13th Edition - January 19, 2018

Final revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) were expected to go into effect on January 19, 2018; however, last-minute government action has delayed the implementation.

HSO staff and investigators were looking forward to taking advantage of the revisions, many of which reduce administrative burden. The HSO is planning to implement some of the changes for non-federally funded research in the near future, in order to offer more flexibility to the research community. Since the HSO was prepared to implement the Common Rule as written, several policy and KC IRB changes need to be reworked before we can do so. Until additional changes are announced:

• New studies should still plan to utilize the revised informed consent document template currently available on the HSO website. The new template includes a summary section of important information and additional elements of informed consent, both of which provide value to human subjects.
• The new exempt categories for chart reviews and benign behavioral interventions will not be available to researchers. Investigators should continue to submit these studies under the current level of review.
• All expedited and full Board research will continue to require renewal as scheduled. Please submit your renewal when requested.

Stay tuned for more information on changes to the IRB process coming in late February.

The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research is effective for grants submitted to the NIH after January 25, 2018.

• The policy applies to NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subject research, and requires that a single IRB (sIRB) provide IRB approval for all participating sites. The policy applies to domestic awardees and participating domestic sites only; foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
• Exceptions to the policy can be requested, based on law or regulation, or due to some other compelling reason.

The NIH policy has important implications for investigators submitting applicable NIH grants and even for investigators who are simply participating sites in grants submitted by external investigators. Please see the HSO's NIH Single IRB Policy Guidance for details.

It is very important that HSO be involved in all discussions regarding sIRB. If you are planning an applicable grant submission, contact the Human Subjects Office immediately to discuss the application requirements and ensure the best possible outcome. Contact Ryan Ballard at 317-278-7812 or rcballar@iu.edu.

Completed your ClinicalTrials.gov registration yet? Need help? Office hours are now available! With the New Year officially underway, now is the time to take advantage of in-person ClinicalTrials.gov registration assistance at ORC. Staff in the ORC Quality Improvement Office are standing by to lend a helping hand as you navigate the Protocol Registration System (PRS).

Beginning January 24, 2018, office hours are Wednesdays from 9AM to 2PM at Lockfield Village, 980 Indiana Avenue, Room 3342. Please email ctgov@iu.edu to reserve a time slot or to let us know you will be stopping in, including a brief description of the area you need assistance with (e.g. registration, study design, arms & interventions, outcome measures or results reporting, etc.). No need to go it alone, we’re here to help!

The National Institutes of Health (NIH) recently issued a Statement on Article Publication Resulting from NIH Funded Research on November 3, 2017. In response to an increase of NIH-funded research papers being published in journals or by publishers that do not follow best practices promoted by professional scholarly publishing organizations, the NIH has provided recommendations to identify credible journals. Resources for researchers include Think Check Submit and an article from the Federal Trade Commission.

For more information, please see the official statement linked above.

UPCOMING: National Conference on Plagiarism

On April 3rd-5th, 2018, a national conference on plagiarism "Plagiarism: Identification, Processing, Prevention and Cultural Context of Plagiarism" will be held in Indianapolis. This conference is being held through the support of an Office of Research Integrity (ORI) grant (#ORIIR170031-01-00).

The goal of the conference is to provide an interactive discussion that will expand the understanding of cultural variables which may contribute to plagiarism in research and supply practical tools and resources in the handling of plagiarism allegations for Research Integrity Officers.

Research Integrity Office Kicks Off RCR Educational Series

The Research Integrity Office (RIO) continues their Responsible Conduct of Research educational series program for the 2017-2018 school year. The first two sessions held in Fall 2017 focused on Threats to Research Integrity, specifically "Research Misconduct and Conflicts of Interest" and "Protection of Research Subjects and Participants: Human Subjects Research and Research with Animals".

The next scheduled session will be held February 15, 2018 and will focus on "Reporting and Reviewing Research, Peer Review and Publications". The last session scheduled for April 26, 2018 which will focus on "Data Acquisition, Collaborative Sciences, Mentor and Trainee Responsibilities". Registration will be available in the near future via the Responsible Conduct of Research Expand Course Listing.

If you have any questions about registration and/or available courses, contact the RIO office via email at rio@iu.edu.