Ontology of Informed Consent: An Approach to Specimen and Data Sharing

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First Spring Workshop of the Clinical and Translational Science Ontology Group

Announcement

The Clinical and Translational Science Ontology Group (CTSOG) invites you to join us February 26-27, 2018 in Little Rock, Arkansas to discuss uses cases and necessary evolution of the informed consent ontology . Example use cases include sharing of biospecimens, precision medicine (e.g. regarding kidney), and informed consent in clinical trials. The workshop is a hands-on event, which aims to provide a new release version of the Informed Consent Ontology (ICO).

Persons working on informatics aspects of informed consent who are interested in participating can register here. If you have any questions, please contact Mathias Brochhausen, mbrochhausen@gmail.com.



Organizers

Workshop Co-organizers:

Brochhausen, Mathias (University of Arkansas for Medical Sciences, Little Rock, AR), mbrochhausen@uams.edu

He, Yongqun (Oliver) (University of Michigan Medical School, Ann Arbor, MI), yongqunh@med.umich.edu

Manion, Frank (University of Michigan, Ann Arbor, MI), fmanion@med.umich.edu

Obeid, Jihad (The Medical University of South Carolina, Charleston, SC), jobeid@musc.edu


CTSOG Co-chairs:

Bill Hogan (University of Florida College of Medicine, Gainesville, FL), hoganwr@ufl.edu

Barry Smith (University at Buffalo, Buffalo, NY), phismith@buffalo.edu

Sponsors

  • The Translational Research Institute ([1]), a University of Arkansas for Medical Sciences institute and CTSA hub supported by the National Center for Advancing Translational Sciences at the National Institutes of Health.


  • The College of Medicine ([2]) at the University ofArkansas for Medical Sciences.

Date

February 26 (Monday) - 27 (Tuesday), 2018

Venue

UAMS Donald W. Reynolds Institute on Aging, 629 Jack Stephens Dr, Little Rock, AR 72205

Room 1180/1190

Map

Sadly, the Marriott does not offer a shuttle to and from UAMS. So, in the morning I would ask you to take a cab or an UBER to the Institute of Aging, UAMS. Sharing cabs/UBERS should make it pretty cheap. Sorry for the inconvenience.


Pre-Workshop Informal Meet & Greet: February 25

We will meet between 7pm and 10pm for an informal meet & greet at the Capitol Bar and Grill, just on the other side of the road from the Marriott. The CBG offers a wide variety of food and drinks . We don't have a reservation, but the staff knows we are coming. Please just ask for Mathias Brochhausen. (Food and drinks are not included in the workshop.)

Schedule Day 1: February 26

8:30am: Registration and Breakfast

9:00am: Welcome addresses and opening remarks

  • Dr. Laura James MD, TRI Director and Associate Vice Chancellor for Clinical and Translational Research, UAMS
  • Dr. William R. Hogan MD, MS, Co-chair of the CTSOG

9:45am: Ontologies in Translational Research - Presenter: Jihad Obeid

10:00am: Introduction to ICO - Presenter: Oliver He

10:15am: Coffee Break

10:45am: Introduction to CRO - Presenter: Frank Manion

11:00am: Introduction to d-acts - Presenter: Mathias Brochhausen

11:15am: Use cases - Facilitator: Mathias Brochhausen

  1. Sharing specimens across protocols (MB)
  2. Generation of electronic informed consent forms (JO)
  3. Rights and obligations derived from informed consent analysis (FM)
  4. Kidney Precision Medicine Project (OH)


12:15pm Lunch

1:15pm Introduction to DUO - Moran N. Cabili/Melanie Courtot

1:45pm: Hands-on use case: Sharing specimens across different protocols 1 (MB) - Facilitator: Frank Manion

3:00pm: Coffee Break

3:30pm: Hands-on use case: Sharing specimens across different protocols 2 (MB) - Facilitator: Jihad Obeid

5:00pm: End of Day 1


6:30pm: Dinner at 7pm Copper Grill. If you want to walk over to the restaurant with a group, please meet Mathias at 6:40 in the lobby of the Marriott (The cost of dinner is not included in the workshop.)

