Download GUIDELINES FOR SUBMISSION REQUIREMENTS FOR IRB REVIEW

GUIDELINES FOR SUBMISSION REQUIREMENTS FOR IRB REVIEW
I.
Forms to be used for submission of IRB protocols.
All forms are available on the HSS Intranet, as follows:
Click on Institutional Review Board (IRB), then on IRB forms. The following forms are
available:
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Clinical Research Proposal
form
Instructions for Completion
of Clinical Research Proposal
Form
Serious adverse event
reporting form
Continuing review
application
Informed consent form
Genetics consent form
Registry consent form
Assent form
Survey consent script
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Short-form SPANISH and
CHINESE informed consent
forms
Protocol deviation form.
Request for Full or Partial
Waiver of HIPAA
Authorization
Request for Waiver of
Informed Consent
Certification for Reviews
Preparatory to Research
Conflict of Interest form and
Disclosure Guidelines
In addition, the Policies and Procedures of the Institutional Review Board are available
under the Policies and Procedures link and should be read before preparing and
submitting a protocol for review.
At http://intranet.hss.edu/, click on HIPAA Compliance Project, then on Research, then on
Research Policy and Forms. The following forms are available:
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Research Authorization
II.
The IRB submission process consists of two phases: Scientific Pre-Review and IRB
Review.
A.
Scientific Pre-Review:
All protocols must be pre-reviewed and approved by the appropriate Departmental
Clinical Pre-Review Panel.
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Complete Parts I & II of the Clinical Research Proposal form and submit it to the
appropriate Clinical Review Panel for scientific review.
Please consult the list below for the Chairpersons and contact individuals to obtain
information for submission requirements and deadlines:
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B.
Orthopedics – Dr. Jo Hannafin is the Chair; Barbara Bosco is the contact person for submissions,
(212) 606-1914.
Medicine - Dr. Michael Lockshin and Dr. Lisa Mandl are the co-chair’s; Veronica Davis, (212) 606-1845, is
the contact person for submissions (includes Pediatric Rheumatology, Neurology, & Integrative Care
Center).
Rehabilitation Medicine – Mary Murray-Weir is the Chair; (212) 774-2269.
Anesthesiology – Dr. Jacques YaDeau is the Chair; Sheryl Stebel is the contact person; (212) 606-1206.
Radiology - Dr. Hollis Potter is the chair; Nina Tufaro is the contact person; (212) 606-1023.
Physiatry – Dr. Gregory Lutz is the chair; Elaine Freeman is the contact person; (212) 606-1648.
IRB Review:
NEW PROTOCOLS
After the departmental pre-review panels have reviewed and approved the science,
complete Part III and Part III A or III B, as applicable.
The completed protocol should be hand-delivered to the IRB Administrative Office
located on the 7th floor of the Caspary Research Building.
New protocol submissions should not be sent via interoffice mail.
Applications for Full Board Review are due on the 1st of every month.
Applications for Expedited Review can be submitted at any time.
Please be sure to complete/answer all fields/questions on the forms or they will be returned.
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You must determine if your protocol requires a full-board review by the convened IRB or if it
qualifies for an expedited review. Below, please find criteria which qualify your protocol for
expedited review. If your research does not fall into one of these categories, then it is a fullboard review.
Expedited Review Categories:
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
(Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the
risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part
812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is
being used in accordance with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn
may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per
week; or (b) from other adults and children,2 considering the age, weight, and health of the subjects, the
collection procedure, the amount of blood to be collected, the frequency with which it will be collected. For
these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection may not occur more frequently than 2 times per week.
2
Children are defined in the HHS regulations as ``persons who have not attained the legal age for consent to
treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the
research will be conducted.'' 45 CFR 46.402(a).
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if
routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need
for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in
an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the
tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane
prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure
is not more invasive than routine prophylatic scaling of the teeth and the process is accomplished in accordance
with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin
swab, or mouth washings; (j) sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the
safety and effectiveness of the medical device are not generally eligible for expedited review, including studies
of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography,
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ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise,
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age,
weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected
or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) 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.
III.
The following documents must be submitted for all new protocols, regardless of full board
review or expedited review.
Full Board Reviews require 1 original single sided and five (5) three-hole punched copies of all
documents listed.
DO NOT PUNCH HOLES OR USE STAPLES IN THE ORIGINAL.
Expedited Reviews require 1 original and two (2) copies of all documents listed.
Three hole punch not required.
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Memo from Pre-Review Panel indicating protocol has been reviewed and approved for IRB
submission. Attach revision memo/critique form so the IRB is aware of revisions that were
made to the protocol.
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HIPAA compliant IRB Application form including PI signature, Research Chief of Service
signature and signature of ancillary departments involved, if applicable.
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HIPAA Compliant Consent form (consent combined with Research Authorization form)
OR
Request for Waiver of Consent (where applicable)
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Genetic testing consent form (if applicable) AND Research Authorization
o Please note, the genetic testing consent is NOT combined with the Research
Authorization. Therefore, the Research Authorization must be submitted separate
from the consent.
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HIPAA compliant assent form (for use with minors – if applicable)
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Request for full waiver of authorization (i.e. Retrospective chart reviews)
OR
Request for partial waiver of authorization (i.e. Accessing health information for eligible
patients to contact; if one or all of the investigators listed on the protocol is/are not a part of the
treatment team you must apply for a partial waiver of authorization)
(See HIPAA Compliance Project on intranet for further clarification on applicability)
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Financial Disclosure Forms from ALL study team members
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Append any questionnaires, advertisement, etc that will be utilized with the study.
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Assemble all forms in a packet.
Confirm that all necessary documents are included.
Incomplete submissions will delay the review process.
IV.
Continuing Review of Previously Approved Research
A.
Determine if your submission requires a full-board review by the convened IRB or an
expedited review.
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Full board reviews are required when the initial protocol was reviewed by a convened
IRB AND the protocol is still active and enrolling patients.
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Expedited reviews are required when the initial protocol was reviewed on an
expedited basis.
HOWEVER, an initial full board review can become expedited when the following conditions are met:
(8) Continuing review of research previously approved by the convened IRB as follows:
(a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have
completed all research-related interventions; and (iii) the research remains active only for long-term follow-up
of subjects; or (b) Where no subjects have been enrolled and no additional risks have been identified; or (c)
Where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do not apply but the
IRB has determined and documented at a convened meeting that the research involves no greater
than minimal risk and no additional risks have been identified.
Full Reviews require 1 original single sided and five (5) three-hole punched copies of all
documents listed.
DO NOT PUNCH HOLES OR USE STAPLES IN THE ORIGINAL.
Expedited Reviews require 1 original and two (2) copies of all documents listed.
Three hole punch not required.
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Continuing Review Form – This form must be completed in its entirety and signed by
both the PI and Department Chair.
B.
The following documents must be submitted for all continuing review protocols, regardless of
full board review or expedited review:
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HIPAA Compliant Consent form (consent combined with Research Authorization form)
OR
Request for Waiver of Consent (where applicable)
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HIPAA compliant assent form (for use with minors – if applicable)
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Request for full waiver of authorization (i.e. Retrospective chart reviews)
OR
Request for partial waiver of authorization (i.e. Accessing health information for eligible
patients to contact; if one or all of the investigators listed on the protocol is/are not a part of the
treatment team you must apply for a partial waiver of authorization)
(See HIPAA Compliance Project on intranet for further clarification on applicability)
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Financial Disclosure Forms from ALL study team members
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Append any questionnaires, advertisement, etc that will be utilized with the study.
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Assemble all forms in a packet.
Confirm that all necessary documents are included.
Incomplete submissions will delay the review process.
V.
Termination/Completion of a study: Submit an original and 1 copy of the following:
A.
Continuing Review Form – This form should be completed with study title and current
approval period as you would prepare for request for continuation. Indicate in the appropriate
check boxes the status of your study.
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Termination: Be sure to indicate why you are terminating the study and complete subject
enrollment information including any subject withdrawals.
Completion: Be sure to indicate enrollment numbers and progress. Additionally, we ask
that you provide the IRB results of the study in the form of a manuscript, presentation,
article, etc. or your plans for presentation. Attach copies of abstracts and/or publications
that have resulted from the study.
Please contact Charles Castel, M.A., IRB Administrator, at (212) 774-2939 or Lucie Koppelman,
IRB Administrator, at (212) 774-2456 in the IRB Administrative office should you have any
questions. You may also contact Tzipora Kuba, Ph.D., Director, Clinical Research
Administration, at (212) 774-7154 with any questions.
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