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WRIGHT STATE UNIVERSITY EXPEDITED ADVISORY COMMITTEE ANNUAL PROGRESS REPORT Form SC - Cont. Rev. [07-2016] - Page -

RESEARCH INVOLVING HUMAN SUBJECTS - CONTINUING REVIEW QUESTIONNAIRE EXPEDITED REVIEW Must be filled in: SC # Principal Project Investigator: Title: Academic Title:

Federal Regulations mandate that all human subject protocols receive continuing review and approval not less than once per year. In order to comply with this updated policy on research involving human subjects (OPRR Reports, Number 95-01), sufficient information must be collected to allow the IRB to conduct a "substantive and meaningful" review. Therefore, in order for the WSU-IRB to comply with this and other directives and, hence, to grant continuing approval of your protocol, the following information/documents are required: a completed continuing review questionnaire, a summary of previous protocol activities and future project plans, and, if subjects are still being accrued, copies of all Informed Consent documents, surveys and/or questionnaires currently being used.

See instructions at end for returning completed form. The appropriate Board/Committee cannot proceed with the request for action on this protocol unless all items have been adequately addressed and this form contains the investigator's signature. If a question does not apply to your protocol, so indicate (e.g., "Not Applicable" or "N/A").

If you do not respond to this questionnaire, we will assume the project is not currently active, the protocol will be placed in the inactive file, and the IRB will be so notified.

The information in this petition may become publicly available either through the Ohio Open Records Act or through open meetings.

Respond to all four sections first:

I. Dates covered by this progress report: Previous 12 months Other period as described:

A. Enter last continuing review approval effective through date

II. Is this project currently active? Yes No

A. Is this study a retrospective record/chart review? Yes No

B. If not currently active, indicate the termination date of your project:

III. Is this project currently open to subject recruitment?

Yes No * N/A

If No, please indicate the date closed to recruitment:

IV. Do you wish to continue this protocol?

Yes ** No

If Yes, please complete the attached project summary (Item V) and return to Research and Sponsored Programs. Attach copies of the appropriate informed consent and other relevant document(s).

*NOTE: For studies that have been closed to recruitment, check here to indicate that there are no changes or adverse events that need to be reported to the IRB ; it is not necessary to complete Item V. **NOTE: If this study was approved as “exempt” and is unchanged, check here ; it is not necessary to complete Item V. V. PROJECT SUMMARY SC - Cont. Rev. (07-2016) - Page -

A. Have there been any changes in leadership, responsibility, or major personnel?

Yes No

If Yes, then fully describe:

If new personnel have been added, has the required CITI training been completed? Yes No N/A

B. Briefly summarize the study objectives and procedures, include applicable treatment regimens: (attach additional page(s) if required)

1. Objectives:

2. Procedures:

C. Concisely summarize any changes in Objectives, Procedures, and Informed Consent Documents that have occurred during the previous period. Provide documentation of IRB approval of these items. If applicable, provide details of any changes (e.g., status of, treatment with, use of) in: Investigational New Drugs (IND), Investigational Devices (ID), experimental surgery, and biohazard usage. Attach additional page(s) if required. If no changes, enter “none.”

D. Research Subjects:

1. List each group, arm, cohort, etc., if applicable, including control groups, on separate lines. If only one group, description would be “All.”

NUMBER OF SUBJECTS AGE RANGE OF SUBJECTS GENDER (at all sites for which you are the PI) (at all sites for which you are the PI) (of subjects to date) This Total Next Period This Next Period % % Group Period Accrual to (anticipated Period (anticipated) Male Female Date** )

** If the accrual of subjects has been lower than anticipated over the past year, explain how this will impact the ability to complete the protocol's research objectives:

2. Was the subject population representative of the population base from which subjects could be selected with respect to: a. Gender representation? Yes No If No, explain: SC - Cont. Rev. (07-2016) - Page -

For VA studies only: Number of Males ______Number of Females ______

b. Minority representation? Yes No If No, explain: For VA studies only: Number of Subjects from Minorities*: ______

*Minorities defined as (1) Asian American (2) Black (3) Hispanic (4) Native American (including American Indian, Alaskan Native, and Native Hawaiian) or (5) Pacific-Islander American

c. For VA studies only: Number of Vulnerable Population Subjects*: ______

*Defined as groups of persons whose range of options is severely limited, who are frequently subjected to coercion in their decision making, or who may be compromised in their ability to give informed consent.

