Institutional Review Board

Overview

Institutional Review Board  |  IRB00001355

The Wright Center for Graduate Medical Education has a proud tradition of leadership in healthcare development and delivery in northeastern Pennsylvania. As part of our commitment to excellence, The Wright Center has provided an Institutional Review Board which has served the patients and medical researchers of our area since 1992.

The mission of The Wright Center for Graduate Medical Education Institutional Review Board (WCGME–IRB) is to protect the rights and welfare of human subjects involved in research. We promote ethical research to ensure that the risks of scientific advancement never outweigh the value of human life.

Federal Guidelines

Please review the following federal guidelines regarding research:

Name

Area of Concern

Organization

Mark V. White

Scientific

The Commonwealth Medical College and Chair, WCGME-IRB

Robert H. Angeloni, MPA

Non-scientific

Health Care Consultant and Co-Chairman, WCGME-IRB

Scott Bolesta, PharmD

Scientific

Faculty, Wilkes University, Nesbitt College of Pharmacy and Nursing

Michael M. Costello, JD

Non-Scientific

Consultant, Moses Taylor Health Care System

Nanci Dobson, RN, CWCA, CCRP

Scientific

Clinical Research Coordinator, Wound Institute & Research Center

Martin Hyzinski, MD

Scientific

Scranton Hematology-Oncology

Fred R. Leri, PharmD

Scientific

Pharmacist, Geisinger Community Medical Center

Vee Pauli, RD, LDN, CCRP

Non-scientific

Regional Hospital of Scranton, Retired

Paula Roe-Prior, PhD, RN

Scientific

Statistical and Nursing Education Consultant

John L. Szarek, PhD

Scientific

Professor of Pharmacology, The Commonwealth Medical College

Mushfyq Tarafder, PhD, MPH, MBBS

Scientific

The Commonwealth Medical College

John Walsh

Non-scientific

President, Mended Hearts and Community Representative

Daniel J. West, PhD

Non-scientific

Chair, Department of Health Administration and Human Resources, University of Scranton

Robert Wright, MD, FACP

Scientific

WCGME Board of Directors

Margarete Zalon, PhD, RN, ACNS-BC, FAAN

Scientific

The University of Scranton, Department of Nursing

Meeting DateMaterials Due By
16 November 201726 October 2017
December 2017 Recess-
25 January 201811 January 2018
22 February 20188 February 2018
22 March 20188 March 2018
26 April 201812 April 2018
24 May 201810 May 2018
28 June 201814 June 2018
July 2018 Recess-
23 August 20189 August 2018
27 September 201813 September 2018
25 October 201811 October 2018
15 November 20181 November 2018
December 2018 Recess-

Federal regulations and policies require IRB approval for research with human subjects. You are required to submit a formal application if your project or study meets both of these conditions:

1. It constitutes “research” with the intent to develop new or expandable knowledge.

AND

2. If human subjects are involved, either directly or through use of identifiable data about them.

Does my study constitute “Research”?

According to the Code of Federal Regulations, research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)] — i.e., “with the intent to develop new or expandable knowledge.”

A. Is your study intended to develop new or expand existing knowledge?

B. Do you expect or intend to publish or present the results of your study?

If you answered YES to (A) and (B), your study is considered to be “Research” and you do need IRB approval before you can begin your study. If you answered NO to either question, your study is considered to be “Research” but it may be exempt.

Is my study considered to be research “on Human Subjects”?

A. Are you planning to obtain information from or about living individuals?

B. Will the study involve direct interaction with individuals or data linked to personal identifiers?

C. Will you gather information that would ordinarily be private?

D. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., their homes)?

If you answered YES to (AAND one or more of the other questions, your study is considered to be “on Human Subjects.” If you answered NO to all the questions, then you do not need IRB approval and can begin your study.

Do I need to submit an IRB application?

A. Does your study constitute “Research”?

B. Is your study considered to be research “on Human Subjects”?

If you answered YES to both questions, then your study or activity is considered “Research on Human Subjects” and you must submit an IRB Application (Word) and review the material found on the Principal Investigator’s Requirements page  especially the IRB Investigator’s Guide (Word).

If you answered NO to either question, then you do not need IRB approval and can begin working on your study.

NOTE: IRBs do not have the option of granting “retroactive” approval after research is done, so you are strongly encouraged to submit your research proposal or consult with the IRB if you are unsure whether you need IRB approval.

You may email your questions to the WCGME–IRB Administrator at: wcgme-irb@thewrightcenter.org or call 570-343-2383, ext. 2261.

Effiective July 1, 2010, The Wright Center for Graduate Medical Education Institutional Review Board (WCGME-IRB) will charge for the review of Industry-Sponsored, Government-Sponsored, Other Grant-Funded as well as Internally-Generated and Un-funded Research studies submitted for review. This policy will apply to the initial and continuing review of these studies. Fees for continuing (i.e., renewal) review will be charged on an annual basis, regardless of the duration of the approval period.

Fee Schedule for WCGME-IRB Review

Type of Review Industry-Sponsored Government-Sponsored and Other Grant-Funded Internally-Generated and Un-funded Research
Initial Review
Full $3,000 $1,500 $750
Expedited* $1,250 $625 $300**
Continuing Review
Full $1,000 $500 $200

The submitting Principal Investigator is responsible for the payment of all fees charged for IRB reviews.

Reductions in IRB review fees will be considered based upon documented budget limitations. Requests must be submitted in writing, with all appropriate budget documentation, to the Administrator, WCGME–IRB. The Principal Investigator will be notified in writing if the request is approved or not approved.

*All studies submitted for Expedited Initial Review must be accompanied by a check payable to The Wright Center for Graduate Medical Education Institutional Review Board in the amount listed above.

**Expedited studies submitted by Interns, Residents or Students will be charged the reduced rate of $100.00.

Responsibilities

Researchers are responsible for:
  • Protecting the rights and welfare of prospective subjects: Protecting Human Research Participants NIH Office of Extramural Research
  • Ensuring that pertinent laws, regulations, and institution procedures and guidelines are observed by participating investigators
  • Obtaining informed consent and ensuring that no human subject is involved in the research prior to obtaining their consent
  • Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research
  • Complying with all IRB decisions, conditions, and requirements
  • Ensuring that protocols receive timely continuing IRB review and approval
  • Reporting unexpected or serious adverse events to the IRB
  • Obtaining IRB review and approval before changes are made to approved protocols or consent forms
  • Seeking IRB assistance when in doubt about whether proposed research requires IRB
  • Assure that research is performed in compliance with Federal Good Clinical Practice Consolidated Guidelines
All materials must be submitted at least two-and-one-half (2 1/2) weeks before the IRB meeting. Submission dates are listed under Scheduled Meetings.

Required Materials

  • Complete copies of the protocol
  • Informed consent
AND

Informed Consent

Investigator’s Guide

Clinical Trial Protocol Development Template and Informed Consent Development Sheet

Contact