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Research and Regulatory Affairs
(317) 338-2194
RESEARCH
DESCRIPTION FORM
THIS FORM MUST BE NEATLY TYPED. (DO NOT TYPE ON THE REVERSE SIDE OF ANY FORMS).
Note: To check a box on this form, double-click the box and select “Checked” under “Default Value.”
RESEARCH PROPOSAL TITLE:
IRB STUDY NUMBER:
SECTION I: STUDY DESCRIPTION
A. Succinctly describe the general purpose and nature of the research in lay terms.
SECTION II: SUBJECT POPULATION
A. State the number of subjects to be recruited both locally and nationally and number of research study sites
(if a multi-center study). List total as a single number, rather than a range.
B.
Check all categories that are likely to be recruited for this study:
None (Proceed to Section III)
Children (Complete Section IIA)
Pregnant Women (Complete Section IIB)
Cognitively Impaired (Complete Section IIC)
Prisoners (Complete Section IID)
Economically/Educationally Disadvantaged (Complete Section IIE)
Students/Residents/Fellows
If any of the above subject populations are likely to be recruited, state the necessity for doing so:
SUBSECTION IIA: VULNERABLE POPULATION: CHILDREN
Federal Regulation 45 CFR 46 requires the IRB to make specific determinations whenever children are enrolled
in research. To assist the IRB in making these determinations, please indicate below in which category the
research belongs and state the rationale for that category’s selection:
Category 1 (§46.404): Research not involving greater than minimal risk to children. Explain how
adequate provisions are made for soliciting the assent of the children and the permission (informed consent) of
their parents or guardians.
Category 2 (§46.405): Research involving greater than minimal risk but presenting the prospect of direct
benefit to the individual child. Explain why the anticipated benefit justifies the risk and why the relation of
the anticipated benefit to the risk is at least as favorable as that of alternative approaches and explain how
adequate provisions are made for soliciting the assent of the children and the permission (informed consent) of
their parents or guardians.
Category 3 (§46.406): Research involving greater than minimal risk and no prospect of direct benefit to
the individual child, but likely to yield generalizable knowledge about the child’s disorder or condition.
Explain why the risk represents only a minor increase over minimal risk, why the intervention or procedure
presents experiences to the children that are reasonably commensurate with those inherent in their actual, or
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expected medical, dental, psychological, social, or educational situations, and why the intervention or
procedure is likely to yield generalizable knowledge about the children’s disorder or condition that is of vital
importance for understanding or amelioration of the disorder or condition. Explain how adequate
provisions are made for soliciting the assent of the children and the permission (informed consent) of their
parents or guardians.*
Category 4 (§46.407): This category should be utilized in any instance where minors will be involved
with research that does not fall under any of the above categories. Any research falling under this category
will have to be reviewed separately under HHS prior to approval. This is per 45 CFR 46.407, which reads:
Research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children. In order to allow the IRB and HHS to evaluate the impact
on children, please explain why the proposed research presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and
explain the risks involved.*
* NOTE. When research is covered by categories §46.406 and §46.407, the informed consent must be
obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available,
or when only one parent has legal responsibility for the care and custody of the child.
Please indicate safeguards you will use for this Vulnerable Population (Children):
Youth Information Sheets (describe:
)
Assent (for what ages:
)
Extra monitoring (describe:
)
Researchers credentialed in pediatrics
Other health professionals with pediatrics experience
Other (describe:
)
SECTION IIB: VULNERABLE POPULATION: PREGNANT WOMEN
Federal Regulation 45 CFR 46 requires the IRB to make specific determinations whenever pregnant women are
enrolled in research. To assist the IRB in making these determinations, please indicate safeguards you will use
for this Vulnerable Population (Pregnant Women):
Inclusion is scientifically appropriate based on preclinical studies
Information will be provided pertaining to how study intervention could impact the woman and the fetus
Individuals engaged in the research will have no part in determining the viability of a neonate
Other -- Describe:
SECTION IIC: VULNERABLE POPULATION: COGNITIVELY IMPAIRED
Federal Regulation 45 CFR 46 requires the IRB to make specific determinations whenever the cognitively
impaired are enrolled in research. To assist the IRB in making these determinations, please indicate safeguards
you will use for this Vulnerable Population (Cognitively Impaired):
Verbal explanation of the research will be provided in lay language
Extra time will be available to answer questions
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At the potential study participant’s request, family members/significant others can participate in informed
consent process
Caregiver to assist with medications and identifying adverse events
Extra monitoring -- Describe:
Subjects will be withdrawn if they appear to be unduly distressed.
