Approval memo - Xanax

Attachment 14

Approval Memo- Xanax

IRB ID #:

201303743

To:

Timothy Brown

From:

IRB-01
Univ of Iowa,

Re:

Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable
Device: Study 2

DHHS Registration # IRB00000099,
DHHS Federalwide Assurance # FW A00003007

Protocol Number:
Protocol Version:
Protocol Date:
Amendment Number/Date(s):

Approval Date:

07/29/13

Next IRB Approval
Due Before:

04/04/14

Type of Application:

Type of Application Review:

New Project
Continuing Review
Modification

Full Board:
Meeting Date:
Expedited

Approved for Populations:
Children
Prisoners
Pregnant W omen, Fetuses, Neonates

Exempt
Source of Support:

US Department of Health & Human Services, National Institutes of Health

Investigational New Drug/Biologic Name:
Investigational New Drug/Biologic Number:
Name of Sponsor who holds IND:
Investigational Device Name:
Investigational Device Number:
Sponsor who holds IDE:

This approval has been electronically signed by IRB Chair:
Anthony Quinlan, MBA, CIP
07/29/13 1550

IRB ID#: 201303743 07/29/13 Page 2 of 2

IRB Approval: IRB approval indicates that this project meets the regulatory requirements for the protection
of human subjects. IRB approval does not absolve the principal investigator from complying with other
institutional, collegiate, or departmental policies or procedures.
Agency Notification: If this is a New Project or Continuing Review application and the project is funded by
an external government or non-profit agency, the original HHS 310 form, “Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption,” has been forwarded to the UI Division of
Sponsored Programs, 100 Gilmore Hall, for appropriate action. You will receive a signed copy from
Sponsored Programs.
Recruitment/Consent: Your IRB application has been approved for recruitment of subjects not to exceed the
number indicated on your application form. If you are using written informed consent, the IRB-approved and
stamped Informed Consent Document(s) are attached. Please make copies from the attached "masters" for
subjects to sign when agreeing to participate. The original signed Informed Consent Document should be
placed in your research files. A copy of the Informed Consent Document should be given to the subject. (A
copy of the signed Informed Consent Document should be given to the subject if your Consent contains a
HIPAA authorization section.) If hospital/clinic patients are being enrolled, a copy of the IRB approved
Record of Consent form should be placed in the subject’s electronic medical record.
Continuing Review: Federal regulations require that the IRB re-approve research projects at intervals
appropriate to the degree of risk, but no less than once per year. This process is called “continuing review.”
Continuing review for non-exempt research is required to occur as long as the research remains active for
long-term follow-up of research subjects, even when the research is permanently closed to enrollment of new
subjects and all subjects have completed all research-related interventions and to occur when the remaining
research activities are limited to collection of private identifiable information. Your project “expires” at 12:01
AM on the date indicated on the preceding page (“Next IRB Approval Due on or Before”). You must obtain
your next IRB approval of this project on or before that expiration date. You are responsible for submitting a
Continuing Review application in sufficient time for approval before the expiration date, however the HSO will
send a reminder notice approximately 60 and 30 days prior to the expiration date.
Modifications: Any change in this research project or materials must be submitted on a Modification
application to the IRB for prior review and approval, except when a change is necessary to eliminate apparent
immediate hazards to subjects. The investigator is required to promptly notify the IRB of any changes made
without IRB approval to eliminate apparent immediate hazards to subjects using the Modification/Update Form.
Modifications requiring the prior review and approval of the IRB include but are not limited to: changing the
protocol or study procedures, changing investigators or funding sources, changing the Informed Consent
Document, increasing the anticipated total number of subjects from what was originally approved, or adding any
new materials (e.g., letters to subjects, ads, questionnaires).
Unanticipated Problems Involving Risks: You must promptly report to the IRB any serious and/or
unexpected adverse experience, as defined in the UI Investigator’s Guide, and any other unanticipated
problems involving risks to subjects or others. The Reportable Events Form (REF) should be used for
reporting to the IRB.
Audits/Record-Keeping: Your research records may be audited at any time during or after the
implementation of your project. Federal and University policies require that all research records be
maintained for a period of three (3) years following the close of the research project. For research that
involves drugs or devices seeking FDA approval, the research records must be kept for a period of three
years after the FDA has taken final action on the marketing application.
Additional Information: Complete information regarding research involving human subjects at The
University of Iowa is available in the “Investigator’s Guide to Human Subjects Research.” Research
investigators are expected to comply with these policies and procedures, and to be familiar with the
University’s Federalwide Assurance, the Belmont Report, 45CFR46, and other applicable regulations prior to
conducting the research. These documents and IRB application and related forms are available on the
Human Subjects Office website or are available by calling 335-6564.