HURC Policy & Procedure Manual - Extranet - University of Rochester

To: All Principal Investigators 

University of Rochester 

Human Use of Radiation Committee 

From: Human Use of Radiation Committee 

Subject: Application for the Use of Radioisotopes or Radiation-Generating Devices in 

Research involving Human Subjects 

The attached information has been prepared to assist you with completing an application to use 

ionizing radiation for human biomedical research. The committee is required to review certain 

activities and information prior to granting approval on an application. Please ensure that each 

application is supported by complete and accurate information so that the Committee can act on 

the application. 

Please submit a copy of CVs for all researchers participating in the proposed work. If CVs have 

been submitted previously, there is no need to submit a new CV. 

If assistance is needed to complete the application, please contact Radiation Safety, 275-3781. 

HURC Manual Rev 3 – March 2008 

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Table of Contents 

A. Background………………………………………………………………………………………………..3 

B. General considerations for Application Submittal………………………………………………………..4 

C. Required involvement of an “authorized user”……………………………………………………….…..4 

D. Assessment of radiation risk……………………………………………………………………………...5 

E. Limitations on radiation dose…………………………………………………………………………….5 

F. Informed consent statements of radiation risk………………………………………………………….. 6 

G. Restrictions on human subject recruitment………………………………………………………………7 

H. Notification of auxiliary personnel………………………………………………………………………7 

I. Misadministrations and adverse reactions……………………………………………………………….7 

J. Modifications……………………………………………………………………….…………………...8 

K. Renewal/termination…………………………………………………………………………………….8 

L. Location for submission………………………………………………………………………………....8 

M. Meeting dates and deadlines………………………………………………………………………….…8 

N. Submission requirements………………………………………………………………………………..8 

O. Instructions for Completing HURC Form “Information Required in Support of the……………….…. .9 

Research Use of a Non-FDA Approved Radioactive Drug” 

P. Special Conditions for the Research Use of a Radioactive Drug That Is Not…………………………..13 

F.D.A. Approved (21 CFR Part 361.1) 


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A. Background 

THE HUMAN USE OF RADIATION COMMITTEE 

Exposure of human subjects to ionizing radiation in the course of a biomedical research 

study involves several considerations in addition to those applied to clinical research studies 

which do not incorporate such an intervention. The risks of involved radiation exposure 

must be appropriately addressed and delineated in a consent form. Also, the research study 

must be conducted in accordance with institutional policies and procedures and with state 

and/or federal regulations that govern the safe use and handling of radioactivity and 

radiation-generating devices. To ensure that these special considerations are properly 

addressed, biomedical research studies involving the exposure of human subjects to ionizing 

radiation must be reviewed and approved by the Human Use of Radiation (HURC). 

Approval of the HURC for such studies is in addition to the requirement for approval 

by the Research Subjects Review Board (RSRB). 

The HURC reviews, comments on and approves the following types of research studies: 

1. Tracer studies: Use of radioactive drugs or tracer compounds to obtain basic 

information about the metabolism of a radioactively labeled drug or regarding human 

physiology, pathophysiology or biochemistry, but not intended for immediate 

therapeutic or diagnostic purposes. The amount of drug or compound administered 

must not evoke a clinical response. 

2. Investigational new drug (IND) studies: Use of drugs at or above levels expected 

to evoke a clinical response. A formal FDA-approved IND application must 

accompany the HURC application. 

3. Research use of a non-FDA approved device (“non-significant risk”): Food and 

Drug administration policies permit the research use, in human subjects, of an 

ionizing radiation-emitting device that is not the subject of an approved 

Investigational Device Exemption (IDE) or 510K application provided that it is 

classified as a “non-significant risk device” based on review by the RSRB. To be 

considered a presenting a “non-significant risk,” use of the ionizing radiationemitting 

device must not be of substantial importance in diagnosing, curing, 

mitigating, or treating disease, or otherwise preventing impairment of human health. 

4. Research use of a non-FDA approved device: Failure to meet the criteria for “nonsignificant 

risk” requires that the sponsor of the device obtain FDA approval of an 

Investigational Device Exemption (IDE). 

5. Research use of a FDA-approved device: Use of a radiation-generating device for 

non-clinical research. 

6. “On label” research use of a FDA-approved radiopharmaceutical: Research 

using a radiopharmaceutical prepared and administered in accordance with the 

approved product labeling. 

7. “Off label” research use of a FDA-approved radiopharmaceutical: Research 

using a FDA-approved radiopharmaceutical prepared using a non-approved (i.e., not 

according to product labeling) method and/or administered by a non-approved (i.e., 

not according to product labeling) route. 


