APPLICATION TO CONDUCT A
CLINICAL INVESTIGATION
Version May 2017
Use this form to submit a new clinical investigation for initial review by the AMITA HEALTH IRB.This application along with the required documents must be submitted to the IRB Office, via email and hardcopy. Please send electronic copies to Shivi Stanley, .
Section 1: Administrative Information
Protocol Title: / Click here to enter text. /
Protocol Number/Name: / Click here to enter text. /
Protocol Version/Date: / Click here to enter text. /
Principal Investigator: / Click here to enter text. /
Title/Affiliation: / Click here to enter text. /
Title: / Click here to enter text. /
Address: / Click here to enter text. /
Phone/ Fax/ Email: / Click here to enter text. /
Employer: / ☐ AMITA Health ☐ Other(please indicate group/practice): Click here to enter text.
Primary Contact/Regulatory Coordinator: / Click here to enter text. /
Address: / Click here to enter text. /
Phone/ Fax/ Email: / Click here to enter text. /
In which facilities will this study be conducted?
☐ / AMITA Health Adventist Medical Center, Bolingbrook
☐ / AMITA Health Adventist Medical Center, GlenOaks
☐ / AMITA Health Adventist Medical Center, Hinsdale
☐ / AMITA Health Adventist Cancer Institute, Hinsdale
☐ / AMITA Health Adventist Medical Center, La Grange
☐ / AMITA Health Alexian Brothers Behavioral Health Hospital, Hoffman Estates
☐ / AMITA Health Alexian Brothers Medical Center, Elk Grove Village
☐ / AMITA Health Alexian Brothers Women & Children's Hospital, Hoffman Estates
☐ / AMITA Health St. Alexius Medical Center, Hoffman Estates
☐ / AMITA Health Alexian Brothers Rehabilitation Hospital, Elk Grove Village, in partnership with Rehabilitation Institute of Chicago
☐ / Other:Click here to enter text.
Protocol Originator: / ☐Investigator
☐External Sponsor; specify: Click here to enter text.
☐Other: Click here to enter text.
Is study funded? / ☐No
☐Yes; specify funding source:Click here to enter text.
Section 2: Project Characteristics, Summary, and Design
Anticipated time frame: / Start Date (mm/dd/yyyy):Click here to enter text.
End Date (mm/dd/yyyy):Click here to enter text.
Characteristics:
☐Investigational drug / ☐Prospective / ☐Multi-arm
☐Behavioral intervention / ☐Investigational device / ☐Retrospective
☐Single blind / ☐Data collection only / ☐Investigational procedure
☐Crossover / ☐Double blind / ☐Placebo controlled
☐Randomized / ☐Other :Click here to enter text.
A research plan or protocol is required with this submission. The following questions must be answered in lay person language. Each question must be completely answered within the form, do not say “See Protocol” or “Protocol Attached”.
State the hypothesis or primary objective, and provide a brief background on participant population, treatment procedures and rationale for conducting study.
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Provide an outline of the experimental design addressing the following: time line of the study from initiation through data analysis, procedures including a time sequence of when those procedures that involve human subjects will be performed and how they will be monitored.
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Explain what participants will be asked to do solely for the purpose of the study.
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Explain how the study design and methods will answer the research question.
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Section 3: Drugs, Biologics, Dietary Supplements, and Food
Does the study involve the use of drugs? / ☐Yes. Complete Section 3 (this section).
☐No. Skip Section 3. Continue to Section 4.
Study Phase: ☐I ☐II ☐III ☐IV
☐Post-Market: describe any post-marketing requirements imposed on the use of this drug by the FDA: Click here to enter text.
List all investigational drugs and biologics.
Name:Click here to enter text. / IND#: Click here to enter text.
Who holds the IND? / ☐Investigator
☐Funding Source/ External Sponsor, specify: Click here to enter text.
☐Other: Click here to enter text.
