Last Updated: April 2014

UnityPoint Health - Des Moines

Institutional Review Board

Request to IRB for Central IRB Oversight

Note: This form is locked and will accept inputs only in check boxes and areas indicated by , which will expand to accommodate text. When completed, the form should be saved with a unique file name.

I.ADMINISTRATIVE INFORMATION

a. / Study Title:
b. / Date of the Request:
c. / *Principal Investigator:
d. / Co-Investigators:
e. / *Other Study Personnel:
f. / *Contact Person:
g. / Email:
h. / Phone:
i. / Fax:

*List all other personnel directly involved in the study, one line per person

All personnel listed above have taken Human Subjects Protection training. YesNo

Training and documentation for all listed personnel must be completed and submitted to the IRB Office before Research is initiated.

II.CONFLICT OF INTEREST:

  1. Do any of the involved investigators, research personnel, or their immediate family have consulting arrangements, management responsibilities, or equity holdings (stock or stock options) in the Sponsoring company, vendor(s), provider(s) or goods, or subcontractor(s)? Yes No
  1. Do any investigators, research personnel, or their immediate family have any financial relationship with the Sponsoring company, including the receipt of honoraria, income, or stock/stock options as payment? Yes No
  1. Is any investigator(s) a member of an advisory board with the Sponsoring company? Yes No
  1. Do any investigators receive gift funds from the Sponsoring company?YesNo
  1. Do any investigators, research personnel, or their immediate family have an ownership or royalty interest in any intellectual property utilized by this protocol? Yes No
  1. Will the study sponsor compensate you or your practice for being an investigator?

Uncertain at this time (provide details when available)YesNo

If one or more of the above relationships exist, please include a statement in the consent form to disclose this relationship. The consent form should disclose what institutions or companies are involved in the study though funding, cooperative research, or by providing study drugs or equipment.

  1. If you are being compensated by the study sponsor, is the compensation consistent with the following statement from the AMA Code of Ethics?: “Any financial compensation received from the trial sponsors must be commensurate with the efforts of the physician performing the research. Financial compensation should be fair market value and the rate of compensation per patient should not vary according to the volume of subjects enrolled by the physician.”

YesNo

If no, please explain how your compensation was determined:

  1. Will the compensation be determined in any way by the outcome of the study?

YesNo

If Yes, please explain the financial arrangement:

  1. Has there been a change in circumstances since the investigator(s) or research personnel last submitted the most current Conflict of Interest Disclosure Form” to the IRB office?

Yes*No

*If yes, submit new COI document.

III.STUDY SUMMARY

a.Type of Study: Double-blind Pilot

Single-blind Other

Open-label

b.Phase of Study N/A (not a clinical trial) Phase 4

Phase 1 Unknown

Phase 2 Other

Phase 3

c.Study Includes Questionnaire/Survey Registry/database

Chart review Genetic Research

International Research

d.Purpose:

  1. In layperson’s language, state the purpose of the study in 3-5 sentences.
  1. State what the Investigator(s) hope to learn from the study. Include an assessment of the importance of this new knowledge.

e.Study Procedures:

  1. Describe all the procedures you plan to implement for screening and recruitment of potential subjects.
  1. Describe all procedures which the participant must undergo in the research project, includingstudy visits, drug treatments, randomization and the procedures that are part of the standard of care.
  1. Explain how the above research procedures are the least risky that can be performed consistent with sound research design.
  1. Will all alternative procedures or courses of treatment be discussed with the participant?

Yes No

  1. Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the conclusion of the study? Yes No N/A

f.Study Endpoint:

  1. What are the guidelines or end points by which you can evaluate the different treatments during the study? If one proves to be clearly more effective than another (or others) during the course of the study, will the study be terminated before the projected total participant population has been enrolled? When will the study end if no important differences are detected?

g.Proposed length:

h.Scientific Rationale:

  1. Describe past experimental and/or clinical findings leading to the formulation of the study.
  1. Describe any animal experimentation and findings leading to the formulation of the study.

IV.RESOURCES

  1. Number of qualified staff on this project:
  1. Describe the training you will provide to ensure that all persons assisting with the research are informed about the protocol and their research-related duties and functions.
  1. Please describe the facilities available for this research project and justify that they are adequate.
  1. Explain whether you will have sufficient time to conduct and complete the research. Include how much time is required.
  1. Explain and justify whether you will have access to a population that will allow recruitment of the required number of participants.
  1. Will this Research project require services from any of the following departments/service lines of UnityPoint Health – Des Moines?

