IRB Renewal Or Closure

IRB Renewal Or Closure

IRB Progress Report/Renewal Page 1

DOMINICAN COLLEGE

INSTITUTIONAL REVIEW BOARD PROGRESS REPORT/RENEWAL FORM

This application is for the purpose of seeking renewal or to report closure of a human subjects research project that has been approved by the IRB. All studies involving human subjects except those exempted by the IRB require continuing IRB review at intervals appropriate to the degree of risk, but at least once per year. Conducting human subject research without current IRB approval is a violation of federal and institutional regulations. If IRB approval of a project expires, no new subjects may be enrolled and all ongoing research activities must stop.

If study has ended:

  • Complete and submit the progress report (i.e., one copy of pages 2–5, note some checklist items are not applicable)

If research is continuing:

  • Complete and submit the progress report and include all items identified in thechecklist on page 3.

Any changes to original research protocol:

  • Any changes made in the research protocol since the original application must appear on a new applicationalong with submission of this Renewal/Progress Report Form. Changes must be underlined and in bold type.

Please address all applications and other correspondence to the current IRB chair (see website for current chair name:

DOMINICAN COLLEGE

INSTITUTIONAL REVIEW BOARD

470 Western Highway

Orangeburg, NY 10962

Action requested by Principal Investigator (choose only ONE):

Renew approval:

__ Study has always involved only analysis of existing data or specimens. Continue as approved.

__ Study involves(ed) direct interaction/intervention or contact with subjects. Continue as approved: Enrollment of new subjects continues.

__ Enrollment of new subjects closed; interaction/intervention with previously enrolled subjects continues.

__ Direct interaction with subjects completed but subsequent monitoring or follow up continues.

__ Subjects’ involvement completed but renewal is requested for data analysis.

__ Study has not commenced.

__ Other. Please explain.

Closure of Study:

__Research completed: Identifiable data or human biological specimens are stored according to plan already approved by the IRB.

__Research completed: All data are deidentified

__Lack of funding or other (specify):

IRB study #:Date:

Title of Study:

Principal Investigator:

Faculty advisor (if applicable):

1.In a few sentences, describe the past year’s work, and describe what you plan for the upcoming year, including data analysis, if relevant.

2.Number of subjects involved through direct contact or use of their data (for multi-site studies, include only subjects covered by this IRB):

a.Number approved for involvement by IRB:

b.Total number of subjects involved to date:

c.Projected number of subjects to be added in next 12 months (if renewing):

Answer the following questions based on information since initialapprovalor last renewal.

3. Have any subjects withdrawn voluntarily or been withdrawn from the study?
If yes, explain below; give number and reasons for withdrawals. / __ yes __ no
4. Have there been any complaints about the research from subjects or others?
If yes, explain. / __ yes __ no
5. Have there been any adverse events since the last renewal? If yes, include all copies of Adverse Event reports with this submission. / __ yes __ no
6. Have there been any modifications approved since the last review? If yes, include all copies of approved changes. / __ yes __ no
7. Have there been any findings (e.g., publications, new information) that alter the risk/benefit ratio or otherwise impact the study? If yes, explain, including whether these new findings are relevant to participants’ willingness to continue. / __ yes __ no
8. Are you requesting any changes to the study or consent documents? If yes, include the form requesting Modification of Approved Human Subjects Research and underline the proposed change in the updated application and/or consent documents. / __ yes __ no
9. Will you be enrolling, consenting or re-consenting subjects in the upcoming approval period? If yes, include any new recruitment materials to be used with subjects. / __ yes __ no

Comments: ______

______

______

______

______

______

If the research is continuing (if a renewal is requested):

  • Check the relevant items below.
  • Include two collated sets of copies (sorted in the order listed) of checked items.

(Submissionswill be returned if these instructions are not followed.

Check / Item / Total No. of Copies
□ / 1. This form is for the purpose of renewal . / 2
□ / 2. Check any items specifically requested in questions # 4 through 10 (in that order). / 2
□ / 3. The most recent application submitted for IRB approval. This application should be updated to include any modifications since the study was initially approved or last renewed. If there are any new modifications included with this renewal, highlight the proposed modifications by underlining. / 2
□ / 4. Clean copies of all consent document(s) to be used in the upcoming approval period. / 2

PRINCIPAL INVESTIGATOR’S STATEMENT OF ASSURANCE

FOR RENEWALS:

I certify that I have read these statements below and will continue to conduct this study in accordance with Ethical Principles as set forth in the Belmont Report and in accordance with the policies of Dominican College’s IRB.

I agree to:

a.Obtain the voluntary informed consent of participants or their legally authorized representative.

b.Promptly report any research problems to the IRB.

c.Obtain approval from the IRB before implementing changes in the approved research protocol or approved documents.

d.Maintain informed consent and other completed research documents for a minimum of three years.

e.Accept responsibility for the conduct and supervision of this research and protect human participants as required by state and federal laws.

Further, if I use student research investigators, I ensure they have been trained,and are qualified to conduct this research and protect human research participants. I will (or have) submit(ted) Ethics certificates as evidence of their training.

FOR STUDY CLOSURE:

I certify that the information I have submitted herein concerning my study (or my student’s study) is accurate to the best of my knowledge.

______

Signature of Principal InvestigatorDate

______

Signature of Co-Investigator (or Faculty Advisor) (if applicable)Date