could be compromised;
 Research targeting special populations (e.g., minors, prisoners, pregnant women, persons with diminished capacity or other vulnerable populations) if the research is conducted outside of a supervised classroom project affiliated with course objectives.
IRB Application
Materials submitted for review, at minimum, include a protocol (application form; exempt, expedited, or full review), legally effective informed consent (assent), and signature page. Other materials may be required, when applicable to the research. These include copies of surveys, measures, apparatus, and materials are to be submitted.
A protocol is ready for submission when the IRB has information about the research in sufficient detail as stated above. All questions on the application must be answered or marked “not applicable” when appropriate. Do not altar wording or delete questions from the form. Once the file is complete, the action the IRB Chair takes depends upon the level of review.
All changes to a research project must be submitted to the IRB as a modification request. Investigators are not permitted to implement any protocol changes without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects.
Department/Program chairs and heads of administrative divisions are responsible for the initial review of all research emanating from their department/divisions. All applications submitted to the IRB must
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be signed by the chair/head and the chair/head will recommend the level of review. No application should be sent to the IRB until the chair/head feels that the application is complete.
Applications must “stand alone” and should provide all information requested, i.e. complete answers must be contained in the application. While you may reference other documents with supporting information, do not respond solely by stating “see attached.” Applications will be returned if these instructions are not followed.
A completed application can be sent directly to the Academic Affairs Office. The address for all applications and other correspondences: La Roche College Academic Affairs Office, Attention: IRB Chair, 9000 Babcock Boulevard, Pittsburgh, PA 15237.
Exempted Research
Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation [45 CFR 46.101 (b) (2)].
This exemption is available for research within any of the stated categories involving adults, unless the information is both recorded in such a way that the human subjects can be identified (by links or otherwise) and the disclosure of the subjects’ responses outside the research could place the subjects at risk or cause personal harm. Thus, surveys involving sensitive topics (such as drug or alcohol use, sexual habits, detailed health histories, illegal behavior, etc.) where there are codes or other links between the information and the subject are not exempt. In studies that will collect data by way of oral history interviews and are designed to create generalizable knowledge in a systematic investigation, the IRB will review such applications as exempt or expedited depending on the level of risk on a case by case basis.
Certain educational tests are exempt from IRB review: tests of knowledge, mastery, and skills that do not include individual subject identifiers or ask sensitive information from the subjects.
Observational research involving sensitive aspects of human behavior or in settings where subjects have a reasonable expectation of privacy is not exempt.
Sensitive survey research is seldom exempt. A sensitive survey includes questions about illegal activities or highly personal aspects of the subject’s behavior, life experiences, or attitudes. Questionnaires or surveys covering sensitive topics, however, may qualify for exemption if they: (a) insure the anonymity
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of the subject; (b) inform the potential subjects as to the sensitive nature of the topics they will be asked to address; and (c) the study does not exceed minimal risk.
Research under this category that would not otherwise be exempt may qualify for exemption if it involves elected or appointed public officials or candidates for public office; for example, surveys, interviews, or observation of public officials or candidates for public office [45 CFR 46.101 (b) (3)].
Research conducted in established or commonly accepted educational settings involving normal educational practices such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [45 CFR 46.101 (b) (1)].
To qualify for exemption under this category, all of the research must be conducted in a commonly accepted educational setting and should not involve sensitive topics (e.g., sexual behavior, drug abuse, personal issues) nor increase the level of risk or discomfort beyond normal, routine educational practices. Provisions should be made to insure the existence of a non-coercive environment for all students, including those who choose not to participate. Written permission of the school or appropriate agency should be obtained prior to the implementation of the research, including review of the proposed study by the human subject’s research office or committee as applicable to or required by each school site.
Also exempt are research and demonstration projects which are conducted by or subject to the approval of department and agency heads and which are designed to study, evaluate, or otherwise examine public benefit or services programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs [45CFR 46.101 (b) (5)].
This category may also be applied to evaluations of State, City, or County programs provided that the program being studied delivers public benefits or services, there is statutory authority over the program, and there is no significant intrusion or invasion of participants’ privacy.
Expedited Review
Research activities that may be accepted by the IRB for expedited review include research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes: collection of data from voice, video, digital, or image recordings made for research purposes;
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• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies (some research in this list may be eligible for exemption);
• Continuing review of research previously approved by full review of the IRB where the research is permanently closed to the enrollment of new subjects, all subjects have completed research-related interventions, and the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
Full Reviews
Most applications submitted to the La Roche College IRB qualify for either exemption or expedited review. Research that does not qualify for these two lower levels of review must undergo a full IRB review by a quorum of IRB members at a convened meeting. The application process and forms remain the same as for the other levels, but investigators should note that a full review may take longer after receipt of a complete, signed application. In the event that no additional information, clarifications, or modifications are requested, the IRB may approve a study within a short time period, but investigators should be aware that the initial full review process often does not result in an outright approval of the research. Minor or major revisions and written clarifications may be requested, adding time to the review process.
In a Full Review, the IRB performs a detailed examination of the review application including the proposed informed consent form, and all supporting documentation, including any recruitment materials, questionnaires, or survey instruments.
IRB members with a potential conflict of interest in any review must recuse themselves from voting and participation in the deliberations. These disclosures should be stated prior to the agenda item where the protocol is presented for discussion. After a full discussion of the complete application, the IRB Chair calls for a vote. Results of IRB decisions are then communicated in writing to the investigator. This letter will justify any conditions required for final approval, may request additional information or revisions, and will indicate the next steps in the review process, if any.
All meetings of the IRB are documented in written minutes to include an agenda of topics, attendance, protocols reviewed, actions taken, voting results, reasons for requiring changes in a project, or reasons for disapproving, suspending, or terminating a project. These minutes are available for review and
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action by IRB members at subsequent meetings; when approved in final form, the minutes are stored in the Academic Affairs Office.
Cooperative Research
Cooperative research projects are those projects which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safe guarding the rights and welfare of human subjects and for complying with this policy. In this case, a Cooperative Research Agreement form must be submitted to the IRB at La Roche College after obtaining the necessary signatures from the lead institution.
IRB Appeals Policy
Any decision or review outcome may be appealed to the IRB. Investigators must submit their appeal in a letter to the IRB Chair outlining the reasons for the appeal and why the IRB decision or review should be reconsidered. If the appeal involves a relatively minor request, the Chair or a subcommittee of the IRB may consider the issue and reach an equitable determination. However, appeals of expedited and full review outcomes or any other substantive matters such as audit findings must be reviewed and decided by the full IRB convened meeting. The investigator may request to be present at the meeting or may be invited to do so by the IRB to clarify any issues pertinent to the written appeal. After presentation of the information and review of the documents, the full IRB will vote to approve or not approve the appeal. The decision of the IRB will be final.
IRB Records and Protocol Monitoring
The La Roche College Academic Affairs office maintains files in electronic or hard copy for each study to include: application forms, consent and assent forms, instruments, recruitment flyers or postings notification of IRB decisions and outcomes, records of any modifications and re-approval reviews, reports on adverse events, correspondence with investigators, and copies of all progress and final reports.
The IRB files are maintained for a minimum of three years after completion and closing of a study. Investigators should maintain duplicate files for their own records and for use during IRB audits while the study is still in progress and for three years after closure of the study.
The Academic Affairs office maintains records of IRB convened meetings: agendas, minutes, protocol status reports, applications reviewed with attachments, and other related material. Copies of inquiries and miscellaneous correspondence are also maintained by the IRB.
2010/2011

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