Attach: / ☐FDA IND Letter
☐Investigator’s Brochure
☐IND application form (Form 1571)
Are subjects provided the opportunity to continue to receive the study drug(s) after the study has ended?
☐Yes. Describe the conditions under which continued access to study drugs may apply and conditions for termination of such access.Click here to enter text.
☐No
List all FDA- approved drugs and biologics, and food or dietary supplements specified in the protocol.
Name / Attach package insert
Click here to enter text. / ☐ /
Click here to enter text. / ☐ /
Click here to enter text. / ☐ /
For drugs only:
Provide the following information relating to the storage, inventory and dispensing of drugs used in this study:
Where will drugs be stored? / ☐AMITA Health pharmacy
☐Other: Click here to enter text.
Describe the storage area and how it meets the required storage conditions for the drug:Click here to enter text.
Describe the security measures in place for inventory control and monitoring of the drug inventory:Click here to enter text.
Describe how and by whom drugs will be dispensed.
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Describe how unused drugs will be handled.
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Describe any special precautions needed for the processing, storing, dispensing, preparation, handling, stability, administration, timing or destruction.
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Section 4: Medical Devices
Does the study involve the use of a marketed medical device? / ☐Yes. Complete Section 4 (this section).
☐No. Skip Section 4. Continue to Section 5.
Device Name: Click here to enter text. / Manufacturer: Click here to enter text.
Device Model: Click here to enter text. / Indications or Use: Click here to enter text.
Is this device approved or cleared for a different indication? / ☐Yes. If yes, provide FDA PMA, HDE or 510(k)# Click here to enter text.
☐No
Does the study involve evaluation of an investigational medical device or a new use for a marketed medical device in this project? / ☐No
☐Yes (Complete device information below)
Device Name: Click here to enter text. / Manufacturer: Click here to enter text.
Device Model: Click here to enter text. / Indications or Use: Click here to enter text.
IDE #: Click here to enter text. Held By (check one): ☐Sponsor ☐Investigator ☐N/A
- If IDE is held by the SPONSOR, provide a copy of the INVESTIGATOR’S BROCHURE and the SPONSOR’S PROTOCOL.
- If IDE is held by the INVESTIGATOR, provide a copy of the IDE APPLICATION submitted to the FDA.
- In addition, please complete AMITA Health IRB Device Risk Assessment
Section 5: Genetic Research
Does the study involve genetic testing? / ☐Yes. Complete Section 5 (this section).
☐No. Skip Section 5. Continue to Section 6.
Provide a separate consent form or additional explanation and signature on the study consent form.
Will the findings be disclosed to the participant?
☐Yes
What information will be provided?Click here to enter text.
Who will provide the information to the participant?Click here to enter text.
At what point in the study will the information be provided?Click here to enter text.
What is the reliability of the information provided?Click here to enter text.
Explain why the findings will be disclosed.Click here to enter text.
☐No
Will unexpected or unrelated findings be disclosed? ☐Yes ☐No
If findings will be published, explain how the participant’s confidentiality will be ensured.
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Will participants’ specimens be stored for future research?
☐Yes. Provide a separate consent form or additional explanation and signature on the study consent form.
☐No
Section 6: Participant Population
Indicate the participant population that may be recruited to this study:
☐Pregnant women or fetuses / ☐AMITA Health employees / ☐Inpatients
☐Viable neonates / ☐Student, residents, or fellows / ☐Outpatients
☐Decision impaired / ☐Economically or educationally disadvantaged / ☐Minority groups
☐Children/Adolescents / ☐Non-English speaking / ☐Other, describe Click here to enter text.
Describe how the nature of the research requires or justifies using the proposed subject population and what safeguards will be put in place to protect subjects.
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Number of participants to be enrolled at AMITA Health: / Click here to enter text. /
Number of participants to be enrolled nationally: / Click here to enter text. /
Estimated enrollment of participants per year: / Click here to enter text. /
Age range: / Click here to enter text. /
Gender: / Click here to enter text. /
Section 7: Recruitment
Indicate recruitment methods. Attach copies of any recruitment materials that will be used.
