Electronic Submission, Review, and Management of ... · Electronic Submission, Review, and Management of Institutional Review Board (IRB) Protocols Request for Information 2-2279

Electronic Submission, Review, and Management of Institutional Review

Board (IRB) Protocols

University of Connecticut Health Center

Request for Information 2-2279

Electronic Submission, Review, and Management of Institutional Review Board (IRB) Protocols Request for Information 2-2279

The University of Connecticut Health Center Page 2

I. Overview of the University of Connecticut Health Center

A. Introduction

UCHC is a vibrant organization that includes the School of Medicine, the School of Dental Medicine, John Dempsey Hospital, the UConn Medical Group, UConn Health Partners, and University Dentists. Founded in 1961, UCHC’s mission is to provide outstanding health care education in an environment of exemplary patient care, research, and public service. UCHC's 206-acre campus is situated around a wooded hilltop in the beautiful, historic community of Farmington, Connecticut. From this vantage point, one can see the skyline of Hartford, the capital of Connecticut, eight miles to the east. The University of Connecticut's main campus is in Storrs, about thirty miles east of Hartford. With about 5,000 employees, UCHC is Connecticut's sixteenth largest employer and an important contributor to the local and regional economy.

B. Health Services

Through John Dempsey Hospital (204 general acute-care beds and 20 nursery beds), UCHC provides specialized and routine inpatient and outpatient services. John Dempsey Hospital has long been regarded as the premier facility in the region for neonatal intensive care and high-risk maternity. It is also widely recognized for its comprehensive cardiovascular, cancer, and musculoskeletal services. In addition, John Dempsey Hospital is home to the only Emergency Department in Connecticut's fast-growing Farmington Valley.

UCHC also offers a wide range of ambulatory and primary care services on the Farmington campus and in physician offices conveniently located in West Hartford, Simsbury, and East Hartford. The UConn Medical Group is the largest medical practice in Greater Hartford, offering patients access to health care services from more than 350 UCHC physicians in more than fifty specialties.

In October 2007, John Dempsey Hospital was honored with a 2007 Premier|CareScience Select Practice National Quality Award for superior patient outcomes in both quality and efficiency. John Dempsey Hospital was one of forty-nine hospitals nationwide, the top 1 percent of acute inpatient facilities, recognized with the Select Practice Award.

In March 2007, UCHC was named one of the nation’s top 100 hospitals in the Solucient 100 Top Hospitals®: National Benchmarks



for Success program. It was one of only fifteen hospitals nationwide recognized in the major teaching hospital category. The award by Solucient, a leading source of health care information, is considered one of the hospital industry’s most prestigious. It uses a scorecard based on objective statistical measurement of performance in critical areas including clinical outcomes, patient safety, operational efficiency, and growth in patient volume. Winning hospitals display a capability to provide sustainable and reliable health care services to their communities.

In April 2005 and again in May 2006, UCHC was named a Top 100 Hospitals®

C. Educational Programs

: Performance Improvement Leader by Solucient. The award was based on statistical analysis of validated measures and a comparison of rates of improvement over five years. The data included more than 800 elements for more than 6,000 U.S. acute-care and specialty hospitals. The analysis showed that the hospitals identified as performance improvement leaders have lower mortality rates, shorter lengths of stay, and lower expenses compared with peer group hospitals.

The Correctional Managed Health Care (CMHC) program, a partnership with the Department of Correction, delivers comprehensive managed health care to State of Connecticut inmates. Medical, mental health, dental, and ancillary services are provided in all eighteen facilities across the state (Bridgeport, Brooklyn, Cheshire-Manson Youth, Webster, Cheshire, Enfield/Somers-Robinson, Willard/Cybulski, Northern, Osborn, Enfield, Hartford, New Haven, Newtown-Garner, Niantic-Gates, York, Storrs-Bergin, Suffield-MacDougall/Walker, and Uncasville-Corrigan/Radgowski).

Dedicated to providing broad educational opportunities in the biomedical sciences, UCHC offers degree programs in medicine (M.D.), dental medicine (D.M.D.), and biomedical science (Ph.D.), master's degree programs in public health and dental science, postdoctoral fellowships, residency programs providing specialty training for newly graduated physicians and dentists, and continuing education programs for practicing health care professionals. Combined degree programs, such as the M.D./Ph.D., D.M.D./Ph.D., Dental Clinical Specialty/Ph.D., and M.D./M.P.H. are also offered.

UCHC is the only academic health center in the nation where a medical school was founded concurrently with a dental school. As the schools took shape during the 1960s, their planners took advantage of



their simultaneous evolution to forge strong links between them. Most notably, medical and dental students share an essentially common curriculum during the first two years of their four-year degree programs. During this period, they study the basic medical sciences together. This experience provides UConn's dental students with an especially strong foundation in the biomedical sciences that undergird the dental profession. Reflecting its close ties to medicine, the dental school awards its graduates the D.M.D. - doctor of dental medicine.

Each year in Farmington, about 320 students work toward their medical doctor's degree and 160 toward their doctor of dental medicine degree. Admission to each school is highly competitive, but both schools offer preferential consideration to qualified Connecticut residents in their admissions policies. In the years since UCHC graduated its first students in 1972, 1,289 men and women have received their D.M.D. degree and 2,744 their M.D. degree.

Through a variety of residency programs, the School of Medicine provides postgraduate training for more than 550 newly graduated M.D.s each year. These physicians come from all over the country to acquire advanced skills in fields such as the surgical specialties, internal medicine, and primary care. Some of the residency training occurs on UCHC's main campus, but much of it takes place in community hospitals in Greater Hartford - thus extending UCHC's influence far beyond Farmington.

D. Research Programs

Since UCHC's inception, its administration and faculty have been committed to maintaining high-quality research programs as part of the institution's fabric. This commitment has enabled UCHC to recruit distinguished researchers with expertise in neuroscience, molecular biology, molecular pharmacology, biochemistry, cell physiology, toxicology, and endocrinology, among other fields. The Alcohol Research Center is one of only fourteen such federally supported centers in the nation. The Connecticut Clinical Chemosensory Research Center is one of five.

Currently, the University is establishing a Center of Innovation that will include its new stem cell institute as well as innovative cell biology and genetics research. The new center, which will be at 400 Farmington Avenue near the UCHC campus, will unite UConn scientists in a cross-disciplinary, collaborative setting to enhance Connecticut’s role as a leader in stem cell research and accelerate discoveries that ultimately



could lead to therapies treating a broad range of diseases and disorders.

Clinical research is facilitated by the Lowell Weicker General Clinical Research Center and the Clinical Trials Unit. Intellectual endeavors of all kinds are supported by the Lyman Maynard Stowe Library.