3. Have any subjects withdrawn from study since the study began?

Yes No

If Yes, explain:

4. Are you aware of any breach in confidentiality? (e.g., unauthorized access to medical record(s))

Yes No

If Yes, describe:

E. Adverse Events - Clinical/Treatment/Intervention studies: [if the study is conducted at multiple sites, please include national trial information as well. If previously reported to the Board, reference the reporting dates.]

1. Have there been any unexpected toxicities or problems?

Yes No

If Yes, please summarize these unexpected toxicities or problems, the number of occurrences, and indicate if they required consent document changes, particularly in the “risks” section. If risks are affected, describe how they are minimized and reasonable in relation to expected benefits. If available, attach copies of data safety monitoring reports.

2. Were there major (e.g., severe or life threatening) toxicities?

Yes No

If Yes, please summarize these major toxicities, the number of occurrences, and indicate if they required consent document changes.

3. Have there been any deaths on study (from any cause)?

Yes No

If Yes, list each separately and the apparent cause. SC - Cont. Rev. (07-2016) - Page -

F. Negative Reactions: Have there been any unexpected/unusual negative responses as a result of subject recruitment? (i.e., angry letters, phone calls, threats of legal action)

Yes No

If Yes, describe:

G. Briefly summarize study findings to date. If findings to date are not available, explain why not.

H. Comment briefly about plans for the next twelve months:

I. Revisions/Amendments/Modifications:

1. Are there revisions/amendments to the protocol, consent form(s), questionnaires, etc. that are included with this renewal? Yes No

If Yes, provide a brief description below and highlight the changes on the document(s) to be reviewed.

2. Will the revisions/amendments change the scope or research objectives of the protocol? Following are examples of actions considered to change the scope or research objectives: A change in the specific aims approved at the time of award (funding); a change from the previously approved use of human subjects; shifting the emphasis of the research from one disease to another. Yes No N/A

If Yes, provide sufficient information/documentation to allow the IRB to review and approve prior to initiation.

3. Will the revisions/amendments change risks to subjects?

Yes No N/A

If Yes, provide sufficient information/documentation to allow the IRB to review and approve prior to initiation. In particular, describe how risks are minimized and reasonable in relation to expected benefits.

J. Provide a listing of all publications, presentations and reports that have resulted from this work since the last review. If none, so state. SC - Cont. Rev. (07-2016) - Page -

Check if this protocol includes proprietary/confidential information. Provide a statement and any relevant documentation. (Note: The IRB cannot act on a request for consideration of confidentiality without appropriate justification and relevant documentation. For further information concerning what constitutes proprietary or confidential information, you may contact the Wright State University Office of General Counsel (775-2475).)

INVESTIGATOR'S STATEMENT:

As PRINCIPAL INVESTIGATOR, I acknowledge that I am responsible for reporting any emergent problems or serious adverse effects or reactions; that I will submit any proposed procedural modifications to the IRB for its review and approval and, except where necessary to eliminate apparent immediate hazards, no such modifications will be put into effect without prior Institutional Review Board (IRB) approval; that unless otherwise directed by the IRB Chairperson, I will renew this application with the IRB no less than annually; that the research project is being conducted in compliance with the IRB's understanding and recommendations; that the IRB is provided all the information on the research project necessary for its complete review; and that this research project will not be put into effect until final IRB approval is received.

______Signature of Principal Investigator Date

______Signature of Faculty Advisor (if applicable) Date

Instructions When form is completed, please print it out, sign it, and attach any additional supporting documents (e.g., current consent form, questionnaires and/or survey forms, data collection sheet). For studies that are open to subject accrual/chart reviews open to data collection, please submit by hard copy one single-sided original of documents, and one double-sided, collated copy. For studies closed to recruitment/data collection, one single-sided original is sufficient. Send your submission to Jodi Blacklidge, 201J University Hall.