GENESIS HEALTH SYSTEM
INSTITUTIONAL REVIEW BOARD & COMPREHENSIVE BIOMEDICAL RESEARCH PROGRAM
NEW RESEARCH APPLICATION
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Instructions:
· Please use this locked form when preparing your New Research Application. Answer each question as indicated below.
· This document will be provided to all IRB members. Please use language that can be understood by both scientific and non-scientific members.
· Please limit additional documents to those requested or suggested.
· Please answer questions completely while attempting to limit the length of this summary.
· If a question does not apply to the research protocol, please indicate "not applicable." Do not leave a question blank.
· If not previously on file, please post on IRBNet the Certificate of Completion for the NIH course "Human Participants Protection Education for Research Teams" or its equivalent. This certificate is required for all principal investigators and research team members involved in recruitment or informed consent. The same training is recommended for all research team members. The NIH training module can be found at the following address http://phrp.nihtraining.com/users/login.php. Full information about this requirement can be obtained from the Office of Research & Grants Administration (RGA).
· Please review your final application for "neatness." Are sections that are cut and pasted readable?
· If you have questions about how to answer any particular question, please use the "Guidance" section at the end of the document. If questions remain, please call the Genesis Research and Grants Office (RGA) at (563) 421-7955.
· Your final "New Research Application" submission package should include the following:
o This application form
o A lined numbered copy of the consent document for IRB review (Word document, 1.2 inch bottom margin, footer right justified)
o A "clean copy" (without line numbers) of the informed consent for patients to sign if approved (PDF document, 1.2 inch bottom margin, footer right justified)
o The complete research protocol
o The Investigator Brochure, if applicable
o Recruitment material, if applicable
o A completed Waiver of HIPAA Authorization Form, if applicable, available in the document library within IRBNet
o A completed Waiver of Informed Consent Form, if applicable, available in the document library within IRBNet
Please delete this instruction section from your submission copy.
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Research Study and Principal Investigator General Information
1. Complete Protocol Title:
2. List all Investigators with the Principal Investigator first.
+ Educ: A checkmark here indicates this investigator has completed a certification course on human subjects protection and verification has been filed with IRB. If not, contact the IRB for certification information. The NIH training module can be found at the following address http://phrp.nihtraining.com/users/login.php.
Name / Telephone / Email / Educ+3. List all research coordinators for whom consenting authority is being requested.
+ Educ: A checkmark here indicates this coordinator has completed a certification course on human subjects protection and verification has been filed with IRB. If not, contact the IRB for certification information. The NIH training module can be found at the following address http://phrp.nihtraining.com/users/login.php.
Name / Telephone / Email / Educ+4. Rationale: In no more than a few sentences describe the background that has led to this research project.
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Guidance from GHS-IRB
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5. List the purpose and objectives of the research as stated in the protocol.
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Guidance from GHS-IRB
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·
6. List all locations where research will be conducted for which GHS-IRB approval is sought.
·
7. Does this research protocol have a Data and Safety Monitoring Committee?
Yes, a formal DSMC or DSMB has been established.
No. If no, what provisions will be taken for monitoring the data to ensure the safety of subjects?
8. Anticipated beginning and ending of the protocol (month/year)
Proposed Start:
Anticipated Completion:
9. Has your study application been denied by another IRB or are you aware of other IRBs that have denied this study?
Yes, Explain:
No
IRB Specific Information
10. Are you requesting a waiver of informed consent?
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Guidance from GHS-IRB
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No
Yes. Please complete and post the IRB Waiver of Informed Consent form. The form is available within the "Document Library" of IRBNet.
11. Are you requesting a waiver of HIPAA authorization?
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Guidance from GHS-IRB
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No
Yes. Please complete and post the IRB Waiver of HIPAA Authorization form. The form is available within the "Document Library" of IRBNet.
