IRB Letter

Certificate of
Action

Investigator Name: Erica Roberts, PhD, MHS

Board Action Date: 04/08/2021

Investigator Address: 3033 Wilson Blvd, Suite 650

Approval Expires: 04/08/2022
Continuing Review Frequency: No CR Required

Arlington, VA 22201, United States
Sponsor: Centers for Disease Control and Prevention

Sponsor Protocol Number: None

Institution Tracking Number:

Amended Sponsor Protocol Number:

Study Number: 1305769

IRB Tracking Number: 20211382

Work Order Number: 1-1416627-1
Protocol Title: Building Indigenous Resilience in Communities and Homes (BIRCH) Study: Formative Research on
Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid
Use Among Children, Youth, and Families in Tribal American Indian and Alaska Native (AI/AN) Communities
THE FOLLOWING ITEMS ARE APPROVED:
Investigator
Advertisement - Flyer - Seeking Participants for Research Study #30405951.0 - As Submitted
Protocol (03-2021)
Consent Form [S0]
Consent Information Sheet - Oral Consent [S0]
Tribal Communities Study Information Letter #30405949.0 - As Submitted
Please note the following information:
WaiveDoc 46.117risk-both rules - The Board found that this research meets the requirements for a waiver of
documentation of consent under 45 CFR §46.117(c)(1)(ii) [2018 Requirements] 45 CFR 46.117(c)(2) [Pre-2018
Requirements] for subjects who are consented over the phone. In-person subjects will provide written consent.
The Board requires that all subjects must be able to consent for themselves to be enrolled in this study. This means that
you cannot enroll incapable subjects who require enrollment by consent of a legally authorized representative.
Under the revised common rule (effective 1-21-2019), continuing review by the Board of the above referenced research is
not required; however, the IRB will maintain our records and continue responsibility for exercising administrative and
regulatory oversight of this research. The IRB will automatically charge an Ongoing Oversight fee for this administrative
effort unless we are notified the research is closing. To avoid unnecessary fees due to closure, a closure form must be
submitted for each site 30 days prior to expiration.
THE IRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH:
James Bell Associates, 3033 Wilson Blvd, Suite 650, Arlington, Virginia 22201

ALL IRB APPROVED INVESTIGATORS MUST COMPLY WITH THE FOLLOWING:
As a requirement of IRB approval, the investigators conducting this research will:
• Comply with all requirements and determinations of the IRB.
• Protect the rights, safety, and welfare of subjects involved in the research.
• Personally conduct or supervise the research.
• Conduct the research in accordance with the relevant current protocol approved by the IRB.
• Ensure that there are adequate resources to carry out the research safely.
• Ensure that research staff are qualified to perform procedures and duties assigned to them during the research.
This is to certify that the information contained herein is true and correct as reflected in the records of WCG IRB. WE CERTIFY
THAT WCG IRB IS IN FULL COMPLIANCE WITH GOOD CLINICAL PRACTICES AS DEFINED UNDER THE U.S. FOOD AND
DRUG ADMINISTRATION (FDA) REGULATIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
REGULATIONS, AND THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) GUIDELINES.

Board Action: 04/08/2021

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Submit proposed modifications to the IRB prior to their implementation.
o Not make modifications to the research without prior IRB review and approval unless necessary to eliminate
apparent immediate hazards to subjects.
For research subject to continuing review, submit continuing review reports when requested by the IRB.
Submit a closure form to close research (end the IRB’s oversight) when:
o The protocol is permanently closed to enrollment
o All subjects have completed all protocol related interventions and interactions
o For research subject to federal oversight other than FDA:
 No additional identifiable private information about the subjects is being obtained
 Analysis of private identifiable information is completed
For research subject to continuing review, if research approval expires, stop all research activities and immediately
contact the IRB.
Promptly (within 5 days) report to the IRB the information items listed in the IRB's "Prompt Reporting Requirements”
available on the IRB's Web site.
Not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”)
Not accept payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus
payments”) without prior IRB approval.
When required by the IRB ensure that consent, permission, and assent are obtained and documented in accordance
with the relevant current protocol as approved by the IRB.
Promptly notify the IRB of any change to information provided on your initial submission form.

Consistent with AAHRPP’s requirements in connection with its accreditation of IRBs, the individual and/or organization shall
promptly communicate or provide, the following information relevant to the protection of human subjects to the IRB in a
timely manner:
• Upon request of the IRB, a copy of the written plan between sponsor or CRO and site that addresses whether expenses
for medical care incurred by human subject research subjects who experience research related injury will be
reimbursed, and if so, who is responsible in order to determine consistency with the language in the consent document.
• Any site monitoring report that directly and materially affects subject safety or their willingness to continue participation.
Such reports will be provided to the IRB within 5 days.
• Reports from any data monitoring committee, data and safety monitoring board, or data and safety monitoring
committee in accordance with the time frame specified in the research protocol.
• Any findings from a closed research when those findings materially affect the safety and medical care of past subjects.
Findings will be reported for 2 years after the closure of the research.
For Investigator’s Brochures, an approval action indicates that the IRB has the document on file for the research.
If the IRB approved an e-consent process that involves uploading the approved consent form to an e-consent platform, please
ensure that the consent form(s) approved for your site is the version of the consent form that gets uploaded to the platform.
If the board approves a change of Principal Investigator - Once approved, the new Principal Investigator is authorized by WCG
IRB to carry out the study as previously approved for the prior Principal Investigator (unless the Board provides alternate
instructions to the new Principal Investigator). This includes continued use of the previously approved study materials. The IRB
considers the approval of the new PI a continuation of the original approval, so the identifying information about the study
remains the same.
If your research site is a HIPAA covered entity, the HIPAA Privacy Rule requires you to obtain written authorization from each
research subject for any use or disclosure of protected health information for research. If your IRB-approved consent form does
not include such HIPAA authorization language, the HIPAA Privacy Rule requires you to have each research subject sign a
separate authorization agreement. ”

For research subject to continuing review, you will receive Continuing Review Report forms from WCG
IRB when the expiration date is approaching.
Thank you for using this WCG IRB to provide oversight for your research project.
DISTRIBUTION OF COPIES:
Contact, Company
Erica Roberts, PhD, MHS, James Bell Associates

COA Template 12-2020

Board Action: 04/08/2021

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