OHRP Educational Workshop: Writing Meaningful Informed Consent and Mastering Common Rule Exemptions

Des Moines, IA US
October 15, 2020

Registration


Registration for this workshop will open on July 1. The cost to attend is $25 and includes breakfast and lunch.

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Once you're logged in, please select the "REGISTER" tab to process your payment and complete your registration.
 

Purpose

This one-day educational workshop, jointly organized by Des Moines University Office of Research, Iowa State University Office for Responsible Research, and the US Department of Health and Human Services, Office for Human Research Protections (OHRP), is designed for institutional review board (IRB) members and IRB administrators/HRPP staff. 

Agenda

TimeSession
8 amRegistration and Breakfast
8:30 amWelcome and Introductions
Yvonne Lau, MBBS, MBHL, PhD
Director, Division of Education and Development, U.S. Department of Health and Human Services Office for Human Research Protections
8:45 am

Overview of the Common Rule and When it Applies##
Misti Ault Anderson, MS, MA
Senior Advisor for Public Health Education, Division of Education and Development, U.S. Department of Health and Human Services Office for Human Research Protections

This session will provide an overview of the scope of the Common Rule, how to determine whether a study comes under the rule, and the associated implications of that determination.

  • Recognize whether a proposed activity constitutes human subjects research according to the regulatory definitions.
  • Describe how to determine whether the HHS regulations for protecting human subjects apply to a proposed research activity.
9:45 am

Case Studies: When Might We Apply Exemptions 1, 2, or 3##**
Yvonne Lau, MBBS, MBHL, PhD

Through examples and case scenarios, this interactive session will take the audience through the thought processes of deciding when exemptions 1, 2, or 3 might apply.

  • Describe the exemption categories 1, 2, and 3 under the revised Common Rule.
  • Explain how these exemptions may be applied.
10:45 amBreak
11 am

Regulatory Flexibilities for Secondary Research with Information and Biospecimens##
Misti Ault Anderson, MS, MA

This session will review key concepts associated with secondary research use of individuals’ private information and biospecimens, relevant requirements under the Common Rule, and the flexibilities it allows. 

  • Recognize the characteristics of secondary research.
  • Describe how to use the regulatory flexibilities for secondary research in the revised Common Rule.
12 pmNetworking Lunch
1 pm

The New Face of Old Questions: Internet, Social Media and Human Research Protections##**
Jaime Hernandez, JD, MBe
Public Health Advisor, Division of Education and Development, U.S. Department of Health and Human Services Office for Human Research Protections

Through case studies, this presentation seeks to identify and address complexities in applying the Common Rule to online research with emphasis on social media and the private vs. public distinction.

  • Distinguish the different types of activities that can be labeled as “internet research.” 
  • Recognize the ethical challenges presented by these activities.
  • Recognize the complexities of applying the Common Rule to social media research.
  • Propose points to consider in making a private vs. public determination.
1:45 pm

Improving Informed Consent: Putting New Common Rule Requirements into Practice##**
Yvonne Lau, MBBS, MBHL, PhD

This discussion session will review the changes to the requirements for informed consent especially those at §46.116(a), including the requirement for a concise key information section, and use examples to illustrate how they could make consent forms more meaningful for research participants.

  • Describe the new requirements for informed consent at 45 CFR 46.116(a)(5).
  • Explore what might be considered “key information” to be included in the concise summary.
  • Describe helpful approaches to improving information provided in consent document especially for clinical trials.
3 pmBreak
3:15 pm

Cultural Awareness in Action - Researcher's Perspective##**
Pamela Duffy, PT, PhD, OCS, FAPTA
Associate Professor, Department of Public Health, Des Moines University
Rachel Reimer, PhD
Director, Department of Public Health, Director, Master of Public Health and Master of Health Care Administration programs, Associate Professor and Chair, Master of Public Health Program, Des Moines University
Natasha Hutchens, BA, PBT(ASCP)CM
Project Manager, “Measurement of Tobacco and Nicotine Use,” Department of Public Health, Des Moines University and University of Iowa

Primary Investigators will guide participants through considerations for embedding cultural competence in the research design, including throughout the conduct and interpretation of a study. For this session, cultural competence will be defined as the action of putting cultural awareness (i.e., understanding the importance of social and cultural influences on beliefs and behaviors; awareness of unique and defining characteristics of populations; responsiveness; safety; and sensitivity) into practice. Challenges faced and lessons learned in the process will also be discussed.

  • Recognize considerations for incorporating cultural awareness in research.
  • Describe the importance of incorporating cultural competence into the study design and research procedures.
4:15 pm

Ask OHRP Q&A Session
Misti Ault Anderson, MS, MA
Jaime Hernandez, JD, MBe
Yvonne Lau, MBBS, MBHL, PhD

This session provides a platform for the audience to ask OHRP staff questions.