12. How many participants are you anticipating in this research project?
Participants to be enrolled locally:
Total (if multicenter research):
13. Categories of participants to be included in the research protocol. Check all that apply.
Normal healthy volunteers
Patients
Other, please list below:
o
14. Will your study include any of the following study populations?
Pregnant Women
Prisoners
Minors
Non-English Speaking
The study will not include any of the above named populations
The study is a retrospective chart review
15. What are your procedures if you encounter an educationally disadvantaged person who in your judgment cannot comprehend the informed consent process?
16. Please describe the following aspects of the recruitment process:
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Guidance from GHS-IRB
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a) How will potential subjects be identified?
b) How will identified subjects be contacted regarding interest in participation?
c) Using IRBNet, please post any recruiting materials (news releases, advertisements, flyers, website content, letters, etc.). Each must be approved by the IRB before distribution. List below, the name of each recruitment document of which you are seeking approval.
17. Describe the following aspects of the consenting process:
a) Where will consenting occur?
b) How much time will the potential subject have to consider participation?
18. Describe the research methods and procedures, including study design and sequence of study procedures. This should answer the question for the participant, “What will be done during the research protocol?"
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Guidance from GHS-IRB
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19. Who will be asked to participate in this research? List inclusion criteria.
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Guidance from GHS-IRB
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20. If the study participant was not part of this research protocol, what would be considered standard therapy for the clinical condition under investigation?
21. Please identify what is considered investigational in this research protocol.
22. The IRB must consider the risk of any research study in comparison with potential benefit.
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Guidance from GHS-IRB
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a) Please provide an overall perspective on the risks of this study compared to standard or alternative therapy.
b) List reasonably forseeable risks of the research. Emphasize those risks that would weigh most significantly in the potential subjects' consideration to participate, including physical and psychological risks. Identify the serious risks of the interventions and side effects of medications in this section. Do not include a list of all potential risks that are listed in the consent form.
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23. List any potential participant benefits.
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Guidance from GHS-IRB
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24. What alternative choices to joining this research protocol do the participants have? Please check all that apply.
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Guidance from GHS-IRB
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Research intervention(s) is not available outside this protocol.
This exact research intervention(s) is available without participation in this trial.
Similar or alternative non-research interventions that would be considered standard therapy are available without participation in this trial.
Known alternative research protocol available.
Other (please explain):
25. Will incentives be offered to the participants for volunteering for this protocol?
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Guidance from GHS-IRB
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No incentives will be offered in this trial.
Incentives will be offered during this trial. Please provide information below on what, when and how incentives will be offered.
26. What measures will you take to ensure participant confidentiality?
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Guidance from GHS-IRB
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27. Please list the items in the protocol for which the sponsor will assume financial responsibility. It will be assumed that anything not on this list will be the study participant’s responsibility to pay.
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28. Are participants required to discontinue or modify any current medications or treatments for any condition in order to be eligible?
No
Yes. Please explain.
29. Does the research protocol include tissue or blood submissions for specific research uses related to this protocol?
No tissue or blood for study-related research
Yes. Can participants be in this trial without participating in the tissue or blood submissions?
Yes
No
30. Does this research protocol include banking blood or tissue for future research not yet specified?
Yes
No
31. Does this Clinical Research Study involve radiation therapy?
Yes
No
32. Does your research protocol include a medical device?
No.
Yes If yes, please indicate the exemption allowing use of the device
Humanitarian Device Exemption (HDE)
Investigational Device Exemption (IDE) - Please provide the following information
1. Device Name:
2. The holder of the IDE:
3. The IDE #:
No exemption required for use of the device
Explain:
33. If this is an IDE, has this device received final approval from the FDA?
Yes
No
34. Will your Research Study involve Off-Label Use of a Test Article? If so, please explain:
35. Post a copy of the Informed Consent for Participants document. Please refer to the Sample Informed Consent to ensure all components are present. A separate consent is required for any optional aspects of a trial such as blood and tissue banking for future research.
