Application for Continuing Review/Renewal of IRB Protocol

Application for Continuing Review/Renewal of IRB Protocol

Part I: Administrative Information

A. Protocol Information

Title of Protocol
Protocol #
Prior Protocol Approval Date
Protocol Expiration Date
Type of Review (full board, expedited)

B. Principal Investigator (PI)

Name
Degree/Title
Dept. & College at RFUMS
Email
Phone
Most recent CITI training*

C. If this is a postdoctoral or student project (supervised and sponsored by the faculty PI) provide name of the trainee:

D. List all members of the research team (add rows as needed):

Name & Title / Email / RFUMS Dept. & College;
Work Address (if non-RFUMS) / Role in project / Date of recent CITI training*

* Include pdfs of all training certificates with application

E. Funding information

Federal funding agency (direct award)
Federal flow through funds (subcontract/collaborator)
Non-federal grant or sponsor
Other
None

External funding agency/sponsor information including Grant or Sponsor’s Project ID number:

F. PI’s Assessment of Risk Level for this project

Minimal* risk
Greater than minimal risk

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

G. Are the research activities subject to FDA regulation?

A research activity is subject to FDA regulation if: 1) the activity involves any use of a drug, other than the use of marketed drugs in the course of the practice of medicine; 2) the activity involves the evaluation of a device for safety or efficacy; or 3) data will be submitted to or held for inspection by FDA.)

Yes / No

Part II: Study Overview

A. Non-technical summary

Please provide a layperson summary of the overall study including the research questions and objectives and a general but complete overview of what activities with human subjects were approved by the IRB. This lay summary should not contain complex terms or undefined abbreviations and should be easily understandable to a high school student. If possible, limit to 500 words.

B. Progress report - since the last IRB approval

Briefly summarize the progress of the study since the last IRB approval (either initial approval or the prior continuing review approval date, whichever applies).

C. Research activities - since the last IRB approval

Indicate all types of research activities that were conducted on this protocol since the last IRB approval date.

Active collection of data from subjects (not biological materials or physiological data)
Active collection and use of biological materials or physiological data from subjects
Use of physiological or biomedical devices, drugs, biologics, or chemicals with subjects
Use of existing data (not human biological materials)
Use of existing human biological materials
Other (briefly describe if checked):

D. Participant Information

1. Number of Participants

Total number approved for enrollment:
Number currently enrolled:
Desired but not yet enrolled:

2. During the next year do you plan to recruit new participants?

Yes / No

If yes, please explain:

3. Do you plan to collect additional data from currently enrolled research participants?

Yes / No

If Yes, please describe the types of information and study procedures that you plan to conduct during the coming year (or approval period if less than a year).

If No, indicate if you are moving into a data analysis/manuscript phase only for the coming year (or provide other explanation).

4. Recruitment: Select which statement accurately applies to your research project:

Statement A: Potential subjects will self-identify based on response to an advertisement, flyer, presentation or respondent driven sampling that was IRB approved.
Statement B: Potential subjects will be recruited based on information contained in private/protected records (medical records, student records). This also includes subjects who will be recruited from the PI or Co-I’s patient population.

If statement B is selected, answer questions a-c below:

a) Explain how the researcher has legitimate access to these records.

b) Identify who will make initial contact with potential subjects.

c) Will the records include MEDICAL (HIPAA protected) records?

No
*Yes

*If Appendix P “Use of Protected Health Information” was not previously approved,

you must attach it with this continuing renewal application

5. Since the last IRB approval has there been any of the following:

Yes* / No
a) Serious adverse event that was not already reported?
b) Unexpected problems involving risk to human participants or others that was not already reported?
c) Subject withdrawals from the study or complaints about the research activities?
d) Discovery of any literature relevant to this research?
e) Interim Findings of relevance to continuing aspects of study?
f) Changes/modifications to your study (including study location/performance sites, recruitment, informed consent, study design and/or research procedures, research personnel, etc.) not previously disclosed or approved by the IRB?
g) Noncompliance with research policies or IRB requirements that was not already reported?
h) Report about activities within a multi-site trial (from the sponsor, another IRB, another PI, or other source) that might affect the rights or welfare of human participants and that was not already reported?
i) Other issues not covered above?