4:30 pmAdjourn

 

Course summary
Course opens: 
07/01/2020
Course expires: 
10/15/2020
Event starts: 
10/15/2020 - 8:00am
Event ends: 
10/15/2020 - 4:30pm
Cost:
$25.00
Rating: 
0
Des Moines University
3200 Grand Avenue
Olsen Center
Des Moines, IA 50312
United States
+1 (515) 271-1596

Des Moines University is located on a 22-acre campus in the heart of Des Moines, Iowa. Just west of downtown on Grand Avenue, the University is located in one of Des Moines' most prestigious neighborhoods. The campus is in a historic neighborhood filled with tree-lined streets and gracious older homes and businesses. Its central location makes it easy to access the rest of the city and outlying communities. The campus is close to the Des Moines International Airport, located on the bus line and just blocks from local shopping and downtown Des Moines.

Travel

Hotel Accommodations

There are numerous hotels available in the Des Moines area. Below are a few options located downtown (close to campus), and more can be found on the DMU accommodations website. Some hotels offer shuttle service to DMU, but you must inquire with the hotel directly. Some hotels may offer a discount (based on availability). Mention DMU to your hotel to see if a discount may be available.

Des Moines Marriott – Downtown
700 Grand Avenue
Des Moines, IA 50309
515-245-5500

  • May offer discounted rates
  • Airport shuttle service
  • Restaurant and lounge
  • Health club and indoor pool

Hyatt Place Des Moines
418 6th Avenue
Des Moines, IA 50309
515-282-5555 or 888-591-1234

  • Airport shuttle service
  • Complimentary shuttle service to Des Moines University
  • Complimentary Hot American & Continental Breakfast
  • Fitness Center & Indoor Pool
  • DMU Discounted Rate (mention Des Moines University Corporate Rate)

Renaissance Savery Hotel – Downtown
401 Locust Street
Des Moines, IA 50309
800-514-4706

  • Airport shuttle service
  • Restaurant and lounge
  • DMU discount on standard rooms (based on availability)

Misti Ault Anderson, MS, MA, serves as a Senior Advisor for Public Health Education in the Division of Education and Development of the HHS Office for Human Research Protections (OHRP). Prior to joining OHRP, Ms. Anderson was a Senior Policy and Research Analyst at the Presidential Commission for the Study of Bioethical Issues, where she served as staff lead for the Bioethics Commission’s educational materials and for both volumes of the Bioethics Commission’s Gray Matters report on neuroscience and ethics. She holds an M.S. in Biomedical Science Policy and Advocacy from Georgetown University, an M.A. in Science Education from UNC-Chapel Hill, and a B.S. in Microbiology from Clemson University.

Yvonne Lau, MBBS, MBHL, PhD, is the Director of the Division of Education and Development (DED) at the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). She joined OHRP in June 2014 from the Office of Extramural Research of the National Institutes of Health (NIH) where she served as the Extramural Research Integrity Officer. Dr. Lau had also worked with the NIH Office of Extramural Program as Human Subjects Specialist and had served on the Institution Review Board of the MedStar Health Research Institute in Maryland. Prior to coming to the U.S., Dr. Lau was a Consultant Surgeon with the Hospital Authority of Hong Kong and founded Hong Kong’s first multidisciplinary breast center and breast cancer patient support group. Dr. Lau received her medical degree from the University of Hong Kong, and is a Fellow of the Royal College of Surgeons of Edinburgh (FRCSEd) in the United Kingdom and Foundation Fellow of the Hong Kong Academy of Medicine (HKAM). She obtained her Master in Bioethics and Health Law (MBHL) and her PhD in Bioethics from the University of Otago in New Zealand.

Jaime Hernandez, JD, MBe, is an attorney and bioethicist who is currently a Public Health Advisor with the Division of Education and Development at the Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services.  Before joining OHRP, Mr. Hernandez was a Senior Research Investigator at the University of Pennsylvania, Department of Medical Ethics and Health Policy.  Prior to that, he was a Litigation Associate at Hughes Hubbard & Reed, L.L.P.  He also served as an Administrator for the social and behavioral science IRB at the University of Pennsylvania, Office of Regulatory Affairs. Mr. Hernandez obtained his Juris Doctorate (J.D.) at the University of California, Berkeley School of Law (Boalt Hall) and his Masters in Bioethics (M.Be.) at the University of Pennsylvania, Perelman School of Medicine.  He also holds a Bachelors in Philosophy from the University of Miami.

Pamela Duffy, PT, PhD, OCS, FAPTA, is an Associate Professor in the Department of Public Health at Des Moines University. Dr. Duffy specializes in interprofessional education, health policy and regulation, and health services research. Her three primary categories of research are 1. Effective methodology for teaching cultural competency skills to health professions students; 2. Health care disparities and access to health care and public health services, including delivering culturally sensitive care, to underserved populations; and 3. Measuring health care quality and efficiency. Dr. Duffy received the Des Moines University President's Recognition Award in 2014, the Faculty Outstanding Service Award in 2016, and the Master of Public Health Student Choice Faculty of the Year Award consecutively in 2017 and 2018.

