I. Study Information

Principal Investigator:
Protocol Title:

II. Exempt Classification

Indicate, by checking the appropriate space(s), the category or categories which may apply to your research.

If your research is not within one of the following six (6) categories, stop here and instead complete (as appropriate) an application either for Expedited or Full Committee review.

1) 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.

2) 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.

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.

3) 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.

4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. PLEASE NOTE: To qualify for this exemption the data, documents, records, or specimens must be in existence before the project begins.

5) 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; 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.

6) 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.

III. Retrospective Chart Reviews

N/A, not a retrospective chart review study

(a) Does the research involve only the study of data, documents, records, pathological specimens or diagnostic specimens that are already in existence as of today’s date?

Yes

No If no, stop here. Your study is not retrospective. Submit an Expedited Project Description. Indicate Category 5, which applies prospective data/specimen research.

(b) For what purpose were the data, records, specimens, etc. originally created?

Beginning Date End Date (must be before IRB submission date)

(d) Who holds the records/specimens you wish to access, e.g., clinic, hospital, collaborator, etc.?

(e) Do you intend to submit the results of your study to the FDA for any reason?

Yes

(f) How many subjects do you plan to study?

(g) How many charts or records do you need to review in order to find appropriate subjects?

(h) Which individual identifiers or demographics will be recorded on your data collection tool?

Names / Ages over 89 years / Street address, city, county, precinct or zip code
Initials / Identifying # or code #* / Health plan # or other account #
Phone / Other unique descriptor / Vehicle identifier, serial #, license plate, etc.
Fax / Facial photos/images / Biometric identifiers (finger/voice/retina)
E-mail / Social Security Number / Device identifiers or serial numbers
URL / Certificate/License #s / Date of birth, date of death, admit/discharge date
IP address / Medical Record #s / Other date related to the person (except year only)
None of the identifiers listed above will be included with the materials used for the study

(i) *If you are keeping a linking list, provide an explanation that shows why the research meets the following four waiver criteria.

The research involves no more than minimal risk to subjects.
The waiver will not adversely affect the rights and welfare of the subjects.
The research could not practicably be carried out without the waiver.
Whenever appropriate the subjects will be provided with additional pertinent information after participation.

Questions related to HIPAA Regulations – For studies that involve health information

If your study involves the use of medical information for research without seeking written permission from the patient, provide an explanation that shows why the research meets the following waiver criteria.

Explain why the research could not practicably be conducted without access to and use of the protected health information
Describe the plan to protect identifiers from improper use and disclosure.
Describe the plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research (how and when 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:
Describe the plan to ensure that identifiable health information will not be reused or disclosed to other persons or entities.
Explain why the research could not be practicably carried out without a waiver of privacy authorization (i.e., why it is not practicable to obtain written authorization from the patient).

IV. Subject Selection

Check all that apply to the target population for this study:

Healthy volunteers Adults 65 years and older

Patients Comatose/traumatized

Children/Minors (under 7 years of age) Terminally ill

Children/Minors ( 7 - 17 years of age) Prisoners

Pregnant women Persons w/ active psychiatric disease

Cognitively impaired KUMC Employees

Males only KUMC Students/Residents/Fellows

Females only

V. Permission from Participants

How do you plan to inform potential participants about the study and obtain their agreement to participate? (Check all that apply)

Letter to participants

Permission by phone

Fact sheet

Introductory information at the beginning of a survey

Other: Specify

VI. Data Security

(a) Where will electronic study data be housed? (Check all that apply)

Web server hosted by sponsor, collaborator or data coordinating center

KUMC CRIS system

KUMC REDCap server

University-supported network drive (e.g., S: drive, J: drive)

University-owned laptop, tablet or iPAD

Other servers, devices or drives: specify

(b) Will KUSM-W study personnel electronically transmit identifiable data to a non-KUSM-W recipient?

Yes

If yes, describe the type of data and the plans for secure transmission:

VII. Conflict of Interest for All Study Team Members

Prior to IRB approval, an annual COI disclosure form must be on file for all study personnel. The following questions relate to the study described in this application.

NOTE: Principal Investigators are responsible for addressing these questions on behalf of the entire study team.

(a) 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?

(b) Yes No Do any investigators, study personnel, or their immediate family listed on this application have consulting agreements, management

responsibilities, ownership interests, equity holdings or options (regardless of value) in the sponsoring company, the providers of the products or services being evaluated, vendors, provider(s) of goods, or subcontractors?

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?

(d) Yes No Do any investigators or their immediate family receive gift funds, educational grants, subsidies or other remuneration from the

sponsoring company?

(e) Yes No Do any investigators or their immediate family have an ownership or royalty interest in any intellectual property utilized in this protocol?

(f) Yes No Does KUMC or the KUMC Research Institute have an ownership

or royalty interest in any intellectual property utilized in this

protocol?

(g) Yes No For drug/device studies only: is the sponsor of the study a

different party than the manufacturer of the drug or device?

(h) If you answered “Yes” to any of the above, please describe in detail. Affirmative answers will be

used for conflict of interest evaluation.

Thank you for your submission.

If you have any questions, please contact the KUSM-W Office of Research Compliance at

(316) 293-2610.

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Revised 01/15/2014