Download Common Form Prospective Application

KUSM-W, VCH-W, WMREF, WSU Prospective Application
Ver: November 2015
APPLICATION FOR REVIEW OF PROSPECTIVE LOW/LESS THAN AND MINIMAL
RISK HUMAN SUBJECT RESEARCH
*THIS FORM MUST BE TYPED*
Where will this application be submitted for review?
KU School of Medicine-Wichita (KUSM-W)
Via Christi Hospitals Wichita, Inc. (VCH-W)
Wichita Medical Research & Education Foundation (WMREF)
Wichita State University (WSU)
316-293-2610
316-268-5114
316-686-7172
316-978-3285
Submit 1 original of this entire application & required documents listed below to each
IRB checked above. Each IRB requires an original submission form.
Submission Checklist
KUSM-W and All IRBs
Research Compliance
1010 N. Kansas St
Wichita, KS 67214
Questions? Call 316-293-2610
http://wichita.kumc.edu/research-compliance/collaboratins-and-irb-reciprocity.html
Required
Prospective Application Form – signed original
1 Signed
Original
Study Protocol – see required elements under “Project Information”
1 Original
Scientific merit review checklist and approval
http://wichita.kumc.edu/research-compliance/forms.html
1 Signed
Original
Consent Form (if full informed consent is required & a waiver is not
being requested)
1 Original
HIPAA Authorization Form (if not incorporated into the consent form)
1 Original
Letter, fact sheet or telephone script (if a modified consent process is
proposed)
1 Original
Study instruments (data collection forms, surveys, interview/focus
group scripts, etc.)
1 Original
Recruitment materials (ads, flyers, radio and/or TV scripts)
1 Original
PRMC (KUMC Protocol Review & Monitoring Committee) Approval
Letter – required for cancer and cancer related studies
1 Copy
Grant application–required for federal, state or private funded studies
1 Copy
Page 1 of 20
N
Enclosed A
KUSM-W, VCH-W, WMREF, WSU Prospective Application
Ver: November 2015
Additional Items for Via Christi
Via Christi Hospitals Wichita, Inc.
Attn: Medical Staff Administration - IRB
929 N. St. Francis
Wichita, KS 67214
Questions? Call 316-268-5114
Enclosed
NA
Enclosed
NA
Budget information
Area/department that the study may affect or the PI must coordinate with
(please attach a separate page with this information )
Where research papers will be submitted
(please attach a separate page with this information)
Listing of research specific procedures and coordination of payment with
institution so participants are not billed for these procedures
Approval of advertising material from Via-Christi Marketing
Additional Items for WMREF
Wichita Medical Research & Education Foundation
3306 E. Central Avenue
Wichita, KS 67208
Questions? Call 316-686-7172
http://www.wichitamedicalresearch.org/
Face page – single page (page 2 of WMREF Research Proposal Application
signed by Wesley Medical Center Administrator and Principal Investigator)
--
Investigator’s Summary – three pages (page 11 – 13 WMREF Research
Proposal Application signed by the Principal Investigator)
--
Budget information – required if WMREF funding is requested (if applicable)
Listing of research specific procedures and coordination of payment with
institution so participants are not billed for these procedures (if applicable)
Study specific standing orders (if applicable)
CVs for investigators and research coordinators
1 Copy
IF USING KU FORMS, Click link for any additional WMREF requirements:
http://www.wichitamedicalresearch.org/InstitutionalReviewBoard/IRBForms/
Submit 1 original of this entire application & required documents to each IRB you are
submitting to. Each IRB requires an original submission form.
Page 2 of 20
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KUSM-W, VCH-W, WMREF, WSU Prospective Application
I.
Ver: November 2015
STUDY INFORMATION
Principal Investigator (PI):
KUSM-W Department:
WSU Department:
Hospital Department(s):
Full Mailing Address of PI:
Email:
Phone:
Alternate Contact Person (e.g., Project Coordinator):
Full Mailing Address:
Phone:
Email:
Protocol Title:
Protocol Number, Version and/or Date:
Use this form for Prospective Studies
NOTE: Prospective studies involve data or specimens that have not
yet been created or collected. This form also should be used for
studies that involve both retrospective and prospective elements.
II.
Research Activity
Approximate time period for conducting the study: Time of IRB approval
to
Do you intend to submit the results of your study to Federal Drug
Administration for any reason?
