October 26, 2016
The only IRB meetings in November and December will be held on 11/9 (deadline: 10/31) and 12/14 (deadline: 12/5). Plan accordingly and submit renewals early so they don’t expire. Feel free to call the Investigators Help Desk at x43042 for any...
September 26, 2016
A recently published finding from investigations by federal regulators [Human Res Rept, Sep. 2016, 31(9), 9]:
The U.S. Food & Drug Administration (FDA) found that a physician-investigator conducting two GlaxoSmith-Kline multisite studies of
September 27, 2016
NIH has recently released its policy on the use of a single Institutional Review Board (sIRB) for multi-site research.
August 2, 2016
You should officially close the IRB record of your human research project just as soon as study activities involving contact with living individuals or their identifiable data are completed. To request IRB closure, complete a Research Report Form...
August 2, 2016
Loma Linda University is hosting the CCRP exam offered by the Society for Clinical Research Associates (SoCRA) on November 9, 2016 (Wednesday) from 8 AM-12 PM. The application deadline is 9/28/16. For more information on candidate eligibility...
June 9, 2016
In case you missed the presentation (Research Affairs “Lunch & Learn,” April 5) by Dr. Travis Losey, IRB Chair, on “Controversies at the IRB,” here are the top four questions asked at IRB meetings:
Is the study ethical (respect for persons,...
May 9, 2016
An excerpt from Dr. Losey's "Controversies at the IRB" April 5 presentation at Research Affairs "Lunch & Learn."
May 17, 2016
Due to the up-coming Memorial Day holiday, all full board IRB applications for the June 8 meeting must be submitted on or before noon on Friday, May 27.
May 5, 2016
The IRB roster has been updated to reflect new membership.
May 5, 2016
The only IRB meeting in July will be held on 7/13, with the deadline on 7/01. The second meeting of the month is cancelled due to scheduling issues. Plan accordingly and submit renewals early so they don’t expire. Feel free to call the...
April 13, 2016
The Study Personnel Change form has been recently updated.
February 10, 2016
Does your study expose subjects to ionizing radiation? If your answers to item V-D of the standard IRB application form result in "RSC review REQUIRED, " call the Office of Radiation Safety (x14003) to confirm that the Radioactive Materials and ...
March 18, 2016
You are invited to "Controversies at the IRB"- A practical discussion of some of the common issues facing researchers in human subjects protection in research
March 22, 2016
Adventist Human-Subjects Research Association (AHSRA) is now accepting proposals for its Spring Conference at Oakwood University May 9-11, 2016.
March 23, 2016
How social media can be used to reach and influence potential research participants is described in a linked article.
February 24, 2016
Recruitment materials (flyers, posters, ads) for minimal risk studies may now specify the incentive amount, a change in practice recently approved by the LLUH IRB. If investigators choose to include this information, they should also specify the
February 18, 2016
The signature block for departmental review of IRB applications has been modified to accommodate those large academic departments desiring to include the division chief in the review/sign-off process. Implementing this additional feature is at...
February 2, 2016
Recently published findings from investigations by federal regulators [Human Res Rept, Jan. 2016, 31(1), 9-10]:
The U.S. Food & Drug Administration (FDA) found that a California investigator persistently failed to ensure that a number of his
February 2, 2016
Due to the President’s Day holiday, the IRB deadline for the February 24th meeting will be on Friday, February 12th at 12:00 noon. Call Deborah at our Investigators Help Desk (x43042) if you have any questions.
January 27, 2016
You can check the approval end dates of all your studies at the Investigator's Portal and submit Research Report Forms accordingly. If you need help with your username and password, call Deborah at our....
October 13, 2015
Policy H-42 Research Records, Documentation, Retention, Storage, and Access For Human Subject Research and H-42.A Procedures for Clinical Research Records Documentation has been approved...
January 8, 2016
Federal regulations require that research should be conducted according to the plans reviewed and approved by the IRB. Instances where this does not occur, either inadvertently due to circumstances beyond the investigator’s control, or due to...
