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Tue, July 26, 2011
The Department of Health and Human Services published an Advance Notice of Proposed Rulemaking to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective.  Changes are proposed to seven aspects of the current regulatory framework:
 
  • refinement of the existing risk-based regulatory framework;
  • utilization of a single IRB review of record for domestic sites of multi-site studies;
  • improvement of consent forms and the consent process;
  • establishment of mandatory data security and information protection standards for all studies involving identifiable data;
  • establishment of an improved, more systematic approach for the collection and analysis of data on unanticipated problems and adverse events;
  • extension of Federal regulatory protections to all research, regardless of funding source, conducted at institutions in the U.S. receiving some Federal funding from a Common Rule agency for research with human subjects; and
  • improvement in the harmonization of regulations and related agency guidance

The paper, "Pruning the regulatory tree: For human subjects research, maximum regulation does not mean maximum protection," authored by CBSSM faculty Scott Kim, Peter Ubel, and Ray De Vries, was cited in the ANPRM.

 

Aisha Langford PhD, MPH

Alumni

Dr. Aisha Langford was a VA and CBSSM Postdoctoral Research Fellow, 2013-2015. She received her PhD from the department of Health Behavior and Health Education at the University of Michigan School of Public Health in Ann Arbor. From 2007 -2013, she directed the University of Michigan Comprehensive Cancer Center’s Community Outreach Program. Her research interests include chronic disease prevention and control, health communications, medical decision making, and clinical trial participation. Aisha is from the San Francisco Bay Area and earned her BA from the University of Virginia.

Last Name: 
Langford

CBSSM recently co-hosted the panel "Incidental Findings in Clinical Exome and Genome Sequencing: The Drama and the Data" featuring Robert C. Green, MD, MPH, Associate Professor of Medicine, Division of Genetics at Brigham and Women’s Hospital and Harvard Medical School, as the keynote speaker. The panel included a lively and interesting discussion. 

Panel presenters were Jeffrey W. Innis, MD, PhD, Morton S. and Henrietta K. Sellner Professor in Human Genetics and Director, Division of Pediatric Genetics, and Wendy R. Uhlmann, MS, CGC, Clinical Associate Professor, Department of Internal Medicine and Department of Human Genetics. The panel was moderated by Sharon L.R. Kardia, PhD, Director, Public Health Genetics Program and the Life Sciences and Society Program, School of Public Health, University of Michigan.

This event was co-sponsored by CBSSM, the Department of Human Genetics, Genetic Counseling Program, and Life Sciences and Society, Department of Epidemiology.

CBSSM affiliates will be presenting at the WMU Ethics Center Conference: "Bioethics: Preparing for the Unknown" (March 17-18th).

CBSSM Postdoc Kayte Spector-Bagdady: “The Google of Personalized Healthcare: 23andMe and Enabling the Privatization of Genetic Biobanking"

Lan Le, Natalie Bartnik, Michele C. Gornick and Nicole Exe: “Examining the Psychosocial and Ethical Issues Arising from the Identification, Disclosure and Communication of Genomic Results to Patients and Clinicians,” Chair: Raymond De Vries

Other presentations with CBSSM/UM bioethics connections include:

"Patient Understanding and Satisfaction Regarding the Clinical Use of Whole
Genome Sequencing: Findings from the MedSeq Project," Archana Bharadwaj, School of Public Health

"The Voice is As Mighty as the Pen: Integrating Conversations Into Advance Care
Planning Policies," Kunal Bailoor, UM Medical School

Here is the link to the the program: http://www.mywmu.com/s/1428/images/gid2/editor_documents/events/prelimin...

Here is the link to register: http://www.mywmu.com/s/1428/gid2/index.aspx?sid=1428&gid=2&pgid=2900&con...

Kerry Ryan, MA

Research Associate

Kerry Ryan joined CBSSM in July 2010. Kerry has a BA in History (Kalamazoo College) and MA in Sociology (University of Michigan). Before joining CBSSM, Kerry worked as a research assistant and an academic advisor. She has been involved with research related to the effects of community violence and prenatal cocaine exposure; college student academic success and retention; at-risk women’s child-bearing decisions in the context of genetic testing and discrimination; surrogate consent for research; and therapeutic misconception. She currently works with Dr. Raymond De Vries and Dr.

Research Interests: 
Last Name: 
Ryan

Aaron Scherer, PhD

Alumni

Dr. Aaron Scherer was a CBSSM Postdoctoral Research Fellow, 2014-2016. Aaron earned his PhD in Psychology from the University of Iowa and utilizes methodologies from social psychology, social cognition, and neuropsychology to study the causes and consequencdees of biased beliefs. His current research has focused on the causes and consequences of biased beliefs regarding health and politics.

Last Name: 
Scherer

CBSSM Seminar: Cheryl A. Moyer, MPH, PhD

Thu, November 03, 2016, 3:00pm
Location: 
NCRC, Building 16, Room 266C

Cheryl A. Moyer, MPH, PhD
Assistant Professor, Learning Health Sciences
Assistant Professor, Obstetrics and Gynecology

Using GIS and Social Autopsy to understand where and why mothers and babies are dying in rural northern Ghana

Abstract: Cheryl Moyer, PhD, MPH, Assistant Professor of Learning Health Sciences and Obstetrics & Gynecology, will describe a 3-year, USAID-funded project that involves identifying all maternal and neonatal deaths and ‘near-misses’ (those who survive a life-threatening event) across four districts in northern Ghana and conducting detailed verbal and social autopsies to determine both the biomedical cause of death and the sociocultural contributors. The project, known as PREMAND (PREventing Maternal And Neonatal Deaths), also involves geocoding the location of births, deaths, health facilities, traditional healer compounds, and other important landmarks to explore the role of geography in influencing outcomes.

Ethical, Legal and Social Implications of Learning Health Systems Symposium

Fri, November 18, 2016, 8:30am to 3:30pm
Location: 
Taubman Biomedical Science Research Building (BSRB) 109 Zina Pitcher Place

This symposium will promote dialogue and contribute to a research agenda on how learning health system organizers should engage the ethical, legal and social implications of this work.

The next generation of health information technology organizes data into large, networked systems to address challenges of U.S. health systems: spiraling costs, poor health outcomes, safety issues, unproductive research enterprises, and failure to implement known clinical best practices. More than simply “Big Data,” these systems are arranged as “learning health systems,” multi-stakeholder federations that gather and analyze data to create useful knowledge that is disseminated to all stakeholders. Harnessing the power of health data for learning strains ethical, legal, and social paradigms for how health information should be collected, stored, accessed, used, and destroyed.

CBSSM is a co-sponsor, along with the Brehm Center, the Michigan Institute for Clinical and Health Research (MICHR), the School of Public Health, and Healthcare Information and Management Systems Society (HIMSS).

EVENT REGISTRATION

CBSSM Seminar: Michele Gornick, PhD

Thu, January 15, 2015, 3:00pm to 4:00pm
Location: 
NCRC 16-266C

Michele Gornick, PhD

VA HSRD Fellow & CBSSM Research Investigator

Title: The public’s preferences for the return of secondary findings identified through genome sequencing: Information and deliberation make a difference

Summary: Genomic sequencing is becoming a part of clinical practice. Existing studies are limited and conclude that people would like unrestricted access to all of their genetic information. However, we do not know the extent to which respondents in these studies took into account the complex scientific and ethical issues that attend genome sequencing. In order to address this gap, we organized a deliberative democracy (DD) session to educate members of the public on genome sequencing, to engage them in dialogue about the benefits and risks of the clinical implementation of this technology, and to elicit their informed perspectives about policies governing the return of secondary findings.

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