No
Yes
If yes, stop here and submit applications for full committee review by
the KUSM-W IRB/HSC, WSU IRB and hospital(s) IRB.
Indicate, by checking the appropriate space(s), the category or categories which may apply
to your research.
A. Research that qualifies for modified informed consent process.
(Research in these categories does not require continuing review.)
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as
(i) research on regular and special educational instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods. [Exempt b(1)]
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
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Ver: November 2015
behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can
be identified, directly or through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability; or be
damaging to the subjects' financial standing, employability, or reputation.
[Exempt b(2)]
PLEASE NOTE: the only research activities involving children that may fall
under this exemption are those involving educational tests or observation
of public behavior where the investigators do not participate in the activity
being observed. To be exempt, these activities must also meet the
condition that the data are recorded without individual identifiers, or the
condition that disclosure of the recorded responses would not place the
subjects at risk of criminal or civil liability or be damaging to their financial
standing, employability, or reputation.
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under category (b) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates
for public office; or
(ii) federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and
thereafter.
[Exempt b(3)]
Research and demonstration projects which are conducted by or subject to the approval
of department or agency heads, and which are 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.
[Exempt b(5)]
Taste and food quality evaluation and consumer acceptance studies:
(i) if wholesome foods without additives are consumed or
(ii) if a food is consumed that contains a food ingredient at or below the level
and for a use found to be safe, or agricultural chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of Agriculture.
[Exempt b(6)]
B. Research that must meet federal informed consent requirements.
(Research in these categories must undergo continuing review at least annually.)
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as
follows:
(a) from healthy, non-pregnant 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, considering the age, weight, and health of the
subjects, the collection procedure, the amount of blood to be collected, and 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
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Ver: November 2015
collection may not occur more frequently than 2 times per week
[Expedited f(2)]
Prospective collection of biological specimens for research purposes by noninvasive
means.
(a) hair and nail clippings in a non-disfiguring 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 prophylactic 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.
(k) other:
[Expedited f(3)]
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.)
(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, 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
(f) other:
[Expedited f(4)]
Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for non-research purposes (such as medical treatment
or diagnosis).
[Expedited f(5)]
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Collection of data from voice, video, digital, or image recordings made for research
purposes.
[Expedited f(6)]
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.
[Expedited f(7)]
III.
Study Personnel
List all study team members by their legal/full name. In order for a research project to be
approved, all members of the study team must demonstrate current training in human
subjects protection. Study personnel also must have on file a current KUMC conflict of
interest disclosure.
For information on KUSM-W human subjects training and Conflict of Interest disclosure, see the KUSM-W
Research Compliance website: http://wichita.kumc.edu/research/research-compliance.html
Name
(Please list MD, PhD,
RN, DO, etc.)
a
b.
c.
d.
e.
f.
g.
h.
Department
Conduct informed consent interview
Complete physical examination
Obtain medical/surgical history
Complete source documents
Complete study data forms
Assess unanticipated problems
Review concomitant medications
Take vital signs, height, weight
Status:
Resident, KU
Faculty,
Hospital Staff,
Graduate/
Undergraduate
Student, etc.
Role – Principal
Investigator
Sub-Investigator,
Assoc Investigator,
Coordinator,
Study Personnel, etc.
Responsibilities – List
all that apply a thru q
below. If not listed,
record in space
provided
i. Review/sign laboratory reports
j. Draw/collect laboratory specimens
k. Perform tests, procedures, interventions, questionnaires
l. Dispense/collect study medication
m. Complete drug accountability forms
n. Manage study database
o. Data analysis
p. Report generation
q. Research laboratory personnel
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Ver: November 2015
IV.
Location of the Study
(a)
Check all study locations under the principal investigator’s responsibility:
Outpatient Clinics and Research Centers
Via Christi Outpatient Clinic
Wesley Outpatient Clinic, specify:
KU Internal Medicine Clinic
KU Midtown Clinic
Other clinic or research center, specify:
Inpatient Setting
Via Christi Hospitals Wichita, Inc. *
*Specify the hospital department & contacts
Wesley Medical Center – Wichita
Galichia Heart Hospital (a campus of Wesley Medical Center)
KU Clinical Trial Unit (CTU)
Other Hospital or Inpatient Clinic, specify:
Classroom setting
KUSM-Wichita campus
WSU campus
Other universities/colleges, specify:
Elementary/secondary schools, specify:
International sites
Other, specify:
(b)
Where will data be stored?
