This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. List the important changes in the HHS ‘Common Rule’
2. Explain the reasons for changes in the ‘Common Rule’
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
A new version of the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) “Common Rule”, governing federally funded human research, was set to become effective on January 19, 2018. On January 17, 2018, The HHS and 15 other federal departments and agencies announced an Interim Final Rule (IFR) that delays the effective date. The general compliance date for the revised Common Rule in now set to January 21, 2019. This new guidance is the first update to the regulations since they were published in 1991 and the delay is to allow regulated entities extra time to prepare. Below is a summary of some of the changes that are scheduled to go in to effect. In addition, the FDA has also issued guidance (October, 2018) to help provide direction, stating that it
…intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule. Because FDA has not revised its regulations, FDA is issuing this guidance to reduce confusion and burden associated with complying with two different sets of human subject protection regulations.
NOTE: The HHS states that the consent forms provision can already be adopted as it does not conflict with current guidance. However other elements, such as eliminating continuing review (at least annually) for all ongoing non-exempt human subject research, cannot be adopted at this time.
Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
NOTE: The IFR does not delay the compliance date for the cooperative research provision of the revised Common Rule, which remains January 20, 2020
Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.
HHS and 15 Other Federal Departments and Agencies Announce an Interim Final Rule That Delays Both the Effective Date and General Compliance Date of the Revisions to the Federal Policy for the Protection of Human Subjects to July 19, 2018
Take a post-test and get CME credits
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.