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Welcome to the

Office of Human Research Protection Programs and

Institutional Review Board

 

OHRPP ANNOUNCEMENTS and NEWS

ANNOUNCEMENT: IMPORTANT CHANGES TO THE OVERSIGHT PROCESS FOR EXEMPT STUDIES

OFFICE NAME CHANGE: The Office of Human Research Protection Programs (OHRPP) is the new name of the Human Subjects Committee. This change reflects a focus in the profession emphasizing human research participants, and to differentiate between the Office per se, and the Institutional Review Board which is the entity responsible for reviewing and approving reserach protocol.

 

...stay tuned for additional news!

 

Pursuant to federal law and University policy, all research involving human subjects, conducted by IUB investigators, must be reviewed and approved by an IU IRB.  In most cases this will be the Bloomington Human Subjects Committee (HSC). (see Location of Review for details)  These policies and procedures are designed to provide an efficient avenue for the processing of applications. The smooth flow of applications is the only way to ensure that each research protocol is provided the level of review it deserves. Cooperation by faculty, students and staff with the Committee is essential if we are to comply with federal and University regulations. The Committee recognizes that the federal regulations and our interpretations of the regulations can be daunting to an investigator on first encounter. The Committee will provide whatever assistance it can to investigators or departments to explain our procedures and to secure compliance with a minimum of delay or disruption of research.

We welcome suggestions for improvement of the information that is provided here.  Feel free to send an e-mail message.

The Committee's office is located at the Carmichael Center L03, 530 E. Kirkwood Ave., Bloomington, IN 47408, 812/855-3067, iub_hsc@indiana.edu.  Office hours are 8-12 and 1-5, M-F.

Office staff are:  Carey Conover, Director, Office of Human Research Protection Programs; Senta Baker, Assistant Director; Ryan Merckle,  Research Risk Coordinator; and Sharon Nejfelt, Office Services Coordinator.

Announcements

Frequently Asked Questions

-- About the human subjects application process

Review levels/categories

  • full
  • expedited
  • exempt

IUB Education Requirement

  • Human Subjects tutorial and test
  • NIH requirements

Definition of Terms

  • human subject
  • research
  • non-research
  • existing data
  • risk

Belmont Report

Researcher Responsibilities

  • sponsorship of applications
  • follow-up
  • file maintenance

Before Submitting a Protocol 

Access Application Forms

  • Interactive PDF forms
          * Study Amendment Form
          * Documentation of Review and Approval
  • Download Paper forms

    • * Application Packet (exempt, expedited, full reviews)
    * Continuing Reveiw
    * Disseration Form  (does not apply to all dissertations)

  • Instructions for Exempt Level Consenting Process

Informed Consent

  • waiver of consent
  • translated consent forms
  • minors
  • students in Indiana public schools
  • persons with mental disabilities
  • secondary data sources
  • deception
  • web based studies

Background

Operations and Procedures of the HSC

  • Policy Revision: minor changes to previously approved protocol
  • review schedule
  • commencement of research
  •  recruitment (advertising, phone scripts, follow-ups)
  •  compensation
  • information mining from the internet (Facebook, My Space, etc.)
  • submission process
  • help with process
  • approval process
  • amendments
  • continuing reviews
  • adverse events
  • record keeping

Student Research

Students as Subjects

  • credit
  • use of researcher's students as subjects

Prisoners as Subjects

Noncompliance

Review Location

  • Non-IU Researchers
  • IU Researchers

 

HIPAA Information
 
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