KUSM-Wichita
Wichita State University
Wesley Medical Center
Via Christi Hospital
Other, specify:
Where will data analysis occur?
KUSM-Wichita
Wichita State University
Wesley Medical Center
Via Christi Hospital
Other, specify:
(c)
In what states will the principal investigator conduct the study? (Check all that
apply)
Kansas
Missouri
Other states, specify:
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KUSM-W, VCH-W, WMREF, WSU Prospective Application
(d)
Provide details below on all study locations, other than KUSM-W, WSU, Wesley
Medical Center and Via Christi Hospitals Wichita, Inc., for which the principal
investigator is responsible:
Name of the Facility
(e)
V.
Ver: November 2015
Primary Contact Name
The site has its IRB approval
own IRB
status at the
site
Yes
No
Yes
No
Yes
No
Yes
No
If the principal investigator is responsible for study conduct at multiple study
locations, the IRB must ensure adequate plans for overall management of the
study. Describe the investigator’s oversight plans, including how the
investigator will ensure adherence to the study protocol, obtain informed
consent, secure and maintain IRB approval at the other sites, obtain IRB
approvals prior to implementing changes to the protocol, monitor adverse
events or other unanticipated problems, and ensure general coordination of
study conduct.
Funding Information
Please indicate funding source.
(a)
UNFUNDED: Check this box only if there will be no funding source for this
project.
(b)
FUNDED
KU Endowment Association Funds (KUEA)
State Funds
KUMC Research Institute Funds (KUMCRI): Grant #
Wichita Medical Research and Education Foundation (WMREF)
Pharmaceutical/Private Funds, specify:
Federal Funds, specify:
Other, specify
Where will funds be deposited?
Note: The IRB requires submission of the grant application for federal,
state or private funded grants.
(c)
SEEKING FUNDING from
Where will funds be deposited?
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(source)
KUSM-W, VCH-W, WMREF, WSU Prospective Application
VI.
Ver: November 2015
Conflict of Interest
Please note that prior to IRB approval, an annual KUMC COI disclosure form must
be on file for all study personnel. The following questions relate to the study
named in this application. Principal investigators are responsible for addressing
these questions on behalf of the study team.
Yes
No
Do any of the investigators or their immediate family (defined as
spouse, children, siblings, parents, equivalents by marriage [inlaws], or other household members) have financial arrangements
with the sponsoring company or the products or services being
evaluated, including receipt of honoraria, income, or stock/stock
options as payments in the past year or will be expected during the
course of the project, that are not publicly traded, or whose value
may be affected by the outcome of the research?
Yes
No
Do any investigators, study personnel, or their immediate family
listed on this application have consulting agreements, management
responsibilities or equity holdings in the sponsoring company, the
providers of the products or services being evaluated, vendors,
provider(s) of goods, or subcontractors?
Yes
No
Is any investigator, or their immediate family, a paid or unpaid
member of an advisory or executive board or have a paid or unpaid
executive relationship with the sponsoring company or the
providers of the products or services being evaluated?
Yes
No
Do any investigators or their immediate family receive gift funds,
educational grants, subsidies or other remuneration from the
sponsoring company?
Yes
No
Do any investigators or their immediate family have an ownership
or royalty interest in any intellectual property utilized in this
protocol?
Yes
No
Does KUSM-W, KUMC Research Institute, WSU, Wesley Medical
Center or Via Christi Hospitals Wichita, Inc. have an ownership or
royalty interest in any intellectual property utilized in this protocol?
If you answered “Yes” to any of the above, please describe in detail. Answers will be
forwarded to the KUMC Conflict of Interest Committee.
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VII.
Ver: November 2015
Project Information
Submit with this application the following documents:
1. Protocol: provide a complete research protocol that addresses all of the
following:












Specific Aims
Background
Preliminary Studies
Hypotheses
Research Design
Subject Selection Criteria and Sample Size Justification
Recruitment Strategies and Informed Consent Process (if applicable)
Methods and Measurement Tools
Statistical Analysis
Data Security
Record Retention
References
2. Protocol materials (as applicable):







Data collection forms
Surveys
Questionnaires
Test instruments
Advertising flyers
Brochures
Recruitment script
VIII. Subject Selection
(a)
How many subjects do you plan to screen in order to identify the eligible
population?
