I. Study Information

Principal Investigator:
Protocol Title:

II. Subject Selection and Recruitment

(a) Maximum Number of Persons to be Enrolled by the KUSM-W PI

Age range:

(b) 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 / Homeless
Fetuses/Neonates / Persons w/ active psychiatric disease
Cognitively impaired / KUSM-W Employees
Males only / KUSM-W Students/Residents/Fellows
Females only

(c) If vulnerable populations (such as children, pregnant women, cognitively impaired, etc.) are targeted for the study, discuss the special protections being implemented to minimize risk of coercion or undue influence. [Special protections may include parental permission and assent (for children); fulfillment of special conditions for research with pregnant women and fetuses (for pregnant women); assessment of cognitive status, use of surrogate decision-makers and assent (for cognitively impaired persons).

(d) How are the inclusion/exclusion criteria designed to minimize risks of the study?

(Do not list I/E criteria; instead, describe how they will help ensure safety)

For Investigator-Initiated Studies only:

(e) What prior studies or other preliminary evidence provide justification for conducting the

proposed study?

(f) Explain how the sample size is sufficient to achieve study aims.

For Community-Based Participatory Research only, if applicable to your specific aims and/or funding requirements. (Note: If these questions are answered in your protocol, this section is not required.)

(a) Participants and the nature of their involvement: Clearly describe the community of interest, including experiences/concerns with the topic and how they are involved in the research. Discuss whether involvement includes commitments and/or partnerships with advocacy organizations, social service organizations, community providers/clinicians/clinics, local public health departments/staff, etc.

(b) Cultural issues: How might cultural or community attitudes affect the research? How are recruitment and consenting methods being adapted to address community needs (such as language, literacy, cultural perspective)?

(c) Origin of the research question: Did the impetus for the research come from the defined community, from the researchers, or from both? How is the effort to study this issue supported by members of the community?

(d) Risks and Benefits: Describe any risks and benefits to the community as a whole. What protections have been put in place to minimize risks (such as potential for stigma or other reputational harms)?

(e) Study Description and Process: Discuss the community’s role in planning, conducting, and/or disseminating results of the research. If community participants are involved in recruitment and/or data collection, what education/training has been/will be provided?

(f) Return of results: How will research outcomes be shared with the community? Is there an explicit agreement between researchers and community participants about the research results? If so, please describe.

(g) Sustainability: What is the plan to build and sustain the research partnership?

III. Locations of the Study

(a) If this is a multi-site study, will the KUSM-W principal investigator oversee or coordinate the research being conducted at non-KUSM-W sites?

Yes (Complete item (c) below)

N/A – study only involves KUSM-W

(b) Specify all study locations under the KUSM-W principal investigator’s responsibility:

KU Wichita Clinical Trial Unit (CTU)

KU-MPA Clinic, specify:

KU Wichita Adult Medicine

KU Wichita Center for Breast Cancer Survivorship

KU Wichita Center for Internal Medicine

KU Wichita Endocrinology

KU Wichita Gastroenterology

KU Wichita Internal Medicine Midtown

KU Wichita General Pediatrics

KU Wichita Subspecialty Pediatrics

KU Wichita Psychiatry & Behavioral Sciences

Outside hospital, specify:

KUSM-W classroom setting

Other, specify:

(c) If the KUSM-W principal investigator is responsible for study conduct at non-KUSM-W study locations, the IRB must ensure adequate plans for overall management of the study. Describe the investigator’s oversight plans below:

Which study activities will non-KUSM-W personnel be performing?
How will you ensure protocol compliance at the non-KUSM-W sites?
How will you obtain informed consent at the non-KUSM-W sites?
Who is responsible for communicating with the non-KUSM-W IRBs about changes to the protocol, adverse events, unanticipated problems, etc. (if applicable)?

IV. Consent Process

(a) How will subjects be informed about the possibility of research participation?

(b) Where will the consent interview occur?

(c) How will you be sure there is sufficient opportunity for the subject to consider whether or not to join the study? (Check all that apply)

Subjects will be allowed to take home the unsigned consent for consideration before

reviewing it with study personnel during the in-person consent discussion.

Subjects will be allowed a waiting period of at least hours to consider their

decision.

Other: specify

(d) Do you anticipate enrolling subjects whose primary language is not English?

Yes

If yes, how will you obtain informed consent in the language of those participants?

If yes, who will be present during study visits to translate instructions, assess adverse events, etc?

FOR ADULT STUDIES ONLY:

(e) Will all adult subjects be able to consent for themselves?

(a) Yes

(b) No. It is expected that all subjects will need a

surrogate decision-maker

If (c), how will study personnel assess the capacity of the subject to consent and to comprehend the consent?

If (c), how will you verify that the surrogate decision-maker is a valid legally-authorized representative under state law?

If (b) or (c), do you plan to obtain written assent from the subjects?

FOR PEDIATRIC STUDIES ONLY:

(f) What are your plans for child assent?

Subjects’ assent will be required for enrollment.

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.

(g) At what age will you obtain assent?

Not applicable

7 - 17

12 - 17

Other: Specify

(h) How do you propose to document assent?

Not applicable

By obtaining the child’s/adolescent’s signature on an assent form

By documenting verbal assent in the research or clinical record

Other: Specify

(i) Will any of the study subjects be foster children or wards of the State or other agency?

Yes Contact the IRB Office for guidance if subjects will be foster children or wards and the research offers no prospect of direct benefit to the child. Additional state requirements may apply.

V. Funded Studies Only

(a) Will you be providing payment to subjects?

