May 26, 2016
The IRB is implementing a change in policy for all studies involving research PET scans and women of childbearing potential.
Historically at NYSPI, women of childbearing potential have been screened for pregnancy prior to undergoing a research PET by means of a rapid serum test on the morning of the scan. Given that rapid serum testing is not approved for waiver under the CLIA criteria, the use of rapid serum testing at NYSPI must cease.
Serum pregnancy testing can only be conducted by an outside laboratory, such as Nathan Kline, NYP, or LabCorp. Given that these tests typically require 1-2 days for return of results, same day serum pregnancy testing prior to the conduct of a research PET scan in most cases is not feasible. However, an investigator certainly could arrange for serum pregnancy tests as close to the date of the scan as feasible if it is logistically possible.
The IRB has determined that for women of childbearing potential a urine pregnancy test should be implemented at baseline and prior to every research PET scan with an appropriate informed consent discussion around its limitations and the importance of ensuring to the extent possible that the subject is not pregnant when undergoing a scan. This new research policy is effective immediately.
With respect to the research consent form, it should carefully explain: a) the limited sensitivity of a urine pregnancy test in detecting a pregnancy several days after conception; b) the chance of receiving a negative pregnancy test result when the participant is actually pregnant (i.e., a false negative test result); c) the risk to the fetus of a pregnant female exposed to PET; and d) the importance of using effective birth control during the course of study.
Below is suggested consent form language to address these issues:
This study requires a research PET scan. If you decide to take part in this study, you must be willing to be tested for pregnancy before the start of your participation.
If you are pregnant or breast feeding a baby, you cannot take part in this research study. If you are pregnant, or think you might be pregnant, it is important to tell the study doctor immediately.
To determine your eligibility for this study, a urine pregnancy test will be conducted on the morning prior to the PET scan procedure. If the pregnancy test is positive, you will not be able to participate in the study. It is important to understand that even if your pregnancy test result is negative you could still be pregnant because this pregnancy test cannot detect very early pregnancies (that is, within the first few days after conception).
Should you have questions regarding this policy, please contact either: Drs. Edward Nunes and Larry Greenhill, IRB Co-Chairs, or Dr. David Lowenthal, Clinical Director, NYSPI.
For information write to Irbmail or contact the IRB Director. Phone # : (646) 774-7155