Other -- Describe:
SECTION IID: VULNERABLE POPULATION: PRISONERS
Federal Regulation 45 CFR 46 requires the IRB to make specific determinations whenever prisoners are
enrolled in research. To assist the IRB in making these determinations, please indicate safeguards you will use
for this Vulnerable Population (Prisoners):
Verbal explanation of the research will be provided in lay language
Procedures for selection of subjects within the prison will be immune from arbitrary intervention by prison
authorities or prisoners.
Other -- Describe:
SECTION IIE: VULNERABLE POPULATION: ECONOMICALLY/EDUCATIONALLY DISADVANTAGED
Please indicate safeguards you will use for this Vulnerable Population (Economically Disadvantaged):
Cost burden will be fully explained
No financial incentives will be provided
Social services will be available to assist study participant
Other -- Describe:
Please indicate safeguards you will use for this Vulnerable Population (Educationally Disadvantaged):
Verbal explanation of the research will be provided in lay language
Extra time will be available to answer questions
At the potential study participant’s request, family members/significant others can participate in informed
consent process
Caregiver to assist with medications and identifying adverse events
Extra monitoring -- Describe:
Other -- Describe:
SECTION III: RECRUITMENT & COMPENSATION
A. Recruitment
1. Describe how potential subjects will be initially identified:
Databases
Medical records
Advertisements
Newsletters
Self-referral
Physician referral
Clinics/office
Other – Describe:
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2.
Describe how potential subjects who are identified will be contacted:
Letter (must be approved by IRB)
Phone call (script must be approved by IRB)
Face-to-Face
Other – Describe:
3.
Who will be contacting them
Physician
Research Coordinator
Nurse
Other – Describe:
4.
List and include a copy of all recruitment material to be shared with potential subjects
B. Compensation
1. Will subjects be compensated for participation in the study (e.g., payment, free services, gifts, course credit,
including extra credit)?
No. Proceed to Section IV.
Yes. Complete items 2, 3, and 4 below.
2.
Explain the compensation arrangements (e.g., amount and timing of compensation and the proposed
method of disbursement), including reimbursement of expenses.
3.
Justify the proposed compensation arrangements described in section 2 (e.g., how this proposed
compensation arrangement is not considered to be coercive).
4.
Explain if there will be any partial compensation if the subject fails screening or otherwise withdraws prior
to completion of the study.
SECTION IV: STUDY PROCEDURES
Provide a brief description of all procedures being performed solely for research purposes. Examples would
include an investigational drug, a blood draw that is taken purely for research (not treatment purposes) or a
standardized survey that is being completed solely for the purposes of this research. This section will be similar
to the corresponding section of the informed consent, and should be documented by a billing grid/coverage
analysis.
Has a billing grid/coverage analysis been prepared for this study, and submitted to the St.Vincent Research and
Regulatory Affairs Department?
Yes
No (If no, please indicate date this will be done
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SECTION V: POTENTIAL RISKS
State the potential risks – for example, physical, psychological, social, legal, loss of confidentiality or other –
connected with the proposed procedures.
SECTION VI: STUDY BENEFITS
A. What, if any, benefit is to be gained by the SUBJECT?
B. What information may accrue to SCIENCE or SOCIETY, in general, as a result of this work?
SECTION VII: CONFIDENTIALITY & SAFEGUARDS
A. Check the items below to explain how confidentiality and privacy of data collected for the purpose of the
research study will be protected. Keep in mind that all members of the research team should only gather or
share the minimum amount of Private Health Information (PHI) needed for the study.
1.
Data Source (Please check all that apply)
a.
Treatment or Test Results, Medical and/or Dental Records, etc.:
Paper
Film
Electronic
b.
Interviews (Phone or Face-to-Face)
c.
Survey or Questionnaire
Paper
Electronic
d.
Video
e.
Audio
f.
Photographs
g.
Other (Please describe):
2.
Data Recording / Collection Method (Please check all that apply)
a.
Computer:
Laptop
Hard Drive
Local Shared Drive
Web-based
CDs, thumb drives, etc.
Other (Please describe):
b.
Smart Phone
c.
Paper (e.g., Notes, Case Report Form, etc.)
d.
Video
e.
Audio
f.
Other (Please describe):
Please describe how you will safeguard data for all the Data Recording / Collection Methods described in
VIII.A.2. by completing #3, #4 and #5 below. Please check all that apply.
3. Secure Storage
a. Who will have access to the individually identifiable information/data?
