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Fall 2017

PROGRAM NEWS

Backes named Cancer IRB vice chair

We are pleased to announce that Dr. Floor Backes, associate professor of gynecologic oncology, has accepted the role of vice chair for the Cancer IRB, effective October 1, 2017. She will take over the role from Dr. Evan Wuthrick who announced his departure from Ohio State. Dr. Backes has served on the Cancer IRB since 2013. Her research interests include Lynch syndrome and novel treatments for endometrial and ovarian cancers. We thank Dr. Wuthrick for his more than five years of service, and we look forward to having Dr. Backes on the Cancer IRB leadership team.

New CITI GCP course for SBS researchers

A new Collaborative Institutional Training Initiative (CITI) course is available for social and behavioral sciences researchers engaged in clinical trials of drugs, devices, biologics and/or behavioral interventions. Good Clinical Practices for Social and Behavioral Researchers supports the NIH policy issued September 16, 2016, stating that NIH-funded investigators and staff “who are involved in the conduct, oversight or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials.

To access CITI, log in at http://go.osu.edu/citi. To enroll in the course, click on “Add a Course” and then check the box for “Good Clinical Practices for Social and Behavioral Researchers.”

For more information on Ohio State's human subjects protection training offerings, visit the ORRP CITI page.

ORRP staff updates

Please join us in welcoming Kara Batte and Jessica Buescher to the Office of Responsible Research Practices (ORRP). Kara and Jessica joined our team as IRB protocol analysts in August and September, respectively. Prior to joining ORRP, Kara worked in the Department of Surgery as a laboratory manager for Dr. Raphael Pollock. She received a BS from Miami University and her MS from Ohio State, both in microbiology. Jessica previously served as a regulatory compliance officer in the Clinical Trials Management Organization. She received a BS in biology from Bowling Green State University and a PhD in integrated biomedical sciences from Ohio State.

Thank you for your service to the IRB

Leadership and staff from ORRP would like to recognize IRB members with five or more years of service. Your expertise is invaluable and your volunteer efforts are greatly appreciated. Thank you for your commitment to the IRB.
 
Biomedical IRB Behavioral IRB Cancer IRB
Joni Barnard Joni Barnard Joni Barnard
Cataland Spero Susan Ebert William Carson
Fern Cheek Jesse Fox Susan Ebert
Jan Clark Kentaro Fujita Kevin Harper
Roy Clark       Michael Glassman     Randall Harris
Bruce Doepker Jackie Goodway Craig Hofmeister
Anne-Marie Duchemin     Howard Klein Mark Ranalli
Marcia Dyas Gerald Kosicki Amy Rettig
Susan Ebert Janalisa Menefee Kate Shane-Carson
Garrie Haas Tom Nelson Evan Wuthrick
Ryan Harrison Daniel Strunk  
Maribeth Hernan David Wallin IRB Policy (IRB)
Dale Kanner Keith Warren William Carson
Kathryn Martin   Jeffrey Cohen
Kristin McNamara   Howard Klein
Mark Merrick   Susan Koletar
William Montgomery   Mark Merrick
Thomas Raasch   Electra Paskett
Julie Rice   Thomas Raasch
Cynthia Shellhaas   Cynthia Shellhaas
Donn Young   Shari Speer
Karla Zadnik   Karla Zadnik

REGULATORY UPDATES

Implementing the Common Rule revisions

Revisions to the Federal Policy for the Protection of Human Subjects (45 CFR 46, Subpart A) were published in January 2017 to “modernize, strengthen and make more effective” the current system of oversight that has been the federal Common Rule since 1991. When implemented, the revisions will decrease burden, improve efficiency and calibrate the review process to the risk of the research.

Ohio State and the other Big Ten Committee on Institutional Cooperation (CIC) institutions are working together to prepare for the January 19, 2018, implementation date by jointly assessing the revised Rule and developing guidance on policies, online submission systems and revisions to best practices. 

The group is working on the following Rule updates:
  • New and revised definitions
  • Changes to the informed consent process to facilitate participant understanding
  • Exempt category revisions and additions
  • Use of broad consent
  • Elimination of continuing review for some research
  • Limited IRB review
For more information, including the official press release and Final Rule, visit the Office for Human Research Protections. For questions, contact Ellen Patricia.

FDA allows informed consent waivers

On July 24, 2017, the U.S. Food and Drug Administration (FDA) issued final guidance entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” Under the 21st Century Cures Act passed by Congress in 2016, the FDA gained the authority to waive or alter informed consent requirements, similar to existing provisions under the Common Rule. As a result, the FDA will not object to an IRB approving consent procedures that do not include, or that alter, “some or all of the elements of informed consent” when the IRB finds:
  • The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects
  • The clinical investigation could not practicably be carried out without the waiver or alteration
  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation
Two Ohio State policies were revised as a result of the new guidance: Informed Consent Process and the Elements of Informed Consent and Assent and Parental Permission. Buck-IRB will soon allow for requests for waiver/alteration of informed consent for minimal risk FDA-regulated studies.
 
