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East Hill Office Building, Suite 320 395 Pine Tree Road Ithaca, NY 14850 p. 607-255-5138 f. 607-255-0758 www.irb.cornell.edu

Institutional Review Board for Human Participants

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To: Christine Olson

From: Jenny Gerner, IRB Chairperson

Protocol ID#: 1001001144

Project(s): Formative Research on Electronically-Mediated Weight Interventions for Pregnant Women

Date of Approval: February 23, 2010

Expiration Date: February 22, 2011

The above-referenced protocol has been reviewed and given expedited approval by the Institutional Review Board for Human Participants (IRB) for the inclusion of human participants in research. This approval

shall remain in effect until February 22, 2011.

The terms of Cornell University's Federalwide Assurance (FWA) with the federal government mandate the following important conditions for investigators:

1. All consent forms, records of study participation, and other consent materials must be held by the investigator for five years after the close of the study.

2. Investigators must submit to the IRB any proposed amendment to the study protocol, consent forms, interviews, recruiting strategies, and other materials. Investigators may not use these materials with human participants until the IRB has reviewed them. For information about study amendment procedures and access to the Amendments application form, please refer to the IRB website: http://www.irb.cornell.edu/forms.

3. Investigators must promptly report to the IRB any unexpected events involving human participants. The definition of prompt reporting depends upon the seriousness of the unexpected event. For guidance on recognizing, defining, and reporting unexpected events to the IRB, please refer to the IRB website: http://www.irb.cornell.edu/forms.

If the use of human participants is to continue beyond the assigned approval period, federal requirements mandate that the protocol be re-reviewed and receive an updated approval. You may not continue to use

information collected from human participants beyond the stated approval period without an updated approval. Please note that the terms of our FWA with the federal government do not allow for an extension

of this period without review. Continuing without an updated approval constitutes a violation of University policy and federal regulations. Research funds administered by the Office of Sponsored Programs will not be released to any project that does not have a current IRB approval.

Federal regulations require that all research be reviewed at least annually. As the Principal Investigator it is your responsibility to obtain review and continued approval before the expiration date. Applications for renewal of approval must be submitted sufficiently in advance of the expiration date to permit the IRB to

conduct its review before the current approval expires. Please allow three weeks for the review. Note: Forms should be downloaded from the IRB website at www.irb.cornell.edu/forms for each use.

**If you do not plan to renew your protocol approval at the end of the year, you must provide the IRB with a Project Closure form. A link to the Project Closure form can be found at

Revision: 11/09/2007

REQUEST TO AMEND

A PREVIOUSLY-APPROVED PROJECT CORNELL UNIVERSITY

Institutional Review Board – Human Participants

Please click in shaded fields to enter information

Project Identification:

Title of Research Project (use same title under which project was approved)

Formative Research on Electronically-Mediated Weight Interventions for Pregnant Women

Protocol ID# (found on latest approval letter): 1001-001-144 Investigator's Name: Christine Olson

Campus Address: 376 MVR Hall, College of Human Ecology Investigator's Signature:

Signature of faculty member supervising project (if applicable): Date of request: September 23, 2010

Anticipated End Date of Project: April 1, 2011

Information on Amendments

1. What type(s) of amendment(s) are you requesting? Please describe in detail.

Focus Groups with Postpartum Women- We will conduct a maximum of two focus group sessions each with six distinct subpopulations of the postpartum women recruited from participating clinics and private practices in Rochester, NY. For recruitment, we will collaborate with the Perinatal Network of Monroe County’s Healthy Start Center program that provides services and education to low income, minority pregnant women and young families. In addition, we will work with private practices and hospital-affiliated clinics in the recruitment of higher income women. We will also work with the Child Care Council Inc. of Monroe county to recruit portpartum women of both low and higher income. We anticipate that the subgroups will be (1) Six weeks-six months postpartum & low-income; (2) Six weeks- six months postpartum & high-income (3) Six - twelve months postpartum & low-income; (4) Six -twelve months postpartum & high-income; (5) Twelve-eighteen months postpartum & low-income; (6) Twelve-eighteen months postpartum & high-income, totaling approximately 12 focus group sessions (6 subgroups x 2 sessions for each subgroup). Each focus group will include 4 to 6 participants for a total of 48 to 72 women. The focus groups will be conducted by a trained and experienced moderator following the guidelines of Krueger in locations that are convenient for women in Rochester, NY (eg. Child Care Council, Clinics, WIC). They will be audio-taped, transcribed, and analyzed using standard qualitative data analysis methods such as the constant comparative method. We have attached an outline of a

All information must be typed. Handwritten applications are not accepted by the IRB.

Attach a copy of all amended/final instruments, highlighting the changes from the previously reviewed and approved instruments.

Submit this form, with appropriate signatures and necessary attachments, to: IRB - ORIA, 395 Pine Tree Road, Suite 320, Ithaca NY 14850

proposed focus group guide. As in the pregnancy focus groups, for partitipation in the focus groups postpartum women will receive $40.

2. Briefly describe the reason(s) you are making amendment(s) to the study.

In order to develop the postpartum intervention for our project we need to conduct focus groups with postpartum women and are ready to do so at this point in time.

3. Are any of these changes the result of something that occurred during human participant interaction?

Yes No

If Yes, please describe the event(s):

4. Are you submitting, for IRB approval, revisions of or new study interviews, questionnaires, study guides, or debriefing forms? Yes (please attach) No

5. Are you submitting, for IRB approval, final forms of study protocols that were reviewed in draft form?

Yes (please attach) No

6. Are you submitting, for IRB approval, a revised version of or a new informed consent document or procedure?

Yes (please attach) No

7. Are you submitting, for IRB approval, any other change in study procedures, such as design, designation of principal investigator, change in the recruitment techniques, etc.? Yes No

East Hill Office Building, Suite 320 395 Pine Tree Road Ithaca, NY 14850 p. 607-255-5138 f. 607-255-0758 www.irb.cornell.edu