Memorandum - Reginfo.gov

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Memorandum

Date September 27, 2017

From Kathy Masterson, CIP IRB Administrator, NIOSH Institutional Review Board

Subject IRB Approval of Continuation of NIOSH Protocol 11-DSR-02XP, “Workplace Violence

Prevention Programs in NJ Healthcare Facilities” (Expedited)

To Marilyn Ridenour, BSN, MBA, MPH, CPH Project Officer, DSR, NIOSH

The NIOSH IRB has reviewed and approved your request to continue protocol 11-DSR-02XP for the maximum allowable period of one year and it will expire on September 21, 2018. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), Categories (7) and (5). The IRB determined that the study poses no more than minimal risk to subjects. A waiver of documentation of informed consent is granted per 45 CFR 46.117 (c)(2). If other institutions involved in this protocol are being awarded NIOSH funds through the CDC Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to the CDC PGO award specialist handling the award. You are also required to verify with the award specialist the awardee has provided PGO with the required documentation and has approval to begin or continue research involving human subjects as described in this protocol. As a reminder, the IRB must review and approve all human subjects research protocols at intervals appropriate to the degree of risk, but not less than once per year. There is no grace period beyond one year from the last IRB approval date. It is ultimately your responsibility to submit your research protocol for continuation review and approval by the IRB along with available IRB approvals from all collaborators. Please keep this approval in your protocol file as proof of IRB approval and as a reminder of the expiration date. To avoid lapses in approval of your research and the possible suspension of subject enrollment and/or termination of the protocol, please submit your continuation request along with all completed supporting documentation at least six weeks before the protocol's expiration date of September 21, 2018. Any problems of a serious nature must be brought to the immediate attention of the NIOSH IRB, and any proposed changes to the protocol should be submitted as an amendment to the protocol for NIOSH IRB approval before they are implemented. If you have any questions, please contact the CDC Human Research Protection Program (513)533-8591 or e-mail: [email protected].

mailto:[email protected]

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O G � W a l m ] c ¹ E a m X i ` a d h W e ^ ` a c ^ X b ` ^ � i � ` c h c h ^ ] h \ ` X i W � c h ^ � W X Y Z [ \ ] ^ b ` W [ ^ a ] ^ Z X ^ b ^ a c ` W a ] W e e ` c c ^ ^ i �


� ; B @ 7 9 ; D ; : K L M Y B 8 6 B y ; D 6 Z oI J I K L M{ ; D N I J I K L M 7 8 < ; > E 8 K L M @ > 7 8 ; < 9 ë @ 7 9 ; D @ E < 6 6 = 6 D 7 P 5 > ? = 9 7 : ; < = W O V � £ V 9 : 7 8 9 5 9 5 @ D 6 G < 6 � > 6 5 7 [K D 5 7 9 7 > 7 9 ; D ; < ; < E @ D 9 ë @ 7 9 ; D A < ; F 9 n 9 D E K L M < 6 F 9 6 G oK L M < 6 E 9 5 7 < @ 7 9 ; D D > = ? 6 < Y 9 : y D ; G D Z oT 6 n 6 < @ C G 9 n 6 @ 5 5 > < @ D B 6 D > = ? 6 < Y 9 : @ D H Z oK L M N n 6 7 6 < = 9 D 6 n C 6 F 6 C ; : < 9 5 y 7 ; 5 > ? ì 6 B 7 5 Y B 8 6 B y ; D 6 Z o½ 9 D 9 = @ C¼ < 6 @ 7 6 < 7 8 @ D = 9 D 9 = @ CQ > E E 6 5 7 6 n C 6 F 6 C ; : K L M < 6 F 9 6 G Y B 8 6 B y ; D 6 Z oQ 6 6 \ ] ^ _ Á � Ê � � d d È Á � � è Ä d c b d c ] d h b d i : ; < n 6 7 @ 9 C 6 n @ 5 5 9 5 7 @ D B 6 O K : < 6 C H 9 D E ; D @ D ; D N I J I K L M z A C 6 @ 5 6 9 D n 9 B @ 7 67 8 6 C 6 F 6 C ; : < 6 F 9 6 G 7 8 @ 7 H ; > 7 8 9 D y 9 5 @ A A < ; A < 9 @ 7 6 > D n 6 < 8 > = @ D < 6 5 6 @ C @ 7 9 ; D 5 OI ; D F 6 D 6 n N ? ; @ < n < 6 F 9 6 G 9 5 5 > E E 6 5 7 6 nL 6 @ 5 ; D : ; E E 6 5 7 6 n z > D n 6 < 7 8 6 : ; C C ; G 9 D E B @ 7 6 E ; < 9 6 5 Y B 8 6 B y @ C C 7 8 @ 7 @ A A C H Z oV @ Q 7 > n H ; : n < > E 5 D ; 7 < 6 � > 9 < 9 D E K D F 6 5 7 9 E @ 7 9 ; D @ C { 6 G J < > E 6 � 6 = A 7 9 ; D : < ; = T J ¾V ? Q 7 > n H ; : = 6 n 9 B @ C n 6 F 9 B 6 5 D ; 7 < 6 � > 9 < 9 D E K D F 6 5 7 9 E @ 7 9 ; D @ C J 6 F 9 B 6 � � 6 = A 7 9 ; D : < ; = T J ¾� @ I ; C C 6 B 7 9 ; D ; : ? C ; ; n : < ; = 8 6 @ C 7 8 H z D ; D A < 6 E D @ D 7 @ n > C 7 5 Ë ? 6 C ; G F ; C > = 6 C 9 = 9 7 z = 9 D 9 = @ C C H 9 D F @ 5 9 F 6� ? I ; C C 6 B 7 9 ; D ; : ? C ; ; n : < ; = ; 7 8 6 < @ n > C 7 5 @ D n B 8 9 C n < 6 D Ë ? 6 C ; G F ; C > = 6 C 9 = 9 7 z = 9 D 9 = @ C C H 9 D F @ 5 9 F 6� p < ; 5 A 6 B 7 9 F 6 D ; D 9 D F @ 5 9 F 6 B ; C C 6 B 7 9 ; D ; : ? 9 ; C ; E 9 B @ C 5 A 6 B 9 = 6 D 5 : ; < < 6 5 6 @ < A ; 5 6 5R I ; C C 6 B 7 9 ; D ; : n @ 7 @ 7 8 < ; > E 8 < ; > 7 9 D 6 z D ; D 9 D F @ 5 9 F 6 A < ; B 6 n > < 6 5 z 9 D F ; C F 9 D E D ; E 6 D 6 < @ C @ D 6 5 7 8 6 5 9 @ z5 6 n @ 7 9 ; D z � N < @ H 5 z ; < = 9 B < ; G @ F 6 5S L 6 5 6 @ 5 6 5 = @ 7 6 < 9 @ C 5 B ; C C 6 B 7 6 n 5 ; C 6 C H : ; < D ; D < 6 5 6 @ < A ; 5 6 5U I ; C C 6 B 7 9 ; D ; : n @ 7 @ : < ; = F ; 9 B 6 z F 9 n 6 ; z n 9 E 9 7 @ C z ; < 9 = @ E 6 < 6 B ; < n 9 D E 5 = @ n 6 : ; < < 6 5 6 @ < A ; 5 6 5£ L 6 5 6 @ 5 6 5 9 D 7 6 < F 9 6 G z A < ; E < @ = 6 F @ C > @ 7 9 ; D z 8 > = @ D : @ B 7 ; < 5 z ; < � > @ C 9 7 H @ 5 5 > < @ D B 6 = 6 7 8 ; n 5I ; D 7 9 D > 9 D E < 6 F 9 6 G ; : < 6 5 6 @ 5 C H @ A A < ; F 6 n ? H 7 8 6 B ; D F 6 D 6 n K L M G 8 6 < 6� @ 7 8 6 < 6 5 6 @ ? ì 6 B 7 5 Ë @ C C 5 > ? ì 6 B 7 5 8 @ F 6B ; = A C 6 7 6 n @ C C < 6 5 6 @ A ; : 5 > ? ì 6 B 7 5� ? D ; 5 > ? ì 6 B 7 5 8 @ F 6 ? 6 6 D 6 D < ; C C 6 n @ D n D ; @ n n 9 7 9 ; D @ C < 9 5 y 5 8 @ F 6 ? 6 6 D 9 n 6 D 7 9 : 9 6 n� B 7 8 6 < 6 = @ 9 D 9 D E < 6 5 6 @ 9 D E < 6 F 9 6 G ; : < 6 5 6 @ D n 6 < K { J � K J � z G 8 6 < 6 B @ 7 6 E ; < 9 6 5 � 7 8 < ; > E 8 � n ; D ; 7 @ A A C H ? > 77 8 6 K L M 8 @ 5 n 6 7 6 < = 9 D 6 n @ D n n ; B > = 6 D 7 6 n @ 7 @ B ; D F 6 D 6 n = 6 6 7 9 D E 7 8 @ 7 7 8 6 < 6 5 6 @ < B 8 9 D F ; C F 6 5 D ;E < 6 @ 7 6 < 7 8 @ D = 9 D 9 = @ C < 9 5 y @ D n D ; @ n n 9 7 9 ; D @ C < 9 5 y 5 8 @ F 6 ? 6 6 D 9 n 6 D 7 9 : 9 6 nI 8 6 B y @ C C 7 8 @ 7 @ A A C H O J 6 5 B < 9 ? 6 @ n n 9 7 9 ; D @ C = @ 7 6 < 9 @ C 9 D 7 8 6 B ; = = 6 D 7 5 5 6 B 7 9 ; D O L 6 � > 9 < 6 n 9 7 6 = 5 @ < 6 9 D n 9 B @ 7 6 n O � A 7 9 ; D @ C9 7 6 = 5 = @ H ? 6 < 6 � > 6 5 7 6 n ? H � L p � ; < 7 8 6 K L M OI ; = A C 6 7 6 A < ; 7 ; B ; C Y < 6 � > 9 < 6 n 9 : < 6 5 6 @ ? ì 6 B 7 5 z 9 5 > D n 6 < K { J � K J � z ; < 8 @ 5B 8 @ D E 6 n 9 D 7 8 6 A @ 5 7 V � = ; D 7 8 5 Z# $ % & ' $ ( )( * + , * - . / 0 1 2 0 3 . 4 3 , 4 3 5 ( * 6 4 * 7( * 6 8 9 : ; 9 : < = ; 2 > 2 ? 1 0 . 0 @ 0 A $ > B C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C ? D 5 * ;J J P Q R S P E H T U

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( m $( * - * D 1 @ ] m 1 4 D 3 5 A * ? D 1 f _ # 2h 3 3 * n * 3 \ 0 3? 1 * 6 4 0 , - A \ 1 * ^ 0 1 . * `# 0 . * 3 5 D 5 * `' 2 2 b ) c : < = : c Ì 8 Z Z �< í 9 = < 9 : < = 88 8 8 = ( * 6 4 * 7 a \ A 0 @ D A $ ( )< � 9 8 < 9 : < = 8( m $ @ 0 e ^ A * . * ` : - , 1 6 * \ - d # 0 . * 3 5 D 5 * ` dJ J P Q R S P E H T U

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