E. Our Campus

Construction of UCHC's main campus began in 1966. The main complex occupies a prominent hilltop near I-84 and the Farmington-West Hartford line. The massive, circular building originally contained about 1.2 million square feet, seven miles of corridors, and 2,000 rooms. Its first major addition, the Andrew J. Canzonetti, M.D. Building, was dedicated in 1994. It added 94,000 square feet next to John Dempsey Hospital. UCHC's Academic Research Building opened in 1999. The impressive eleven-story structure provides 170,000 square feet of state-of-the-art laboratory space.

The Medical Arts and Research Building (MARB), which opened in 2005, added to the campus a four-story, 99,000 square-feet facility for care and research related to conditions affecting bones, joints, and connective tissue. The MARB houses an open magnetic resonance imaging (MRI), the region’s first warm-water SwimEx therapeutic pool, and physical therapy and rehabilitation services, as well as, clinical services including orthopedics, rheumatology, and neurosurgery. It also is home to the Farmington Surgery Center, a multi-specialty outpatient surgery center.

All told, the UCHC campus consists of thirty-nine buildings totaling over 2 million square feet.

II. Purpose of Request for Information (RFI)

There are multiple Institutional Review Boards (IRB) constituted at the University of Connecticut Health Center (UCHC). Institutional policy number 2002-42, Review and Approval of Research Involving Human Subjects, assigns authority and responsibility to the IRB. Each panel meets once per month. With one exception, studies requiring full board review are assigned to a panel based on the submission date of the initial application. Once a study is assigned to a panel, it remains under the oversight of that same panel for the life of the study. The one exception is that any study proposing to involve prisoners must be assigned to Panel 02, which has a prisoner advocate as a member. Members are appointed by the Director of the Human Subjects

http://policies.uchc.edu/policies/policy_2002_42.pdf�

http://resadm.uchc.edu/hspo/irb/meet.html�

http://resadm.uchc.edu/hspo/irb/members.html�



Protection Office and are selected for their experience and expertise, as well as for their diverse backgrounds.

Federal mandate (45 CFR 46, referred to as the Common Rule) requires that the IRB review and approve any biomedical or behavioral research involving human participants, data or specimens that may be identifiable directly or through codes prior to it being started and that, in the majority of cases, legally effective informed consent of the subject or the subject's legally authorized representative is obtained prior to any involvement in the study.

Vested with an ethical imperative to safeguard the rights and welfare of human subjects in research studies, the IRB reviews protocols to assure that the research activities proposed include no unnecessary risks, minimize potential risks to subjects, and that overall potential benefit to the subject, or to society, is reasonable in relation to the risks. The Board also measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects.

UCHC is seeking information from qualified organizations to regarding their product’s capabilities for electronic submission, review, and management of Institutional Review Board (IRB) protocols. The goal of this RFI is to find a product that will facilitate submission, review, and management of clinical research protocols by reducing costs of IRB submissions (saving time on preparation and paper), improving communication between the IRB and investigators, and managing protocols. Facilitating clinical research is in furtherance of UCHC’s mission to help people achieve and maintain healthy lives and restore wellness/health to maximum attainable levels.

III. Functional Requirements

Below are the functional requirements of the Electronic Submission, Review, and Management of Institutional Review Board (IRB) Protocols project:

A. Electronic Submission of IRB Protocols - Capability to:

1. Create and upload large research-related documents such as

protocols, investigator brochures, informed consent forms, IRB forms, and data collection tools

2. Route submissions for various sign-offs/approvals (for example,

to research pharmacy or to research safety or budget review)

3. Create electronic forms to capture structured data including details of submission such as names of co-investigators,

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm�



locations of recruitment, and number to be recruited) (Refer to Appendix A - IRB Application)

4. Track qualifications and training/certifications of research team

members

5. Track Conflict of Interest disclosures for investigators

6. Submit and code various types of information for review (for example, initial review, continuing review, problem reports, requests for modifications, and discussion items)

7. Add user-defined fields/tables

8. Allow for skip out in forms, for sections not applicable to a

particular investigator

9. Link to detailed instructions for each question on the form

10. Expand form fields to accommodate length of response

11. Populate unchanged sections of the modified form with the investigator’s previous responses so that only the modified sections of the form need to be entered by the investigator (all sections must be available for updating by the investigators) when forms are modified by the Human Subjects Protection Office, if an investigator needs to submit that form and has previously submitted an earlier version of that form

12. Record and track submission times to ensure submission meets

deadlines

13. Identify if any required documents that have not been uploaded by the deadline and alert the investigator and the IRB staff

14. Generate an electronic confirmation to the investigator when

submission has been successfully completed with all required documents uploaded

15. Copy over another document from a similar type submission

16. Have more than one document open at a time for purpose of

comparison

17. Comply with 21 CFR 11



B. Electronic Review of Protocols - Capability to:

1. Comment on any/all aspects of electronic submission by all IRB

members and by expert consultants

2. Manage various stages of review process (initial review, review of contingencies, and continuing review)

3. Capture vote and decision of IRB

4. Capture details of IRB determinations (criteria for approval and

criteria for inclusion of vulnerable populations)

5. Have more than one document open at a time for purpose of comparison (for example, review of consent form in relation to protocol)

6. Easily read system fields in terms of font size, area for text, and

expandable fields and allow reviewer to zoom in or out to increase or decrease effective font size

7. Specify which fields, screens, and/or information within the

review process are also visible to investigators (for example, contingencies for approval) and which are accessible only to IRB members (for example, vote of membership and assigned reviewers)

8. Allow Web-based secure access from any computer with

appropriate log-in credentials (user-name and password) and allow various levels of access based on role (investigator vs. IRB personnel vs. IRB reviewers)

9. Automatically log off if there is no activity for ten minutes

C. Management of IRB Panel Membership - Capability to:

1. Assign and track reviewers to protocols

2. Track membership history on panels (for example, add new

members and retire members who leave)

3. Track member characteristics (for example, affiliated, non-affiliated, scientific, non-scientific, prisoner representative, and gender)



4. Track training of IRB members

5. Track evaluations of IRB members and Chair members

6. Track meeting attendance and the number and types of reviews

assigned to each member

7. Track Conflict of Interest disclosures for IRB panel membership

D. Report Generation - Capability to:

1. Generate meeting agendas/minutes

2. Export/merge with programs such as Microsoft Excel and Microsoft Word

3. Create customizable ad-hoc reports on the fly

4. Create and edit tables

5. Concatenate field values for export and reporting (for example,

report/export all active investigators as one field and all active sponsors as one field)

6. Search on any field and export data

7. Create letters

8. Email reports and letters

E. Management of Protocols - Capability to:

1. Track initial approval dates and continuing review cycles

2. Track drugs/devices used (with the ability to differentiate

between marketed and investigative drugs/devices)

