Your IRB News and Updates – Farewell Issue

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.

Link to Article

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.

Link to Article

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.

Link to Article

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.

January 21, 2019 is almost here!

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

• IRUs are video presentations consisting of a title slide and ~5 text slides on a specific topic.
• IRUs are provided in three different formats

• • Recorded PowerPoint (.pptx) – which may be printed if desired
  • For Windows Media Player (.wmv)
  • YouTube link

• Each presentation averages 15 minutes to view
• The brief format is ideal for busy IRB members.
• PowerPoint and Window Media Player files are access through DropBox.  YouTube links allowing viewing via the Internet.

Content

• There are 25 IRUs and a sample.  All are  provided at once when you purchase.
• Topics cover the key changes in the regulations that IRB Member and Staff need to know.
• Brief but detailed information, each on a specific topic.
• Each presentation includes how the changes affect IRB review and items for consideration and discussion that your IRB and administration must address.

Click Here to Access the List of IRUs

Suggested Uses

• Use IRUs now to prepare for the changes or use them throughout 2019,
• Use one or more  IRUs for brief education sessions at IRB meetings or IRB Staff meetings.
• Send one or more IRUs to IRB Members on a weekly or monthly basis.
• Provide all IRUs to IRB Members or Staff to view at their convenience.
• IRUs can also be used to educate researchers or administrators on the changes.

Cost

• One or two IRBs – $600
• Three to Five IRBs – $700
• >5 IRBs – $800

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.

Link to Website Page

Act now to sign up for this timely and important education tool!

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

Purchase as bundles – Save $$ !  Get all issues of IRB EasyEd at once!

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:   

• 1(1)    The Definition of Minimal Risk
• 1(6)    Assessing Scientific Validity
• 1(11)  Enhancing Relationships Between the IRB and Researchers
• 2(3)    Controverted Issues
• 2(5)    Minor versus Substantive Amendments
• 2(12)  What Reading Levels Should Consent Forms be Written At?
• 3(1)    What is IRB Creep and Are We Guilty?
• 3(7)    Disapproving Research:  When and How
• 3(13)  Equipoise

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * 

More information, request sample, or purchase

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
Link to Abstract

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
Link to Abstract

Institutional Review Board (IRB)
Cara East
In  Developing a Successful Clinical Research Program, 2018, Springer, Cham
Link to Abstract

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
Note:  this article talks about the challenges of meeting common rule requirements for emergency research without consent.

Developing Community Engaged Research Practices in Family, School, and Community Partnerships
MP Evans
Journal of Family Diversity in Education, 2018
Link to Article

What do you mean by ‘informed consent’? Household survey ethics in development research
Anna Josephson and Melinda Smale
2019 Allied Social Sciences Association (ASSA) Annual Meeting, January 4-6, 2019, Atlanta, Georgia 281172, Agricultural and Applied Economics Association.
Link to Abstract

Independent Review of Research Proposals From Ethical Point of View in Pakistan
Mohammad Salim, Saima Hamid
J Ayub Med Coll Abbottabad 2018;30(4)
Link to Article

Extended Commentary: Military Service without the Common Rule
Harwood R. Garland II
International Social Science Review Volume 94 Issue 3, December, 2018.
Link to Article

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
Link to Abstract

Optimising research ethics review: Combining regulatory support and ethics consultation to enhance efficiency of university research