Please indicate below the readability score for your informed consent document (Can be determined using the spell/grammar function under tools in Microsoft Word). It is strongly recommended that the readability be at the 9th grade level or less.
NOTE: Consents with higher reading levels or other readability issues may be returned for modification before IRB review.
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Guidance from GHS-IRB
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Flesch Kincaid grade level:
CBRP Specific Information
36. Budget Development and Cost Analysis
The Principal Investigator must submit a Master List of Services to the RGA for the Research Study. The Principal Investigator can obtain a blank Master List of Services from the RGA.
37. Funding Source
Check the appropriate box and fill in contact information (contact name, address, and phone number) for every funding source.
Grant:
Sponsor Grant:
Sponsor Compensation:
Subsidy:
Residual Balance Funding:
To receive Residual Balance Funding, a Principal Investigator must complete a Residual Balance Disbursement Request Form (see CBRP Appendix No. [IX.C.30], Forms, Residual Balance Disbursement Request Form).
None
Other:
38. Legal Considerations
Please forward to the RGA all research agreements or other contracts with third-parties or grant documents relating to the research study.
39. Conflicts of Interest
All Genesis Health System Members involved in conducting the research study must complete the Conflicts of Interest Disclosure Form. You can obtain the[Conflicts of Interest Disclosure Form from the RGA during normal business hours or from Genesis Health System’s website, at http://www.genesishealth.com/research. Detailed instructions are on the Conflicts of Interest Disclosure Form.
Principal Investigator Assurance Statement
My electronic signature that will accompany the submission of this application and all supporting documents to the Genesis Health System Institutional Review Board certifies that the research described in this application and all supporting materials will be conducted in full compliance with the Genesis Health System Institutional Review Board Guidelines and Federal regulations governing human subject research. Furthermore, I will:
· accept responsibility for the scientific and ethical conduct of this research study and for the conduct of my research team.
· obtain prior approval from the IRB before amending or altering the research protocol or implementing changes in the approved informed consent form.
· report to the IRB, within one (1) week, any Unanticipated Problems Involving Risks to Subjects or Others that meet the definition of a Serious Adverse Event.
· report to the IRB, within two (2) weeks, any Unanticipated Problems Involving Risks to Subjects or Others (those that don’t meet the definition of a Serious Adverse Event).
· complete Continuing Review documentation annually, unless requested more frequently by the IRB.
· use only Genesis Health System Institutional Review Board approved, stamped consent forms for studies in which consent forms have been approved for the research activity.
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GENESIS HEALTH SYSTEM
INSTITUTIONAL REVIEW BOARD & COMPREHENSIVE BIOMEDICAL RESEARCH PROGRAM
GUIDANCE ON PREPARING A NEW RESEARCH APPLICATION
4. This section is asking for a brief history of previous work that has led to the study question being investigated in this study. We do not want the “purpose” of the study here. We want what justifies the purpose of the study.
Examples:
Drug X has been shown to reduce the progression of kidney disease in diabetic patients. Preliminary studies indicate that Drug X may also help in non-diabetic patients with kidney disease. This hypothesis will be tested in this large trial.
or
Device Y is currently commercially available. Device Z has all of the features of Device Y but it also can tell time and call ahead for reservations at the Olive Garden. It is not yet determined if patients desire these features in their pacemakers.
Return me to question 4.
5. This section should include the purpose and objectives of the study, as stated in the protocol (not the informed consent). This should be brief.
Return me to question 5.
9. If you answer YES to this question, please complete the Waiver of Informed Consent Request Form available within the "Document Library" in IRBNet. Please consult the appropriate FDA documents that outline the criteria for waiver of informed consent available at http://www.genesishealth.com/research
Return me to question 10.
10. If you answer YES to this question, please complete the Waiver of HIPAA Authorization Request Form available within the "Document Library" in IRBNet. Please consult the appropriate HIPAA documents that outline the criteria for waiver of informed consent available at http://www.genesishealth.com/research
Return me to question 11.