3. Track review history of protocol (initial review, continuing review, and review of modifications)

4. Track approval history of protocol

5. Add and report on user-defined fields



6. Send reminder alerts

7. Track document version

8. Track sponsors/funding sources and identify sources of funding including, but not limited to, Federal and non-Federal funding

9. End date/inactivate values (for example, note end date of when

National Institutes of Health (NIH) funding is over, end date when a co-investigator is removed from a study)

10. Access security and audit trails of end user activity

11. Track all active protocols for an investigator and track all active

protocols for an IRB panel

12. Track pending issues and send reminders to investigator and IRB staff if not resolved by deadline entered (for example, if a pending DSMB report is not received by a certain date)

F. Conversion - Capability to:

1. Convert data from current system (for example, InfoEd Human

Subject Management Module and GE IDX)

G. Test or Training Environment - Capability to:

1. Provide a test or training environment

H. Interface/Integration - Capability to:

1. Support interfaces/integration IV. Proposer Qualifications and Requirements

A. Qualifications

Qualified proposers shall be established firms with:

1. Concrete implementation experience with academic medical centers

2. Knowledge of IRB regulatory requirements



3. At least three years of experience with implementation of the proposed product

Subcontractors cannot be used to meet specified requirements.

B. Proposer Credentialing

UCHC is committed to providing the best patient care available to our patients. To that end, we must ensure that our vendors are compliant with hospital policy and industry standards. UCHC requires that vendors provide documentation that they will abide by our standards for environmental health, safety, privacy, and quality. To assist with credentialing all vendor representatives in the most efficient way, UCHC has contracted with Status Blue.

C. Background Checks

In accordance with UCHC Policy No. 2001-3 and applicable Federal and state laws, the UCHC Public Safety Department shall conduct security background investigations and Federal sanctions checks on all contractor and proposer employees prior to commencing work on UCHC premises. There is a fee of $75 for each background check completed. The fee is payable in advance and shall accompany the submission of the Background Information Check Sheet.

V. Purchasing Services Contact Information

Any questions, comments, proposals, and other communications regarding this RFI must be submitted in writing and must be clearly identified as pertaining to this RFI. Proposers who solicit information about this RFI, either directly or indirectly, from sources other than the individual listed below may be disqualified. The contact person for this RFI is:

John Russell III

Fiscal Administrative Officer University of Connecticut Health Center

16 Munson Road, 2nd

Email:

Floor Farmington, CT 06034-4036

Mail Code: 4036 Telephone: 860-679-7395

Fax: 860-679-2508 [email protected]

mailto:[email protected]�



VI. Request for Information (RFI) Schedule

The following schedule, up to and including the deadline for submitting proposals, shall be changed only by an Addendum to this RFI. Dates after submittal of proposals are target dates only. They are provided for planning purposes only and are subject to change.

The following schedule is tentative and is subject to change.

Milestone Target Date 1. RFI posting/release May 13, 2009 2. Proposals due (no later than 3:30 p.m.

eastern standard time) June 22, 2009

3. Meetings with proposers end July 27, 2009 VII. Proposal Submission Requirements

A. Number of Copies

To submit a responsive proposal, proposers shall provide UCHC with one original (clearly marked) and six exact, legible copies of the proposal in clearly identified sealed envelopes or sealed boxes by the stated due date/time. In addition, one exact electronic copy (compact disk or jump drive) of the entire proposal in a non-PDF format must be submitted with the original. Those required documents that cannot be converted into electronic format may be excluded from the electronic copy. All materials must be in Word or Excel except those items such as pictures or signatures that cannot be scanned into a Word document.

B. Binding of Proposals

To submit a responsive proposal, proposers shall submit a proposal in a format that will allow pages to be easily incorporated into the original proposal. An original (clearly marked) and all copies must be submitted in loose-leaf or spiral-bound notebooks with the proposer’s official name on the outside front cover of each binder and on each page of the proposal (location is at the proposer’s discretion).

C. Page Numbers

Each page of the proposal must be numbered consecutively in Arabic numbers from the beginning of the proposal through all appended materials.



D. Cross-referencing RFI and Proposal

Each section of the proposal must cross-reference the appropriate section of this RFI that is being addressed. This will allow UCHC to determine uniform compliance with specific RFI requirements.

VIII. Proposal Requirements

Proposers shall include responses to all requested information in their RFI response in sufficient detail for UCHC to determine that all RFI requirements have been met. Failure to provide all information may result in proposal rejection. Proposers should not include a copy of this RFI as part of their response. UCHC does not want a rewrite of this RFI’s requirements, since such a proposal would show a lack of understanding of the project and an inability to implement the project.

A. Organizational Capability and Structure

Responses to this section must describe the proposer’s background and experience. The responses must also address the details regarding the proposer’s size and resources relevant to this RFI. To submit a responsive proposal, proposers shall:

1. General Proposer Information - Provide detailed information on

its company including, but not limited to, the following:

a) Company name and address

b) Name, telephone number, fax number, and email address of contact person

c) Number of staff

d) Year the company was established and number of years

in business

2. Proposer Qualifications - Describe how its experience meets the requirements of this RFI.

3. Summary of Relevant Experience - List the projects completed

within the last three years in the area of IRB management of clinical research protocols with emphasis on activities relevant and related to the requirements specified in this RFI.



4. Organizational Chart - Provide an organizational chart showing the hierarchical structure of functions and positions within its organization.

B. Proposer’s References

To submit a responsive proposal, proposers shall provide three specific references for the proposer. References must be able to comment on the proposer’s capability to perform the services specified in this RFI. The contact person must be an individual familiar with the proposer and its day-to-day performance. If the proposer has been a State contractor within the last five years, the proposer must include a State of Connecticut reference. Proposers are strongly encouraged to call or write their references to ensure the accuracy of their contact information and their willingness and capability to be references. References must include:

1. Organization’s name, address, telephone number, fax number,

email address, and Web address (organizations must be of comparable size and complexity as UCHC)

2. Name and title of a contact person

3. Brief description of the services provided to referenced

customer

4. Initial service date

C. Scope of Work

To provide a responsive proposal, proposers shall provide the following:

1. Work Plan - Completed Functional Requirements Sheet

(provided as Appendix A)

2. Sample of Similar Services - Written sample of similar services from a related previous engagement



D. Cost

To provide a responsive proposal, proposers shall provide a detailed cost proposal using the chart below:

Description Total Costs

Initial costs Annual support Integration and conversion Implementation cost Test and training environment Other (specify): Other (specify): Other (specify): Other (specify): Other (specify): Other (specify):

Total: IX. Meetings with Proposers

At its discretion, the UCHC may convene meetings with some proposers to gain a better understanding of the proposals. The meetings may involve demonstrations, interviews, presentations, and/or site visits. If warranted, a UCHC contact person will call or email proposers to schedule the meetings.