Schedule Day 2: February 27

8:30am: Breakfast

9:00am: Hands-on use case: Generation of electronic informed consent forms (JO) - Facilitator: Mathias Brochhausen

10:30am: Coffee break

10:45am: Hands-on use case: Rights and obligations derived from informed consent analysis (FM) - Facilitator: Jihad Obeid

12:15pm: Lunch

1:15pm: Hands-on: Research permissions and informed consent (JO) - Facilitator: Frank Manion

2:15pm: Future directions and curation of ICO - Facilitator: Oliver He

3:15pm Preparation of Workshop paper - Facilitator: Mathias Brochhausen

4:00pm: Workshop adjourns


Rationale

Informed consent is an ethical and legal requirement for biomedical research. Federal policy for the protection of human subjects under the Common Rule addresses several basic elements required for the informed consent process. However, in the era of genomic research, biobanking and data sharing, several challenges arise in pinning down exact obligations included on consent forms, giving rise to ambiguity and the potential for misinterpretation of what has been consented to.

This workshop will be guided by brief presentations of use cases (5-10 minutes each) followed by hands-on sessions during which participants will propose and discuss solutions to known issues regarding the Informed Consent Ontology (ICO). Participants will be provided with background information about ICO and the Document Act Ontology (d-acts). The results will be published and the updated ontology will be released in the public domain.

Goals

The Clinical and Translational Science Ontology Group was established in 2012 to leverage the use of common ontologies to support different aspects of information-driven clinical and translational research. The focus of this meeting is to explore new and existing uses of common ontologies to support creation, sharing, and analysis of clinical data.

Like its predecessors in the series, this meeting is designed to bring together clinical and translational scientists from across the CTSA Consortium who are interested in using ontologies to promote discoverability and interoperability of biomedical data.

The goal of this particular workshop is to evolve the Informed Consent Ontology (ICO) to where it can provide the basis of specimen and data sharing for CTSA related efforts, including information sharing across different sites with different Institutional Review Board (IRBs). How ICO can be used to support specimen and data sharing for precision medicine research will also be investigated. One target is to prepare a new release version of the ontology and publish the results of our workshop as a journal paper.

Persons interested in attending or in presenting at the meeting should write to Mathias Brochhausen, mbrochhausen@uams.edu.

Preparatory material

Our plan is to conduct this workshop in a "hands-on" manner and to address and resolve issue related to the Informed Consent Ontology and the way it represents consent. We will also discuss additional use cases and how those can be addressed. Hence, some preparation by the participants would be useful. We suggest that everyone familiarizes themselves with ICO and d-acts before the workshop.

ICO

ICO paper

d-acts

File:Brockhausen et al DocumentActs Ingvar.pdf

(To view the OWL files, we suggest downloading Protégé or another ontology viewer/editor to your computer and open the file using that tool.)

Accommodations

The UAMS Translational Research Institute has reserved a block of rooms at the Little Rock Marriott in Little Rock’s historic River Market District, 3 Statehouse Plaza, Little Rock, AR 72201. The room rate is $129 each and the reservation "UAMS Clinical and Translational Science Ontological Conference Feb 2018". Please book your room here [3] by February 15, 2018.

Travel Fund Application

UAMS' Translational Research Institute (TRI) is providing two travel stipends of $1000 each for new investigators to attend the workshop.

If you are interested, please submit a short vita with a rationale for attendance to Mathias Brochhausen at mbrochhausen@uams.edu by January 15, 2018. Decisions will be made January 31, 2018.

Participants

Christoph Brochhausen-Delius (Universität Regensburg, Regensburg, Germany)

Mathias Brochhausen (University of Arkansas for Medical Sciences, Little Rock, AR)

William Duncan (Roswell Park Cancer Institute, Buffalo, NY)

Marcelline Harris (University of Michigan, Ann Arbor, MI)

Yongqun (Oliver) He (University of Michigan Medical School, Ann Arbor, MI)

William R. Hogan (University of Florida, Gainesville, FL)

John Judkins (University fo Arkansas for Medical Sciences, Little Rock AR)

Frank Manion (University of Michigan, Ann Arbor, MI)

Jihad Obeid (The Medical University of South Carolina, Charleston, SC)

J. Neil Otte (University at Buffalo, Buffalo, NY)

Paula Roberson (University of Arkansas for Medical Sciences, Little Rock, AR)

Cui Tao (University of Texas Health Science Center at Houston, Houston, Texas)

Christopher Trudeau (University of Arkansas for Medical Sciences, Little Rock, AR)

Joseph Utecht (University of Arkansas for Medical Sciences, Little Rock, AR)