How many subjects do you plan to enroll?
If unknown, provide further clarification:
(Note: If unknown, once the number is determined, it must be reported to the IRB of
record)
(b)
Check all that may apply to the study population:
Healthy volunteers
Patients
Children/Minors (under 7 years of age)
Children/Minors (7 - 17 years of age)
Pregnant women
KUSM-W, WSU or hospital employees
Males only
Persons w/ active psychiatric disease
Women of child-bearing potential
Economically/educationally disadvantaged
(c)
Adults 65 years and older
Comatose/traumatized
Terminally ill
Prisoners
Cognitively impaired
Students, residents or fellows
Females only
If vulnerable populations (such as children, pregnant women, cognitively
impaired, etc.) are being used, discuss the special protections being used to
minimize risk of coercion or undue influence. Special protections may include
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Ver: November 2015
parental permission and assent (for children); fulfillment of special conditions for
research with pregnant women and fetuses; and others.
(d)
Explain how you will ensure that subject selection is equitable and that all
relevant ethnic groups, genders, and populations have access to the study.
(e)
Explain how you will be able to recruit the required number of subjects in a timely
manner.
(f)
Will you use ads, flyers, recruitment scripts, etc, for this study? Submission at initial
review is optional, but all recruitment materials must be IRB-approved prior to their use. All
recruitment materials must be reviewed by KUSM-W Public Affairs for studies involving KUSM-W.
No
Yes
If yes, specify type
Recruitment materials have been submitted to KUSM-W Public Affairs?
N/A
No
If no, explain:
Yes
(g)
Will you be providing payment or incentives to subjects?
No
Yes If yes, payment and/or incentives must be described in the payment
section of the consent form. Total amount of payment or
incentive:
IX.
Benefit/Risk Information
(a)
How will risks to participants be minimized? Address all relevant physical,
psychological, economic, social, or legal risks.
(b)
Will any information, data or specimens that have already been collected, or are
expected to be collected, for diagnostic or treatment purposes, also be used for
research purposes as well?
(c)
How are the risks to subjects
reasonable in relation to the potential benefits?
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Discuss both benefits that may accrue to the individual and those that may
accrue to society.
X.
Type of Informed Consent
Choose answers in either Section A or Section B, as determined by
the research activity
A.
Research that qualifies for modified informed consent process
Letter of introduction
Fact sheet
Telephone script
Other; specify
------------OR ------------------B.
Research that must meet federal informed consent requirements
Choose written, oral or request for waiver of consent
Written Consent - submit the consent form(s) with this application. If
subjects are children, provide a parental consent form with a youth assent form.
Consent Forms included with this submission:
Adult Participant
Surrogate Decision Maker/Legally Authorized Representative (LAR)
Consent
Parental Permission with Child Assent
Foreign language consent & certification
Tissue repository
Other:
------------OR ------------------Oral Consent or Consent without Signature (Waiver of
Documentation of Consent) If checked, indicate rationale below and
submit the verbal script or written document you intend to use.
Rationale for Requesting Waiver of Documentation of Consent
A signed consent form would be the only record linking the subject
and the research, and the principal risk of a subject signing a
consent form would be potential harm resulting from a breach of
confidentiality.
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Explain
------------OR ------------------The research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is
normally required outside the research context.
Explain
Note: Documentation of HIPAA authorization cannot be waived.
------------OR ------------------Request for Waiver of Informed Consent If checked, demonstrate that
the research meets the federal criteria for waiving the informed consent
requirement
1.
The research involves no more than minimal risk to subjects.
2.
The waiver will not adversely affect the rights and welfare of the subjects.
3.
The research could not practicably be carried out without the waiver.
4.
Whenever appropriate the subjects will be provided with additional pertinent
information after participation.
If you are requesting a waiver of informed consent, demonstrate that
the research also meets the following criteria for waiver of privacy
information (HIPAA Waiver of Authorization Request):
1. Explain why the research could not be practicably be conducted without access to
and use of protected health information.
2. Describe the plan to protect identifiers from improper use and disclosure.
3. Describe the plan to destroy the identifiers at the earliest opportunity, consistent with
the conduct of the research (how and when the identifiers will be destroyed) . If there
is a health or research justification for retaining the identifiers or such retention is
otherwise required by law, provide the reason to retain identifiers.