Appendix A Electronic Submission, Review, and Management of Institutional Review Board Protocols Request for Information

Functional Requirements Sheet Guidance: Below are the functional requirements of the Electronic Submission, Review, and Management of Institutional Review Board Protocols project. For each requirement, the proposer must respond by making a checkmark (X) in the appropriate column. Provide comments if necessary. If a checkmark is not provided for a requirement, UCHC will assume that the requirement cannot be met.

A - The function is available and active for more than three years. B - The function is available and active.

C - The function is in development. Provide the date the function will be available to general client base under Comments. D - The function requires customized development. Provide the estimated cost under Comments.

E - The function is not available.

Functional Requirement A B C D E Comments A. Electronic Submission of IRB Protocols

1. Create and upload large research-related documents such as protocols, investigator brochures, informed consent forms, IRB forms, and data collection tools

2. Route submissions for various sign-offs/approvals (for example, to research pharmacy or to research safety or budget review)

3. Create electronic forms to capture structured data including details of submission such as names of co-investigators, locations of recruitment, and number to be recruited) (Refer to Appendix A - IRB Application)

4. Track qualifications and training/certifications of research team members

5. Submit and code various types of information for review (for example, initial review, continuing review, problem reports, requests for modifications, and discussion items)

6. Track Conflict of Interest disclosures for investigators 7. Add user-defined fields/tables 8. Allow for skip out in forms, for sections not applicable to a

particular investigator

9. Link to detailed instructions for each question on the form 10. Expand form fields to accommodate length of response



Functional Requirement A B C D E Comments 11. Populate unchanged sections of the modified form with the

investigator’s previous responses so that only the modified sections of the form need to be entered by the investigator (all sections must be available for updating by the investigators) when forms are modified by the Human Subjects Protection Office, if an investigator needs to submit that form and has previously submitted an earlier version of that form

12. Record and track submission times to ensure submission meets deadlines

13. Identify if any required documents that have not been uploaded by the deadline and alert the investigator and the IRB staff

14. Generate an electronic confirmation to the investigator when submission has been successfully completed with all required documents uploaded

15. Copy over another document from a similar type submission 16. Have more than one document open at a time for purpose

of comparison

17. Comply with 21 CFR 11 B. Electronic Review of Protocols

1. Comment on any/all aspects of electronic submissions by all IRB members and by expert consultants

2. Manage various stages of review process (initial review, review of contingencies, and continuing review)

3. Capture vote and decision of IRB 4. Capture details of IRB determinations (criteria for approval

and criteria for inclusion of vulnerable populations)

5. Have more than one document open at a time for purpose of comparison (for example, review of consent form in relation to protocol)

6. Easily read system fields in terms of font size, area for text, and expandable fields and allow reviewer to zoom in or out to increase or decrease effective font size



Functional Requirement A B C D E Comments 7. Specify which fields, screens, and/or information within the

review process are also visible to investigators (for example, contingencies for approval) and which are accessible only to IRB members (for example, vote of membership and assigned reviewers)

8. Allow Web-based secure access from any computer with appropriate log-in credentials (user-name and password) and allow various levels of access based on role (investigator vs. IRB personnel vs. IRB reviewers)

9. Automatically log off if there is no activity for ten minutes C. Management of IRB Panel Membership

1. Assign and track reviewers to protocols 2. Track membership history on panels (for example, add new

members and retire members who leave)

3. Track member characteristics (for example, affiliated, non-affiliated, scientific, non-scientific, prisoner representative, and gender)

4. Track training of IRB members 5. Track evaluations of IRB members and Chair members 6. Track meeting attendance and the number and types of

reviews assigned to each member

7. Track Conflict of Interest disclosures for IRB panel membership

D. Report Generation 1. Generate meeting agendas/meetings 2. Export/merge with programs such as Microsoft Excel and

Microsoft Word

3. Create customizable ad-hoc reports on the fly 4. Create and edit tables 5. Concatenate field values for export and reporting (for

example, report/export all active investigators as one field and all active sponsors as one field)

6. Search on any field and export data 7. Create letters 8. Email reports and letters

E. Management of Protocols 1. Track initial approval dates and continuing review cycles



Functional Requirement A B C D E Comments 2. Track drugs/devices used (with the ability to differentiate

between marketed and investigative drugs/devices)

3. Track review history of protocol (initial review, continuing review, and review of modifications)

4. Track approval history of protocol 5. Add and report on user-defined fields 6. Send reminder alerts 7. Track document version 8. Track sponsors/funding sources and identify sources of

funding including, but not limited to, Federal and non-Federal funding

9. End date/inactivate values (for example, note end date of when National Institutes of Health (NIH) funding is over, end date when a co-investigator is removed from a study)

10. Access security and audit trails of end user activity 11. Track all active protocols for an investigator and track all

active protocols for an IRB panel

12. Track pending issues and send reminders to investigator and IRB staff if not resolved by deadline entered (for example, if a pending DSMB report is not received by a certain date)

F. Conversion 1. Convert data from current system (for example, InfoEd

Human Subject Management Module and GE IDX)

G. Test or Training Environment 1. Provide a test or training environment

H. Interface/Integration 1. Support interfaces/integration

1- Revised 5/24/06, 3/22/06, 9/26/05,

Application for Initial and Continuing Project Approval Date of IRB Receipt Institutional Review Board University of Connecticut Health Center All applications must be typed. Point, click and type in the appropriate cell. Cells will expand to accommodate text. Tabbing out of the last cell on the right of a table will insert another row. Referencing the protocol is not acceptable since not all IRB

members receive the complete protocol. The IRB reserves the right to return applications that do not provide sufficient responses. When submitting for continuing review the application must reflect the currently approved status of the study. For example, if inclusion / exclusion criteria were changed via a request for modification the application must reflect that approved change. For continuations the Addendum to the Application to Request Continuing Review must be appended to this form. Any modifications being proposed with the continuation are to be noted on that form in the proposed modification section. NOTES: If you will be applying to the General Clinical Research Center to provide support for this study you must also submit this application and supporting documents electronically to Lisa Godin for review and approval by the GCRC. Investigators may apply to the GCRC prior to or concurrent with the IRB submission. For question related to GCRC submission contact Lisa Godin at 679-4145, or [email protected]. For complete direction for GCRC submission refer to the application instructions. If you are request approval for a Humanitarian Use Device, use the application specific to HUDs. If you are requesting approval for a registry/repository use the application specific to registry/repositories. If the study involves the use of Recombinant DNA or gene therapy you must first obtain approval from the Institutional Biosafety Committee. Refer to the complete and detailed instructions for specific questions to ensure that all elements are adequately addressed. You may print the document in color or in grayscale. SECTION 1 – BASIC STUDY INFORMATION 1.0 TYPE OF SUBMISSION: INITIAL APPLICATION RESUBMISSION DUE TO DEFERRAL CONTINUATION RESUBMISSION TO ADDRESS CONTINGENCIES CONTINUATION WITH MODIFICATION 1.1 IRB Number (NA TO NEW APPLICATIONS): 1.2 Name of Principal Investigator for IRB Proposal:

