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Summer 2017

PROGRAM NEWS

National online IRB reliance system launched for multi-site research

SMART IRB is a new system that connects Institutional Review Boards (IRBs) across the nation and facilitates reliance on each other's review of human subjects research. The system is designed to ease the challenges associated with initiating multi-site research and to provide a means for institutions to implement the NIH Single IRB Review policy.

SMART IRB is not an IRB. It is an online system, freely available to institutions and investigators, that allows flexibility in the size and scope of collaborations to enable IRB reliance for multi-site studies across the nation, regardless of funding status. Investigators and IRBs can request, track and document reliance arrangements on a study-by-study basis.
 
Can I use SMART IRB for my multi-site study? 
Ohio State lead principal investigators (PIs) planning to conduct large multi-site studies (5-20 sites or more) with a designated single IRB of record, should submit a request to the Office of Responsible Research Practices (ORRP) at IRBAgreements@osu.edu prior to submission for IRB review. ORRP staff, working with the appropriate Ohio State IRB chair and IRB contacts from the other participating sites, will determine if Ohio State can serve as the IRB of record, and if the SMART IRB Agreement and SMART IRB Standard Operating Procedures (SOPs) are appropriate for use. If Ohio State is to be the IRB of record and all sites are SMART IRB participating institutions, the PI may initiate a request in SMART IRB when they submit their Buck-IRB study application. Click here for instructions to request ceding review to an external IRB. PIs of smaller multi-site studies (<5 sites) should contact ORRP with questions. 

How does SMART IRB work?
To submit a request for reliance, the lead PI or a designee will need to:
  • Request access and register in the system with their home institution
  • Provide study details
  • List the engaged sites
  • Identify site activities and personnel
  • Upload the research protocol and any consent templates
For more information, see the SMART IRB Resources page.
Contact Ohio State’s SMART IRB point of contact at IRBAgreements@osu.edu.

New CITI module on data and safety monitoring

The Collaborative Institutional Training Initiative (CITI) and PRIM&R recently released a new CITI module on Data Safety Monitoring Plans (DSMPs)/Data and Safety Monitoring Boards (DSMBs) and IRBs. The module covers identifying clinical trials that require regular monitoring, processes and requirements for DSMPs and the different roles of IRBs and DSMBs with regard to the protection of human subjects. This module was added to the Biomedical Research Human Research Basic coursework.

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

REGULATORY UPDATES

Common Rule still under review

The Department of Health and Human Services (DHHS), along with 15 other federal agencies, issued a final rule on January 18, 2017, updating the regulations that safeguard human research participants – generally known as the "Common Rule.” The majority of items in the rule go into effect on January 19, 2018. Portions of the rule that address cooperative research will not go into effect until January 20, 2020. Because the rule is subject to the Congressional Review Act, it is still possible for Congress to pass a resolution of disapproval for presidential signature (or veto) until the review period has ended. Though many believed the 60-day window had recently passed, a federal representative from the Office for Human Research Protections (OHRP) indicated on May 11, 2017, that the current administration has only recently begun reviewing the revised rule. For more information, please see the White House Reviewing Obama-Era Update of Human Research Rule.

DHHS noted that the new rule "strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research." If implemented, the rule will enhance participant protections by establishing specific requirements for the informed consent process, including requiring a concise introductory explanation of key information about the study to assist potential participants in their decision-making. It will also streamline many of the regulatory processes for minimal risk research, including greatly expanding the exemption categories.

Ohio State is continuing to review its policies and procedures in order to comply with the changing regulations. ORRP will provide updates as the rule moves toward confirmation, including what the changes mean for university researchers.

For more information, including the official press release and Final Rule, visit the Office for Human Research Protections.
 
For questions, contact Cheri Pettey.

HELPFUL GUIDANCE

Updated guidance for event reporting

Events that occur in human subjects research (medical or non-medical) may include occurrences such as adverse events, subject complaints, protocol deviations and other untoward events involving risk. Events that involve physical, psychological, social, legal or economic harms may require prompt reporting by investigators to the IRB. These events may represent a possible unanticipated problem involving risks to subjects or others (UPIRSO) and/or potential noncompliance. ORRP has updated the Event Reporting webpage and created new guidance that provides case examples for when and how to report events to the IRB.

For more information, see the HRPP policy Event Reporting – Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems.
 
For questions, contact Vanessa Hill.

Submitting banking and repository protocols

Creating a data and/or specimen bank for future research purposes is considered “research involving human subjects” and requires IRB review and approval. As part of the IRB’s review of banking/repository protocols, the IRB will ensure that Ohio State banks stand alone and are separate from other research activities (i.e., not included in a clinical research project and not combined with analysis projects). Additionally, informed consent and HIPAA authorization (when the data include protected health information) are required for collection of data and/or biological specimens to be stored for future research. 

This guidance applies only to current internal banks or repositories controlled by Ohio State researchers. A separate protocol for data and/or specimens collected and sent to external banks (e.g., other institutions, sponsors, NIH, NCI, cooperative groups, etc.) is not required.

For more information, please see the Ohio State Data and/or Specimen Banking and Research Use of Banked Materials policy.
 

BY THE NUMBERS

Human Subjects Research Portfolio

IN THIS ISSUE
  • National online IRB reliance system launched for multi-site research
  • New CITI module on data and safety monitoring
  • Common Rule still under review
  • Updated guidance for event reporting
  • Submitting banking and repository protocols
  • By the numbers
EVENTS
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OHRP Research Community Forum

September 6-7, 2017
Cincinnati, OH
EDUCATION SESSIONS

IRB Submission Process Overview

June 20, 2017
8 – 9 a.m.
Clinical Skills Education and Assessment Center
Room 620, 6th Floor Prior Health Sciences Library
 

IRB Reliance Models for
Ohio State Researchers Collaborating with External Partners

August 8, 2017
11 a.m. – 12:30 p.m.
Clinical Skills Education and Assessment Center
Room 620, 6th Floor Prior Health Sciences Library
 

Research Recruitment & Participant Compensation

August 15, 2017
8 – 9 a.m.
Clinical Skills Education and Assessment Center
Room 620, 6th Floor Prior Health Sciences Library
 
BUCK-IRB WORKSHOPS

Amendments and Buck-IRB

July 18, 2017
8 – 9 a.m.
Clinical Skills Education and Assessment Center
Room 620, 6th Floor Prior Health Sciences Library

Initial Submissions
and Buck-IRB

September 6, 2017
11 a.m. – 12:30 p.m.

September 12, 2017
8 – 9:30 a.m. 

Research Commons, 3rd Floor 18th Avenue Library
175 West 18th Avenue
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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