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B. General Considerations for Application Submittal 

In planning a research study, investigators should first consider whether it is necessary to use 

ionizing radiation to obtain the desired information. Any investigation requiring the use of 

ionizing radiation must produce the needed information at minimum radiation dose to the 

minimum number of human subjects and the research must be defensible in terms of clinical 

and scientific relevance. 

The application must clearly state: 

Hypothesis(es) to be tested and the specific aims of the research 

Why the use of radioactivity or a radiation-generating device is necessary to address 

the specific aims 

Scientific and statistical justification (where appropriate) for the number of subjects 

Justification for the estimated radiation dose 

C. Required involvement of an “authorized user” 

The use of radioactivity and radiation-generating devices in humans is strictly controlled by 

State and Federal regulations. Only a professional practitioner (physician, dentist, podiatrist, 

osteopath or chiropractor) or certified nurse practitioner or physician assistant working 

within a practice agreement with a physician may order the use of x-rays. 

Radiopharmaceuticals may only be ordered by a physician who is approved by the University 

of Rochester Radiation Safety Committee. 

An “authorized user” is an individual possessing the appropriate qualifications for the 

proposed human use of the radiation-emitting device or drug. Listed below are requirements: 

Tracer studies: individual approved by the Radiation Safety Committee who is 

qualified by training and experience to conduct the proposed research studies. 

Radioactive drugs administered under an IND or “on label” or “off label” 

research use: physician authorized by the Radiation Safety Committee to prescribe 

radioactive materials 

Use of radiation-generating device: professional practitioner (physician, dentist, 

podiatrist, osteopath or chiropractor) or certified nurse practitioner or physician 

assistant working within a practice agreement with a physician. NOTE: only a 

professional practitioner or a licensed radiologic technologist or a properly 

supervised student technologist may position subjects, set techniques or apply 

radiation. 

The authorized user is responsible for 

Compliance with all statements and conditions approved by the HURC 

Ensuring that each study is approved in writing by the appropriate individual, as 

described above, before administration 

Submission of routine reports (e.g., Research Study Progress Report, Modification 

Requests) and special (e.g., adverse event, misadministration) reports required by the 

HURC 


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D. Assessment of radiation risks 

A major responsibility of the HURC is the review of the radiation risks to human subjects 

participating in the proposed research project. The HURC pays special attention to the 

radiation risks associated with a single study (i.e., inclusive of all procedures performed on 

the subject during a single study session) and the cumulative risks (i.e., inclusive of all single 

studies performed on the subject) associated with total project participation. The HURC also 

reviews the methods or sources of information that were used to approximate these risks. 

Estimates of radiation exposure to human subjects must be made in advance and included as 

part of the research protocol submitted to the HURC. For radioactive materials, the dose to 

the whole body as well as specific organs known to be targeted by the drug/compound must 

be provided. Estimated doses to gonads, lens of the eye and red marrow must be provided as 

well, even though the drug or compound may not specifically target these organs. For 

studies involving radiation-generating devices, the skin entrance exposure or dose must also 

be provided. It is appropriate to assume 1 Roentgen = 1 rad = 1 rem for x-rays, gamma rays 

and beta particles. (Assistance is available from the Radiation Safety Unit, 275-3781.) 

The following radiation units must be included as appropriate: 

Whole body dose (effective dose equivalent) – mrem/rem 

Organ dose – mrad/rad 

Entrance skin dose – mrad/rad 

E. Limits on radiation dose 

The amount of the radioactive drug administered or exposure to radiation-generating devices 

shall be such that the subject receives the smallest radiation dose with which it is practical to 

perform the study without jeopardizing the benefits to be obtained from the study. 

Under no circumstances may the radiation dose to an adult research subject from a single 

study exceed 3 rem effective dose equivalent to the whole body, 3 rem to active bloodforming 

organs, lens of the eye or gonads; or 5 rem in a single study to any other organ. (A 

“single study” is defined as all procedures performed on a subject during a single study 

session). The total dose commitment from multiple studies (by all investigators) performed 

on the same subject within 1 year may not exceed 5 rem effective dose equivalent to the 

whole body, 5 rem to active blood-forming organs, lens of the eye, or gonads; or 15 rem to 

any other organ. 

• Radiation doses from x-ray or other procedures that are part of the research study 

(i.e., would not have occurred but for the research study) shall be included when 

determining the single study radiation absorbed doses and total dose commitments. 

• For research subject under 18 years of age at his/her last birthday, the radiation dose 

shall not exceed 10% of the limits described above. 