Rachel Reimer, PhD, is the Director for the Department of Public Health, Director for the Master of Public Health and Master of Health Care Administration programs, and Associate Professor and Chair of the Master of Public Health Program at Des Moines University. Dr. Reimer's research is focused broadly on examining how individuals make decisions about health, and the social, cultural, and environmental factors that affect those decisions. Her current research is focused primarily on using social psychology theory to examine disparities between White and Latina women on factors associated with HPV vaccination (such as parent-child communication, religiosity, and perceived norms). She also researches decision making for adolescent health risk behaviors such as alcohol consumption and risky sexual behaviors, and is involved in experimental research examining the longitudinal effects of a childhood obesity prevention program.

Natasha Hutchens, BA, PBT(ASCP)CM, is the Project Manager for “Measurement of Tobacco and Nicotine Use,” a research study currently being conducted by investigators from the Department of Public Health at Des Moines University and collaborators at the University of Iowa. The project goal of detecting and quantifying the behaviors of smoking, chewing, and vaping is at the intersection of public health concerns and emerging biomedical research methods. Previously, she has been a team member on a projects researching the relationship of AHRR methylation, an epigenetic method of measuring smoking behavior, and risky behavior in adolescence. In her current role, decisions about the methods used for participant recruitment and administration of informed consent are made daily as the project seeks to uphold institutional and governmental regulations.

Disclosures

The following individuals have no conflicts with commercial interest companies to disclose relevant to the content of this educational activity:

  • Kerry Agnitsch, PhD - Planning Committee Member
  • Diane Ament, BBA, MPA - Activity Coordinator and Planning Committee Member
  • Misti Ault Anderson, MS, MA - Speaker
  • Jeffrey Gray, PhD - Activity Director and Planning Committee Member
  • Natasha Hutchens, BA, PBT(ASCP)CM - Speaker
  • Yvonne Lau, MBBS, MBHL, PhD - Speaker and Planning Committee Member
  • Rachel Reimer, PhD - Speaker

The below individuals disclose the following financial conflicts of interest:

  • Pamela Duffy, PT, PhD, OCS, FAPTA - Speaker - Grant funding from Healthy Birth Day, Inc. also known as Count the Kicks.

Accreditation Statements

  • DPM: Des Moines University (DMU) is approved by the Council on Podiatric Medical Education as a provider of continuing education in podiatric medicine. DMU has approved this activity for a maximum of 6.25 continuing education contact hours.
  • DO: Des Moines University (DMU) is accredited by the American Osteopathic Association (AOA) to provide osteopathic continuing medical education for physicians. DMU designates this program for a maximum of 6.25 AOA Category 2-A credits and will report CME and specialty credits commensurate with the extent of the physician’s participation in this activity.
  • MD: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Iowa Medical Society (IMS). Des Moines University (DMU) is accredited by the IMS to provide continuing medical education for physicians. DMU designates this live activity for 6.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • Nurse: Des Moines University is Iowa Board of Nursing approved provider #112. This live activity has been reviewed and approved for 6.25 continuing education contact hour(s). No partial credit awarded.
  • Other Healthcare Professionals: This live activity is designated for 6.25 AMA PRA Category 1 Credit(s)™.
  • CIP: Workshop sessions marked with a double asterisk (**) meet the criteria in the Certified IRB Professional (CIP) recertification guidelines and are eligible as accredited continuing education units. A maximum of 4.0 hours of continuing education credits can be claimed. 
  • SOCRA: Workshop sessions marked with a double hash (##) on the agenda meet the criteria for SOCRA recertification and are eligible as accredited continuing education units. A maximum of 6.0 hours of continuing education credits can be claimed. 

EDUCATIONAL GRANTS

No commercial interest company provided financial support for this continuing education activity.

DISCLOSURE

Everyone in a position to control the content of this educational activity will disclose to the CME provider and to attendees all relevant financial relationships with any commercial interest. The speaker(s) will disclose if any pharmaceuticals or medical procedures and devices discussed are investigational or unapproved for use by the U.S. Food and Drug Administration (FDA). Determination of educational content and the selection of speakers is the responsibility of the activity director. Firms providing financial support did not have input in these areas.

Disclaimer

The information provided at this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. The content of each presentation does not necessarily reflect the views of Des Moines University.

Price

Cost:
$25.00
Please login or Create an Account to take this course.

Registration for this workshop will open on July 1, 2020.

The cost to attend is $25 and includes breakfast and lunch. To register a group using a single payment submission, please email cme@dmu.edu.

CANCELLATION POLICY

  • All cancellations must be received in writing at cme@dmu.edu.
  • A nonrefundable administrative fee of $20 will be charged for all cancellations.
  • No refunds will be given three (3) business days prior to the activity start date.
  • Cancelled registrations can be transferred to another individual for the same activity.
  • Individuals who fail to attend the activity (no-shows) will not receive any refund. Forfeited fees may not be applied to any other activity.