Attachment D: IRB Determination Letter

Attachment D: IRB Exemption Determination Letter

April 17, 2024

Chi Connie Park, MA, PhD
James Bell Associates, Inc.
2000 15th St N
Suite 100
Arlington, Virginia 22201
Dear Dr. Park:
SUBJECT:

IRB EXEMPTION—REGULATORY OPINION
Investigator: Chi Connie Park, MA, PhD
Protocol Title: National Endowment for the Arts: ArtsHERE Equity Pilot
Evaluation

This is in response to your request for an exempt status determination for the abovereferenced protocol. WCG IRB’s IRB Affairs Department reviewed the study under the
Common Rule and applicable guidance.
We believe the interview and survey portions of this study is exempt under 45 CFR §
46.104(d)(2), because the research only includes interactions involving educational
tests, survey procedures, interview procedures, or observations of public behavior; and
any disclosure of the human subjects’ responses outside the research would not
reasonably place the subjects at risk of criminal or civil liability or be damaging to the
subjects’ financial standing, employability, educational advancement, or reputation.
We believe the record review portion of this study is exempt under 45 CFR §
46.104(d)(4), because the research involves the use of identifiable private
information/biospecimens; and information, which may include information about
biospecimens, is recorded by the investigator in such a manner that the identity of the
human subjects cannot readily be ascertained directly or through identifiers linked to the
subjects, the investigator does not contact the subjects, and the investigator will not reidentify subjects.
This exemption determination can apply to multiple sites, but it does not apply to any
institution that has an institutional policy of requiring an entity other than WCG IRB
(such as an internal IRB) to make exemption determinations. WCG IRB cannot provide
an exemption that overrides the jurisdiction of a local IRB or other institutional
mechanism for determining exemptions. You are responsible for ensuring that each site
to which this exemption applies can and will accept WCG IRB’s exemption decision.

Chi Connie Park, MA, PhD

3

April 17, 2024

WCG IRB’s determination of an Exemption only applies to US regulations; it does not
apply to regulations or determinations for research conducted outside of the US.
Please discuss with the local IRB authorities in the country where this activity is taking
place to determine if local IRB review is required.
Please note that any future changes to the project may affect its exempt status, and you
may want to contact WCG IRB about the effect these changes may have on the
exemption status before implementing them. WCG IRB does not impose an expiration
date on its IRB exemption determinations.
If you have any questions, or if we can be of further assistance, please contact Tara
Coffin, PhD, MEd, at 360-252-2418, or e-mail [email protected].

TBC:bg
D2-Exemption-Park (04-17-2024)
cc: Patricia Moore Shaffer, National Endowment for the Arts
WCG IRB Accounting
WCG IRB Work Order # 1-1757904-1