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Principal Investigator
Research Coordinator
Co-Investigators
Governmental Agencies
Research Sponsor, Monitor, Other Research
Organizations
Other (Please describe – e.g., outside multi-center collaborators, or other colleagues not listed as
sub-investigators, etc.):
b
4.
Please describe the measures you are taking to safeguard the information/data:
Locking cabinets and doors
Information is located in an area with limited public access
Computers and/or files will be password-protected
Removable media (such as CDs, thumb drives, etc…) will kept in a secure location
Regular back-ups of electronic data. NOTE: All electronic data should be backed up on a
regular basis.
Describe any other measures you are using to safeguard the data:
Secure Disposal
a. How long will you retain the data before discarding?
Minimum of 3 years for non-health data
Minimum of 7 years for health data, per Indiana State law
Per sponsor requirements
Indefinitely
Other (Please describe):
b.
How will you discard the data?
Paper will be shredded
Delete files from or destroy thumb drives and CDs*
Permanently delete data from computers and smart phones*
Other (Please describe)
5. Sharing Data
For this purpose, sharing may include releasing, transmitting or providing access to research and
health data within the research team, to research sponsors, etc. You must use reasonable safeguards
when sharing any form of research data, health or non-health.
a.
Will you share data in any of the following formats?
Non-Health Data only.
De-identified Data.
Identifiable Data (i.e., includes patient identifiers, names, initials, Subject ID numbers, etc. Please answer items 1. and 2. below.)
1. Indicate which secure method(s) of transmission will be used? Check all that apply:
Secured web site
Encrypted email
US Postal Service or other trackable courier services (not campus mail)
Fax in a secured area
Shared drive with password protection
Personal delivery by authorized research personnel
Private telephone conversation to authorized personnel
Other: (describe)
2.
Will you share identifiable health data with anyone not listed as a sub-investigator or
sponsor?
1.
No – Proceed to Section IX.
2.
Yes – Please list those individuals or entities:
Data will not be shared – Please explain:
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SECTION VIII: FEDERAL FUNDING
A. Has a proposal for funding been submitted to or is this study funded by a federal agency (e.g., NIH, CDC,
etc.)?
No. (Proceed to Section IX)
Yes. Provide one copy of the entire funding proposal or explain why one is not needed (e.g., the investigator
is not the direct recipient of the grant money [i.e., federal pass-through]):
B. Is this study a National Institutes of Health (NIH) multi-center clinical trial that includes an NIH-approved
sample informed consent?
No.
Yes. Provide a copy of the NIH-approved sample consent document.
SECTION IX: GENE THERAPY
A. Does this study involve the use of gene therapy or recombinant DNA?
No. (Proceed to Section X)
Yes.
B. If the study involves the use of gene therapy or recombinant DNA please provide a description of
biomedical materials involved and the need for pharmacy support:
SECTION X: FINANCIAL CONFLICT OF INTEREST
A. Do any of the individuals or their immediate family (spouse and dependent children) listed under Section
XII of this document have any of the following financial interests related to the research?
Yes (check all that apply)
Hold an ownership interest (equity or stock options) related to the research with value in excess of $5,000
Hold ownership interest (equity or stock options) related to the research with value that exceeds 5% ownership
Have proprietary interest in the research, such as a patent, trademark, copyright, or licensing agreement
Has received or will receive payments other than payment for the conduct of clinical research from the sponsor
that exceed $5,000 in the last 365 days.
Has received or will receive compensation with value that may be affected by the outcome of the study
Is an employee of the agency or company sponsoring the research
Is on the board of directors of the sponsor
Has a financial interest that requires disclosure to the sponsor or funding source
Has any other financial interest that the investigator believes may interfere with his or her ability to protect
subjects.
No, none of the above are true
[Note: Complete a Financial Interest Disclosure form (FRM-1101) for each individual with financial interests related to
the research. Completed forms should be included with the IRB submission package for this research proposal.]
SECTION XI: INVESTIGATIONAL DRUGS/DEVICES
N/A (Proceed to Section XII)
A. Investigational Drugs
Name of Drug Sponsor:
Name of Drug:
Investigational New Drug (IND) Number:
Study Phase:
I
II
III
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If this study involves the investigational use of a marketed drug or biologic, and in the opinion of the
investigator does not require submission of an IND, six conditions must be met (e.g., responses to conditions
listed below must be “yes” for an IND to not be required). Please respond to the following conditions:
No
 The study is not intended to be reported to FDA in support of a new indication for use or to support
any other significant change in the labeling for the drug.
