1_Protocol1_MCAM_Adults_WIRB_OMI_Approval thru 20210312

Certificate of
Action

Investigator Name: Andreas M. Kogelnik, MD, PhD

Board Action Date: 02/12/2020

Investigator Address: 319 N. Bernardo Ave

Approval Expires: 03/12/2021
Continuing Review Frequency: Annually

Mountain View, CA 94043, United States
Sponsor: Centers for Disease Control and Prevention

Sponsor Protocol Number: None

Institution Tracking Number:

Amended Sponsor Protocol Number:

Study Number: 1130042

IRB Tracking Number: 20120023
Panel: 1
Work Order Number: 1-1248818-1
Note: Panel 18 is a shared panel of CGIRB and WIRB.
Panel 19 is a shared panel of Aspire and WIRB.
Protocol Title: Multi-site Clinical Assessment of Chronic Fatigue Syndrome (CFS)
THE FOLLOWING ITEMS ARE APPROVED:
Study and Investigator for an additional continuing review period. This approval expires on the date noted above.
Please note the following information:
THE IRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH:
Richard Podell, M.D. P.A., Suite 140, 11 Overlook Road, Summit, New Jersey 07901
Hunter-Hopkins Center, P.A., Suite 320, 7421 Carmel Executive Park Drive, Charlotte, North Carolina 28226
Sierra Internal Medicine, 926 Incline Way, Incline Village, Nevada 89451
Robert Fafalak, MD - Rheumatology / Internal Medicine, 36 West 9th St., New York, New York 10011
Bateman Horne Center, 24 South 1100 East, Salt Lake City, Utah 84102
Osteopathic Medical Associates, 3706 Ruffin Rd, San Diego, California 92123
Integrative Health Practices, 2850 N.Ridge Rd. Ste. E, Ellicott City, Maryland 21043
Open Medicine Institute & Clinic, 319 N. Bernardo Ave, Mountain View, California 94043
Open Medicine Institute - Tick-Borne Illness Center of Excellence, 240 Maple St., Woodruff, Wisconsin 54568
Internal Medicine of Northern Virginia, 1860 Town Center Drive, Suite #230, Reston, Virginia 20190

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.
• 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
This is to certify that the information contained herein is true and correct as reflected in the records of this IRB. WE CERTIFY THAT
THIS 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: 02/12/2020

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 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 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 board approves a change of Principal Investigator - Once approved, the new Principal Investigator is authorized by the 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 this
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
Andreas M. Kogelnik, MD, PhD, Open Medicine Institute
Elizabeth R. Unger, MD, PhD, Center for Disease Control and Prevention
Catrina (Catt) Phan, Open Medicine Institute
Haleh Ashki, OMI

COA Template 01-03-2018

Board Action: 02/12/2020

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