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Fall 2016

PROGRAM NEWS

Welcome

Kim ToussantWelcome to this first issue of our online Human Subjects Research Newsletter. We hope this new format and expanded content will be easier to read and better meets your information needs. We plan to increase the number of issues distributed this year since regulations on human subjects research are evolving quicker than ever before.

In this newsletter, be sure to check out the combined consent and Health Insurance Portability and Accountability Act (HIPAA) authorization template, the latest Buck-IRB updates, and our upcoming workshops and outreach events scheduled for the fall.

The Office of Responsible Research Practices (ORRP) team has been very busy working to improve Institutional Review Board (IRB) submission turnaround times. We are also preparing for our Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) re-accreditation submission. We will keep you updated throughout the year on our progress.

Toussand Signature



Kim Toussant
Director
Office of Responsible Research Practices

New combined consent and HIPAA authorization templates available

A single form combining consent to participate in research and HIPAA research authorization is now available for use. The combined forms can be used in submissions to any Ohio State IRB (Behavioral, Biomedical or Cancer), allowing consent and HIPAA authorization to be obtained using a single form and signature. Investigators can still use a separate consent form alongside the stand-alone HIPAA research authorization if desired. This process may be more appropriate or required in some studies.

Improved assistance routing

Adam McClintockFour telephone routing options are available to facilitate direct connection with ORRP content experts. Callers will be presented with selections for CITI (1), collaborative research (2), animal research/biosafety (3) and exempt research (4). Remain on the line for assistance with general regulatory questions. In addition, the ORRP ‘Contact Us’ webpage has been updated to include direct staff contact information for specific topics.

REGULATORY UPDATES

New NIH policy for multi-site research

The National Institutes of Health (NIH) published a new policy for NIH-funded, multi-site studies involving non-­exempt human subjects research. Effective May 25, 2017, a single Institutional Review Board (sIRB) will be used to conduct the ethical review required by the Department of Health and Human Services (DHHS) regulations for the protection of human subjects.
 
Over the next few months, ORRP will be identifying and implementing changes in local policies and workflow in order to be compliant with this national mandate. For more information regarding the new policy, go to NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research or sIRB FAQs.

BUCK-IRB

Buck-IRB workshops

Class Cheri PetteyORRP is offering several workshops to help investigators prepare human subjects research submissions using the online Buck-IRB system. Learn more about the systems functionality and the ways to navigate the different submission types. Anyone involved in preparing IRB submissions is welcome and encouraged to attend.

Updates to Buck-IRB

Several updates to the Buck-IRB system went into effect on August 18, 2016. A number of updates addressed requests made by investigators and research staff to enhance the Buck-IRB work experience. Additional updates were made to satisfy regulatory or policy requirements.

HELPFUL GUIDANCE

Investigator/staff guidance for FDA inspections

The Food and Drug Administration (FDA) conducts inspections to determine if investigators are compliant with FDA regulations. Guidance and additional resources on the inspection process can be found on the ORRP website. Note that a copy of post-audit communications should be forwarded to the IRB and that ORRP staff is available for assistance in responding to audit findings.  

Welcome back student researchers

StudentsWith the start of fall semester, many undergraduate and graduate students will begin thinking about developing research projects involving human subjects. Please remember that in addition to working closely with their advisor, a few requirements need to be completed before research proposals are submitted for review.

All investigators and key personnel who participate in the design, conduct or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. The university uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the human research subjects protection training requirement for Ohio State researchers.

In addition, federal regulations, state of Ohio laws, Ohio State policies and accreditation requirements mandate that faculty, staff and students who are investigators or key personnel on human subjects protocols complete an annual conflict of interest (COI) disclosure.

Human subjects FAQs

A list of ‘Frequently Asked Questions’ related to human subjects research can be found on the ORRP website. This new page contains answers to questions on topics such as research engagement, review determinations, exempt research and research involving secondary use of data and/or specimens. New topics will be added on a regular basis. 

BY THE NUMBERS

Active IRB studies by board:
As of August 4, 2016

IN THIS ISSUE
  • Welcome
  • Combined consent/HIPAA authorization template
  • Approved assistance routing
  • New NIH policy for multi-site research
  • Buck-IRB workshops
  • Updates to Buck-IRB
  • Investigator/staff guidance for FDA inspections
  • Welcome back student researchers
  • Human subjects FAQs
  • By the Numbers
EVENTS

September 27, 2016

8:30-9:30 a.m. (Opening Reception)
9:30 a.m.-noon (Expo)
Research Commons
18th Avenue Library (3rd floor)
EDUCATION SESSIONS

Secondary Analysis of Data and Specimens
(Medical Research)

September 20, 2016
8-9 a.m.
Prior Health Sciences Library
 


Secondary Analysis of Data and Specimens (SBS)

September 21, 2016
3-4 p.m.
Research Commons
18th Avenue Library (3rd floor)

IRB and Classroom Research

September 29, 2016
12:30-1:30 p.m.
Research Commons
18th Avenue Library (3rd floor)

Collaborative Human Subjects Research

October 11, 2016
8-9 a.m.
Prior Health Sciences Library

Human Subjects Research and the HIPAA Privacy Rule

October 19, 2016
8-9 a.m.
Prior Health Sciences Library

IRB Training for Graduate Students

October 19, 2016
4-5 p.m.
Research Commons
18th Avenue Library (3rd floor)

IRB and International Research

November 29, 2016
4-5 p.m.
Research Commons
18th Avenue Library (3rd floor)
BUCK-IRB WORKSHOPS

Buck-IRB Submissions

September 15
9:30-11 a.m.
165 Davis Heart and Lung Research Institute (DHLRI)

September 22
9:30-11 a.m.
165 Davis Heart and Lung Research Institute (DHLRI)
OFFICE OF RESEARCH RESOURCES
Office of Responsible Research Practices

© 2016 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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