Which Irbs Are Required to Review This Proposal?

KUSM-W, VCH-W, WMREF Prospective Application Ver: August 2013

Which IRBs are required to review this proposal?

KU School of Medicine-Wichita (KUSM-W) 316-293-2610

Via Christi Hospitals Wichita, Inc. (VCH-W) 316-268-5114

Wichita Medical Research & Education Foundation (WMREF) 316-686-7172

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.html / Required / Enclosed / NA
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-and-instructions.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
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
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/ / Enclosed / NA
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.

I. Study Information

Principal Investigator (PI):
KUSM-W Department:
Hospital Department(s):
Full Mailing Address of PI:
Email: / Phone:
Alternate Contact Person (e.g., Project Coordinator):
Full Mailing Address:
Email: / Phone:

Protocol Title:

Protocol Number, Version and/or Date:

II. Research Activity

Approximate time period for conducting the study: 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 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 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 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)]

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.

Name
(Please list MD, PhD, RN, DO, etc.) / Department / Status: Resident, KU Faculty, Hospital Staff, 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

a Conduct informed consent interview i. Review/sign laboratory reports

b. Complete physical examination j. Draw/collect laboratory specimens

c. Obtain medical/surgical history k. Perform tests, procedures, interventions, questionnaires

d. Complete source documents l. Dispense/collect study medication

e. Complete study data forms m. Complete drug accountability forms

f. Assess unanticipated problems n. Manage study database

g. Review concomitant medications o. Data analysis

h. Take vital signs, height, weight p. Report generation

q. Research laboratory personnel

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

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

KU Clinical Trial Unit (CTU)

Other Hospital or Inpatient Clinic specify

Classroom setting

KUSM-Wichita campus

Other universities/colleges specify

Elementary/secondary schools specify

International sites

Other specify

(b) In what states will the principal investigator conduct the study? (Check all that apply)

Kansas

Missouri

Other states specify

(c) Provide details below on all study locations, other than KUSM-W, Wesley Medical Center and Via Christi Hospitals Wichita, Inc., for which the principal investigator is responsible:

Name of the Facility / Primary Contact Name / The site has its own IRB / IRB approval status at the site
Yes No
Yes No
Yes No
Yes No

(d) 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.

V. 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

Federal Funds

Other: Specify

Note: The IRB requires submission of the grant application for federal, state or private funded grants.

(c) SEEKING FUNDING from (source)

VI. 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 [in-laws], 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?