The new guidance is available here: IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects - Guidance for Sponsors, Investigators, and Institutional Review Boards

For questions, contact Ellen Patricia.

NIH policy change for issuing certificates of confidentiality

NIH is updating its policy for issuing Certificates of Confidentiality (Certificates) for NIH-funded and conducted research. The update states that “the Secretary, HHS, shall issue Certificates to persons engaged in biomedical, behavioral, clinical or other research, in which identifiable, sensitive information is collected.” Certificates protect the privacy of participants by limiting the disclosure of identifiable, sensitive information.

Effective October 1, 2017, all research that began or was ongoing on or after December 13, 2016, will be issued a Certificate. The updated policy will be included in the NIH Grants Policy statement as a standard term and condition of award, effective October 1, 2017, for new and non-competing awards. Institutions and their investigators are responsible for determining whether research they conduct is subject to the updated policy and therefore issued a Certificate. Certificates issued in this manner will not be issued as a separate document, but will be issued automatically to NIH-funded recipients conducting research applicable to the policy. For non-federally funded research, NIH will continue to consider requests for Certificates for specific projects in accordance with the current NIH policy for issuing Certificates.

HELPFUL GUIDANCE

Grant congruency assistance available

Grant congruency review is an evaluation of a grant award/proposal compared to the associated research protocol to ensure consistency in human subjects research protections and the research activities that will be conducted. Congruency review is required by the Department of Health and Human Services (HHS) for all HHS-supported human subjects research and requires review and approval by an Ohio State Institutional Review Board (IRB) prior to research initiation. As soon as the investigator learns that he or she has a score that is likely in the fundable range, the principal investigator should contact their sponsored program officer (SPO) and the Office of Responsible Research Practices Grant Congruency Inbox, or call 614-688-8457 to obtain guidance on the congruency review process. The SPO will work with ORRP staff to confirm IRB congruency review. Waiting for the Notice of Award (NOA) from the sponsor may increase the possibility for a delay in HHS release of funds.

Additional investigator guidance can be found in the Human Subjects Research FAQs.

Accessing CITI training courses

Ohio State employs the Collaborative Institutional Training Initiative (CITI) web-based courses to provide required and additional training to the human subjects research community. When Ohio State study team members access CITI courses, it is imperative that they do so via the Office of Research (OR) CITI Portal. Accessing CITI courses without going through the OR portal will result in training completion records not being properly synced with one's Ohio State profile. This disconnect requires ORRP intervention to correct and will prevent submissions to the IRB when the training in question is required. To prevent potential delays and the need to contact ORRP support, always access the CITI web-based courses via the OR CITI Portal at http://go.osu.edu/citi.

For more information on Ohio State's human subjects protection training offerings, visit the ORRP CITI page. For questions or assistance, contact John Yocom.

Clinical trial requirements for grants and contracts

NIH is launching a series of initiatives in 2017-2018 to enhance accountability and transparency of clinical research. These initiatives target key points along the entire clinical trial life cycle, from concept to results reporting.

To learn more about these changes and how they will affect your research, visit NIH Clinical Trial Requirements.

Do you teach a research methods course?

Please contact Joni Barnard (SBS Education and Outreach quality improvement specialist) for information or to request a visit to your class to provide an overview of the IRB process. This introductory overview covers:
  • Why we have an IRB process
  • Types of review
  • Application components
  • Tips for a successful submission

BY THE NUMBERS





IN THIS ISSUE
  • Backes named Cancer IRB vice chair
  • New CITI GCP course for SBS researchers
  • ORRP staff updates
  • Thank you for your service to the IRB
  • Implementing the Common Rule revisions
  • FDA allows informed consent waivers
  • NIH policy change for issuing certificates of confidentiality
  • Grant congruency assistance available
  • Accessing CITI training courses
  • Clinical trial requirements for grants and contracts
  • Do you teach a research methods course?
  • By the numbers
EVENTS
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Save the Date

October 17, 2017
Noon - 2 p.m.*
Research Commons
18th Avenue Library (3rd floor)

*Doors open at 11:30 a.m. for early career faculty
EDUCATION SESSIONS

Tools of the Trade: Introduction to Clinical & Translational Research

September 19, 2017
8 a.m. – 2:15 p.m.
Biomedical Research Tower, Room 115

Revised Common Rule Overview

October 17, 2017
8 – 9:30 a.m.
Prior Health Sciences Library

IRB and International Research

October 24, 2017
2 - 3 p.m.
Research Commons
18th Avenue Library (3rd floor)
BUCK-IRB WORKSHOPS

Submission to Western IRB

October 23, 2017
2 - 3:30 p.m.
James Cancer Hospital and Solove Research Institute, B050
OFFICE OF RESEARCH RESOURCES
Office of Responsible Research Practices
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© 2017 The Ohio State University – Office of Research
Office of Responsible Research Practices – Human Research Protection Program
Research Administration Building, 1960 Kenny Road, Columbus, OH 43210
Phone: 614-688-8457 | Fax: 614-688-0366 | Email the IRB

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