Guidance to Principal Investigators
Introduction - The Roles and Responsibilities of the IRB#1
The Institutional Review Board for the Protection of Human Subjects (IRB/IRB#1) is charged with the task of protecting the interests and rights of human subjects involved in research at Touro College of New York (TCNY), with an emphasis on behavioral, educational, and social science research studies.
The IRB#1 strives to fulfill its important ethical charge in a manner that minimizes interference with the autonomy, research objectives, and specific timetables of individual principal investigators yet complies with the law and College policies regarding human subjects protection.
Academic programs served by the IRB#1 include Touro's Graduate Schools of Business, Education, Psychology, Information Technology, Jewish Studies, and Social Work, the schools that constitute Touro's Undergraduate Division, and the Jacob D. Fuchsberg Law Center; additionally, IRB#1 is responsible for review of human subjects research proposed by any office of Touro College's central administration.
IRB#1 is not responsible for the review of human subjects research proposed at the College of Osteopathic Medicine, the College of Pharmacy, or the School of Health Sciences; those schools fall under the jurisdiction of the Health Sciences Institutional Review Board.
All research at Touro involving humans as subjects is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," usually referred to as the "Belmont Report"). These principles apply whether or not the research is subject to Federal regulation, and regardless of whether the research is externally or internally funded or is non-funded research.
The IRB#1 has an approved Federal-wide Assurance (FWA). Its policies and procedures primarily follow from the Code of Federal Regulations Title 45 Part 46 - Protection of Human Subjects. The FWA covers all non-exempt human subjects research that is supported by the U.S. Department of Health and Human Services or that is funded by any other federal department or agency that has adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) and relies upon the FWA. The FWA has been extended voluntarily by Touro to cover all human subjects research at Touro irrespective of the source of support for the particular research activity and to unfunded research. It is important to note that non-federal sponsors may have additional or other requirements for human subjects research and the College must adhere to those requirements when accepting such research awards.
IRB#1 Review - Types of Review Conducted, General Review Criteria, and Meeting Schedule
The IRB#1 will review, and has the authority to approve, require modification to, or disapprove all research activities involving human subject research, including proposed changes in previously approved human subject research studies.
For approved research, the IRB#1 conducts reviews no less than annually. The IRB#1 also determines which activities require continuing review more frequently than every twelve months or which need verification that no changes have occurred if there was a previous IRB#1 review and approval granted.
Human subjects research proposals are submitted either for exempt review (meeting specific criteria established under federal regulations and College policy) or non-exempt review (full Board consideration). Exemption criteria preface the form that is submitted when requesting exempt review. When a critical time factor for approval of a research project is involved (for example, when there is a limited window of opportunity to undertake the research or when a sponsor requires IRB#1 approval prior to awarding a grant), the Principal Investigator may request IRB#1 consideration of a proposal on an expedited basis if the project involves no more than minimal risk to subjects or if only minor changes in previously approved research are being proposed during the period (one year or less) for which the approval was originally authorized.
Before research with human subjects can commence, the IRB#1 first determines if the research falls under the exempt or nonexempt criteria. If non-exempt, then the Chair of the IRB#1 determines if a proposal meets the criteria for expedited review; if not, then the proposal will be reviewed in the standard manner. For nonexempt research, the IRB#1 gives consideration to: the risks to the subjects; the anticipated benefits to the subjects and others; the importance of the knowledge that may reasonably be expected to result; and the informed consent process to be employed. IRB#1 approval criteria for non-exempt review are detailed in Appendix A.
The IRB#1 meets regularly during the academic year, and, if necessary, will coordinate an ad hoc review for projects that require review during the summer. A listing of Submission Deadlines and Scheduled IRB#1 Meeting dates for the current academic year appears on IRB#1's website. Note that proposals for exempt review may be submitted at any time; however, if it is determined that the proposed research does not qualify for exemption (usually within a week of submission to the IRB#1), the Principal Investigator will need to prepare and submit a proposal for full review within the dates listed on the schedule.
Required Training in Human Subjects Research
Principal Investigators and other study personnel must meet required human subjects research training prior to commencement of any research involving human subjects by completing the certification program provided by the National Institutes of Health (NIH) at http://phrp.nihtraining.com/users/login.php; copies of the certificates indicating successful completion of the human subjects training program must be submitted with all IRB#1 proposals, or as staff join the project, but prior to beginning their work with subjects.
