Instructions - Directions for submitting a complete protocol for quorum review REV 8/12
Policies and Procedures for the Protection of Human Subjects REV 11/02/11
Financial Disclosure *fillable fields!*

HHS Issues New Regulations on FCOI Disclosure in Research

New U.S. Department of Health and Human Services regulations concerning financial conflicts of interest (FCOI) in research took effect on August 24. As of that date, any new or renewing grant, contract, Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) submission will not be processed unless all investigators associated with the submission meet the new requirements.

There are four significant areas of change from the previous requirements:

• An increase in the extent of information investigators must disclose to institutions

• Institutions are required to provide investigators with FCOI training

• An increase in FCOI-related information that institutions must make accessible to the public and to sponsors

• Enhanced institutional responsibility for managing the disclosure process and identified FCOIs

The National Institutes of Health Office of Extramural Research has a resource page on FCOIs, including “Frequently Asked Questions and Answers,” which can be accessed at http://grants.nih.gov/grants/policy/coifaq.htm

Between August and December 2012, investigators can complete their training requirement by taking the on-line NIH course on federal FCOI regulations: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

Instructions on Research Authorization
Research Authorization Form - English *fillable fields!*
Research Authorization Form - Spanish
Research Authorization Form - Russian
Consent Form Instructions - Suggested consent statements, patient questionnaire      REV 2/23/12

FDA has published a new regulation located at 21 CFR 50.25(c) regarding a mandatory consent form statement for applicable clinical trials* initiated on or after March 7, 2012.

Under this new regulation, the following statement (in blue) must be reproduced word-for-word in informed consent documents for applicable clinical trials:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at any time.”

*”“Applicable clinical trials” generally include controlled interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).  Trial sponsors and investigators have the responsibility of determining whether or not a trial is an “applicable clinical trial.””  Definitions vary for applicable device and drug trials including biologics. [FDA Guidance Feb 2012]

Abstract Guide
HIPAA Business Agreement *fillable fields!*

TO submit a continuing review, renewal request, or amendment, log into the IRBManager web site at https://irbmanager.becirb.com, choose the study you would like to submit a form for by clicking on the study number and choose 'startxform' within that study.

NOTE:  ALL RESEARCH INVOLVING HUMAN SUBJECTS MUST BE APPROVED OR DEEMED EXEMPT BY THE IRB BEFORE RESEARCH CAN BEGIN. 

How to Submit a Chart Review
HIPAA De-ID Form
HIPAA Limited Data Set LDS Form
HIPAA Researcher Certification Form
If you would like to request exemption of IRB review for your study, please fill out researcher certification form completely and submit along with your detailed abstract and REASON for exemption

Guidance on Reporting Adverse Events
To report adverse event, log onto the IRBManager web site at https://irbmanager.becirb.com and choose 'startxform'.