ATTACHMENT D. Documentation of Initial IRB Approval FINAL

ATTACHMENT D:
MULTI-SITE IMPLEMENTATION EVALUATION OF TRIBAL HOME VISITING
(MUSE)
1. Documentation of Initial IRB Approval
2. Documentation of Amendment Approval for Waiver of Parental Consent
for Minor Caregivers (Ages 14-17)

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The OMB
number for the described information collection is 0970-0521 and the expiration date is
12/31/2021.

Colorado Multiple Institutional Review Board, CB
F490
University of Colorado, Anschutz Medical Campus
13001 E. 17th Place, Building 500, Room N3214
Aurora, Colorado 80045

303.724.1055
303.724.0990
COMIRB Home Page
comirb@ucdenver.edu
FWA00005070

[Phone]
[Fax]
[Web]
[E-Mail]
[FWA]

University of Colorado Hospital
Denver Health Medical Center
Veteran's Administration Medical Center
Children's Hospital Colorado
University of Colorado Denver
Colorado Prevention Center

Certificate of Approval
09-Apr-2018
Investigator:

Nancy Whitesell

Subject:

COMIRB Protocol 18-0109 Initial Application

Review Date:

06-Apr-2018

Effective Date:

06-Apr-2018

Expiration Date:

05-Apr-2019

Sponsor(s):

Administration for Children and Families/DHHS~

Title:

Multi-Site Implementation Evaluation of Tribal Home Visiting

Submission ID: APP001-1

SUBMISSION DESCRIPTION:
Initial expedited submission

Your COMIRB Initial Application submission APP001-1 has been APPROVED until the expiration date listed
above. The investigator will need to submit this research for Continuing Review at least 45 days prior to
the expiration date.
Study personnel are approved to conduct the research as described in the documents approved by COMIRB, which are
listed below the REVIEW DETAILS section.
Please carefully review the REVIEW DETAILS section because COMIRB may have made red-line changes (i.e. revisions)
to the submitted documents prior to approving them. The investigator can submit an amendment to revise the documents if
the investigator does not agree with the red-line changes. The REVIEW DETAILS section may also include important
information from the reviewer(s) and COMIRB staff.
Effective May 23, 2017, COMIRB will only approval-stamp consent documents (e.g. consent forms, assent forms,
information sheets, etc.) and local advertisements. Stamped copies of these documents are available for download
through COMIRB’s electronic submission website, eRA(InfoEd). COMIRB approval letters will continue to list all reviewed
and approved documents.
Click here for instructions on how to retrieve stamped documents.

REVIEW DETAILS:
COMIRB staff has redlined in the COMIRB contact information in your verbal script parental consents.
The following documents have been reviewed as part of this approval:
18-0109 Signed IAAs
Application Form v. 3.26.18 with attachments A,F, G,H, J, M
Community Flyer v7 Design.pdf
Cover letter_v5.docx
Family Flyer v7 Design.pdf
MUSE Data Flow Diagram_v4.pptx
MUSE Email Templates_Staff Survey_Whitesell_18-0109.docx
MUSE Study Sites_Whitesell_18-0109_.pdf
MUSE Study Sites_Whitesell_18-0109_.pdf
MUSE VerbalParentalConsentScript_CONTINUING_v2 CLEAN.docx
MUSE VerbalParentalConsentScript_CONTINUING_v2 REDLINED.docx
MUSE VerbalParentalConsentScript_CONTINUING_v2 STAMPED.docx
MUSE VerbalParentalConsentScript_CONTINUING_v2.docx
MUSE VerbalParentalConsentScript_NEW_v2 CLEAN.docx
MUSE VerbalParentalConsentScript_NEW_v2 REDLINED.docx
MUSE VerbalParentalConsentScript_NEW_v2 STAMPED.docx
MUSE VerbalParentalConsentScript_NEW_v2.docx
MUSE_Ad Components Form_Whitesell_18-0109.docx
MUSE_Administrative Data Elements_Whitesell_18-0109.pdf
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_

MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_CONT Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Family Resources Check-In_Whitesell_18-0109.pdf
MUSE_Home Visitor Interview Questions_Whitesell_18-0109.pdf
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Home Visitor Survey_Whitesell_18-0109.pdf
MUSE_Implementation Logs_Whitesell_18-0109.pdf
MUSE_IRB Authorization Agreement_Whitesell_18-0109
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_IRB Authorization Agreement_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Letter of Support_Whitesell_18-0109_
MUSE_Local Evaluator Interview_Whitesell_18-0109.pdf
MUSE_Local Program Evaluator_Whitesell_18-0109.pdf
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_

MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Over 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_NEW Caregiver Under 18 Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Participant 6 12 Month Follow-up Survey_Whitesell_18-0109.pdf
MUSE_Participant Baseline Survey_Whitesell_18-0109.pdf
MUSE_Participant Interview Questions_Whitesell_18-0109.pdf
MUSE_PI Oversight Plan_Whitesell (COMIRB #18-0109).pdf
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Professional (non home visitor) Quant_Consent HIPAA_Whitesell_18-0109_
MUSE_Program Coordinator and Program Director Interview Questions_Whitesell_18-0109.pdf
MUSE_Program Coordinator-Manager Survey_Whitesell_18-0109.pdf
MUSE_Program Director Survey_Whitesell_18-0109.pdf
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_

MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Caregiver Over 18_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Qualitative_Professional_Consent HIPAA_Whitesell_18-0109_
MUSE_Rapid Reflect Caregiver Self-Completed Questionnaire_Whitesell_18-0109.pdf
MUSE_Rapid Reflect Home Visitor Self-Completed Questionnaire_Whitesell_18-0109.pdf
MUSE_Site Logos_Whitesell_18-0109.docx
MUSE_Study Protocol_Whitesell_18-0109.docx
Personnel Form (eForm) 1-3-15
v. 3.22.18
Staff Flyer v7 Design.pdf
Volume I Technical Proposal-MUSE 7-29-2016.pdf
Application for Protocol Review includes Attachment M: Waiver of Documentation of Consent—Determined to meet
criteria for waiver of documentation of consent
Affiliated Site(s):
UCD Anschutz Medical Campus
Non-Affiliated Sites: 17

If this protocol requires full-board review and includes attachment C and/or D, the PI will be required to complete GCP
training. COMIRB will begin enforcing this new requirement on 9/1/15. It is highly recommended that you complete this
training as soon as possible to prevent delays on approvals after the 9/1/15 deadline.
For the duration of this research the investigator must:
Submit any change in the research design, personnel, and any new or changed study documents (including
new/changed consent forms, questionnaires, advertisements, ect.) to COMIRB and receive approval before
implementing the changes.
Use only a copy of the COMIRB-approved, stamped Consent and/or Assent Form. The investigator bears the
responsibility for obtaining from all subjects "Informed Consent" as required by COMIRB. COMIRB REQUIRES that the
subject be given a copy of the consent and/or assent form after it is signed.
Provide non-English speaking subjects with a certified translation of the approved Consent and/or Assent Form in

the subject's first language or use a Consent Short Form, as approved for the study.
Inform COMIRB immediately of any Unanticipated Problems that are unexpected and related to the study in
accordance with COMIRB Policies and Procedures.
Maintain approval for the research. COMIRB approval is generally given in one year increments, but the period may
be shorter. Research is required to be submitted for continuing review and re-approval at least 45 days prior to the
expiration date. If a study's approval expires, investigators must stop all research activities immediately (including
data analysis) and contact the COMIRB office for guidance.
Remain actively engaged in the conduct of the research. The investigator must ensure that all enrolled participants
are appropriate for the study prior to study procedures beginning.

Information on how to submit changes (amendments) to your study, requests for continuing review, and reports of
unanticipated problems to COMIRB can be found on the COMIRB website http://www.ucdenver.edu/research/comirb
/training/.
Contact COMIRB with questions at 303-724-1055 or COMIRB@ucdenver.edu.

As part of this review it was determined that for this research:
1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result.
3. Selection of subjects is equitable.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative in
accordance with, and to the extent required by, §46.116.
5. Informed consent will be appropriately documented in accordance with, and to the extent required by, §46.117.
6. The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. Appropriate safeguards are in place to protect potentially vulnerable populations from coercion and undue
influence.

Sincerely,
UCD Panel S

Colorado Multiple Institutional Review Board, CB
F490
University of Colorado, Anschutz Medical Campus
13001 E. 17th Place, Building 500, Room N3214
Aurora, Colorado 80045

303.724.1055
303.724.0990
COMIRB Home Page
comirb@ucdenver.edu
FWA00005070

[Phone]
[Fax]
[Web]
[E-Mail]
[FWA]

University of Colorado Hospital | Denver Health Medical Center | Colorado Prevention Center | Children's Hospital
Colorado | Denver Health and Hospital Authority | VA Eastern Colorado Health Care System (Denver VAMC)

Amendment Approval
04-Jan-2019
Title:

Multi-Site Implementation Evaluation of Tribal Home Visiting

Subject:

COMIRB Protocol 18-0109 Amendment

Investigator:

Nancy Whitesell

Sponsor(s):

Administration for Children and Families/DHHS~

Approval Date:

26-Dec-2018

Submission ID: PAM001-1

REQUESTED CHANGES:
Description of change: We are requesting a waiver of parental consent for minor caregivers (ages 14-17) who enroll in
the study. Attachment M is included with this Modification Request Form. Caregiver Under 18 Quant_Consent+HIPAA
forms (two versions, see Question 2 above) will no longer be necessary and will be removed from the study protocol.
Caregiver Over 18 Quant_Consent+HIPAA forms (two versions, see Question 2 above) will be revised to apply to all
Caregivers (i.e., Caregiver Quant_Consent+HIPAA).
Documents changed: Application and consent forms

REVIEW DETAILS– Please read carefully:
The following documents have been reviewed by the Chair as part of this approval:
1. 18-0109_MUSE_Application-for-Protocol-Review_Amendment, v 12_21_18
2. Change Form, no date
3. CONT Caregiver Quant_Consent HIPAA_FINAL 12.20.18_clean.docx
4. NEW Caregiver Quant_Consent HIPAA_FINAL 12.20.18_clean.docx
5. Personnel eForm PAM 1-3-15, v 12.21.18
The Application for Protocol Review includes a Full Waiver of Consent for parental consent, which was reviewed and
determined to meet criteria for full waiver of consent.
COMIRB only stamps the approved versions of consent documents and local advertisements in the top right hand corner.
Approved copies of the study documents are available for download via eRA(InfoEd).
If red-line changes were made, the tracked changes and clean versions have been uploaded into eRA (InfoEd). If the PI
disagrees with these changes, submit a change form to COMIRB with the revised documents.

Click here to your submission: Submission Page
Please reply to the email containing this letter, contact the COMIRB Help Desk at COMIRB@ucdenver.edu or call
303-724-1055 if you have questions or concerns.

Sincerely,
UCD Panel S