These requirements apply to all individuals who will work directly with subjects or who will have access to identifiable subject data. While other study personnel are not required to undertake this training, the IRB#1 encourages that they do so for obvious educational benefits. Alternatively, certification of completion of Collaborative Institutional Training Initiative (CITI) modules in human subjects research may be substituted for the NIH certification. IRB#1 currently is transitioning from use of the NIH training program to exclusively using the CITI training program during the 2014-2015 academic year.
Principal Investigators and Their Responsibilities
For purposes of its policies and procedures, the IRB#1 uses the term “Principal Investigator” to cover the roles of principal investigator/project director and/or co-principal investigator/co-project director on a research project involving the use of human subjects. These are the individuals who lead or have a central and substantive role in the decision, implementation, and proper conduct of the study (whether the project is funded or non-funded research), and generally expect to be the key authors on any academic publication or presentation resulting from the study.
Principal Investigators generally hold a regular appointment on the Touro faculty at a rank established by the Faculty Handbook; exceptions for Principal Investigator status are approved by established process. When the IRB#1 reviews proposals, the qualifications of the Principal Investigator will be considered as they relate to the degree of proposal complexity and the risk to human subjects. Proposals that require expertise regarding the treatment of human subjects beyond those held by the Principal Investigator may have to be modified, have additional qualified personnel added, or be disapproved.
While undergraduate and graduate students conducting research may technically serve as Principal Investigators for approved humans subjects research projects they are conducting, a Touro faculty sponsor also is required for such projects. The College and the IRB#1 expect the Touro faculty sponsor to be responsible for overall direction and guidance of the research plan and its implementation and for making certain the student researcher adheres to all College policies and procedures.
Classroom projects involving students may or may not require IRB#1 review depending upon the nature of the proposed activity. Faculty instructors and researchers should consult the IRB#1’s “How to Determine if IRB#1 Review and Approval is Required: Course-Required Student Research Projects Involving Human Subjects [under construction]” and “Using Course-Enrolled Students as Human Subjects [under construction],” and with the Chair of the IRB#1 if they have further questions.
Through the submission of proposals for research involving human subjects to the IRB#1 for review, Principal Investigators acknowledge and accept their responsibility for protecting the rights and welfare of research human subjects and for complying with all applicable laws, regulations, and policies. Particular attention also should be paid to the issue of informed consent as part of the proposal preparation (see Appendix B, “Informed Consent - Guidance for Investigators and Sample Consent Forms”).
A critical responsibility of all Principal Investigators is timely, thorough, and accurate submission of the appropriate proposal and related materials for full IRB#1 review or for exempt review (see Appendix D for the schedule of proposal submission deadlines and IRB#1 meeting dates). The IRB#1 encourages Principal Investigators to consult with the Chair of the IRB#1 or individual members of the IRB#1 to address any questions they may have prior to submission of their proposals to enhance the success of the review process. Senior colleagues who have conducted human subjects research may also be a valuable resource. Principal Investigators may wish to contact the Chair of the IRB#1 to discuss working with subjects in any of the protected populations (minors, prisoners, pregnant women, fetuses, institutionalized mentally disabled), given special requirements associated with them.
Principal investigators must adhere to the submission deadline established for each board meeting and preferably submit their proposals earlier. The Board requires sufficient time to properly review proposals it receives in order to meet its legal, regulatory, and policy requirements for the protection of the subjects.
Submitted proposals will be reviewed for completeness and readiness for review prior to their being placed on a meeting agenda, or in the case of exempt review prior to review by the IRB#1 Chair. Those proposals that are determined not to be ready for formal IRB#1 review will be returned to the Principal Investigator along with direction on the corrective action required prior to submission of a revised proposal for consideration. Principal Investigators should prepare their proposal with care; they should read all questions closely and respond to the specific requests contained; text should forego disciplinary jargon and plain English should be used wherever possible, since the membership reflects a broad range of disciplines and members who are not TCNY faculty; and, when completing answers a different text font should be used to distinguish responses from the proposal questions (and, in the case of revised proposals, the "Track Changes" format should be used to differentiate between originally submitted text and new material along with adding the date of the revised proposal version on each page of the submission).