October 29, 2015
Hello Researchers:
Research Affairs would like to invite you to the November 10 Lunch Seminar:
Have your IACUC submission approved the very first time it is reviewed
Why experience frustration and lose valuable time getting your project started?
October 22, 2015
Protocol Violations: Don’t let this happen to you!
Recently published findings from investigations by federal regulators [Human Res Rept, Oct. 2015, 30(10), 8-9]:
The U.S. Food & Drug Administration found that a California investigator...
October 20, 2015
Sex in the Laboratory: NIH expectations for gender representation in human and animal research
A recent
notice from the NIH will likely change how human subject research is planned, reviewed, and conducted. Although women now account for...
October 20, 2015
The following IRB application names have been updated on the IRB Toolkit for Investigators to clarify when to use them:
"Social Behavioral" > "Minimal Risk Studies"
"Standard" > "Clinical
October 20, 2015
The IRB Applicant Checklist has been updated to provide information about naming conventions for full board electronic submissions. Further details about naming conventions are provided in this guidance.
October 15, 2015
NIH has simplified the Vertebrate Animals Section of Grant Applications. These requirements, as applicable, will take effect for all grant applications except Fellowship (F series) and Training (T series) grants for due dates on or after January 25, 2016, and will take effect for all applications for due dates on or after May 25, 2016.
July 8, 2015
Remember that the Social/Behavioral consent template has been replaced with the consent template for
Minimal Risk Studies. The revised template incorporates further edits to simplify and is renamed so investigators recognize that it is useful...
July 8, 2015
The only IRB meeting in July will be held on 7/22, with the deadline on 7/13. The first meeting of the month is cancelled due to scheduling issues. Feel free to call the Investigators Help Desk at x43042 for any questions.
July 8, 2015
The
Standard IRB application has been updated to: 1) include wording about standard of care procedures and 2) modify the question on data safety monitoring. Note that this application is best used for complex studies such as clinical trials. We...
May 15, 2015
Only 4 paper copies (1 original and 3 copies) will be required for all Full Board submissions, not 28!
April 30, 2015
The only IRB meeting in July will be held on 7/22, with the deadline on 7/13. The first meeting of the month is cancelled due to scheduling issues. Plan accordingly and submit renewals early so they don’t expire. Feel free to call the...
April 20, 2015
The IRB Roster was updated this month to reflect new membership.
March 27, 2015
Due to the upcoming President's Day holiday, all IRB applications for the February 27 meeting must be submitted on or before noon on Friday, February 15.
March 31, 2015
Due to the upcoming President's Day holiday, all IRB applications for the February 27...
February 23, 2015
“Investigators Help Desk” (Deborah Rodman, x43042 or
dyoderrodman@llu.edu) has been designated at RPP to answer your questions, such as:
Where can I find an IRB/IACUC application forms on-line?
What is the status of my study? (Note that...
October 8, 2014
Are you Interested in contributing to LLUH's Institutional Review Board? The IRB formally reviews, approves and monitors all research involving humans, including clinical trials, behavioral research, and biomedical science projects using human materials conducted by anyone associated with LLUH - faculty, students, residents, postdocs or employees.
August 7, 2014
Research Protection Programs is please to offer the 'Investigator's Help Desk' and the 'IRB Reviewer's Help Desk' to assist investigators and reviewers.
April 1, 2014
The Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) present The Research Clinic, an interactive training video that educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct.
April 21, 2014
Tips on making the IRB process for new or existing human study protocols go smoothly.
May 9, 2014
1. Several documents in the IRB Toolkit for Investigators have been revised. 2. Quorum IRB will be hosting a free webinar - Understanding reporting Obligations to the IRB.
June 26, 2014
Four IRB documents (HIPAA authorizations, Protocol Change Form, and Waiver of Consent) have been updated.
March 27, 2015
As the academic year comes to a close, a number of students and faculty develop plans for travel and research abroad.
March 27, 2015
Investigators are reminded to check the IACUC calendar.