4. Describe the plan to ensure that identifiable health information will not be re-used or
disclosed to other persons or entities.
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5. Explain why the research could not be practicably carried out without a waiver of
privacy authorization.
XI.
Informed Consent Process - required unless a waiver of consent is
requested
Not applicable; Waiver of Consent requested
(a) How and by whom will initial contact with potential subjects take place?
(b) Where and when will the consent interview take place?
(c) Describe the steps that will be taken to minimize the possibility of coercion or undue
influence.
(d) What is(are) the primary language(s) of prospective subjects or their legally
authorized representatives (LAR)?
(e) What are the languages used by those obtaining consent?
Federal regulations for the protection of human subjects require that informed consent information be
presented “in language understandable to the subject” and, in most cases, that informed consent be
documented in writing (45CFR46.116 and 117). If an investigator is planning to consent non-English
speaking subjects, the KUSM-W Institutional Review Board requires a separate consent form to be
drafted in the language of the population. Subsequently, the non-English consent form version must be
certified by professional translator and proof of such provided to the KUSM-W IRB.
FOR ADULT STUDIES ONLY:
Will all adult subjects be able to consent for themselves?
(a)
(b)
(c)
Yes
No; It is expected that all subjects will need a surrogate decisionmaker/LAR
No; It is expected that some subjects may need a surrogate decisionmaker/LAR
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If (c), how will study personnel assess the capacity of the subject to consent and
to comprehend the consent?
If (b) or (c), do you plan to obtain written assent from the subjects?
XII.
Privacy and Confidentiality
(a)
How will subjects be identified? Check all that apply
Selection during the course of usual clinical care
Chart reviews by persons involved in the patients’ care
Chart reviews by persons not involved in the patients’ care
Self-referral in response to IRB approved ads or web-sites
Referrals from outside physicians
Database searches; specify the database:
Other
(b)
What measures will you take to protect privacy during the recruitment and
consenting process?
(c)
What measures will you take to protect the privacy interests of subjects during
the conduct of the study?
(d)
How will you protect the confidentiality of data? Include information about where
the data will be stored and persons who will have access to the data.
(e)
Indicate whether or not a Certificate of Confidentiality will be obtained for this
study. A Certificate of Confidentiality may be appropriate in studies where sensitive information
will be collected during the research (e.g., illicit drug use, illegal activities, genetic data, HIV
status).
No
Yes
If yes, provide a copy of the Certificate of Confidentiality
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XIII.
(a)
Ver: November 2015
Data Security
Will identifiable data be transmitted electronically from one entity to another?
No
Yes
If yes, describe the type of data, where it comes from, where it will be stored, and
the plans for secure transmission:
NOTE: Any identifiable data transmitted electronically, outside the institution
where it was obtained, MUST be encrypted.
(b)
Where will electronic study data be housed/stored, even temporarily? Check all
that apply:
Web server hosted by sponsor, collaborator or data coordinating center –
Specify:
KUMC CRIS system
KUMC REDCap server
KUMC-supported network drive (e.g., S: drive, J: drive)
WSU-supported network drive (e.g., S: drive, J: drive)
Via Christi supported network drive
Wesley Medical Center supported LIMITED ACCESS network drive
KUMC-owned laptop, tablet or iPad
WSU-owned laptop, tablet or iPad
Via Christi-owned laptop, tablet, iPad, flash drive or other mobile device
Wesley Medical Center owned laptop, tablet, iPad, flash drive or other
mobile device
Other servers, devices or drives: specify
(c)
Does the study involve inputting or storing data on a mobile device?
No
Yes
If yes, describe how the information on the device is secured:
NOTE: Any data housed or stored, even temporarily, on a mobile device (laptop,
tablet, iPad, flashdrive, etc.) MUST be encrypted.
(d)
Will study personnel electronically transmit identifiable data or samples to a
recipient outside of their own institution?
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No
Yes
If yes, describe the type of data, where it comes from, where it will be stored, and
the plans for secure transmission:
(e)
Will study personnel electronically receive identifiable data or samples from an
outside institution?
No
Yes
If yes, describe the type of data, where it comes from, where it will be stored, and
the plans for secure transmission:
XIV.
Child/Minor Studies Only – Risk Assessment
Not Applicable; this is not a pediatric study
All studies involving children must undergo a separate risk assessment. Please indicate
below your judgment of the research risks. Check only one.