☐Flyers / ☐Newspaper / ☐Internet
☐Department outreach / ☐Letter / ☐Radio
☐Television / ☐Email / ☐Department newsletter
☐Posters / ☐Telephone / ☐Web-based clinical trial
☐Department website / ☐Other, describe Click here to enter text.
Describe how potential participants will be identified.
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Describe how potential participants will be contacted.
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Describe who will be contacting potential participants.
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Will any screening activity occur prior to obtaining the participant’s consent/authorization?
☐Yes
Describe screening procedures (for example, medical record review, email or telephone correspondence, collection of identifiers).Click here to enter text.
List all health information to be collected as part of screening. Identify the HIPAA identifiers to be collected and retained during the screening process.Click here to enter text.
☐No
Section 8: Reimbursement
Will gifts, payments, compensation, reimbursement, services without charge, or extra credit be provided to study participants?
☐Yes
Indicate the type of compensation and the maximum value a participant may receive during the course of the study.Click here to enter text.
When will compensation be provided? Include if payment for multiple visits is prorated and the compensation schedule.Click here to enter text.
Who will receive the compensation? ☐Participant ☐Other, specify:Click here to enter text.
☐No
Section 9: Consent Procedures
Waiver of Consent
The IRB may, in some rare and specific circumstances, waive the requirement for consent in accordance with 45 CFR 46.116(d).
Is a waiver of consent requested?
☐Yes / Address the criteria below to determine if wavier of consent may be considered.
The research involves no more than the minimal risk to subjects. / ☐Yes / ☐No
(waiver may not be granted)
Granting a waiver will not adversely affect the rights and welfare of the subject. / ☐Yes / ☐No
(waiver may not be granted)
The research cannot practically be carried out without a waiver or alteration. / ☐Yes / ☐No
(waiver may not be granted)
If consent is waived, whenever appropriate the participants are to be provided with additional pertinent information after participation.
Describe the process for providing subjects with this information.Click here to enter text.
☐No
Waiver of Documentation of Consent
Waiving written documentation of consent assumes there will be an informed consent process but signatures will not be collected on the consent form. The IRB may waive the requirement for written documentation under specific conditions.
A consent form without signature lines must be submitted with the IRB application.
Is a waiver of documentation of consent requested?
☐Yes / Address the criteria below to determine if wavier of documentation of consent may be considered.
The only record linking the subject and the research would be the consent form and the principal risk of the research would be the potential harm from a breach of confidentiality. The IRB may allow an option to sign or decline. / ☐Yes / ☐No
(waiver may not be granted)
The research presents no more than minimal risks and includes no procedures for which written consent is normally required outside the research context. / ☐Yes / ☐No
(waiver may not be granted)
☐No
Waiver of HIPAA Authorization
A Waiver of HIPAA Authorization must be obtained whenever patient data is to be consulted and/or collected for research purposes without prior consent from the patient. An IRB or Privacy Board can grant a Waiver of HIPAA Authorization to permit use and/or disclosure of PHI for research purposes, without obtaining authorization for research where it is impracticable for researchers to obtain written Authorization from research participants. For more information refer to the ABHS Use and Disclosure of Protected Health Information (PHI) for Research policy.
A waiver is not required if patient data is accessed a) for recruitment purposes only; and b) if the person consulting the patient record has access to this data as part of clinical duties.
Is a waiver of HIPAA Authorization requested?
☐Yes
☐For the entire study
☐For recruitment only
Submit an AMITA Health PHI Authorization Waiver Application Form with this application.
☐No
Consent Process
Describe how the privacy of participants and/or Legally Authorized Representatives (LARs) will be maintained throughout the consent process.
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Describe in detail the process for obtaining consent, including steps that will occur, the estimated length of the discussion, and how will it be ensured that participants and/or LARs have enough time to consider their decision regarding participation.
