Do I, (the PI) have to attend the meeting?
Although the meeting is open to the public, the Radiation Safety Committee does not require the PI to attend, and in general, investigators do not attend. The RSC will promptly, (within a few business days) notify the PI of results of Committee deliberation.
How often does the Radiation Safety Committee meet?
Generally, the Radiation Safety Committee meets once per month, (with exception of August at which time the committee is on recess). Typically, the meeting is held the last Thursday of the month. During holiday season, (Thanksgiving and Christmas) the meeting is held mid-month. The meeting schedule is usually set by the beginning of the calendar year.
How do I know if I must apply to the Radiation Safety Committee for my protocol?
Oftentimes your IRB will inform you that the radiation use in your protocol is deemed indicated for research purposes, (as opposed to clinically indicated), and hence, you must apply to the Radiation Safety Committee. If you are unsure of the indication, it is best to consult with your IRB, as the Radiation Safety Committee defers to the IRB to determine if radiation is research indicated or is clinically indicated. (Note: clinically indicated radiation use need not be approved by the Radiation Safety Committee).
If I determine that I must apply to the RSC, what must I submit?
You must submit 13 copies of each the following components:
- Protocol,
- Consent(s),
- Assent(s) (where applicable),
- NIH form 88-23(a) (see blank 88-23(a) available on RSC website, or request copy from Dr. Sarah Kindrick
- Cover letter explaining progress of the study, (for triennial reviews only)
How do I fill out the tables in the 88-23(a) form, (dosimetry tables)?
We have dosimetry tables for typical x-ray, PET and nuclear medicine studies and, upon request, can provide you a copy for inclusion in the form 88-23(a). Some x-ray studies, such as fluoroscopy, are unique and will require a consult with a medical physicist (James Vucich), who will need to provide dosimetry services and estimates that are unique to your study. The medical physicist will generate a “dosimetry memo” that I can submit to RSC staff for use in generating a dose table for inclusion in the form 88-23(a),
What if I have a new compound that is not on file with the RSC?
Then you will have to have pre-clinical, (animal) data to approximate the doses that will be received by human beings in the study. Typically, you will have to cite in the 88-23(a) dosimetry table the reference to the article referring to the animal data that extrapolates to human dose. Depending on the situation, the RSC may require some human whole body imaging prior to imaging for the sake of the study. Consult with the RSC on this matter prior to submitting your application.
Do I always need animal data?
There is new policy called the exploratory IND, which allows testing new drugs in tracer amounts first to study the brain imaging on a few subjects to determine whether they are worth spending money to develop. In these cases, (and only with FDA approval), the tracer can be used first in humans prior to animal testing for dosimetry.
What is an RDRC drug?
An RDRC drug is one that is used to obtain basic scientific knowledge and not intended for immediate therapeutic or diagnostic use. It is to be used in a small number of participants, preferably less than 30. In addition to requiring Radiation Safety Committee approval, it also requires approval of the Radioactive Drug Research Committee. The NIH RDRC has individuals with expertise in nuclear medicine, pharmacology and radiation dosimetry. The PI must satisfy stipulations of both the Radiation Safety Committee and the Radioactive Drug Research Committee. For a study involving a radioactive non-IND drug, the PI must submit an RDRC application form. This form requires information about the dosimetry and safety of the drug. Since some members of the RDRC are not on the RSC both the RSC forms and the RDRC application must be submitted in electronic format, i.e. Word, PDF, or a combination, for distribution to the members. Following its review, the RDRC will submit its recommendation for approval to the RSC. The RDRC protocol application is available on the RSC website.
Can pregnant or nursing women receive research radiation?
No. The Radiation Safety Committee feels that since the radiation is not medically necessary, that any risk to the baby, no matter how small, should not be allowed, since there is no benefit to the mother or her baby. We also require that a “pregnancy exclusion statement” be included in the consent. This tells a woman that she may not participate in the protocol if she is pregnant. For x-rays, a woman is not excluded if she is nursing, since it has not been demonstrated that external radiation affects the breast milk.
Does the RSC have any limits or guidelines about the radiation dose for research radiation?
The RSC has guidelines only, meaning that they are flexible, and if there is potential for benefit from the study, they may be exceeded slightly. These guidelines are an effective dose of 5 rem in adults and 0.5 rem in children. If an RDRC drug is involved then there are FDA limits that must be meet; a tissue dose not to exceed 3 rem per administration or 5 rem per year to the whole-body, lens of eye, red bone marrow and gonads; and 5 rem per single administration and 15 rem per year to all other organs. Note that if there is an RDRC drug, the dose to the annual limit applies to the sum of the tissue doses from ALL radiological studies (that give research radiation) in the protocol; not just the RDRC drug dose.
Are there any special restrictions for radiation in children or infants?
Since they are not deriving benefit, NIH does not allow PET scanning in healthy children. Occasionally, the RSC will allow a single patient exemption for a patient who is very sick (and could derive benefit from the protocol) and very close to the 18 year age limit for adulthood. Children in their late teens have essentially the same sensitivity to radiation as adults.
Once I have approval do I have to have continuing review by the RSC?
Yes, but only every three years. The Radiation Safety Committee will send out reminders about 7-8 months prior to the due date for triennial review.
What are common stipulations from the Radiation Safety Committee?
Most often, the committee gives stipulations if the information is inconsistent between the 88-23(a), protocol and consent(s). Other times, there will be stipulations if there is not enough information in the consent regarding radiation risk. Typically, when the PI uses the consent templates available on the RSC website, there are unlikely any omissions of required statements.
Can I respond to the stipulations by e-mail?
Yes. In fact the RSC prefers email response. As long as you have an electronic copy of the file that needs revision, you may send an e-mail to Dr. Sarah Kindrick attaching the file with the changes highlighted. Note that the RSC permits the PI up to six months to respond to stipulation requests. No response from the PI after 6 months may result in the application being dropped from consideration.
Are there any special exemptions for low dose studies?
Yes. For studies that only have DEXA scan as a radiological procedure, there is an accelerated process of approval. A subcommittee of the RSC will perform an expedited review of these applications. This review occurs soon after the application is received and is not held for review at the next schedule full meeting of the Committee. Hence, approval can be achieved relatively quickly.
What is a Clinical Authorized User and when do I need one?
A Clinical Authorized User (CAU) is someone with advanced training in radiology or nuclear medicine who has been given special status by the Radiation Safety Committee to guide researchers in the conduct of the use of radioactive material or radiation in their research. These individuals have applied and been approved by the RSC as CAUs. For names of currently approved CAUs , please contact RSC Staff. Whenever radioactive material is injected into the participant, a Clinical Authorized User is needed. His or her signature is needed on page 1 of the 88-23(a) form. For PET studies, the CAU is usually Dr. Peter Herscovitch. For nuclear medicine studies it might be Dr Chen or Dr. Reynolds. No authorized user is necessary for x-ray studies, as we have a radiologist on the Radiation Safety Committee who gives close scrutiny to studies with x-rays. For studies that involve DEXA scan in the Clinical Center, Dr. James Reynolds serves as the CAU.