• Numerical definitions of the radiation dose shall be based on an absorbed fraction 

method of calculation such as the system set forth by the Medical Internal Radiation 

Dose Committee (MIRD) of the Society of Nuclear Medicine or the International 

Commission on Radiological Protection (ICRP). 


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F. Informed Consent statements of radiation risk 

The discussion of radiation risks in the informed consent document and patient dialogue 

should include comparisons with natural background (i.e., for low risk procedures) or 

occupational worker limits. Examples of statements that are reasonable include the 

following: 

(1) For whole body Effective Dose Equivalent (EDE) < 1000 mrem: 

“Participation in this research study involves exposure to radiation from (specify 

respective procedure(s) to be performed). The amount of radiation exposure that you 

will receive from this (these) procedure(s) is equivalent to a uniform whole body dose 

of mrem which is approximately (indicate multiplication factor, fraction, 

or percentage of) the average amount of natural environmental radiation exposure (360 

mrem dose) that each member of the general public receives per year. There is no 

known minimum level of radiation exposure that is recognized as being totally free of 

the risk of causing genetic defects (cellular abnormalities) or cancer. However, the risk 

associated with the amount of radiation exposure that you will receive from this study is 

considered to be low when compared to other everyday risks. 

(2) For a whole body Effective Dose Equivalent (EDE) of 1000 mrem - 5000 mrem: 




of rem which is approximately (indicate fraction or percentage of) the 

annual radiation exposure (5 rem) permitted to radiation workers by federal regulations. 

These is no known minimum level of radiation exposure that is recognized as being 

totally free of the risk of causing genetic defects (cellular abnormalities) or cancer. 

However, the risk associated with the amount of radiation exposure that you will 

receive from this study is considered to be low and comparable to other everyday risks. 

(3) For a whole body Effective Dose Equivalent (EDE) of > 5000 mrem. 




of rem which is approximately (indicate multiplication factor) the annual 

radiation exposure (5 rem) permitted to radiation workers by federal regulations. 

Excess cancer risk associated with this level of radiation exposure is estimated to be 

(specify BEIR III, BEIR V, or ICRP 64 factor*) the standard risk.” 

*Contact the University Radiation Safety Unit 275-3781 for assistance in 

obtaining this data. 

(4) Note: Comparisons of radiation exposures or risks from radioactive drugs to those from 

X-ray procedures shall not be approved unless the risks are stated in comparable units 

(i.e., Effective Dose Equivalent). 


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G. Restrictions on human subject recruitment 

Definitions: 

• “Subjects” are defined as participants in research activities other than patients; these 

people include controls. 

• “Patients” are defined as participants in research activities for whom there is a 

professional responsibility for diagnosis or treatment. 

• “Minors” are defined as subjects or patients < 18 years of age. 

If a research study involving exposure to ionizing radiation involves female subjects or 

patients, pregnancy must be ruled out on the basis of the research subject’s clinical history or 

by a highly sensitive test performed within a short time frame prior to exposure. 

Nursing females should not be included in any research study involving the administration of 

a radioactive drug. 

H. Notification of auxiliary personnel 

All auxiliary personnel involved directly (e.g., radiologic or nuclear medicine technologists) 

or indirectly (e.g., nursing staff, laboratory technologists) in the conduct of the research 

study, in the care of human subjects or patients participating in the research, or in the 

handling of respective radioactive samples must be adequately informed of the nature of the 

research study and any radiation risks (including methods to reduce such risks) that may be 

associated with their involvement. Radiation safety training may be required for those 

personnel. Please contact Radiation Safety for information on Radiation Safety Training at 

275-3781. 

I. Misadministration and adverse reactions 

Any unintentional exposure to radiation (i.e., misadministration) or adverse reaction to a 

radioactive drug or radiation exposure occurring during the research study must be reported 

immediately to the Radiation Safety Officer at 275-3781. 

A misadministration is defined as administration of 

A radioactive drug or radiation from a source other than the one ordered; 

A radioactive drug or radiation to the wrong person; 

A radioactive drug or radiation by a route or to a part of the body other than that 

intended by the authorized user; 

An activity of a radioactive drug for diagnostic purposes that differs from the activity 

ordered by more than 50%; 

An activity of a radioactive drug for therapeutic purposes that differs from the 

activity ordered by more than 10%; 

Therapeutic radiation dose from any source other than a radioactive drug differing 

from the final ordered dose by more than 10%; 

Therapeutic radiation dose in any fraction of a fractionated treatment such that the 

administered dose in the individual treatment or fraction differs from the dose ordered 

by more than 50%. 


