NIH new policy | Single IRB for multi-site studies

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Accelerating clinical research studies benefits researchers, research participants, and all who stand to gain from research results. Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research. 

This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. For contracts, the policy applies to all solicitations issued on or after May 25, 2017. For the intramural program, the policy applies to intramural multi-site studies submitted for initial review after May 25, 2017.

image courtesy of skeeze @pixabay.com

image courtesy of skeeze @pixabay.com

IRBs play a critical role in reviewing and approving studies involving human research participants. IRBs evaluate the potential benefits of research and risks to participants. In the past, most clinical research studies were carried out at single institutions. Now studies are increasingly conducted at multiple sites to help increase the number and diversity of the participants, improve operational efficiencies, and accelerate the generation of research results. However, for the majority of multi-site studies, the IRB at each participating site continues to conduct an independent review. This review adds time, but generally does not meaningfully enhance protections for the participants.  This new NIH policy seeks to end duplicative reviews that slow down the start of the research.

NIH will support applicant and awardee institutions as they implement the new policy with guidance and resources, such as a model authorization agreement that lays out the roles and responsibilities of each signatory, and a model communication plan that identifies which documents are to be completed, and when.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health

Resources:

NCATS SMART IRB Reliance Platform

Scenarios for indirect and direct costs

Frequently asked questions

Federal Register notice on the final sIRB policy

NIH guide notice on the final sIRB policy

Final NIH Policy on single IRB for multi-site research

Public comments

Email questions to: SingleIRBPolicy@mail.nih.gov

 

Johannes Dryander | June 2016 Notes from the John Martin Rare Book Room @Hardin Library

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JOHANNES DRYANDER (ca. 1500-1560). Anatomiae. Marburg: Apud Eucharium Ceruicornum, 1537.

Dryander (also known as Eichmann), professor of surgery at Marburg, was a friend of Vesalius and among the first anatomists who made illustrations after their own dissections.

This Anatomiae appeared six years before Vesalius’ great work. This was the first significant book on the anatomy of the head and contains 20 full-page woodcuts made from Dryander’s own dissections.

Sixteen of the plates are of the head and brain and were done to show successive stages of dissection. The first eleven plates appeared earlier in his Anatomia capitis humani (1536) and the remaining four plates of the chest and lungs were added as an appendix.  dryander3

 

You may view this book in the John Martin Rare Book Room, Hardin Library for the Health Sciences.  Make a gift to the Hardin Library for the Health Sciences by donating online or setting up a recurring gift with The University of Iowa Foundation.

Find information faster |PubMed workshops |Wed., June 15, 1-2pm

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pubmedPubMed is the National Library of Medicine’s index to the medical literature and includes over 22 million bibliographic citations in life sciences. This one-hour session will show you how to improve your search results by using subject headings (MeSH) and advanced keyword searching techniques.
Our sessions this summer:

Register online or by calling 319-335-9151.

 

 

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Jacqueline Leskovec, Network Librarian, National Network of Libraries of Medicine, Greater Midwest Office

Jacqueline Leskovec, Network Librarian, NN/LM, GMR
Jacqueline Leskovec, Network Librarian, NN/LM, GMR

Jacqueline Leskovec, Network Librarian, NN/LM, GMR

Meet Jacqueline Leskovec, Network Librarian for the National Network of Libraries of Medicine’s Greater Midwest Regional Office.

Jacqueline Leskovec, MLIS, MA, RN has been with the National Network of Libraries of Medicine since 2005. Her roles at the former office in Chicago evolved from Outreach and Communications Coordinator, Outreach and Evaluation Coordinator, and Outreach, Planning, and Evaluation Coordinator during that time.

Prior to her work at the Greater Midwest Region, Jacqueline was on the faculty at the University of South Florida Area Health Education Center program, providing outreach services over a nine-county region. She was branch manager at the Advocate Illinois Masonic Medical Center in Chicago, IL. Before her foray into health sciences librarianship, Jacqueline worked for almost twenty years as a nurse.

In her new role, Jacqueline will enhance network membership by building upon current connections and creating new partnerships throughout the Greater Midwest Region and nationally.

Jacqueline will be working from her home office in Chicago and traveling to the office in Iowa City once monthly for staff meetings.

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Spend an evening with Nicholas Meyer |Star Trek writer & director |Friday, May 20 @Main Library

Nicholas Meyer on set with Leonard Nimoy during the shooting of Star Trek VI: The Undiscovered Country. The photo is archived in the University of Iowa Libraries' Special Collections as part of a collection donated by Nicholas Meyer.

The UI Libraries is pleased to host Nicholas Meyer, who will make an appearance as a guest speaker in conjunction with the Main Library Gallery exhibition 50 Years of Star Trek.

