| Check out this free newsletter which provides a quick review of the latest issues, events, and services in human research protection. |
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| Your IRB News & Updates for January-February 2019 |
| Apex Ethical Services, a leader in HRPP and IRB education and consulting, keeps you informed about the latest issues in human research protection and services available to you and your program. |
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| IRB News
Chinese Gene-editing Research
Anyone involved in research ethics and human research protection must be aware of the Chinese physician who altered the genes in two human embryos to be resistant to HIV. Numerous articles and opinions have been published on this issue. The article I cite here is an excellent and understandable synopsis of the ethical issues by a university IRB member, Tom Steiger (Indiana State University). This is a great topic to discuss with your IRB, if you haven’t done it already. With the ever escalating technical advances, issues like this are going to present challenges to research ethicists and IRBs. And professor Steiger is a sociologist, which illustrates that the opinion of all scientists and ethicists, including social scientists are important. The more you prepare your IRB for these type of issues, the better we will be to deal with them and make the best decisions possible.
EPA Issues Proposed Rule to Harmonize EPA-specific Regulations in Revised Common Rule
My last newsletter highlighted the point that the FDA is not completely on board with the revised common rule. In addition, every Common Rule Department has to consider changes to their idiosyncratic requirements to be in harmony with the revised regulations. The EPA (Environmental Protection Agency) has issued their specific changes for harmonization. You can assume other affected Departments will issue similar changes.
Dealing with the Therapeutic Misconception in Biomedical Research
This is an excellent article by Jennifer McCormick, PhD, about the challenges of dealing with the therapeutic misconception. She talks about what the therapeutic misconception is and how it impacts subject decision making as well as ways of dealing with the challenges that the therapeutic misconception present.
Reminder: Implementation of the Revised Regulations January 21, 2019
Days from this mailing (January 10, 2018) until implementation (January 21, 2019): 11
See the tips below for implementing the revised regulations. |
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A New and Timely Innovative Education Tool
IRB Revisions Updates (IRUs)
The revisions to the Common Rule (45 CFR 46) are set to go into effect on January 21, 2019. Apex Ethical Services is developing an educational tool to inform IRB Members and IRB staff about the key changes in the revised regulations.
Format
Content
Click Here to Access the List of IRUs
Suggested Uses
Cost
Payment may be made by check or ACH Sorry, we no longer accept credit cards.
IRB Revision Updates will be available on or before September 14. To access the sample, express your interest and get on our pre-order list, use this link to our website.
Act now to sign up for this timely and important education tool! |
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| Upcoming Events
When: April 17-18, 2019 Who: Office of Human Research Protections (OHRP) What: OHRP Research Community Forum: Pioneers for Discovery: Reinventing the Research Enterprise Where: Overland Park Convention Center at Overland Park, Kansas
When: April 20 – May 1, 2019 Who: The University of Southern Maine’s (USM) Maine Regulatory Training and Ethics Center (MeRTEC) What: Maine Research Integrity Symposium Where: Portsmouth, Maine
When: May 5-8, 2019 Who: Model Agreements & Guidelines International (MAGI) What: MAGI’s Clinical Research Conference – 2019 East Where: Sheraton Boston Hotel, Boston, MA
When: May 21-23, 2019 Who: AAHRPP What: 2019 AAHRPP Annual Conference Where: The Ritz Carlton New Orleans, LA
When: May, 2019 Who: Office of Human Research Protections (OHRP) What: OHRP Educational Workshop Where: Grand Rapids, Michigan Note: OHRP will provide updated details in their newsletter and on their website
When: May, 2019 Who: OHRP and NIH What: NIH OER Pre-Seminar Educational Workshop Where: Baltimore, Maryland Note: OHRP will provide updated details in their newsletter and on their website
When: July, 2019 Who: Office of Human Research Protections (OHRP) What: Research Community Forum Where: Seattle, WA Note: OHRP will provide updated details in their newsletter and on their website
When: November 17, 2019 Who: Public Responsibility in Medicine and Research (PRIMR) What: Social, Behavioral and Educational Research Conference Where: Boston, MA
When: November 17-20, 2019 Who: Public Responsibility in Medicine and Research (PRIMR) What: 2019 Advancing Ethical Research Conference Where: Boston, MA |
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| The Complete Set of IRB EasyEd is Now Available!
Purchase as bundles – Save $$ ! Get all issues of IRB EasyEd at once! |
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Apex Ethical’s landmark education tool, IRB EasyEd, is being utilized as a vital education tool at institutions across the country. IRB EasyEd is designed for a 15-minute education session at IRB meetings. The response to IRB EasyEd has been phenomenal.
Each IRB EasyEd issue comes with a link to 30 minute recorded summary sessions in three different forms (recorded PowerPoint, Window Media File, and YouTube). The summary sessions are designed for the person leading the discussion but you can use them anyway you like.
When changes are possible due to the revised regulations which (may) go into effect on July 19, 2018, addendums on the changes are included in any previously written IRB EasyEd issues. There are versions of the recorded summary sessions with the addendums.
Quote from an IRB EasyEd subscriber: “Hi, just wanted to tell you that we did the first IRB EasyEd (on minimal risk) at both our medical and campus board this week, and they loved them!. Generated good discussion.”
Over 1,000 IRB Members and Staff are using IRB EasyEd each month – how about you?
When you purchase complete volumes you will be provided with all issues and summary session recordings in one complete bundle.
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Examples of Issues:
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| Recent Articles of Interest
Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight Holly Fernandez Lynch et al. Journal of Empirical Research on Human Research Ethics, First Published December 12, 2018; https://doi.org/10.1177/1556264618812625
Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants’ Genomic Results K.L. Edwards et al. Public Health Genomics 2018, doi: 10.1159/000490235 Institutional Review Board (IRB) Barriers to clinical research in trauma Richard Miskimins, Shibani Pati, Martin Schreiber Transfusion, first published: 26 December 2018; https://doi.org/10.1111/trf.15097 Link to Abstract Developing Community Engaged Research Practices in Family, School, and Community Partnerships What do you mean by ‘informed consent’? Household survey ethics in development research Independent Review of Research Proposals From Ethical Point of View in Pakistan Extended Commentary: Military Service without the Common Rule Variations in the Application of Exception from Informed Consent in a Multicenter Clinical Trial Jestin N.Carlson et al. Resuscitation, first published online December 17, 2018 Optimising research ethics review: Combining regulatory support and ethics consultation to enhance efficiency of university research |