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Describe how on-going consent of the participants and/or LARs will be obtained throughout the conduct of the study.
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Explain provisions in place to ensure comprehension for research involving non-English speaking participants.
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Specify the documents that will be used during the consent and assent process. Copies of all documents should be appended to the protocol in the same format that they will be given to subjects.
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Section 10: Privacy and Confidentiality of Data
Confidentiality & Security of Data:
What protected health information (medical information along with the HIPAA identifiers) about subjects will be collected and used for the research?
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How will the research data be collected, recorded and stored? Distinguish between hard copy data and electronic data.
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Indicate plans for storage and security of hardcopy data, including human biological specimens, CDs, tapes etc.
☐Data de-identified by research team / ☐Locked suite or office
☐Data coded by research team with a master list secured and kept separately / ☐Locked cabinet
Other:Click here to enter text.
Indicate plans for storage of digital data.
☐CD / ☐DVD / ☐Flash Drive / ☐Portable Hard Drive
☐Secured Server / ☐Laptop / ☐Desktop / ☐Other:Click here to enter text.
Do alldevices contain encryption software? ☐Yes ☐No
What procedures will be used to safeguard the confidentiality and security of the identifiable study data and the storage media indicated above during and after the participant’s participation in the study? Include the use of study identifiers or coding.
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Are there plans to destroy the identifiable data?
☐Yes. Describe how, by whom and when identifiers will be destroyed.Click here to enter text.
☐No.Describe how the data and/or identifiers will be secured.Click here to enter text.
What will be done with the data when the research is completed?
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Indicate how long the data be maintained.
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Who will have access to the protected health information(sponsor, investigator, the research staff, all research monitors, FDA, etc)? Distinguish between PHI and de-identified data.
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Did the researcher request a Certificate of Confidentiality? Yes or No
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Section 11: Risks, Benefits, and Alternatives
Describe the potential risks of study participation.
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What benefit, if any, may be gained by the participant and society? Explain how the risks to participants are reasonable in relation to the anticipated benefits to participants and others.
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What alternatives are available to the participants?
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Section 12: Data Safety Monitoring Board
Indicate the entity responsible for safety monitoring of the study and after the type(s) of safety monitoring in place for this study.
☐Internal to AMITA Health; provide name and contact information for Safety Monitor: Click here to enter text.
☐Sponsor
☐Other, describe:Click here to enter text.
Indicate the type(s) of safety monitoring in place for this study.
☐Data Safety Plan / ☐Data Safety Board
☐Independent Monitor / ☐Other, describe:Click here to enter text.
For multi-center trials and trials with external monitoring, the following are required:
☐Monitoring plan
☐DSMB charter (includes membership, frequency of meeting etc.)
☐Summaries of DSMB meetings or findings that have already occurred
Describe plans for communicating significant findings to participants, in particular those findings that may impact participants’ willingness to continue to participate or that relate to the safety or medical care of participants.
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Section 13: Investigator Acknowledgement
The Principal Investigator will:
1.Acknowledge and accept responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Institution’s IRB.
2.Be responsible for the compliance of all co-investigators, student investigators and research associates with the IRB decisions, conditions, and requirements.
3.Complete periodic training in the protection of human subjects, as required by Federal regulations and IRB policy.
4.Be responsible for obtaining consent and for providing a copy of the IRB-approved and signed consent document to each participant at the time of consent.
5.Be responsible for ensuring that only authorized research staff will conduct the consent process.
6.Promptly report changes in previously approved human subject population or research activities to the IRB. Changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants.
7.Be responsible for reporting progress of approved research to the IRB, as often as and in the manner prescribed by the IRB, on the basis of risks to participants, but not less than once per year.
8.Be responsible for notifying the IRB of any changes in financial relationships of any investigators that may result in a conflict of interest that was previously undisclosed.