Office of Clinical TrialsLaboratoriesPharmacy

RadiologyCardiothoracicOncology

Other (specify)

  1. Describe your communication plan with the departments that you will be utilizing.
  1. Location where study will be conducted:

IMMCILHMWHBCH/Blank Physicians Group John Stoddard IORA UP Clinic TIC MOHA

Other* (specify) ______

*For “other” locations:

Is the location aware that you will be conducting research? Yes No

Has another IRB approved the research at this site? Yes No

i.Is the PI listed above the lead investigator in this multi-site study or will he/she provide study wide services such as data collection? Yes No

If yes, please describe the procedures for management of study wide information such as: Unanticipated problems involving risks to participants or others, interim results, and protocol modifications:

V.POPULATIONS

Please indicate the vulnerable populations that you will potentially enroll.

children illicit drug use women

cognitively impaired physically disabled non English speaking

elderly pregnant women other

minorities prisoners

VI.DATA SAFETY AND MONITORING PLAN

a.Is there Data Safety Monitoring Board for this study?

Yes (include the charter for the Board in the documents submitted)

No (describe the formal plan to monitor the safety of participants)

b.What are the specific triggers or stopping rules that will dictate when some action is required?

VII.PRIVACY AND CONFIDENTIALITY

  1. Describe provisions to protect the privacy interest of participants (Definition: “Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others”):
  1. Describe provisions to maintain the confidentiality of data (Definition: “Methods used to ensure that information obtained by researchers about their subjects if not improperly divulged.”):

VIII.INFORMED CONSENT FORMS

Unless waived by the IRB, informed consent is necessary for all research involving human subjects and must be documented in some manner. The investigator may determine which method would best serve the interest of the subject population, but the IRB reserves the right to require alternative or more stringent means of securing consent.

Check all of the following that apply to this study:

Comprehensive written Informed Consent/Authorized Forms

Assent of Children

Informed Consent will be obtained from all participants and documented with a signed, written consent form.

Informed consent will be obtained from subjects, but no signed consent form will be used. This includes oral consent and implied consent.

Informed consent will not be obtained from all participants. This includes deception, withholding information, etc.

Waiver of one or more elements of informed consent.

Waiver of documentation of informed consent.

Will this study’s participant population require foreign language consent forms?

Yes No

IX.ACCOMPANYING DOCUMENTS (check all documents submitted)

Complete Protocol

Investigator Brochure (if one exists)

IND Documentation

Grant Application (if one exists)

Final Contract with Sponsor (if not available at time of submission, please submit a “Good Faith” version).

Informed Consent Documents

All recruitment materials, including advertisements intended to be seen or heard by potential participants.

For DHHS supported multi-center clinical trials:

Approved DHHS sample informed consent document (if one exists.)

Completed DHHS approved protocol (if one exists.)

Documentation of Human Subject’s Protection Training, if not already on file in the IRB office.

Updated “Financial Conflict of Interest in Research” form, if necessary.

X.AFFIRMATION OF PRINCIPAL INVESTIGATOR

As principal investigator of the study being submitted for review, I accept responsibility for:

  • Protecting the rights and welfare of human research participants and for complying with all applicable provisions of the Federal Wide Assurance between UnityPoint Health-Des Moines and the Federal Office of Human Research Protection.
  • Providing a copy of the IRB approved and signed informed consent document to each participant at the time of consent, unless the IRB has specifically waived this requirement or the study is determined by the IRB to be exempt.
  • Unless otherwise authorized by the IRB, obtaining and documenting informed consent in accord with applicable federal regulations at 45CFR46.111; 45CFR46.116; 45CFR46.117;21CFR50.20; 21CFR50.23: 21CFR50.25; 21CFR50.27; 21CFR56.111.
  • Promptly reporting proposed changes in previously approved research activities to the IRB. My proposed changes may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to my participants.
  • Reporting to the IRB any problems that require prompt reporting to the IRB within 7 calendar days of my first discovering it.
  • Reporting to the IRB about the progress of the proposed research.

Signature of principal InvestigatorDate

Page 1 of 6