Attach 17 - IRB Approvals

Attachment 17 – ASA24 Dietary Recall Comparison and Feeding Studies

IRB Approvals

NCI IRB – Dietary Recall Comparison Study (TO BE ATTACHED)

NCI IRB – Feeding Study

Westat IRB - Dietary Recall Comparison Study – Page 2-3

Westat IRB - Feeding Study – Page 4

Henry Ford IRB – Page 5-6

Kaiser IRB - (TO BE ATTACHED)

NCI Feeding Study IRB Approval

Date:	June 10, 2009
To:	Susie McNutt, Project Director
From:	Kerry Levin, Chair Westat IRB
Subject:	Initial Approval of ASA24 Comparison Study, Project 8372.02.22 FWA 5551

As Chair of the Westat Institutional Review Board (IRB), I have reviewed the materials submitted for the following: ASA24 Comparison Study, Project 8372.02.22. Pursuant to 45 CFR pt. 46, the IRB reviews all studies involving research on human subjects. This project is sponsored by The National Cancer Institute (NCI). The IRB overseeing protections of human subjects for this project is the Marshfield Clinic Research Foundation.

The 24 hour dietary recall comparison study is designed to compare self-reported dietary intake data using the newly developed web-based Automated Self Administered 24-hour Recall (ASA24) to the current standard of interview-administered 24-hour recall, the Automated Multiple Pass Method (AMPM).

The sample will be drawn from three health maintenance organizations (HMO) ---Security Health Plan (using the Marshfield Clinic), Wisconsin; Henry Ford Health System, Michigan; and Northern California Kaiser-Permanente, California, all participants of NCI’s Cancer Research Network. Interested participants from each center will be directed to a study website where they will provide their contact information through a secure on-line consent form.

Westat’s role will include monitoring and tracking consents from the initial contact and provide the centers with a list of those who do not respond within 10 days of mail out. Each center will follow-up with these non-responders and send a second mailing. Westat will continue to track consents until the quota for each stratum is met. Westat will follow-up with individuals who have consented to participate and administer, by telephone, a screening questionnaire to ascertain eligibility for the study. Following, Westat will conduct cognitive interviews in order to test questions for a survey about late life disability trends and dynamics in individuals over 65 years.

Electronic data will be password protected and stored by the data management contractor, and also will be destroyed after a year.

The IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt. 46.110 (b) (1)]. This study can be considered minimal risk. I am therefore approving this study under expedited authority. Per 45 CFR 46 117, your request for a waiver of documentation of informed consent is also approved.

If activities change, please contact the IRB Office to ensure that the status is accurately reflected in our records. You are only required to submit the study for a continuing review on or before June 10, 2010 if activities change for this project. In the interim, you are responsible for notifying the Office of Research Administration as soon as possible if there are any injuries to the subjects, problems with the study, or changes to the study design that relate to human subjects.

cc: Institutional Review Board

Susan Crystal Mansour

Date:	June 10, 2009
To:	Susie McNutt, Project Director
From:	Kerry Levin, Chair Westat IRB
Subject:	Initial Approval of ASA24 Feeding Study, Project 8372.02.23 FWA 5551

As Chair of the Westat Institutional Review Board (IRB), I have reviewed the materials submitted for the following: ASA24 Feeding Study, Project 8372.02.23. Pursuant to 45 CFR pt. 46, the IRB reviews all studies involving research on human subjects. This project is sponsored by The National Cancer Institute (NCI).

The NCI ASA24 Feeding Study is designed to assess the validity and reliability of the ASA24 by comparing results of a 24-hour dietary recall collected using a telephone-administered AMPM interview with results obtained from the ASA24.

Westat will enroll 100 participants from a list generated by a well known recruitment firm. Participants will be invited to Westat for two consecutive days, the first day to eat 3 meals and the second day to try to recall what they consumed the day before while at the study site. Researchers will observe and weigh the food intake of the participants, and then compare the observed intake to later self-reported intake using either one of two methods being compared. Standard informed consent will be collected from all participants.

Security protocols will be implemented to ensure that all data are recorded and stored in such a manner that individual research subjects cannot be identified directly or through identifiers. No identifying information will be recorded in the data file and there will be no way to detect the identification of any respondent. After the data collection is completed, Westat will store the paper informed consent forms and paper questionnaires in a locked, secure facility for a year, and then they will be shredded. Electronic data will be password protected and stored by the data management contractor, and also will be destroyed after a year.

The IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt. 46.110 (b) (1)]. This study can be considered minimal risk. I am therefore approving this study under expedited authority. If activities change, please contact the IRB Office to ensure that the status is accurately reflected in our records. You are only required to submit the study for a continuing review on or before June 10, 2010 if activities change for this project. In the interim, you are responsible for notifying the Office of Research Administration as soon as possible if there are any injuries to the subjects, problems with the study, or changes to the study design that relate to human subjects.

cc: Institutional Review Board

Susan Crystal Mansour

Attachment 17 – ASA24 Dietary Recall and Feeding Study – IRB Approvals – Page 9