*For any “yes” response, please list category and describe fully here (attach materials as needed to this application at submission):

Part III: Proposed Changes to Study Design (complete only if relevant)

A. Please select ALL of the categories of amendment you are requesting (Details will be added in section III.B):

1. None
2. Addition or change of key research personnel – *Attach CITI training certifications
3. Addition or change in funding source – *Attach updated OSR form
4. Change to research/study design, methods or procedures - *Attach as separate document if extensive, otherwise discuss in section III.B.
5. Addition of/change to the study population - Provide details in section III.B
6. Addition of/change to recruitment or compensation procedure(s) *Attach copies of the revised instrument/s
7. Addition of/change to survey(s), questionnaire(s) or other research instruments - *Attach copies of the revised instrument/s
8. Addition/change in Performance Sites for research - *Attach any new authorizations or agreements that are relevant
9. Addition of/change to the identifiers collected in the study, or any others that would impact the privacy and confidentiality of the study participants. Provide details in section III.B
10. Addition of/change to informed consent/assent document(s) and/or procedures - *Attach copies of revised documents.
11. Change in Study Title- Provide details in section III.B
12. Change in Principal Investigator - *Attach CV to application and discuss reason for change and relevant experience of new PI and in section III.B
13. Other changes (List) here - Provide details in section III.B:

Note: “key” personnel refers to anyone who will interact directly with human subjects or access identifiable private data from subjects.

*A copy of the modified documents/instruments with the proposed changes in yellow highlighting and a clean copy of the modified study materials you propose to use for this project in the coming year must be submitted with this application.

B. Description/Rationale for each proposed change noted in Section IIIA (above)

1. For each of the modifications checked above: List topic (by number), describe the proposed change, and discuss the purpose or reasons you wish to make the change. Be sure to attach the modified materials you are seeking approval for with this application.

2. Are any of the proposed changes the result of something that occurred during participant interactions or an unexpected event?

Yes / No

If yes, please explain:

3. Do the changes involve addition of vulnerable populations not previously approved for this study?

Yes / No

If yes, please explain additional safeguards that will be used to protect these individuals and attach the relevant Appendix (V-B, V-C, V-D) available on the IRB website if required:

4. Will the proposed changes have an impact on the risks or benefits to research participants?

Yes / No

If yes, please explain:

5. Will the proposed changes alter the informed consent process?

Yes / No

If yes, please explain:

6. Do the proposed changes involve information that might relate to a subject's willingness to continue to take part in the research?

Yes / No

If yes, please explain:

Part IV: Conflict of Interest (COI) Disclosure

Rosalind Franklin University Policy requires that personnel conducting research involving human participants at Rosalind Franklin University disclose any significant personal conflict of interest that would reasonably appear to be affected by, or potentially influence the research project. A personal interest is any interest held by the individual that is not associated with employment or affiliation with the University (e.g. salary from this University is not a personal interest). Although the scope of the term is extensive, the most common types of personal interests are: financial, familial, and institutional:

·  Financial interest is the receipt or expectation of receiving a thing of monetary value of any amount (e.g., stock, patent, partnership, gift, income, reimbursements, and honoraria, but does not include a publicly traded mutual fund).

·  Familial Interest is an existing or expected relationship with a particular person by blood, marriage, or adoption (or substantially similar relationship).

·  Organizational Interest is a current, recent, or expected status as member, employee, officer, director, trustee, consultant, or agent of an entity.

Yes / No
Do you, your spouse and/or your dependent children have any personal interests (defined above):
§  That could reasonably appear to be affected by the results of this research project?
§  With the external sponsor of this research project?
§  With any other entity whose financial interests could reasonably appear to be affected by this research project?
§  That creates an actual or apparent bias or improper influence upon your judgment relating to this research project?
§  In the experimental item of this research project?
Does this protocol include research that overlaps with any patent you are part of?
Does any member of your research team have a situation where that person would answer “yes” to any of the subparts of the questions above?

