IRB v. 2014.09.19
IRB #
BUTLER HOSPITAL
INSTITUTIONAL REVIEW BOARD
BUTLER HOSPITAL IRB NEW SUBMISSION FORM
For: (check one)
☐Protocol for Research Involving Human Subjects: Complete Sections 1-4 & 6-9
☐Waiver of Authorization for use of Protected Health Information (PHI) Study: Complete 1, 5, 6 & 7
☐Waiver of Authorization for use of Protected Health Information (PHI) Preparatory to Research: Complete 1, 6 & 7
Protocol Status: ☐ New ☐ Renewal
Authorization Waiver Status: ☐ New ☐ Renewal
-or-
1.) TITLE OF PROJECT:
Principal Investigator (P.I.)(s):
Signature(s) of the P.I.(s):
Other Investigator(s):
Corresponding Investigator:
Mailing Address:
Telephone/FAX/E-mail:
Funding: (Source, PI):
Duration of Project: ___________________
Duration for Individual Subjects: (if waiver: n/a)
Specific Location(s) of Project:
Check if applicable:
☐ Investigational New Drug/Device (IND/IDE#
)
☐ Use of Radioisotopes
☐ Student Research (Student
☐ Minors
☐ Prisoners
)
☐ Fetuses ☐ Intellectually disabled ☐ Abortuses
☐ Pregnant Women
☐ Special racial/ethnic group (Specify
Check if requirements have been met (submit written explanation if “no”):
Have all investigators completed research ethics training?
☐ YES
Have all investigators completed FCOI training in the past 4 years? ☐ YES
Have all investigators completed FCOI Disclosure forms?
☐ YES
)
☐ NO
☐ NO
☐ NO
ATTENTION:
Before completing this protocol, go to the Butler IRB Forms website:
http://www.butler.org/irb/forms.cfm
Download the most recent version of this and any other needed IRB forms
and consult the IRB Guidelines for updated directions.
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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2.) Description of Study
A. Specific Aims
B. Background
C. Experimental Method
C1. Brief Description of Subjects
C2. Study Design
C3. Specific Procedures or Treatments
C4. Data Analysis
D. Material Inducements
E. Training of Research Personnel
3) Human Subjects
A. Subject Population (include number; gender; age; diagnosis; inpatient vs. outpatient; physical
health; inclusion/exclusion criteria; rationale for use of special groups)
B. Recruitment and Consent Procedures
C. Potential Risks
D. Protection of the Subject (include: D.1. measures to minimize potential risks; D.2 measures to
ensure confidentiality; D.3. data safety monitoring plan)
E. Potential Benefits
F. Risk-Benefit Ratio
4) REFERENCES
5) STUDY RATIONAL: (complete for studies where only waiver is requested):
Date most recently revised (m/d/y)
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6) CRITERIA FOR WAIVER OF AUTHORIZATION FOR USE OF PROTECTED HEALTH INFORMATION (PHI)
6A. Does the requested use of PHI involve more than minimal risk to privacy?
☐ YES [if " YES," project is not eligible for PHI Waiver]
☐ NO [if "NO," address 1-3 below]
Plan to Protect Patient Identifiers from Improper Use and Disclosure:
Plan to Destroy Identifiers or Justification for Retaining Identifiers:
Assurances that the PHI will not be Re-used or Disclosed:
6B. Could the research be practicably conducted without a waiver?
☐ YES ☐ NO
6C. Could the research be practicably conducted without access to and use of the PHI?
☐ YES ☐ NO
6D. PHI is only needed for activities preparatory to research
☐YES ☐NO
7) DESCRIPTION OF NEEDED PHI
8) ADVERTISEMENTS
9) INFORMED CONSENT FORM (ICF)
The consent form is a required part of the protocol submission package. The ICF template below should
be cut, pasted and saved as an independent document with its own pagination (i.e., starting with page 1
on the front page of the consent) for each ICF associated with this study. If there are multiple ICFs, specify
the name of each ICF in the footer to make identifying them easy. Text in bold is required template
language and must be part of the consent form.
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT
Butler Hospital/Care New England and Brown Medical School
[Title of Research Project]
Sponsorship
This study is being paid for by a grant from [name of sponsor].
Invitation to Participate and Description of Project
You are invited to participate in a study designed to [indicate purpose of study].
You have been invited to participate because you [indicate general qualifications of person
being enrolled]. Your participation in the study will last [indicate number of visits or
procedures and duration of time for subject to complete all study procedures]. It will require
approximately [indicate hours per week and activities subject will be engaged in].
In order to decide whether or not you wish to be a part of this research study, you should
know enough about its risks and benefits to make an informed judgment. This consent
form gives you detailed information about the research study which a member of the
research team will discuss with you. This discussion should go over all aspects of this
research: its purpose, the procedures that will be performed, any risks of the procedures,
possible benefits and possible alternative treatments. Once you understand the study,
you will be asked if you wish to participate; if so, you will be asked to sign this form.
Description of Procedures
If you decide to participate, [describe procedures subject will undergo and use subject headings
to describe each procedure separately if there are multiple visits or procedures].
Risks and Inconveniences
[for each drug or intervention, list the associated risks and side effects, indicating which are most
common. Include mention of possible severe adverse events that can reasonably be anticipated for
participants].
[If relevant include the following, modified as appropriate]: Any medication may have
unforeseen side effects. You should know that the prediction of drug effects in any
individual cannot be done with certainty, and unexpected potentially harmful effects
occasionally occur with the administration of any type of drug. If you have questions
about medications, or if you experience any disturbing side effects during the study,
inform study personnel. In the event of any unexpected, potentially harmful effects of any
drug administered in this study, we will monitor your condition closely and institute
appropriate treatment.
Benefits
[If relevant, explicitly mention who will benefit from this study, for example, "You may not
benefit directly from participation in this study. The main benefits of this study are to help
researchers and clinicians develop future interventions that improve care for …”
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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Economic Considerations
[If relevant, describe all payments that might be made to subjects in exchange for their
participation, and how such payments would relate to participation in specific aspects of the
study.] If subjects will be offered payment, include the following as a separate paragraph:
"Depending on the amount of payment you might receive for your participation in this
study together with payments for participation in research in other studies within the
CareNewEngland (CNE) hospital system, you might have to provide your name, address,
and taxpayer ID or Social Security number to the Butler/CNE Research Accounting
Department. If you are paid $600 or more in any calendar year for research participation,
you will be issued a Form 1099 by the CNE Research Accounting Department and the IRS
will be notified of the total amount you were paid, in accordance with federal regulations.
You should ask the researcher for more information if you have questions about this
process."
In Case of Injury
[If relevant include the following, modified as appropriate; if emergency treatment will be offered,
the investigator must accept responsibility for its funding]. All forms of medical diagnosis and
treatment, whether routine or experimental, involve the risk of injury. If you are injured
as a direct result of your participation in this research, emergency medical treatment will
be offered by Butler Hospital and paid for by our research funds, except for costs that are
covered by your insurance or governmental programs. No additional financial
compensation is available.
In the event that you need hospitalization for medical or psychiatric care, the study
investigators, Butler Hospital, and Brown Medical School will not assume responsibility
for treatment expenses. If your insurance will not pay for inpatient care, you may be at
risk for personal financial responsibility for hospitalization.
Women Please Note: [If relevant include the following, modified as appropriate:]
[Specify drugs used in this study] are not recommended for use during pregnancy. [Insert
name of drug or procedure: _____________ may be harmful to the developing fetus. Therefore,
you may be tested for pregnancy at the time of your admission to the study. Prior to your
beginning the study we will discuss with you in more detail the importance of avoiding
pregnancy. We will specifically ask you to let us know if you change your mind and decide
to become pregnant during the study.
Alternative Treatments
[State whether or not treatments are offered in this study. If so, briefly describe alternative
treatments that comprise standard of care]
Alternative to Participation
[State something such as “As an alternative to participating, you may choose not to participate in
these research procedures and have usual assessments of your …. Your care at Butler Hospital will
not be affected in any way if you decide not to participate in this research study.”]
Confidentiality
[Describe measures to ensure confidentiality of data; Indicate if a copy of the consent form or a note
identifying participant with description of main study procedures will be contained in Butler
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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medical record.] You will not be personally identified in any reports or publications that
may result from this study. The confidentiality of the information you provide to us will
be maintained in accordance with state and federal law. [If the protocol involves research on
a product regulated by the FDA, including foods, dietary supplements, drugs, medical devices, or
other biological products, include the following: "The U.S. Food and Drug Administration (FDA)
may inspect all study records to ensure that the study is being conducted in accordance
with FDA regulations. General information about this study has been or will be submitted
to the federal clinical trial registry databank, which can be accessed on the Internet at
www.ClinicalTrials.gov."] Subject to these restrictions, authorization to use data collected
from you in the course of this study, including your protected health information, will
have no expiration date. While this study is in progress, you will not be allowed access to
protected health information about you maintained by the researchers, but you may
request access to such information when the study is over.
Voluntary Participation
You are free to decide whether or not to participate in this study, and you are free to
withdraw from the study at any time by informing the researchers verbally or in writing.
If you decide you do not wish to provide additional protected health information to the
researchers, you may withdraw from the study. Research information collected up to the
time that you decide to withdraw will remain as part of the study data. A decision not to
participate or to withdraw from the study will not adversely affect future interactions
with Butler Hospital or Brown University. Your participation in the study may be
terminated by the researchers without regard to your consent; in that case, you are
entitled to an explanation of the circumstances leading to that decision.
Financial Disclosure
{If the protocol is supported by a for-profit sponsor, include the following, modified as appropriate
for each investigator: [Name of investigator] has received grant or research support
from/has served as a paid consultant to/has been paid to give professional lectures
by/owns a significant amount of stock or financial interest in [name of sponsor]}
{If there is a for-profit sponsor but no financial relationships with any investigators, so indicate. If
there is no for-profit sponsor, indicate: Not applicable.}
Questions
In preparation of this consent form it was necessary to use several technical words.
Please ask for an explanation of any that you do not understand.
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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Authorization: I have read this form and decided that
(name of subject)
will participate in the project described above. Its general purposes, the nature of my
involvement, and possible hazards and inconveniences have been explained to my satisfaction.
My signature also indicates that I have received a copy of this consent form.
Signature
Relationship (self, parent, guardian)
Date
Signature of Principal Investigator
Telephone
or
Signature of Person Obtaining Consent
Telephone
If you have further questions about this project or about research-related injuries, please contact
[insert appropriate investigator(s) and telephone numbers]. If you have questions about
your rights as a research subject, please contact Linda L. Carpenter, M.D., Chair, Butler Hospital
Institutional Review Board, at 401-455-6349.
THIS FORM IS NOT VALID UNLESS THE FOLLOWING
BOX HAS BEEN COMPLETED IN THE IRB OFFICE
THIS FORM IS VALID ONLY UNTIL
(date)
IRB PROTOCOL #
INITIALED:
Date most recently revised (m/d/y)
Protocol/Waiver Version (if applicable)
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