Introduction - The Roles and Responsibilities of the IRB

The Institutional Review Board for the Protection of Human Subjects #1 (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 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 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 Review - Types of Review Conducted, General Review Criteria, and Meeting Schedule

The IRB 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 conducts reviews no less than annually. The IRB 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 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 approval prior to awarding a grant), the Principal Investigator may request IRB 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 first determines if the research falls under the exempt or nonexempt criteria. If non-exempt, then the Chair of the IRB 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 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 approval criteria for non-exempt review are detailed in Appendix A.

The IRB 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 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), 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 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 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 2012-2013 academic year.

Principal Investigators and Their Responsibilities

For purposes of its policies and procedures, the IRB 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 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 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 review depending upon the nature of the proposed activity.  Faculty instructors and researchers should consult the IRB’s “How to Determine if IRB 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 if they have further questions.

Through the submission of proposals for research involving human subjects to the IRB 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 review or for exempt review (see Appendix D for the schedule of proposal submission deadlines and IRB meeting dates).  The IRB encourages Principal Investigators to consult with the Chair of the IRB or individual members of the IRB 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 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.

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 Chair.  Those proposals that are determined not to be ready for formal IRB 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 change format should be used to differentiate between originally submitted text and new material).

IRB Decisions Regarding Humans Subjects Research Proposals

While the goal of the IRB is, wherever possible, to approve proposals at the IRB meeting at which initial reviews have been scheduled, Principal Investigators must recognize that the IRB 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, but are the responsibility of the academic program and should be conducted before the proposal is submitted to the IRB 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’s decisions will be sent in writing by the IRB approximately two weeks after the IRB meeting; in the case of exempt review, the notification usually will be sent within two weeks of submission to the IRB.  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 decisions, conditions, and requirements.  They also are responsible for reporting the progress of the research to the IRB and/or appropriate institutional officials as often as, and in the manner, prescribed by the IRB, but not less than once per year.

No project will be approved for more than one year at a time by the IRB, and approval may be for less than one full year.

Any untoward results must be reported to the IRB by a Principal Investigator, as quickly as reasonably possible, to the IRB 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 for reevaluation.  Changes to a project with an existing IRB approval may not be initiated by a Principal Investigator without additional IRB 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 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 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 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 approval) and may not resume until approval is granted.

IRB 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, acceptance of proposals for review, and communication of review outcomes to Principal Investigators (and, when required, to research sponsors).

The IRB maintains records of all required human subjects training certifications for all investigators and individuals working on projects filed with the IRB as part of each proposal file.  The IRB 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:  Theodore Repa, Chair, 43 West 23rd Street, New York, NY 10010, (212) 463-0400 x 5285, theodore.repa@touro.edu; or, Vincenza Colon, IRB Coordinator, 43 West 23rd Street, New York, NY 10010, (212) 463-0400 x5260, vincenza.colon@touro.edu. The fax number is (212) 627-3692.

	Request for Full IRB Review. For new and renewal protocols
	Request for Exempt Review (including Exemption Criteria). For projects that do not require full IRB review
	Request for Continuing Review. For ongoing projects

APPENDIX Aback to the top

Criteria for IRB Approval of Research

In order to approve research, the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (a) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (b) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.  In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).  The IRB will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable.  In making this assessment the IRB will take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by regulation.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by regulation.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards will have been included in the study to protect the rights and welfare of the subjects.

APPENDIX B back to the top

TOURO COLLEGE OF NEW YORK
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS # 1

Informed Consent—Guidance for Investigators and Sample Consent Forms

Foremost in responsibility for the investigator is to secure informed consent from the subjects participating in a study.  Clear communication is central to achieving that goal, including providing an easily understood description of the research to be conducted (geared to the level of the subject), a careful explanation of the subject’s rights, the compensation (if any) the subject will receive by participating, and contact information.  When a study involves any form of deception, a processed debriefing is required.

Most informed consent is obtained in writing.  There are, however, circumstances when informed consent may instead be obtained orally, based upon the nature of the study and the low risk involved through participation. 

Research involving minors requires an assent by the child and accompanying parental/guardian permission; in New York and most states, the age of majority is 18, so these requirements come into play for all studies involving participants that are younger than eighteen.  Note that New York state law requires licensed professionals, as well as certified teachers and administrators, to report any instances of suspected abuse (investigators working in other states should carefully research and comply with the appropriate statutory requirements, and cite those requirements in the proposal to the IRB). If Touro students or staff are working with the subjects who are children and suspect abuse they should immediately inform the investigator. Investigators conducting research with children should discuss their studies with the Chair of the IRB to arrive at the appropriate assent/permission format and content to be used prior to submission of their proposals to the IRB for review.