The research does not involve greater than minimal risk. (45 CFR 46.404)
Rationale for Decision
The research involves greater than minimal risk but presents the prospect of
direct benefit to the individual subjects. (45 CFR 46.405)
Rationale for Decision
The research involves greater than minimal risk and no prospect of direct benefit
to individual subjects, but is likely to yield generalizable knowledge about the
subjects’ disorder or condition. (45 CFR 46.406)
Rationale for Decision
The research is not otherwise approvable but presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health or welfare
of children. (45 CFR 46.407)
Rationale for Decision
(a) What are your plans for child assent?
Subjects’ assent will be required for enrollment.
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KUSM-W, VCH-W, WMREF, WSU Prospective Application
Ver: November 2015
The study will be discussed with the child subject, but parental permission will
determine enrollment, due to the therapeutic nature of the trial.
Subjects will not be capable of providing assent.
(b) At what age will you obtain assent?
(c) How do you propose to document assent?
Not applicable
By obtaining child’s signature on assent form
By documenting verbal assent in the research or clinical record
Other: Specify:
(d) Will any of the study subjects be foster children or wards of the State or other
agency?
Yes
No
XV.
Cancer and Cancer-Related Studies
Does the proposed study relate to cancer or cancer prevention?
No
Yes
If yes, see instructions below
KUSM-Wichita requirement: all human subject cancer or cancer-related
protocols (therapeutic/treatment, prevention, ancillary/companion and
correlative), must be reviewed, approved, and monitored by the KU
Cancer Center Protocol Review and Monitoring Committee (PRMC). In
addition to the submission of this form, please submit an application to the
PRMC. See the PRMC submission instructions posted at:
http://prmc.kumc.edu/submission.aspx.
Page 18 of 20
KUSM-W, VCH-W, WMREF, WSU Prospective Application
XVI.
Ver: November 2015
Certifications
Principal Investigator Certification
As Principal Investigator,
 I agree this application accurately reflects the proposed research plan.
 I confirm that I have adequate time, assistance, equipment, support services, and
finances to safely conduct this study.
 I accept responsibility for the scientific conduct of this study and for the rights and
welfare of human subjects.
 I accept responsibility to ensure that all study personnel are adequately trained
for their role.
 I agree to submit any amendments to the protocol or consent form to all
reviewing IRBs for approval prior to implementation.
 I agree to report any problems with the research, in accordance with university,
institution, and IRB policy, as well as regulatory and sponsor requirements.
 I agree to maintain all required research records, including consent forms, during
the study. I recognize the authority of the IRB to inspect those records.
 I agree to archive research records in accordance with the KUMC Records
Retention Policy and applicable hospital and IRB policies.
 I agree I will not commence research activities without final IRB approval (and full
executed contract, if applicable).
________________________________
Principal Investigator Signature
Page 19 of 20
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Date
KUSM-W, VCH-W, WMREF, WSU Prospective Application
Ver: November 2015
Administrative Certification
As Department Chair or Chair representative/Division Director/Dean/Executive
Administrator/Center Director, I approve the submission of this proposal. The principal
investigator is qualified, and adequate resources (in terms of time, assistance,
equipment, support services and finances) are available to safely conduct the research.
Method of Scientific Review (check all that apply)
The scientific review has already been accomplished:
The individuals/groups below have determined that the research uses procedures
consistent with sound research design, which do not unnecessarily expose subjects
to risk; the research is likely answer the proposed question; and the knowledge
reasonably expected to result from the research has scientific importance.
Department Chair/Director/Dean or a designee*
WMREF (Wichita Medical Research & Education Foundation) Scientific
Review Committee
KUMC Protocol Review & Monitoring Committee (PRMC) – cancer and
cancer related studies
NIH
Other external review process: Specify
*Include a copy of the department scientific review checklist and any
correspondence between the investigator and the scientific reviewer.
The Scientific Merit Review checklist is located here:
http://wichita.kumc.edu/research-compliance/forms.html
The proposal is being referred for scientific review by:
WMREF (Wichita Medical Research & Education Foundation) Scientific
Review Committee
PRMC (Protocol Review and Monitoring Committee) cancer and cancerrelated proposals
_______________________________________
Chair/ Director/Designee Signature
_______________________________________
Print Name
Page 20 of 20
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Date