Except OHRP also said this:



This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.


Regards,
Theresa Defino
https://twitter.com/TheresaDefino
Editor
Report on Research Compliance
Report on Patient Privacy

301-738-3721
xxxxxx@aol.com


-----Original Message-----
From: Collette L. Ryder <xxxxxx@MAIL.ROCKEFELLER.EDU>
To: RESADM-L <xxxxxx@lists.healthresearch.org>
Sent: Thu, Jan 18, 2018 11:59 am
Subject: Re: [RESADM-L] OHRP announcement

I agree with your interpretation. It would appear that we have to continue to operate under the “old” rules for now.
 
The full text confirms this:
Prior to July 19, 2018, regulated entities will continue to comply with the pre-2018 Requirements
and those requirements will be enforced by the Common Rule departments and agencies. To
clarify, regulated entities are not allowed, prior to July 19, 2018, to comply with the 2018
Requirements in lieu of the pre-2018 Requirements. Unless further regulatory action is taken,
studies initiated on or after July 19, 2018, will be required to comply with the 2018
Requirements. Studies initiated prior to July 19, 2018 (i.e., studies initially approved by an IRB,
studies for which IRB review was waived pursuant to §_.101(i), or studies determined to be
exempt, before July 19, 2018) would, as a default, continue to be subject to the pre-2018
Requirements for their duration. This will maintain the ability of institutions to hold such studies
to the same set of standards throughout the studies’ duration, and will avoid a requirement that
such research be subject to two sets of rules. However, on or after July 19, 2018, institutions may
elect instead to conduct such studies in compliance with the 2018 Requirements, as set forth in
§_.101(l)(3).
 
**RU is implementing a new grants management system – RAS-Grants. Please see http://www2.rockefeller.edu/sr-pd/?page=ClickProject_Home for more information.**
 
Collette L. Ryder, MBA, CRA
Director
Office of Sponsored Programs Administration
The Rockefeller University
1230 York Ave., Box 82
Founders Hall, Room 301
New York, NY  10065
Email: xxxxxx@rockefeller.edu
Tel: (212) 327-8054
 
From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Megan Roth
Sent: Thursday, January 18, 2018 11:39 AM
To: RESADM-xxxxxx@lists.healthresearch.org
Subject: [RESADM-L] OHRP announcement
 
Hi everyone!
 
What is your interpretation of the OHRP announcement this morning about the Common rule? 
 
The Final Rule published last year said we could implement at any time. Today’s announcement suggests that we are not permitted to implement until July. 
 
Is that your interpretation? How in the world can they pull the plug 24hrs before implementation. I have everything ready to roll out, have already trained my IRB, am giving a talk to faculty in an hour, have already pulled all my old forms off the website and updated my website. 
 
What in the world is going on????
 
Megan 
--
Megan Roth, Ph.D.
Executive Director of Research
Abilene Christian University
320 Hardin Administration Bldg
ACU Box 29103
Abilene, TX 79699
O: 325-674-2885
F: 325-674-6785
xxxxxx@acu.edu
= = = = = =
Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "RESADM-L" link under "Sponsored Programs").
A link directly to helpful tips: http://tinyurl.com/resadm-l-help
= = = = = =
= = = = = =
Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "RESADM-L" link under "Sponsored Programs").
A link directly to helpful tips: http://tinyurl.com/resadm-l-help
= = = = = =
= = = = = =

Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "RESADM-L" link under "Sponsored Programs").

A link directly to helpful tips: http://tinyurl.com/resadm-l-help

= = = = = =