 The study is not intended to support a significant change in the advertising for the product.
 The study does not involve a route of administration or dosage level, use in a subject population, or
other factor that significantly increases the risks (or decreases the acceptability of the risks)
associated with the use of the drug product.
 The study is conducted in compliance with the requirements for IRB review (21 CFR 56) and
informed consent (21 CFR 50).
 The study is conducted in compliance with the requirement concerning the promotion and sale of
drugs (21 CFR 312.7).
 The study does not intend to invoke 21 CFR 50.24 (Exception from informed consent for emergency
research).
B. Investigational Devices
Name of Device Manufacturer:
Name of Device:
Investigational Device Exemption (IDE) Number:
Type:
IMPORTANT: Unless the device is exempt from the IDE requirements, the IRB is required to determine whether or
not the device is significant risk. To help in this determination, please provide the sponsor’s documentation on the risk
assessment and the rationale used in making the risk determination. Please provide the investigator’s assessment of
the device risk below:
Significant Risk
Non-significant Risk
IDE Exempt
Risk assessment and rationale for above risk determination (if Non-significant Risk is checked, this section must
be completed):
SECTION XII: INVESTIGATORS
List the principal investigator and any co-investigators and their respective departments. (If there are multiple
investigators, please indicate only one person as the principal investigator; others should be designated as coinvestigators).
A. Principal Investigator:
Department
B. Co-investigators: (Please include the respective department)
List those directly interacting or intervening with subjects (including persons obtaining consent):
Name
Department
C. List other co-investigators who are not directly interacting or intervening with subjects:
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D. If this study is a collaboration with investigators at unaffiliated institutions, and our IRB is providing the
review and approval for their role in the study, list all such co-investigators, their respective institutions,
and specify their role and what procedures they will be performing:
Name of Co-investigator
Institution
Role
Procedures performed
COMPLETE THE REMAINING SECTIONS ONLY IF THIS PROPOSAL IS FOR AN
INTERVENTIONAL DRUG, DEVICE, OR OTHER CLINICAL TRIAL
SECTION XIII: RESEARCH RESOURCES
A. How many actively accruing research studies, for which you are the PI, do you have open (including studies
reviewed by IRBs other than the St.Vincent IRB)?
B. How many study participants are currently receiving study intervention for studies on which you are the PI
(including studies reviewed by IRBs other than the St.Vincent IRB)?
C. How many research staff (research nurses/coordinators, data analysts, other) do you have supporting you in
conducting your research studies (including studies reviewed by IRBs other than the St.Vincent IRB)?
Please list each of these individuals, their role, and their research role FTE (e.g. if you employ a full-time
assistant who devotes ½ of her time supporting your studies, the FTE listed here should be .5).
D. Which processes will you, the PI, use to ensure that all persons assisting with the study are adequately
informed about the protocol, the investigational product(s), and their trial-related duties and functions.
E.
What precautions will be used to ensure subject privacy is protected? (check all that apply)
Use of drapes or other barriers for subjects who are required to disrobe
Research intervention is conducted in a private room
The collection of sensitive information about subjects will be limited to the amount necessary to achieve
the aims of the research so that no unneeded sensitive information will be collected
Other – Describe
SECTION XIV: CONSENT PROCESS
Please answer the following questions to describe the process used to introduce a trial to a potential study
participant and obtain their informed consent.
A. Where will the consent discussion take place?
In a private room
In a waiting room
In a group setting
In in-patient room in hospital
In emergency situations – Describe:
Online, in public, over the phone, or in another unusual situation – Describe:
Other – Describe:
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B. Who will conduct the consent discussion?
Principal Investigator
Sub-Investigator – Identify:
Research Coordinator/Research Nurse
Other – Describe:
C. How will you be sure there is sufficient opportunity for the subject to consider whether to consent?
Subjects will be allowed to take home the unsigned consent document prior to signing it
Subjects will be allowed a waiting period of at least
hours to consider their decision.
Other – Describe:
D. Which processes will you use to assess a potential study participant’s ability to provide consent and their
understanding of the consent process?
Participant asked to state their understanding of the study after initial consent discussion
Participant asked specific questions about study after initial consent discussion
Participant asked to “teach-back” the major elements of the study to the consenter
Participant encouraged to ask questions during the consent process
Other – Describe:
E. Please indicate the language(s) of the subjects you plan to enroll. (All consent forms and other subject
materials must be in a language easily understood by the subject, and you must have plans for conducting the
consent discussion and for ongoing communication with the subject in that language).
English
Other Language(s) – Specify:
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