Yes Total amount:

*Payments must be described in the consent form

(b) When will payments be disbursed?

Yes

Don’t know

(d) Does the consent regarding payment for injury match the contract signed with the funding organization?

Yes

Don’t know

VI. 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: specify

(b) By whom will initial contact with potential subjects take place?

(d) What measures will you take to protect the privacy interests of subjects during the conduct of the study?

VII. Data Security

(a) Which of the PHI elements listed below will be recorded for research purposes?

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 in the records used for research

(b) Will the study team access patient medical records to enter or collect study data?

Yes

Who holds the records you wish to access:

The University of Kansas Health system

Outside clinic/collaborator, etc. Specify: ______

In paper format; specify the location where paper will be stored:

Records will be kept in a secure location and only accessible to personnel approved

on the study.

Other (specify): ______

In Electronic format - Where will electronic study data be housed? Check all that apply. Note: Storage of individually identifiable information on study participants is acceptable in the locations highlighted in bold below. Storage of individually identifiable study participant information elsewhere may be prohibited unless the data is encrypted. If you have questions, please contact KUSM-W Information Technology.

Not applicable, e.g., all study data will be stored on paper

Server hosted by a research sponsor or data coordinating center, with which

KUMC has an approved sponsored research agreement.

Vendor provided devices (check all that apply):

Electronic diary

Wearable devices

Tablets

Other (specify):

KUMC CRIS System

KUMC REDCap server

KUMC department network drive provided by Information Technology (e.g., J:

drive) [Note: files on these network drives are not encrypted by

default. Encrypted file locations must be requested by contacting KUSM-W IT]

KUMC owned desk top computer

KUMC owned laptop, tablet, iPad

KUMC SharePoint server

Network attached storage devices (i.e. storage that is not directly attached to a device

and is available over the network)

Cloud storage (note: Dropbox or similar cloud storage locations are not permitted if

they have not been reviewed and authorized by KUSM-W Information Technology for compliance with specific security requirements. Please contact KUSM-W Information Technology for additional information.)

External hard drive

CDs/DVDs

Jump/Flash drives

Other servers, devices or drives

Specify:

KU Lawrence server

Specify:

Date of approval by KU-Lawrence Information Security staff:

Personally owned laptop(s) or device(s)

(d) Does the study involve research participants inputting data on a mobile device (i.e. electronic diaries, iPads, tablets, etc.)? Note - If you are using a mobile app, either loaded onto a researcher-provided device or the participant’s device/phone, then fill out the “Use of Mobile Applications Supplement” posted on the IRB forms page.

Yes

a) Who does the mobile device belong too:

Personal device

Researcher provided device (i.e. purchased with grant funds, endowment, etc.)

b) Please describe the plan for return or secure disposal of the devices at the end of the study

c) Please describe the plan for secure removal of study data from the device

(e) After the study is over, does the study team plan on maintaining individually identifiable participant data in a database or department spreadsheet (i.e. screening logs, future contact/research recruitment, etc.)?

Yes

a) Who will have access to the database/spreadsheet?

b) Specify where the information will be stored:

Same location as identified in question #3

Other (specify):

(f) Please describe all software programs utilized to collect, process, transmit, and store data for this study:

Sponsor hosted software

REDCap

CRIS

Excel

Access

Other (specify):

Software Name / Software purpose / Person/Group responsible for Management

VIII. Study Procedures

Indicate whether this research project includes any of the following procedures.

(a) Yes No Use of Radiation or a Radioisotope?

If yes, upload review by the hospital or clinic’s licensed radiation personnel.

(b) Yes No Testing for reportable diseases (HIV, Hepatitis, TB, etc.)?

(d) Yes No Blood Draw(s) / Tissue Collection for use in this project?

(e) Yes No Genetic Testing?

(f) Yes No Storage of Blood/Tissue for purposes not related to this project?

(g) Yes No Investigational surgical procedures?

(h) Yes No Inpatient stay?

(i) Yes No Audio taping or videotaping? (Please be aware of storage requirements

per the KUMC Record Retention Policy)

For Clinical Studies only:

(j) What is standard care for the patient population being studied?

(k) Why is the current standard of care not sufficient to meet treatment goals?

(Alternatively: Why is the research needed? What is the knowledge gap?)

(l) Will subjects be withdrawn from standard care for the purpose of the study? If so, provide

rationale:

(m) How will subjects be cared for after the study is over?

IX. Benefit/Risk Information

(a) What are the primary risks specific to the research? (Consider physical, psychological, economic and social/legal risks)

(b) How will these risks be minimized? (For example, how will subject selection, safety monitoring, dose adjustments, etc. help ensure subject safety?)

purposes? If yes, specify.

(d) How are the risks to subjects reasonable in relation to the potential benefits?

Discuss both benefits that may accrue to the individual and those that may accrue to society.

X. Safety Monitoring

Describe below the plan to monitor the data collected to ensure the safety of subjects. This may include monitoring by the principal investigator, members of the study team, consultants, supervisors, an independent data monitoring committee (IDMC), a data and safety monitoring board (DSMB), or other central monitoring entity.

(a) What type of safety monitoring is being proposed for this project?

Data and Safety Monitoring Board

Data Monitoring Committee

Other central monitoring entity; Specify

Medical Monitor designated by the sponsor (for multi-center trials)

Medical Monitor designated at the local level

Name:

Affiliation:

KUSM-W study team members only

(b) Describe the types of data and assessments that will be reviewed to evaluate the nature and frequency of adverse events.

(d) Will there be an interim analysis for safety and/or futility?