Grand Rounds 4: Modifications and Waivers of Informed Consent in Pragmatic Clinical Trials

In this Grand Rounds, Jason Karlawish, MD, discusses waivers and alterations of written informed consent in pragmatic clinical trials. He provides two case studies of pragmatic clinical trials to determine whether or not it is appropriate to permit a modification or a waiver of research informed consent. Focusing on regulatory criteria addressing acceptable levels of research risk, the practicability of conducting the research with informed consent, and efforts to respect the rights and welfare of PLWD.

 

Webinar Date: February 20, 2020

Speaker: Jason Karlawish, MD 

Learning Objectives

  1. Identify how consideration of ethical and regulatory issues in the design phase of an ePCT with PLWD can help make the study more pragmatic.
  2. Review the regulatory requirements for a waiver or alteration of informed consent and discuss related ethical considerations.
  3. Apply what we’ve covered to two case studies.

Watch the Webinar

Webinar Slides

Download the slides: IMPACT Grand Rounds February 20 2020.

Additional Resources

  • 45 CFR 46 – Protection of Human Subjects
  • Scott Kim and Frank Miller. “Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons.” IRB: Ethics and Human Research. January-February 2016, Vol 38, issue 1.
  • January 31, 2008 SACHRP letter to HHS Secretary: Recommendations related to waiver of informed consent and interpretation of “minimal risk,” available at https://hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html

Grand Rounds 3: Using a Pilot to Test and Refine Your Measurement Strategy

Grand Rounds GraphicThis Grand Rounds webinar uses a case example to describe how a pilot can be used to test the adequacy of existing data for evaluating an ePCT outcome. Dr. McCreedy also describes a potentially efficient ePCT design that accommodates under-detection in existing data while maintaining large-scale implementation and evaluation.

Speaker

Ellen McCreedy, PhD, MPH

Watch the Webinar

NIA IMPACT Grand Rounds from NIA IMPACT Collaboratory on Vimeo.

Download the Presentation

Using a Pilot to Test and Refine Your Measurement Strategy a NIA IMPACT Collaboratory Grand Rounds presentation.

Keywords

Administrative data, dementia-related behaviors, measurement, piloting

Learning Objectives

  1. Describe how a pilot study can be used to test the adequacy of existing data sources for the purposes of evaluating your ePCT.
  2. Give three reasons why existing administrative data may suffer from under-detection of behaviors in persons with dementia.
  3. Discuss an alternative ePCT design that addresses potential under-detection in existing administrative data sources.

Related Articles and Resources

McCreedy EM, Yang X, Baier RR, Rudolph JL, Thomas KS, Mor V. Measuring effects of nondrug interventions on behaviors: music & memory pilot study. Journal of the American Geriatrics Society. 2019 Oct;67(10):2134-8.

Grand Rounds 2: Stepped Wedge Cluster Randomized Trials: What, How, And When?

This Grand Rounds webinar focuses on the use of stepped wedge design in cluster randomized trials (SW-CRT). SW-CRT is a novel research design embraced by clinical researchers. It is unique from conventional parallel arm CRTs in that all clusters receive the intervention. The three main types of SW-CRT designs are presented, along with common justifications for employing these designs and their implications.

Speaker

Monica Taljaard, PhD

Watch the Webinar

Stepped Wedge Cluster Randomized Trials: What, How, And When? from NIA IMPACT Collaboratory on Vimeo.

Download the Presentation

Stepped Wedge Cluster Randomized Trials: What, How and When? a NIA IMPACT Collaboratory Grand Rounds presentation.

Keywords

Stepped wedge cluster, SW-CRT, sample size calculation

Learning Objectives

  1. Describe the key characteristics and main types of stepped wedge cluster randomized trials (SW-CRTs) with examples.
  2. Explain the main approach to analysis and sample size calculation for SW-CRTs.
  3. Discuss what is an appropriate justification for using a SW-CRTs.

Related Articles and Resources

  1. Kasza J1, Taljaard M2,3, Forbes AB1 Information content of stepped-wedge designs when treatment effect heterogeneity and/or implementation periods are present https://www.ncbi.nlm.nih.gov/pubmed/31321806
  2. Teerenstra S, Taljaard M, Haenen A, Huis A, Atsma F, Rodwell L, Hulscher M. Sample size calculation for stepped-wedge cluster-randomized trials with more than two levels of clustering. Clinical Trials. 2019; 16(3):225-236. doi: 10.1177/1740774519829053.
  3. R package ‘swCRTdesign’  http://faculty.washington.edu/jphughes/pubs.html
  4. R-Shiny (Hemming & Kasza) https://clusterrcts.shinyapps.io/rshinyapp/ 

Grand Rounds 1: Are you ready for a pragmatic trial? The RAPT model and implementation considerations

This Grand Rounds webinar focuses on using the Readiness Assessment for Pragmatic Trials (RAPT) model to assess an intervention’s readiness for an embedded pragmatic clinical trial (ePCT). RAPT includes nine domains that reflect a range of considerations regarding the feasibility of successfully employing pragmatic methods and the prospect of an intervention’s widespread adoption, if proven effective. Researchers using RAPT to evaluate an intervention are asked to qualitatively assess each domain from low to high readiness and can use the results to inform team discussion about when and how to proceed with an ePCT. In this session, we describe the model’s creation, domains, and scoring criteria, and then provide an example of its application to iterative phases of a pragmatic study.

Speakers

Rosa Baier, MPH
Laura Gitlin, PhD, FGSA, FAAN
Eric Jutkowitz, PhD

 

Watch the Webinar

IMPACT Grand Rounds_RAPT Model from NIA IMPACT Collaboratory on Vimeo.

Keywords

Assessment, Pragmatic Trials, Implementation, RAPT Model

Learning Objectives

  1. Understand how RAPT complements and differs from PRECIS-2
  2. Understand RAPT’s domains and their relevance for conducting an ePCT
  3. Learn how RAPT results can inform decisions about and preparation for proceeding to an ePCT
  4. Be prepared to apply RAPT to interventions and use results to guide team discussion