1.3 Complete IRB Project Title:

1.4 Complete Associated Grant Title (if possible grant and project title should match):

1.5 Name of PI on the grant: 1.6 Abbreviated Project Title ( ≤ 56 characters):

1.7 Identify any external funding source for this study (e.g. NIH, Pfizer, Donaghue etc):

1.8 Identify any institution from which UCHC will receive a sub-award:

1.9 Identify any internal funding source for this study (e.g. HCRAC, dept. funds etc.):

1.10 Identify the sponsor for this study (e.g. PI, ECOG, Pfizer, etc):

1.11 Will the sponsor indemnify subjects in the event of a research-related injury?

1.12 Will the GCRC provide any type of support /resources for this study (If yes, you must complete Appendix A and submit to the GCRC for review and approval. Refer to GCRC submission instructions)?

1.13 If expedited review, which category is applicable (If 9, attach the IRB letter stating the minimal risk determination.)? SECTION 2– RESEARCH PERSONNEL INFORMATION


2- Revised 5/24/06, 3/22/06, 9/26/05,

PRINCIPAL INVESTIGATOR (last, first)

STUDY COORDINATOR (last, first if other than PI)

CONTACT PERSON (last, first if other than PI or SC)

2.0 Name

2.1 Degree(s) Held

2.2 Professional Licenses (type & #)

2.3 Professional Certifications

2.4 Job Title

2.5 Department

2.6 Room Number

2.7 Mail Code

2.8 Phone Number

2.9 Emergency Number

2.10 Fax Number

2.11 Pager Number

2.12 E-mail Address

2.13 Date of HS Training

2.14 Other Affiliations of PI (e.g. CCMC, Hartford Hospital, Storrs, UCHC)

*************************** ***************************

2.15 Off-hours/weekend contact information (Optional):

2.16 Provide a brief summary of the qualifications of the PI to conduct this study or refer to an attached NIH biosketch:

2.17 Provide information on co-investigators for the study (tabbing out of the bottom right cell will insert another row if needed)

Name (Last, First)

Degrees Held

Licenses (type, St. #) / Certifications

Department Affiliation (other than UCHC)

Assurance # (other than UCHC)

Date of HS Training

Primary Function(s) Performed In Study

Additional Information on Co-Investigators (e.g. previous research experience):

SECTION 3 – COLLABORATING INSTITUTIONS / MULTI-CENTER TRIALS 3.0 Are there any collaborating sites involved with this study? (If no skip to 3.3. If yes, proceed to 3.1)

3.1 If collaborating with other sites, provide the name of each institution, including UCHC, and place an x under the column(s) that describes the type of involvement for each institution. Provide the date that the other institution obtained IRB approval or indicate that it is pending. (If one of the collaborating institution is Hartford Hospital, CCMC, or UConn-Storrs proceed to 3.2 , otherwise skip to 3.3)

Institution’s Name Recruitment Enrollment /

Consenting Subjects

Interactions (e.g. survey)

Interventions (e.g. needle stick)

Follow-up Analysis IRB Approval Date

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UCHC

Additional Comments:

3.2 Indicate the expected percentage of enrollment at each applicable site, and place an X in the appropriate cell to indicate which institution, based on the preponderance of the expected enrollment, you are requesting serve as the IRB of record or that independent IRB approval will be sought from each applicable site.

Institution’s Name % to be Enrolled/Consented Requested IRB of Record Independent IRB Review UCHC Hartford Hospital CCMC Storrs

Information on multi-center trials 3.3 Is this a multi-center trial? (If no, skip to section 4, if yes proceed to 3.4) 3.4 Will UCHC serve as the statistical center, operational center or lead institution? If yes, indicate which role

UCHC will serve, complete and attach Appendix C. (Proceed to 3.5 if UCHC is the lead institution, otherwise skip to section 4.)

3.5 If UCHC is the lead institution, describe the plans for communication among sites in terms of protocol

modifications, unanticipated problems and interim results: SECTION 4 – PROJECT CHARACTERISTICS, SUMMARY AND DESIGN 4.0 Provide the anticipated time frame during which the study will be conducted:

Expected Start Date (mm/dd/yyyy): Expected Completion Date (mm/dd/yyyy):

4.1 Provide the general therapeutic area and sub-area(s) that best describe your study (e.g., cancer, gastrointestinal, pancreatic or psychiatry, addictive behaviors, gambling).

Primary Area Sub- Area 2nd Sub- Area

4.2 Place an X after the applicable study phase:

Phase I Phase II Phase III Phase IV (Post Marketing) Not a clinical trial 4.3 For post-marketing trials, describe any post-marketing commitments imposed on the use of this drug by the FDA.

4.4 Place an X after all characteristics that are applicable to the study design:

Pilot Study Case-Control Study

Randomization

Observational Study Double-blind Placebo Cross-Sectional Study Chart review Normal Controls

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Other (specify):

4.5 Provide 2 or 3 sentences describing your project in lay terms.

4.6 Provide a clear and succinct summary description of this project addressing the items noted below. (Responses 4.7, 4.8 and 4.9 combined should not exceed the equivalent of five pages.) For expedited and exempt applications only, you may refer to the protocol but must provide specific page #s and locations for each item referenced (e.g. hypothesis, objects and aims: see protocol pages 2-4 starting with section title hypothesis).

Hypotheses, Objectives and Aims: Scientific Background and Significance: Preliminary Studies:

4.7

Provide either a flow diagram or outline of the experimental design addressing the elements noted below. (Responses 4.7, 4.8 and 4.9 combined should not exceed the equivalent of five pages.) For expedited and exempt applications only, you may refer to the protocol but must provide specific page #s and locations for each item referenced (e.g. flow diagram: see protocol pages 5-6 starting with section title study schema)

Flow diagram or outline including a 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): Description of sample size: Estimated enrollment per year: Primary and secondary outcomes and endpoints:

4.8 Describe methods of analysis, sample size supported by appropriate power calculations. (Responses 4.7, 4.8 and 4.9 combined should not exceed the equivalent of five pages.) For expedited and exempt applications only, you may refer to the protocol but must provide specific page #s and locations for each item referenced (e.g. methods of analysis: see protocol pages 7 starting with section title analysis.)

