Amendments must be submitted separately from the Continuing Review.
IRB Project No.: / 870260
Previous Expiration Date: / 03/16/17
Project Title: / Nutritarian Women’s Health Study (NWHS)
Investigator: / Jay Sutliffe PhD RD
Investigator'sContact Information: / 928.523.7450
Alternate Contact: / Wendy Wetzel RN MSN FNP
Alternate Contact's Information: / 928.523-6954
SECTION 1:BRIEFABSTRACT OF THE HUMAN RESEARCH:
NWHS is a national longitudinal study assessing the health outcomes of women who adopt a Nutritarian Diet as defined by Joel Fuhrman MD.
SECTION 2: CURRENT PROTOCOL STATUS
Check all that apply
  1. Enrollment in progress or still planned (please send only word version of the consent(s) if applicable)

  1. The research is permanently closed to enrollment (including the addition of new records or specimens from people not previously "enrolled" on chart review or specimen- only studies)

  1. All subjects have completed all research-related interventions and/or interactions

  1. The research remains active only for long-term follow-up of subjects

  1. Collection of private identifiable information is completed

  1. The remaining research activities are limited to identifiable data analysis. NOTE: If all enrollment, treatment, follow-up and data analysis of identifiable data are completed the project may be concluded - submit Closure instead.

SECTION 3: ENROLLMENT STATUS: Please complete the following table related to enrollment of participants in your study. For definitions and guidance on how to determine enrollment,see HSPP Guidance, Enrollment and Accrual of Study Participants.
IRB Approved: / Since activation: / Since last approval: / Male
(total) / Female
(total) / Other/
Unknown
(total)
Number of participants enrolled in the study locally:
Number of participants enrolled at all sites (if available; only for multi-site research): / 1104 / 1104 / 0 / 1104 / 0
If available, provide the number of subjects enrolled locally since activation of the study for each racial/ethnic category:
Caucasian / Black / Asian/Pacific Islander / American Indian/ Alaska Native / Other, Unknown
999 / 30 / 17 / 3 / 55
Hispanic or Latino / Not Hispanic or Latino / Unknown
57 / 1016 / 31
If available, provide the total number of subjects from specific populations:
Children / Prisoners / Fetuses / Pregnant / Student/ Employees / Cognitively Impaired / Other
0 / 0 / 0 / 0 / 0 / 0 / 0
SECTION 4: STATUS REPORT ON THE PROGRESS OF THE HUMAN RESEARCH:
1. Status of subjects consented into this study (describe if subject consenting is completed, number of and whether any subjects were screen failures, or whether any subjects withdrew from the research and the reason why):
Subjects are required to read a provided nutrition book and answer a short quiz, then consent to the full study. All applicants are accepted to the study. See withdrawal information below (Section 5, Item 4).
2. Status of achieving the aims of the human research:
We project total enrollment of 5-10,000 women. Data collection will include diet history, updated health history, and blood tests as described in the initial IRB.
3. Expected progress to be made during the next approval period:
Enrollment will continue. First data collection will be in fall of 2017 to determine level of understanding and compliance with the approved meal plan.
4. A thorough summary of any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research, please note N/A is not accepted by the IRB ("Last IRB review" means an initial or continuing review, whichever is most recent):
A recent literature review shows no current research showing substantial risk with Nutritarian (or whole food/plant based) diet.. The same team is conducting local studies which have shown significant reduction in cardiovascular and diabetes risk for participants. These studies were of short duration (6-12 weeks) with long term follow-up planned but not yet completed. Pilot study data was published in Altern Ther Health Med. 2016;22(5),24-29).No risks to participants have been identified.
SECTION 5: QUESTIONNAIRE
  • For Questions 1-10, attach a summary explanation or description for each question whose answer is "Yes." Summaries are not required for "No" answers.
  • "Last IRB review" means an initial or continuing review, whichever is most recent.

YES / NO
  1. Since the last IRB review, have subjects experienced harms (expected or unexpected)?

  1. Since the last IRB review, have subjects experienced any benefits? Too soon to determine

  1. Since the last IRB review, have there been any reportable information items, including unanticipated problems involving risks to subjects or others?
Date of IRB Approval / Brief description of reportable item
  1. Since the last IRB review, have any subjects withdrawn from the research?
To date, 14 participants have withdrawn. Participants feel they cannot fully participate with the meal plan due to personal choice, time constraints, and/or motivation. Two women have declared pregnancy and will be temporarily withdrawn until after the conclusion of their pregnancies.
  1. Since the last IRB review, have any subjects or others complained about the research?
Participants have requested more nutrition information and an online blog has been created to meet that need. Participants have access to research team via email.
  1. Since the last IRB review, have there been any interim findings, multi-center trial reports; sponsor/monitor findings or reports; or data safety monitoring board reports? If Yes, provide a copy of the findings or report.

  1. In the opinion of the principal investigator, have the risks or potential benefits of this research changed?

  1. Since the last IRB review, have there been any amendments to the research?
Date of IRB Approval / Brief description of amendment
09/05/16
09/22/16 / Amendment with requested edits
Amended Consent Form
  1. Have any problems that required prompt reporting NOT been submitted as required?

  1. Since the last IRB review, have there been any changes in funding to the research?
Date of IRB Approval / Brief description of amendment

Provide 1 copy of the following:

  • Consent documents (in Word) to be used in the next approval period (including HIPAA authorization documents, if applicable). This may be omitted if the research is permanently closed to enrollment and if re-consent is not needed.

Consent attached.

  • A script of information to be provided orally to subjects if consent will not be documented in writing. This may be omitted if the research is permanently closed to enrollment and if re-consent is not needed.

All participants are consented on line. Participants are not consented in person.

  • Summary regarding any "Yes" answers from Section 5; questions 1-12 above.

Requested information is contained within each question above.

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