IACRN Research Committee Minutes

Annual Conference Baltimore, Oct 16, 2015

Members Present:

Cheryl Fisher / Shaunagh Browning
Catherine Griffith / Kathy Hall
Carolynn Thomas Jones / Penny Jester via phone

Announcements:

Leadership transition effective January 1, 2016

Incoming Chair: Cheryl Fisher

Past Chair: Joy Bailey

Incoming Chair Elect: Kathy Hall

Facilitator: Catherine Griffith

  1. Goals for this Committee Meeting: (Since no new members at the table).
  2. Review workgroup progress of operational definitions, using worksheet where applicable.
  3. Eligibility Screening: Cheryl Fisher; Kathy Grinke
  4. Protocol Deviations: Carolynn TJ; Penny Jester; Kathy Hall
  5. Participant Retention: Clare Hastings; Michelle Purdom
  6. Study Management: Joy Bailey; Catherine Griffith
  7. Establish a definition for each of the variables.
  8. Establish a Project Plan with Timeline.
  1. Handouts:
  2. Research Committee Annual Report slide presentation from business meeting.
  3. Operational Definition Tool (worksheet) to use during discussion.

Discussion

Definitions:

  • Eligibility Screening: # of participants meeting criteria/ # of participants screened.
  • Protocol Deviations: defined as incomplete or contradictory data that require queries, corrections and clarifications
  • Participant retention: # of participants enrolled/# of those enrolled who finish
  • Informed consent: # of participants who score “2” on the UBACC (University of California, SanDiego Brief Assessment of Capacity to Consent).

Background information: Penny Jester joined the meeting via speaker phone. Associated with Penny’s professional role at UAB, she has access to study participant charts (NIAID) with a balance of pediatrics and adults.

  • The studies include those related to infectious disease, HIV, and autoimmune. N = close to 150 combined.
  • Data for Variables: ‘Eligibility Screening’, ‘Protocol Deviations’, and ‘Participant Retention’ can be retrieved retrospectively from chart review.
  • Variable ‘Informed consent’ requires another step and a pilot study to explore this will be deferred to middle of year 2016. The missing step is the patients’ scores on the UBACC. This assessment would need to be conducted shortly after giving informed consent to participate in a study.

Decisions

Steps:

  • Penny will work on a research proposal and go thru the Univ of Alabama IRB
  • Timeline:
  • Protocol written and IRB approved in winter with Expedited review;
  • Data collection sometime in the late winter/early spring.
  • Pennywill pull charts. Group will make a field trip to Penny’s site to review charts and collect the data.
  • Analyze data and have preliminary results or final results to present at #IACRN16.

Next Meeting: November 11, 2015; 3:30 to 4:30; EST

Submitted,

Catherine Griffith, RN

Facilitator

Edits to 10/16/2015 minutes made at 12/09/2015 meeting:

  1. In discussion of the variables to be studied as a pilot, PROTOCOL DEVIATIONS, PARTICIPANT-RETENTION, and ELIGIBILITY SCREENING were chosen to be suitable. Penny Jester indicated via teleconference that data collection on these is feasible at her site and can be acquired via retrospective chart review.
  2. The variable “INFORMED CONSENT” is the representative pilot variable for STUDY MANAGEMENT and is not going to be included in the first pilot study. Rationale is that the participant needs to give a score in real time on how much of the protocol information understood/comprehended/retained from the discussion in which informed consent was given. The UBACC (University of California, San Diego Brief Assessment of Capacity to Consent) would be used to score. This cannot be accomplished using retrospective chart review.
  3. Motion was made to accept October minutes with the above edits (1stKHall; 2ndSBrowning).

Submitted 12/09/2015,

Catherine Griffith, RN

Facilitator

Cgriffith draft 10/29/2015