4.9 List specific clinical eligibility requirements for subjects, and clinical criteria that would exclude otherwise acceptable subjects. For expedited and exempt applications only, you may refer to the protocol but must provide specific page #s and locations for each item referenced (e.g. inclusion/exclusion: see protocol pages 8 starting with section title inclusion/exclusion criteria.)

Inclusion Criteria Exclusion Criteria a.

b.

c.

4.10 Provide the age range or age description of subjects and justification for the age selection:

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4.11 Are there any non-clinical factors that will exclude subjects, e.g. race/ethnicity, gender, language? If so, justify why the exclusion is necessary.

SECTION 5 –PROTECTION AGAINST AND MINIMIZATION OF RISKS (45 CFR 46.111(A)(1)) 5.0 List all procedures to be performed on human subjects. Also list alternative therapies or procedure that

may be advantageous to the subject. Discuss the risks and benefit of any alternative therapy.

Non-Experimental Procedures: Experimental Procedures: Alternative Options: Risks and Benefits of Alternatives:

5.1 Describe the potential risks associated with the proposed research, the procedures to protect against or

minimize potential risks and assess the likelihood of the risk occurring and if it were to occur the seriousness to the subject.

Physical Risks: Procedures to Protect

Against / Minimize Risks Likelihood of Occurrence

Seriousness to Subject if Risk Occurs

Psychological Risks: Procedures to Protect



Economical Risks: Procedures to Protect



Social Risks: Procedures to Protect



Legal Risks: Procedures to Protect



Other Risks:

Procedures to Protect Against / Minimize Risks

Likelihood of Occurrence


5.2 Describe any costs related to the research activities that are not part of standard of care and indicate who

will be responsible for payment, e.g. subject, sponsor, dept. funds.

Research Activity (including medication) Beyond Standard of Care Party Responsible for Payment

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5.3 Describe any other costs that may be incurred by the subject due to participation in this study, e.g. travel

costs, lodging, care for research related injury etc. Additional Approvals for Drug Usage Required to Ensure Risks are Minimized and Compliance with IND Regulations 5.4 Will the study involve the use of drugs (if no skip to 5.11, if yes complete 5.5 – 5.10)? 5.5 Identify all drugs that will be administered as part of the research study. For studies involving INDs also

attach 1) confirmation from the manufacturer of compliance with federal regulations and Good Manufacturing Practices, 2) the 1572 form and 3) if the IND # is not provided, a letter from the sponsor confirming IND approval. When possible submit IND safety reports. If the investigator/UCHC is the sponsor attach the documentation from the meeting with the Research Compliance Monitor. (Tabbing out of the bottom right cell will insert another row.)

Need Pharmacy Approval for columns 1-3 Drug Name Dosage,

Frequency & Duration

Method of Administration

Pharmacy Approval

IND # if Available

Manufacturer of IND

Sponsor of IND

Supporting Documents Attached

5.6 Provide the following information relating to the storage, inventory and dispensing of drugs used in this

study. Investigational drugs for inpatient use must be stored in the John Dempsey Pharmacy. The Director of Pharmacy, or delegated pharmacy staff, must approve of plans for control of investigational drugs maintained outside of pharmacy and documentation of that approval must be provided. Also submit the signed statement of investigator responsibilities for INDs. (Per CT Law only those with prescribing authority (physician, pharmacist, APRN) may dispense.)

Where will drugs be stored? If other than John Dempsey Pharmacy, also answer the questions noted below. Describe the storage area and how it meets the required storage conditions for the drug: Describe the security measures in place for inventory control and monitoring of the drug inventory? How and by whom will drugs be dispensed? Describe how the disposition of unused drugs will be handled: Obtain approval from the Pharmacy Dept. for these plans via signature here or refer to attached document:

Additional Information Regarding an Investigational New Drug Application. (If yes to 5.8, 5.9 or 5.10 an IND is needed). 5.7 Has an IND already been obtained for the drug(s) used within the study? (If no, answer 5.8 – 5.10. If yes, be sure

information requested in 5.5 is provided and skip to 5.11) 5.8 Is the proposed investigation intended to be reported to the FDA in support of a new indication or to

support any other significant change in the labeling for the drug? 5.9 Is the investigation intended to support a significant change in the advertising for the product? 5.10 Does the investigation involve a route of administration or dosage level, or use in a patient population or

other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product?

http://www.fda.gov/cdrh/devadvice/32.html�



http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.pdf�

7- Revised 5/24/06, 3/22/06, 9/26/05,

Additional Information for Investigational Devices

5.11 Will the study involve the use of an investigational device (If no skip to 5.15, if yes complete 5.12 -5.14)?

5.12 Provide Name, IDE number and manufacturer. For studies involving IDEs also attach confirmation from the manufacturer of compliance with federal regulations and Good Manufacturing Practices and of IDE approval from the sponsor. If the investigator/UCHC is the sponsor attach the documentation from the meeting with the Research Compliance Monitor

Device Name IDE Number Manufacturer

of IDE Sponsor of IDE

Confirmation of GMP Attached

Confirmation of IDE Approval Attached

5.13 Is the device considered a significant risk or non-significant risk (NSR) device? For NSR devices, attach

the sponsor’s description of the device, reports of prior investigations with the device, the proposed investigational plan, a description of patient selection criteria and monitoring procedures. The sponsor must also inform the IRB if other IRBs have reviewed the proposed study and what determination was made by those IRBs.

5.14 Describe plans for maintaining inventory of the investigational device. Also submit the signed statement of

investigator responsibilities for IDEs.

Where will the device be stored? Describe measures in place for inventory control: Describe measures for monitoring / tracking of the device: How and by whom will the device be used: Describe plans for return of unused devices to the sponsor:

Additional Approvals Required from Office of Research Safety 5.15 Place an X after each category of material that is used within the study. For any category selected, also

identify the specific material within that category and provide a brief description of how it is used within the study. Also, obtain and attach a Risk Assessment Report from the Office of Research Safety. If none of these materials are used, place an X after that option.

Category X to

Select Examples Specific material

used in the study Brief description of how it is used

Ionizing Radiation radioactive materials and / or radiation producing equipment etc

Non-ionizing radiation laser, microwave, electronic/magnetic fields etc

Biological material human, animal or plant pathogenic, organisms, viruses, toxins, etc.)

Hazardous chemicals

Other potential hazards

None of the Above


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Additional Approvals Required from Office of Research Safety and Institutional Biosafety Committee 5.16 Does the project involve the use of recombinant DNA? If yes provide proof of approval for the study from

the Institutional Biosafety Committee and the Risk Assessment Report from the Office of Research Safety. (Approval from the Institutional Biosafety Committee must be obtained prior to seeking IRB approval for all studies that deal with recombinant DNA.)

SECTION 6 –REASONABLENESS OF RISKS IN RELATION TO BENEFITS, IF ANY (45 CFR 46.111(A)(2)) 6.0 Place an X after the level of overall risk that, in the opinion of the PI, is associated with this study.