IRB#1 Decisions Regarding Humans Subjects Research Proposals
While the goal of the IRB#1 is, wherever possible, to approve proposals at the IRB#1 meeting at which initial reviews have been scheduled, Principal Investigators must recognize that the IRB#1 may request revisions or additional information before granting final approval. Therefore, the process could take up to two months or longer. Principal Investigators should take this timetable into account, particularly for complex research studies and research involving vulnerable populations. The timetable is inclusive of the pre-review submission deadline and post-review communication.
Appropriate reviews for scientific merit generally are not the responsibility of the IRB#1, but are the responsibility of the academic program and should be conducted before the proposal is submitted to the IRB#1 for review; the exception is if the proposed research entails possible risks to subjects that outweigh the scientific merit. Mechanisms for monitoring the progress of the research must be in place.
Notification to investigators of the IRB#1’s decisions will be sent in writing by the IRB#1 approximately two weeks after the IRB#1 meeting; in the case of exempt review, the notification usually will be sent within two weeks of submission to the IRB#1. The written notification will either: (a) grant approval to proceed with the study; (b) grant conditional approval, indicating what information is required before final approval is granted and how the approval process will be completed; (c) indicate a deferred decision and detail the reasons why approval was not granted at this time and what must be done (e.g., requests for revision or additional information) to allow the review process to proceed; (d) disapprove a study, detailing why the study was not approved.
Managing Your IRB-Approved Study, Including Reporting of Untoward Events, Seeking Approval for Changes to Approved Research, and Continuation Review
Principal Investigators are responsible for conducting the research as described in their approved proposals and for complying with all associated IRB#1 decisions, conditions, and requirements. They also are responsible for reporting the progress of the research to the IRB#1 and/or appropriate institutional officials as often as, and in the manner, prescribed by the IRB#1, but not less than once per year.
No project will be approved for more than one year at a time by the IRB#1, and approval may be for less than one full year.
Any untoward results must be reported to the IRB#1 by a Principal Investigator, as quickly as reasonably possible, to the IRB#1 Chair (or, in his/her absence, to the assigned designee) by phone or by e-mail depending upon the urgency. Any changes in procedures of the approved research must be reported to the IRB#1 for reevaluation. Changes to a project with an existing IRB#1 approval may not be initiated by a Principal Investigator without additional IRB#1 review and approval, except when necessary to eliminate apparent immediate hazards to the subjects.
In addition to the conditions described above, submission of a continuing review proposal in advance of the IRB#1 approval anniversary date is mandatory when any of the following conditions describe the study: subject data collection is ongoing; contact with subjects is ongoing after initial data collection; analysis of data by which subjects are directly identifiable is ongoing; or analysis of coded data (by which subjects can still be identified via a master coded listing) is ongoing.
Submission of a continuing review proposal generally is not required in other circumstances. However, if a Principal Investigator is uncertain on interpretation of this guidance, he/she should contact the Chair of the IRB#1 to discuss the particulars of the study.
Note that all research involving human subjects that requires annual or more frequent review must cease if continuous IRB#1 approval is not secured by the Principal Investigator in a timely manner (i.e., by the time of the anniversary date of the last IRB#1 approval) and may not resume until approval is granted.
IRB#1 Administration
The Office of Sponsored Programs [(OSP) provides support to the IRB#1 and exercises administrative oversight for the process of review and certification, as well as insures that all research complies with federal and Touro assurances for protecting the rights and welfare of human subjects. This includes providing guidance as directed by the IRB#1, acceptance of proposals for review, and communication of review outcomes to Principal Investigators (and, when required, to research sponsors).
The IRB#1 maintains records of all required human subjects training certifications for all investigators and individuals working on projects filed with the IRB#1 as part of each proposal file. The IRB#1 may also offer training in the conduct of research involving human subjects.
If you have any questions regarding the responsibilities of a Principal Investigator or any aspect of TCNY IRB#1 policy or procedure, please feel free to contact: Lawrence Raful, Chair of IRB#1, 225 Eastview Drive, Central Islip, NY 11722; or, Arnita Liebman, IRB#1 Coordinator, 43 West 23rd Street, New York, NY 10010, (212) 463-0400 x5260, IRB1@touro.edu. The fax number is (212) 741-0195.