Meyer, who is an alumnus of the University of Iowa, directed the movie Star Trek II: The Wrath of Khan (1982) and contributed to the shooting script for that film (uncredited). He wrote portions of the screenplay for Star Trek IV: The Voyage Home (1986) and went on to direct Star Trek VI: The Undiscovered Country (1991), for which he also co-wrote the screenplay.

A long-time Sherlockian, Meyer’s writing prowess led to a best-selling novel, The Seven-Per-Cent Solution: Being a Reprint from the Reminiscences of John H. Watson, M.D.  The novel, crafted by Meyer in a style faithful to the original series, follows Holmes through cocaine addiction and recovery.  Meyer received an Oscar nomination for his screenplay of the novel.

Meyer will deliver a brief talk, titled The Last Man To Understand Anything. There will be a Q&A session afterward.

The event is free and open to the public. RSVPs are appreciated. http://bit.ly/UI-LIB-Meyer

Nicholas Meyer on set with Leonard Nimoy during the shooting of Star Trek VI: The Undiscovered Country. The photo is archived in the University of Iowa Libraries' Special Collections as part of a collection donated by Nicholas Meyer.

Leonard Nemoy and Nicholas Meyer on set during the shooting of Star Trek VI: The Undiscovered Country. The photo is archived in the University of Iowa Libraries’ Special Collections as part of a collection donated by Nicholas Meyer.

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Elizabeth (Liz) Kiscaden, Associate Director, National Network of Libraries of Medicine, Midwest Regional Office

Liz Kiscaden, Associate Director, NN/LM, GMR

Liz Kiscaden, Associate Director, NN/LM, GMR

As of May 1, Elizabeth (Liz) Kiscaden is the new Associate Director for the National Network of Libraries of Medicine’s (NN/LM) regional office, located at Hardin Library for the Health Sciences. This office serves the Greater Midwestern Region (GMR), comprising of a ten-state area surrounding Iowa.

In her new role, Liz will be responsible for operations and staffing and will collaborate on strategic planning for the new program office. She will be located at the GMR office on the second floor of Hardin Library, for which construction is still underway.

During her time at the University of Iowa, Liz served as the Head of Hardin Library Services and served temporarily as a Clinical Education Librarian. Prior to joining the University of Iowa, she was employed as the Library Director at Waldorf College, Forest City, Iowa and solo hospital librarian at Mercy Medical Center – North Iowa. Liz’s professional experience has centered primarily on library administration and biomedical information instruction for health professionals.

Liz enjoys living in Iowa City and taking advantage of events and activities offered through the University of Iowa. In her free time, she takes her dog cruising, enjoys the outdoors and watches old martial arts movies with friends.

John Dix Fisher | May 2016 Notes from the John Martin Rare Book Room @Hardin Library

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JOHN DIX FISHER (1797-1850). Description of the distinct confluent, and inoculated small pox, varioloid disease, cow pox, and chicken pox. 2nd ed. Boston, 1834  
Our copy has six vaccination needles inserted into the margins of two of the pages, seemingly indicating the book may have been used as a treatment room reference tool.

pox needles

Fisher graduated from Harvard Medical School in 1825 and went to Paris where he spent the next two years studying under Laennec, Andral, and Velpeau. Fisher was present at Massachusetts General Hospital when ether was introduced into surgery and was one of the first to use it during childbirth.

Fisher founded the Perkins Institution for the Blind in Boston, was its physician, and was a proponent of education for the blind. The paintings from which the plates were engraved were made when Fisher was studying at Paris in 1825 and were available for this edition. The delicately colored plates, drawn from life, illustrate the various forms and stages of pox and varioloid disease as recognized by the author.

You may view this book in the John Martin Rare Book Room, Hardin Library for the Health Sciences.  Make a gift to the Hardin Library for the Health Sciences by donating online or setting up a recurring gift with The University of Iowa Foundation.

Get ready for finals @Hardin Library | Therapy Dogs | Free Coffee |Free Popcorn |Later Hours

image by wokandapix @pixabay

It’s crunch time.  What are you going to do to get ready for your finals?  Hardin Library can help.
1. Free coffee.
2. Free popcorn Friday and Saturday.
3. Visit therapy dogs on Friday!
4. Easy to schedule group study rooms.
5. Quiet computer lab: West Commons, 2nd Floor.
6. Entire quiet floor of study space: 4th Floor.
7. 24 hour study space when the library is closed.
8. Help!  Our desk is staffed whenever the library is open.
9. Color printing.
10. Longer hours: library open until Midnight Friday, May 6 and Saturday, May 7.

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