Comments may also be provided to justify the assessed risk level. (Guidelines for assessing risk are available on the HSPO / IRB website.)*

Risk Level X to select Comments None: Minimal: Slight Increase Over Minimal Moderate: High

6.1 What benefit, if any, may be gained by the subject and/or society? Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.

6.2 Discuss the importance of the knowledge that may be gained as a result of the proposed research. Discuss

why the risks to subjects are reasonable in relation to the importance of the knowledge that may result.

6.3 For studies requiring full board review, describe the scientific review process that the study has undergone

and attach the results, or indicate that review by the IRB’s Scientific Review Committee is being requested. (For requests for continuation indicate NA.)

. SECTION 7 – SUBJECT SELECTION / RECRUITMENT DATA (45 CFR 46.111(a)(3) &(a)(7)(b)) 7.0 Place an x after the type(s) of human subjects that are likely to be recruited for this study. If the category is

followed by a letter, and the study is not eligible for exempt status, complete the corresponding form to certify that the additional protections required for vulnerable populations have been met.

Pregnant Women or Fetuses (B204 or B207)

Children/Adolescents (D404, D405, D406 or D407)

Prisoners (C )

Neonates of uncertain viability or non-viable (B205 or B207)

Decisionally Impaired (S and (D404, D405, D406 or D407))

UCHC Inpatients- Including Prisoners (C )

Abortuses (B206 or B207)

Viable Neonates (D404, D405, D406 or D407)

UCHC Inpatients–No Prisoners

UCHC Employees (S)

Educationally Disadvantaged (S) Outpatients

UCHC Students (S) Economically Disadvantaged (S) Terminally Ill (S) Other (describe)

Provide any additional comments to describe subject populations (e.g. terminally ill with average life expectancy of less than one year, or only involvement of subjects is via data collected from chart reviews):

7.1 Explain why the inclusion of any vulnerable populations identified in 7.0 in necessary:

http://resadm.uchc.edu/hspo/irb/files/risk_guidelines.doc�

9- Revised 5/24/06, 3/22/06, 9/26/05,

7.2 What is the maximum number of subjects to be enrolled at or by UCHC? If UCHC enrollment is anticipated

to be 250 or more, complete and submit Appendix D. 7.3 Explain on what basis it is reasonable to expect that recruitment goals will be met. 7.4 If applicable what is the national expectation for enrollment? Data Collection and Recruitment Methods 7.5 Place an x after the source(s) from which information will be collected. Any data from prisoners will require

review under subpart C and the corresponding worksheet must be completed.

Medical interventions Labs results

Existing directly identifiable specimens Identifiable Waste material

Existing coded specimens De-identified Waste material

Existing de-identified specimens Excess material

Interviews Medical records – excluding prisoners

Focus groups:

Medical records – including prisoners (C)

Surveys

Research registry *

Other sources of information (provide description): *Provide the name and IRB number of the registry that will be used:

7.6 Place an X after all methods and materials that will be used to recruit subjects and describe how recruitment strategies will be implemented. (Note: All materials for and methods of recruitment must receive IRB approval prior to use, including final versions of recorded ads for which a script is provided. It is acceptable to identify a recruitment method and note that IRB approval will be sought when the material is developed.)

Methods/Materials X to Select Description of Implementation Closed to enrollment

Radio spots

Newspapers

Magazines

Broadcast messages

Purchased mailing lists

Patient base

Flyers

Proband

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Phone Calls

Web postings*

Other methods, materials and strategies that will be used for subject recruitment(provide description):

Describe any outreach programs for recruiting women and minorities into clinical research trials:

*Note: Listing an approved and active clinical trial on the web does not require IRB approval when the posting is limited to the following elements: title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information. IRB review and approval must be sought if any additional information is to be posted. The IRB may conduct random audits of web postings to ensure compliance with these terms. 7.7 Describe any financial or other compensation that will be paid to the subjects and the disbursement

schedule for such compensation. SECTION 8 – INFORMED CONSENT PROCESS (45 CFR 46.111(A)(4)) 8.0 Have you requested exempt status or a waiver of the requirement to obtain consent (If yes skip to section 10.

If no and study is open to new enrollment complete all items in this section. If no and study is closed to new enrollment but subjects remain on active treatment, respond to item 8.9 and if applicable 8.12 )?

8.1 Provide the version reference of consent form submitted for review and approval: 8.2 Who will be authorized to obtain consent/assent/authorization?

Name or position of those authorized Fluent in Language(s) Date of Human Subjects Training

8.3 Are non-English speaking subjects likely to be consented? If so describe plans for ensuring that

information is presented in a language understandable to the subject/Legally Authorized Representative (LAR) If not, explain why. (translated consent forms must be submitted to the IRB).

8.4 Who will provide consent/permission (e.g. the subject, parent, LAR)? 8.5 If consent will be obtained from LARs, describe the process for ensuring that the LAR is in fact the child’s

parent(s), court-appointed conservator or guardian, or individual designated as having power of attorney for health care, or individuals designated as a health care representative. Consent from next-of-kin is not acceptable absent one of the prior designations:

8.6 Will anyone other than the subject/LAR be a part of the consent process (e.g. witness)? 8.7 How will the privacy of the subjects/LARs be maintained throughout the consent process? 8.8 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 subjects / LARs have had enough time to consider their decision regarding participation?

8.9 How will on-going consent of the subjects /LARs be obtained throughout the conduct of the study?

11- Revised 5/24/06, 3/22/06, 9/26/05,

8.10 Will any screening activity occur prior to consent / authorization being obtained? 8.11 Describe the process of obtaining assent from children or decisionally impaired adults. 8.12 Provide any additional comments regarding the consent process. Ensuring There Is No Undue Influence Within the Consent Process 8.13 Describe plans to minimize the possibility of coercion or undue influence during the consent process: 8.14 What benefit, if any, is to be gained by the research personnel for subject recruitment into the study, e.g.

payment for enrollment? If applicable, disclose the value of the benefit and explain how it is justified. SECTION 9– INFORMED CONSENT DOCUMENTATION (45 CFR 46.111(A)(5) AND .117(C)) 9.0 Will consent be documented via use of a consent form? (If yes skip to section 10. If no, respond to 9.1 – 9.2, or 9.3

– 9.4 as applicable to your study)

Note: The majority of studies will require documentation of consent. The IRB will make the final determination as to whether consent must be documented.

Option 1 for waiver the requirement to document consent - Option 1 is not applicable for FDA regulated studies. If option 1 is requested, the subject must still be given the option of signing and dating a consent form and the subject’s wishes prevail. Therefore a consent form must be submitted to the IRB for review / approval. In order for option 1 to be acceptable the answer to 9.1 and 9.2 must be yes.

