BRANY SBER IRB

BRANY **** Marcus Avenue, Suite **0, Lake Success, NY 11042 516-***-**** T 516-***-**** F www.brany.com Page 1 of 2

DATE: 07/24/2019

TO: Irene M. Bravo, Ph.D.

CC: Rolando Santana, Ph.D., Jean Rasquin, M.S.

FROM: Raffaella Hart, MS, CIP, BRANY SBER IRB (IRB00010793) SUBMISSION TYPE: SBER-Initial Review

PROTOCOL NUMBER: 19-026-447M /

STUDY TITLE: Father Involvement, Nurturance and Parenting Style and their Influence on the Intergenerational Transmission of Divorce and Quality of Life IRB ACTION: EXEMPT

DETERMINATION DATE: 07/23/2019

ANNUAL REPORT DUE: 07/22/2020

REVIEW TYPE: Exempt

Thank you for your submission for the above-referenced study. 1. BRANY SBER IRB Determination

BRANY SBER IRB has determined your submission is exempt from IRB review under category # (2)(i), as detailed in 45 CFR 46.104(d) and BRANY’s Standard Operating Procedures (category excerpted below).

(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) with the following criterion is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects

*This determination requires that all procedures and activities are performed in accordance with relevant state and local law (including tribal law, when applicable). 2. Documents Acknowledged with this Submission

a. SBER Study Application (submitted 6/24/2019), including:

• Attachment 1 - letters of support

• Attachment 2 – Flier (BRANY stamp 7/23/2019)

• Attachment 3 – Demographic (BRANY stamp 7/23/2019)

• Attachment 4 – Study Measures (BRANY stamp 7/23/2019)

• Attachment 5 – Referral Form (BRANY stamp 7/23/2019) b. Form IRB-1 - IRB Proposal (signed 5/24/2019, revised 7/22/2019) c. Informed Consent Form (Version A) (BRANY stamp 7/23/2019) BRANY SBER IRB

BRANY 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042 516-***-**** T 516-***-**** F www.brany.com Page 2 of 2

Modifications are in accord with those required by the IRB, and were incorporated as indicated in the enclosed redlined version.

3. Provisions of BRANY SBER IRB’s Determination

Although this study has been determined to be exempt for further IRB review, any proposed changes to the research must be reviewed by the BRANY SBER IRB prior to implementation. The BRANY SBER IRB will evaluate the proposed change(s) and determine whether the activity remains exempt.

4. Study Personnel

The following study personnel have provided the required evidence of training in human subjects protection and conflict of interest disclosures, and therefore may participate in the conduct of this activity.

a. Irene M. Bravo

b. Jean Rasquin

c. Eshagh Shehniyilagh

5. IRB Approval Period and Expiration of IRB Approval: Research that has been determined to be exempt from BRANY SBER IRB review is not subject to continuing review. However, BRANY SBER IRB requires you complete an annual report, or notify the IRB if the study is completed before then.

Your Exempt Annual Report to BRANY SBER IRB is due on 07/22/2020. BRANY IRB requires you

"check in" at least annually to ensure your study status is up to date, and your study remains in compliance. If your research is completed before then, you must submit a notification of study closure to BRANY SBER IRB (submit via xForm in IRBManager). If you have any questions or require any additional information, please call me at 516-***-**** or send an email to me at ad31if@r.postjobfree.com. Thank you.

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