Research with other special populations may require additional informed consent protections.  Investigators should consult the appropriate regulations and discuss the circumstance with the IRB Chair prior to submission of their proposals for review.

Requests to waive or modify basic elements of informed consent may be sought from the IRB, but generally approval is rare.

The federal requirements for, and documentation of, informed consent are detailed below.  These requirements should be taken into account as you decide how to pursue informed consent while conducting your study and for preparing the informed consent material you must include as part of your proposal to the IRB.  When evaluating the informed consent section of your proposal and rendering its decision, the IRB will use the federal Informed Consent guidelines among other considerations.  Investigators are encouraged to consult with the Chair of the IRB or with individual members of the IRB, particularly if they are from the same academic discipline or School, for additional guidance on implementation of the informed consent requirements.

General Requirements for Informed Consent (45 CFR 46.116)

Except as provided elsewhere under federal policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.  An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.  The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.  No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional elements of informed consent.  When appropriate, one or more of the following elements of information shall also be provided to each subject:

(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
(6) The approximate number of subjects involved in the study.

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided the IRB finds and documents that:

(1) The research or demonstration project is to be conducted by, or is subject to, the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver or alteration.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

(e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under
applicable federal, state, or local law.

Documentation of Informed Consent  (45 CFR 46.117)

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Samples Consent Format/Forms

Below are sample consent formats and forms.  Note that investigators are not bound by these models; rather, the formats and forms are merely illustrative.  The format an investigator ultimately chooses to use should address the requirements for informed consent as they pertain to an individual study.

Telephone, Internet Survey and Pen and Paper Survey Scripts.  The following templates may be used for minimal risk surveys on non-protected populations.  The information in brackets must be provided, but an investigator should feel free to alter the remaining text to suit his/her particular needs:

(a)  Telephone Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am calling to ask if you would be interested in participating in a research study about [INSERT PURPOSE OF THE STUDY]. It will take approximately [INSERT TIME]. Is this a good time to talk? (If not, ask for a different time). Your responses will be kept confidential as I have not written down your name or phone number on the answer sheet. Feel free to skip any questions that you do not want to answer. Let me give you a number where I can be reached if you have any questions after the study is over [INSERT CONTACT NUMBER]. Are you ready to begin?

(b)  Internet Survey Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am a conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT APPROXIMATE TIME REQUIRED] to fill out the survey attached to this introduction? Your responses will be anonymous; there is no way for me to know who completed a survey. Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION—you may also include a phone number or use a phone number instead of an email address. If you choose to participate, please click on I ACCEPT at the bottom of the screen to begin the survey. Thank you in advance for your time.

(c)  Pen and Paper Survey Script

Hello, my name is [INSERT NAME] from [INSERT INSTITUTION]. I am conducting a research study about [INSERT PURPOSE OF THE STUDY]. Would you be willing to take [INSERT APPROIXIMATE TIME REQUIRED] to fill out the survey? Your responses will be anonymous; there is no way for me to know who completed a survey.  Feel free to skip any questions that you do not want to answer. If you have questions about the survey, please feel free to email me at [INSERT CONTACT INFORMATION]—you may also include a phone number or use a phone number instead of an email address. If you choose to participate, please take a survey packet that includes a self-addressed envelope that you can use to mail me the completed survey. (If appropriate, use “please deposit your survey in the drop box located at [INSERT LOCATION]”). Thank you in advance for your time.

Written Consent Forms

The following written consent forms—Standard Adult Consent Form, Minor Assent Form, and Parent/Guardian Permission Form—are basic outlines containing the absolute minimum information required.  Please develop your forms to be inclusive of all requirements as they apply to the study you are undertaking.  Note that the consent/assent/permission forms complement information that has been conveyed orally.

	Standard Adult Consent Form
	Standard Minor Assent Form
	Standard Parent/Guardian Permission Form

APPENDIX C back to the top

Student Classroom Projects—How to Determine if IRB Review and Approval is Required

[under development]

APPENDIX D back to the top

Protocol Submission Deadlines and IRB Meeting Dates
Academic Year 2009-2010

All protocols requiring full IRB review must be submitted by the submission deadline dates listed below to be a considered at the referenced IRB meeting scheduled approximately two weeks later.  Protocols that miss the submission deadline will be deferred until the next regularly scheduled meeting of the IRB.  Exceptions to this policy only may be granted by the Chair of the IRB.