9.1 Would the consent form be the only record linking the subject to the research study?

9.2 Is the principal risk that of potential harm caused if there were a breach of confidentiality? If yes, describe.

Option 2 for waiver the requirement to document consent. In order for option 2 to be acceptable the answer to both 9.3 and 9.4 must be no. The IRB may require that subjects be provided with a summary of the research and that summary must be reviewed by the IRB.

9.3 Does the research present more than minimal risk? If no, explain the rationale for this assessment.

9.4 Does the research involve any procedures for which written consent is normally required outside of the research context?

SECTION 10 - PROTECTION OF PRIVACY OF SUBJECTS & CONFIDENTIALITY OF DATA (45 CFR 46.111(A)(7) & HIPAA) 10.0 How will the privacy interest of subjects be maintained throughout the conduct of the study (note, privacy pertains to the individual not to the data)?

10.1 What information, if any, will be sought from the subject about other living individuals?

10.2 Describe the procedures to protect the confidentiality of data during the conduct of the study by addressing each element noted below (note, confidentiality pertains to the data, not the individual).

Who will own the data (UCHC or sponsor)? Describe plans for storage and security of information on hard copy, including how research records will be labeled and if applicable, how information will be protected during transportation from external sites to UCHC. Will lab results be posted to medical records or research records?

12- Revised 5/24/06, 3/22/06, 9/26/05,

Will other study related information, e.g. the informed consent document, survey tools, be posted to the medical record or research record? Describe plans for storage and security of identifiable/coded samples. Describe plans for storage and security of electronic data. Describe the security measures that are in place for the equipment that houses identifiable data. Who will have access to hardcopy, samples, and / or electronic data? How will access be managed? Describe the plans for storage or destruction of identifiable data for screened failures.

10.3 Describe procedures to continue to protect confidentiality after study closure by addressing each element noted below.

How long will information continue to be stored (note minimum is 3 years)? Describe plans for on-going storage and security of hard copy data. Describe plans for on-going storage and security of identifiable samples. Describe plans for on-going storage and security of electronic records. Who will have access to hardcopy, samples and/or electronic data? How will access be managed? Describe the plans for the destruction of identifiable data.

SECTION 11 –SAFETY MONITORING (45 CFR 46.111(A)(6)) 11.0 Have you requested exempt or expedited status for a non-GCRC supported, non-NIH funded study? (If yes,

skip to item 11.3. If no answer all questions in this section.) 11.1 Place an X after the entity responsible for safety monitoring of the study and after the type(s) of safety

monitoring in place for this study. Note: If monitoring is internal to UCHC append the completed template for creating a DSMP/B available in Appendix B. For multi-center trials, or trials with external monitoring submit the monitoring plan; and when applicable the DSMB charter, describing details of membership, frequency of meeting etc., and when possible summaries of DSMB meetings or findings that have already occurred.

Entity responsible for monitoring: If applicable describe other entities below. Monitoring internal to UCHC

Monitoring by sponsor

Monitoring by other entity (describe)

Mechanism(s) in Place Data Safety Plan Independent Monitor If applicable, describe other mechanisms below:

Data Safety Board Other (describe)

13- Revised 5/24/06, 3/22/06, 9/26/05,

11.2 Describe plans for communicating significant findings to subjects, in particular those findings that may impact the subject’s willingness to continue to participate or that relate to the safety or medical care of the subjects.

11.3 Provide a brief description of the resources available to conduct this study, including the

accessibility/availability of such resources. If a certain type of resource is not needed, explain why.

Resource Description of available resource

Accessibility /Availability

Financial resources (internal and external):

Staff (e.g. for medical/professional intervention):

Equipment (e.g. crash carts, shielding, resuscitation equipment, etc.):

Supplies:

Laboratory space:

Bed space:

Services (e.g. counseling, ancillary care):

Other Resources:

General Comments:

SECTION 12– KNOWLEDGE OF LOCAL RESEARCH CONTEXT (REQUIREMENT PER OHRP GUIDANCE DOCUMENT) 12.0 Will the study, in whole or in part, be conducted off of UCHC grounds? (If yes answer 12.1 – 12. 4. If no, skip

to section 13)

12.1 Provide the location(s) where the research will be conducted:

12.2 If the study is conducted within the U.S., describe who granted permission to conduct the research on the premises of the facility and their authority to do so. Attach proof of permission.

12.3 For study locations outside of the U.S., describe who granted permission for the study to be conducted at the foreign site and provide an explanation of the of the local experts authority to grant such approval. Attach proof of review and approval by the local equivalent of IRB or local experts.

12.4 If the study is conducted outside of the U.S., describe the investigators knowledge of the culture and language of the area:

SECTION 13– ADDITIONAL INFORMATION PERTAINING TO GENETIC RESEARCH 13.0 Does the study involve genetic research (If no skip to section 14. If yes, respond to the remaining questions in

this section.)?

13.1 Will findings related to the study be disclosed to the subject (If yes, answer 13.2 – 13.7. If no, skip to 13.8. Note that if the researchers plan to release findings the subjects must also be given the opportunity to decline receiving information.)?

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13.2 Describe what information will be provided.

13.3 Describe who will provide the information to the subject. 13.4 Describe at what point in the study the information will be provided: 13.5 Describe by what means it will be provided. 13.6 Describe the reliability of information provided: 13.7 Explain the basis upon which the disclosure decision was made.

13.8 Will unexpected and/or unrelated findings be disclosed?

13.9 If findings will be published explain how the subject’s confidentiality will be ensured.

SECTION 14 – SIGNATURE OF PRINCIPAL INVESTIGATOR AND DATE 14.0 Indicate if this protocol, or one similar to it, has previously been denied approval by any IRB panel. If it has

previously been denied approval, also provide details regarding the IRB that denied approval, for what reasons approval was denied, when it was denied and how the concerns have been addressed.

14.1 Signature of Principal Investigator. The undersigned assures that all key study personnel 1) have completed the

required human subjects training, 2) are knowledgeable of the protocol and the institutions policy for reporting unanticipated problems, non-compliance (protocol deviations/violations) and adverse events, 3) commit to conducting the study in accordance with the protocol as approved by the IRB, state law, federal regulations, Health Center policies and with the ethical principles of respect for persons, beneficence and justice as set forth in the Belmont Report. The undersigned also accepts primary responsibility for all aspects of the management of this study.

For continuing review the undersigned also believe that the information presented on this form and the addendum for continuing support on-going approval of the research.

Signature.............................................................................. Date................................... Reminder: If applying to the GCRC for support you must submit this form and all supporting document to Lisa Godin ([email protected]) for GCRC review and approval. Refer the submission instruction to determine which documents to submit to the GCRC electronically and which to submit in hard copy.
