Appendix K2 Confidentiality Agreement

K.2 Confidentiality Agreement

SNACS Study – Individual Confidentiality Agreement

Institution and Federal-wide Assurance (FWA) #: Abt Associates Inc. FWA #: 00000664

Individual’s Name: ___________________________

Study Covered by this Agreement: Study of Nutrition and Activity in Child Care Settings (SNACS)

1. The above-named Individual has participated in training required by Abt/study team and has reviewed the following materials: materials/manual describing the study protocol to be followed, including procedures to recruit and obtain informed consent from participants, and procedures to maintain participants’ privacy and protect the privacy of participants’ information. The study protocol and documents have been reviewed and approved by Abt’s research ethics committee called the Institutional Review Board (IRB).
   
   

2. The Individual understands and hereby accepts the responsibility to comply with the standards and requirements stipulated in the above documents and to protect the rights and welfare of the subjects in the research study conducted under this Agreement. The Individual acknowledges that the participant’s rights and welfare must take precedence over the goals and requirements of the study.
   
   

3. The Individual will abide by all determinations of the Abt IRB as communicated by the Abt/study team representative and will accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated study activities.

4. The Individual will report promptly to the IRB (via Abt/study team representative) any proposed changes in the study conducted under this Agreement. The Individual will not initiate changes in the study without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants.

5. The Individual will report immediately to the IRB (via Abt/study team representative) any unanticipated problems involving risks to participants or others in the study covered under this Agreement and any deviations from the study protocol and/or data security procedures.

6. The Individual, when responsible for enrolling participants, will obtain, document, and maintain records of informed consent for each such participant or each participant’s legally authorized representative as stipulated by the IRB. The Individual will not begin to enroll participants in the study until approval (by the IRB) has been communicated by the Abt/study team representative.

7. The Individual acknowledges that he/she will be allowed access to private or personal information and/or records so that he/she may perform his/her role in this study. Individual further understands and agrees not to disclose or use private or personal information and/or records outside the scope of his/her assigned role in this study without the prior consent of the appropriate authority(s).

Individual’s Signature: ___________________________ Date:_______________

Name: ______________________________________________________

Work Address: ________________________________________ Work phone #: ________________

_____________________________________________ Work email:________________________

(City) (State) (Zip)__

Abt Associates FWA Institutional Official (or Designee): __________________ Date ____________

Name: Teresa Doksum Institutional Title: IRB Chair

Address: 55 Wheeler Street Phone #: 617-349-2896

Cambridge, MA 02138 Email: irb@abtassoc.com

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