If you answered “Yes” to any of the questions, please contact Rosalind Franklin University’s COI office for guidance on next steps regarding disclosure, review of the financial interest and resolution or management of any real or apparent conflict of interest. The IRB is not able to approve this project until it has been determined by the COI office that no investigator or personnel involved in this research activity has a conflict of interest related to this research.

Part V: Assurances and Signatures

Before submitting an electronic copy of this application, “X” or otherwise clearly mark the attestation box and type your name and today’s date.

As Principal Investigator of this study, I assure the IRB that the following statements are true:

• I acknowledge that the information provided and that I have the duty and responsibility to protect the rights and welfare of the human participants as well as the scientific and ethical integrity of this research project

• I have determined I have the resources necessary to protect participants, such as appropriately trained research staff, necessary facilities and equipment and funds needed to accomplish the objectives.

• I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in procedures, co-investigators, funding agencies, etc.

• I will promptly report any unexpected or otherwise significant adverse events or unanticipated problems or incidents that may occur in the course of this study.

• I will report in writing any significant new findings which develop during the course of this study that may affect the risks and benefits to participants.

• I will not begin my research until I have received written notification of final IRB approval.

• I will comply with all IRB requests to report on the status of the study.

• I will maintain records of this research according to IRB guidelines.

• If these conditions are not met, I understand that approval of this research could be suspended or terminated.

Attestation of Principal Investigator

Name/Signature of PI Date

Please save a copy of this completed and signed application form and send it, along with the attached checklist and any required materials electronically to . After review and approval by the IRB, you must also send one final printed hard copy of all of the application materials to the IRB office via campus mail before IRB will issue an approval letter.

If you have any questions or need assistance, please contact the IRB staff.

Phone: 847-578-8713; email:

CHECKLIST - Protocol Submission: IRB Continuing Review/Renewal

PI must type an “x” for each item included (or “n/a” for not applicable).

Principal Investigator
·  Confirm: The PI has a faculty appointment at RFUMS as professor, associate professor, assistant professor or instructor.
·  Confirm: The PI is not listed on the FDA Debarment list and isn’t disqualified or restricted in any way from clinical research.
·  ONLY if requesting a change in PI: Provide CV of the new PI
Application Documents
·  Fully completed application form
·  PI and research team members most recent CITI training certificates (date of training should match date provided on the application)
·  Appendix P – Use of Protected Health Information (PHI) (if applicable and not previously approved)
·  ONLY if funding source has changed or new personnel have been added to the study: Include screening form for OSR & EHS
·  ONLY if modified and seeking approval for recruitment process: Include new materials (e.g. flyer, letter, printed ad, e-mail text, phone script, etc.)
·  ONLY if modification includes addition of new recruiting sites: Include letters of support/permission from any recruitment sites outside of RFUMS campus
·  ONLY if modified and seeking approval for new research instruments: Include materials (e.g. tests, interviews, surveys, questionnaires, etc.)
·  ONLY if modified and seeking approval for OTHER documents (not listed above): Include other relevant documents (e.g. Required Appendices, updated sponsor brochures)
·  Certificate of Confidentiality (Only if modifications make this applicable)
·  Data Use Agreement (Only if modifications make this applicable)
Informed Consent Document
·  Informed Consent form(s)
·  Assent form – minor subjects
·  Parent/guardian permission form – for minor subjects
·  Check ONLY if no longer recruiting subjects for this project
Other Application Documents for Collaborative Studies
·  ONLY if modification includes addition of new performance site(s) off campus, or that involve outside investigators (non-RFUMS). One or more of the following documents will be required:
o  Individual Investigator Agreement RFU
o  IRB Authorization Agreement 1 RFUMS as IRB of record
o  IRB Authorization Agreement 2 RFUMS Not the IRB of record
·  You have marked the attestation box and TYPED your name and the date.

Approval by Institutional Review Board: