Approval Letter for Study

CORRESPONDENCE LETTER-Approval Initial
Exempt Study
NUMBER
HRP-510c

Version Date
10/18/2023

PAGE
1 of 4

See HRP-001 for definitions of applicable key terms and acronyms.

Oak Ridge Sitewide Institutional Review Board (IRB#: IRB00000547)
July 11, 2024
Title of Study: Science Undergraduate Laboratory Internship (SULI)
Program Long-Term Follow-Up Study, FY 2014 – FY
2016
Investigator: Tony Garcia
Type of Review: Initial Study
Exempt Category: (2)(ii) Tests, surveys, interviews, or observation (low
risk)
Submission ID: ORAU001159
Funding Source: DOE/Office of Science
Documents Reviewed: • Incentives Plan Approval Letter from ORAU Legal,
Category: Other;
• Invitation and Consent for Comparison Cohort,
Category: Consent Form;
• Invitation and Consent for SULI Alumni
• Language for Participant Queries and Evaluation
Strategy for Incentive Plan, Category: Other;
• List of Incentive Schemes from Federally Sponsored
Surveys, Category: Other;
• Matrix of Variables, Category: Other;
• Reminder for Comparison Cohort
• Reminder for SULI Alumni, Category: Consent Form;
• Review of Federal Survey Program Experiences with
Incentives, Category: Other;
• Study , Category: IRB Protocol;
• SULI Alumni Survey Instrument, Category: Other;
• SULI Comparison Cohort Survey Instrument,
Category: Other;
• SULI LFS Study Proposal
Action: Approved
Approval Date: 7/3/2024
Consent Waiver: Waiver of Written Documentation of the Consent
Process

CORRESPONDENCE LETTER-Approval Initial
Exempt Study
NUMBER
HRP-510c

Version Date
10/18/2023

PAGE
2 of 4

See HRP-001 for definitions of applicable key terms and acronyms.

As noted above your study has been reviewed by the Oak Ridge Sitewide Institutional
Review Board (ORSIRB) and determined to be Exempt human subjects research. This
determination is based on an appropriate risk/benefit ratio and a study design wherein
the risks have been minimized, to the extent practicable. All research must be
conducted in accordance with this approved submission.
Annual follow-up is required on exempt studies. Before the IRB approval anniversary
date or within 30 days of study closure, whichever is earlier, you must provide an
update to the IRB in IRB8, following the directions provided by the IRB.
Please note that all principal investigators must immediately report to the IRB:




Upon finding of a suspected or confirmed data breach involving PII in printed
or electronic form (see DOE Order 443.1C).
All unanticipated problems, adverse events, non-compliance issues, and
complaints (see DOE Order 443.1C).
Any new information that might increase the risks or decrease the benefits to
research subjects, or affect a subject’s willingness to continue participation in
the study.

If annual review is not received before the anniversary date of all study activity that
involves human subjects must cease.
All research records must be retained for a minimum of three years after the
completion of the study.
Sincerely,

Kelli Bursey, MPH, CHES
IRB Chair
ORSIRB@orau.org
513-245-1286
Attachment:
Reminder: What are my obligations as a PI after IRB approval?

CORRESPONDENCE LETTER-Approval Initial
Exempt Study
NUMBER
HRP-510c

Version Date
10/18/2023

PAGE
3 of 4

See HRP-001 for definitions of applicable key terms and acronyms.

Reminder: What are my obligations as a PI after IRB approval?
1) Do not start Human Subjects Research activities until you have the final IRB approval
letter.
2) Do not start Human Subjects Research activities until you have obtained all other
required institutional approvals, including approvals of departments or divisions that
require approval prior to commencing research that involves their resources.
3) Ensure that there are adequate resources to carry out the research safely. This
includes, but is not limited to, sufficient investigator time, appropriately qualified
research team members, equipment, and space.
4) Ensure that research staff are qualified (e.g., including, but not limited to, appropriate
training, education, expertise, credentials, protocol requirements and, when relevant,
privileges) to perform procedures and duties assigned to them during the study. Note
that all members of the research team who have access to PII or who are responsible
for subject interaction or intervention must complete training on the protection of
human subjects research. DOE offers this training to researchers at DOE
laboratories/sites and to DOE-funded researchers from institutions outside the DOE
complex.
5) Update the IRB office with any changes to the list of study personnel.
6) Personally conduct or supervise the research.
a) Conduct the research in accordance with the relevant current protocol as
approved by the IRB.
b) When required by the IRB, ensure that consent or permission is obtained in
accordance with the relevant current protocol as approved by the IRB.
c) Do not modify the research without prior IRB review and approval unless
necessary to eliminate apparent immediate hazards to subjects.
d) Protect the rights, safety, and welfare of subjects involved in the research.
7) Submit to the IRB:
a) Proposed modifications.
b) A continuing review application as requested in the approval letter.
c) A continuing review application when the research is closed.
8) Report any of the new information items in a Reportable New Information (RNI) in the
IRB Electronic System to the IRB immediately. In the case of loss of PII, for example,
reporting to the IRB and other authorities is required immediately.
9) Submit an updated disclosure of financial interests within thirty days of discovering or
acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.
10) Do not accept or provide payments to professionals in exchange for referrals of
potential subjects (“finder’s fees.”)

CORRESPONDENCE LETTER-Approval Initial
Exempt Study
NUMBER
HRP-510c

Version Date
10/18/2023

PAGE
4 of 4

See HRP-001 for definitions of applicable key terms and acronyms.

11) Do not accept payments designed to accelerate recruitment that were tied to the rate
or timing of enrollment (“bonus payments.”)
12) Ensure that you comply with the requirements of sponsoring organizations/agencies,
which may be in addition to those that are required by the Federal Regulations and
DOE. You must comply with the more stringent requirements. Consult with the IRB
if you need clarification.