GENESIS HEALTH SYSTEM
INSTITUTIONAL REVIEW BOARD & COMPREHENSIVE BIOMEDICAL RESEARCH PROGRAM
NEW RESEARCH APPLICATION
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
o A "clean copy" (without line numbers) of the informed consent for patients to sign if approved
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.
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+
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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.
Guidance from GHS-IRB
5.
List the purpose and objectives of the research as stated in the protocol.
Guidance from GHS-IRB

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?
Guidance from GHS-IRB
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?
Guidance from GHS-IRB
No
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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:
Guidance from GHS-IRB
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?"
Guidance from GHS-IRB
19. Who will be asked to participate in this research? List inclusion criteria.
Guidance from GHS-IRB
20. If the study participant was not part of this research protocol, what would be considered standard
therapy for the clinical condition under investigation?
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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.
Guidance from GHS-IRB
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.
23. List any potential participant benefits.
Guidance from GHS-IRB
24. What alternative choices to joining this research protocol do the participants have? Please check
all that apply.
Guidance from GHS-IRB
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?
Guidance from GHS-IRB
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?
Guidance from GHS-IRB
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.
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
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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.
Guidance from GHS-IRB
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:
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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 10 business days, any serious adverse and/or unanticipated events on study
participants and research team that may occur as a result of this study.
 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.
15. Discussing approved research studies with the investigator’s patients has no restrictions. Information of interest
to the IRB includes making contacts with persons not cared for by the research team (i.e., not their own
patients), reviewing medical records or electronic databases to identify patients. HIPAA issues must be
considered in “cold calls” to patients or searching databases for potential subjects. These may require a
“preparation to research” exception.
Items such as posters, brochures and media advertising used to identify study patients must be submitted to the
IRB for approval.
Handout material used to assist consented patients in the conduct of a research study does not need IRB
approval. This would include research calendars, reminder cards, etc. Anything that could be considered a gift –
pens, pillows, clock radios, etc. – must be listed as an “incentive” in question 25 of this application.
Return me to question 16.
17. Please provide a brief narrative that describes the research design. It does not have to include minute or minor
details. A schema or study calendar can be used to assist in describing the research, but are insufficient used
alone.
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If the schema cannot be pasted here or if it is large and makes this document difficult to read, please post on
IRBNet as a separate document. It is preferred that you post only the pages with the schema or calendar rather
than referring the reader to a page number of a larger document.
Example: This is a randomized, open trial comparing two different treatments for depression. Patients will be
randomized to either drug therapy with 40mg of Happiness or treated with Cognitive Behavior Therapy (CBT).
Patients will meet the diagnostic criteria of the DSM-IV for major depressive disorder. Patients will have a
baseline visit that will include a history and physical exam, an EKG, a mini-mental state examination, and
completion of the HAM-D depression rating scale. Patients will receive either 40mg of Happiness or a placebo
tablet. Those randomized to CBT will be scheduled for 6 one-hour long sessions with a licensed mental health
counselor. All patients will return to the office for monthly evaluations for 12 months. The dose of Happiness
can be increased at the discretion of the research physician. The posted schema outlines the schedule of
evaluations.
Return me to question 18.
18. This should be taken from the research protocol. Some lists can get very long and technical. Please edit for the
IRB audience. These items might be important: men/women, ages, stage of disease, severity of disease. These
items might not be important: allergic to test drug, must be able to come to follow-up visits.
Return me to question 19.
21. This is a tough question. What we don’t want here is a cut/paste list from the consent form. Information here
might be used as a cross-check that important risks are placed in the consent.
A copy/paste from the protocol may also be more than the IRB wants.
For our purpose, I would suggest you focus on the serious adverse events.
Risks can be physical, psychological, or emotional. The patient may assume risks because they will not receive
standard therapy. Risks also include loss of confidentiality.
Return me to question 22.
22. In most cases the participant may not expect any direct benefit. We know it is possible in a comparison trial of
new therapy that they may receive an inferior treatment. It is acceptable to mention altruistic rewards. Monetary
awards or gifts cannot be listed in the consent form as a benefit. These are to be listed as incentives in Q25.
Return me to question 23.
23. The consent form will have a section that tells the participant what options they have instead of participation in
this trial. Q23 is designed to provide the IRB an idea of what these options might be. Only one of the first 2
boxes should be true – either the research intervention is or is not available outside the research protocol.
Check either the 3rd or 4th box if you know them to be true.
Return me to question 24.
24. Incentives include items such as monetary payment, free medical services, free drugs, or gifts. Explain when and
how these items will be received by the participant. For example, if money is provided – will it be given as cash
from you or a check from the sponsor? Will it be given at each qualifying event (like an office visit) or all at
once at the end of the trial? Monetary awards should always be pro-rated. Payment should not require
completion of the trial.
Return me to question 25.
25. Confidentiality involves a number of issues. It is more than just HIPAA. Issues to consider:
 Will research records contain personal identifiers?
 If code numbers are used, are they derived from PHI, such as patient initial or medical record number?
 If you have a document that links coded research records to personal identities, where is this document
kept?
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


How will you limit access to paper documents? Keep them locked?
How will you limit access to computer records? Passwords?
Are research records kept with medical records –accessible to many?
Return me to question 26.
34. The following are instructions on how to display readability statistics using Microsoft Word
a. On the Tools menu, click Options, and then click the Spelling & Grammar tab.
b. Select the Check grammar with spelling check box.
c. Select the Show readability statistics check box, and then click OK.
d. Click the Spelling and Grammar icon in the Standard toolbar.
e. When Word finishes checking spelling and grammar, it displays information about the reading level of the
document.
Return me to question 35.
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