The Illinois Department of Children and Family Services Institutional Review Board met March 22.
Here are the meeting minutes as provided by the Illinois Department of Children and Family Services Institutional Review Board:
CHICAGO Debra Dyer, Robin Albritton, Mark Holzberg, Paula Jaudes, Brooke Taylor
ON PHONE Janet Ahern
EXCUSED Arricka Newingham
CALL TO ORDER Debra Dyer called the meeting to order at 2:05 p.m. A quorum was present.
APPROVAL OF MINUTES MOTION: Mark Holzberg made a motion to approve the minutes.
Paula Jaudes seconded the motion, Robin Albritton abstained from the vote and a unanimous vote from the remaining board members carried the motion.
FOLLOW UP
Heather Woltman. Youth Exiting Foster Care: The Role of Risk and Protective Factors in Predicting their Readiness for the Transition to Adulthood.
No follow up from the researcher.
MOTION: Motion made to take this research proposal off the agenda until the researcher contacts again.
Yotem Shem-Tov. The Effects of Public Defenders vs. Court Appointed Panel Attorneys on Juvenile Defendants Trial and Future Outcomes.
No follow up from the researcher.
MOTION: Motion made to take this research proposal off the agenda until the researcher contacts again.
NEW PROPOSALS
Ira Chasnoff. Project Thrive: A Partnership to EnhanceChild Well-Being, Safety and Permanency – AMENDMENT.
Page 3, last paragraph of the amendment, sentence that says “If after analyzing control participants’ baseline data they do match with the intervention group, we will let them know that we will not be seeking follow-up data from them.” Should this say that if they do not match with the intervention group? If it’s not, then it makes sense.
Brooke will check with the researcher to identify what the sentence is supposed to really say.
No other discussion.
MOTION: Mark Holzberg motioned to approve the proposal, pending the correction of the made to the sentence.
Janet Ahern seconded the proposed motion, Paula Jaudes abstained from the vote and will send follow up via email, and a unanimous vote from the remaining board members carried the motion. Follow up: Paula Jaudes reviewed the proposal and had no issues with it voting with the motion made.
Richard Epstein. DCFS Residential Monitoring. Looks as if they are doing research with residential partners. Do they need to come through us?
Board will review the proposal and send comments via email.
Follow up: Paula Jaudes reviewed the research project and indicated that she does not think that we need to call this research – just an evaluation piece.
Janet Ahern agreed, not sure what it was, but it was not research. She indicated that it appears to be a cross between an evaluation of the program and monitoring.
Mark believes this is an evaluation proposal for a newly implemented program. While they talk about ‘controls’, this is really the waitlist for a phased implementation. This is very common for new program implementation. The ‘controls’ are a natural occurring group of residential providers that are not included in the initial phase of the program roll-out.
One could make the argument that they are ‘testing’ out a new program design and will be comparing it to a control group of pre-existing providers. However, while they will be collecting data to make this comparison, they opening state that the intent is to have this program in all residential settings which makes it seem that this is ‘simply’ a new program being rolled-out and evaluated.
No need for our IRB review.
MOTION: No need for our IRB review. It has been determined that this is a program evaluation.
Richard Epstein. DCFS Regenerations PILOT Evaluation.
They want an ongoing project, not a PILOT. No word about trauma in the research project, should be talking about trauma interventions. Should be a part of their intensive WRAP programs. TARFE designed for females in prison. SPARC – emotional, dysregulation of prisoners.
Evaluation, not research. Already happening – already been sanctioned by the Director.
Board questions as to whether the researcher plans to publish the findings of this evaluation? If so, they should come to us at that time. Needs to submit the data and what they plan to publish.
MOTION: No need for our IRB review. It has been determined that this is a program evaluation.
Ram Yogev. IMPAACT P1112: Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC02, a Potent Anti-HIV Neutralizing Monoclonal Antibody, in HIV-1 Exposed Infants, Version 1.0, dated August 4, 2014.
Phase I study. Test new drug to small group of people to test side effects (rats, adult males). Antibody could do wonders to prevent HIV.
More than a minimal risk. Parent consents at the time of birth, not DCFS. This is just an ‘in case’ they come in to DCFS custody. DCFS would only be doing follow up with the blood work (weekly/monthly follow ups) and the foster parent would get $50 to take the child to the visits.
Not doing this study on preemies.
Approving for a child that may never come into foster care. Cannot submit/consent when temporary custody is involved (maybe abandoned children?)
Is this an FDA approved drug? If not, then we cannot approve experimental drugs.
Brooke will follow up with the researcher to find out.
MOTION: Paula Jaudes motioned to approve the proposal, pending the answer to the question about the FDA approval of the drug.
Janet Ahern seconded the proposed motion and a unanimous vote from the remaining board members carried the motion.
OTHER
Robin Albritton. New board member was introduced to the group. She is replacing Kay Clark who retired in December 2015.
Who is in charge of HIV program to assist with HIV approvals?
Next meeting was scheduled for April 26, 2016 at 2 PM.
The meeting adjourned at 3:05 p.m.
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