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The Chair of the HURC/RDRC shall investigate and report the circumstances of the event to 

appropriate individuals, committees, and outside agencies as required: 

Medical Quality Assurance Committee 

Risk Management Committee 

Diagnostic Medical Imaging Quality Assurance Committee 

Research Subjects Review Committee 

Radiation Safety Committee 

New York State Department of Health 

U.S. Food and Drug Administration 

J. Submission requirements 

Submit eight (8) copies the following documents 

Application For The Research Use Of Ionizing Radiation (Appendix A); and 

Research protocol and informed consent document (RSRB format). This must include a 

statement of how the authorized user will ensure that approval is obtained in writing 

before administration of x-rays or radioactive drugs or compounds; and 

Curriculum vitae (C.V.) of the principal investigator and authorized user; and 

For research involving evaluation of a non-FDA-approved radiation generating device: 

device manufacturer’s clinical protocol and/or investigator’s brochure or the investigatorsponsored 

IDE application, if appropriate; or 

For research involving “off label” use of a FDA-approved radiopharmaceutical: 

completed “Information Required in Support of the Research Use on a Non-Approved 

Radioactive Drug” (Appendix B); or 

For research involving use of a non-FDA approved radioactive drug or compound: 

“Information Required in Support of the Research Use of a Non-Approved Radioactive 

Drug” (Appendix B) and notification that the proposed research study has been approved 

by a scientific review committee representing the principal investigator’s primary 

academic or center affiliation; or 

For research evaluation of a radioactive drug which is the subject of a FDA-approved 

Investigational New Drug (IND) exemption: manufacturer’s clinical protocol and/or 

investigator’s brochure or the investigator-sponsored IND application. 

K. Modifications 

HURC must be notified of any changes in the research protocol that affect 

• Number of subjects 

• Age distribution if more minors will be included 

• Dose to subjects either from individual studies or from the total protocol 

The principal investigator will be required to submit additional documents supporting these 

changes and may be required to re-submit the initial forms described above. 

L. Renewal/Termination 

The HURC will monitor the status of approved research projects by requiring that the 

principal investigator and/or authorized user complete, on a periodic basis, a Research Study 

Progress Report. 


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M. Location for submissions 

Materials submitted for review and approval by the HURC should be delivered to Radiation 

Safety Unit, Box HPH, 275-3781. 

N. Meeting dates and deadlines 

The HURC is required by regulation to meet as a full committee to review research studies 

involving radioactive drugs. The HURC meets in each calendar quarter, (February, May, 

August and November). Other times can be arranged. 

The review of research studies involving (ionizing) radiation-emitting devices can be 

expedited by limited review process. Such research studies will be reviewed as received. 

O. Instructions for Completing HURC Form “Information Required in Support of the Research 

Use of a Non-FDA Approved Radioactive Drug” 

1. General Instructions 

a. Responses to the requests for information should be type written (i.e., handwritten 

responses will not be accepted. 

b. Use of supplementary pages or appendices is permitted if additional space is required. 

c. One completed HURC Form for given radioactive drug may serve as a “Master File” 

for multiple research projects involving the administration of that radioactive drug. 

Each new submission of a research protocol should specifically cite the current 

Master File for the applicable radioactive drug. 

2. Specific Instructions 

a. Identity of the Radioactive Drug 

• Identify the [radionuclide]-active ingredient/carrier (e.g., [C-14] glucose) 

• Identify the non-radioactive drug (e.g., glucose) 

b. Specify the maximum mass dose (i.e., ug or mg) of non-radioactive drug to be 

administered per subject, per single dose. 

c. Identify the non-radioactive ingredients that appear within the final dosage form (e.g., 

10% V/V ethanol in 0.9% Sodium Chloride for Injection, U.S.P.) 

d. Identify radionuclide contaminants (e.g., Mo-99 when Tc-99m is administered). 

State the percent (%) of administered activity attributable to contaminants. 

3. Route of Administration 

a. Indicate the number of doses per subject and proposed route of administration. 


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3. Estimated Radiation Dose to Human Subjects 

a. Absorbed calculations: 

• Provide radiation absorbed dose estimates for the radioactive drug. At a 

minimum, radiation dose estimates must address the effective dose equivalent and 

absorbed doses to the total body, gonads, active blood-forming organs, critical 

organ, and lens of the eye. (The latter may be assumed to be equivalent to the 

total body dose unless specific eye uptake of the radioactive drug has been 

demonstrated or is expected.). Submit a complete list, to include absorbed doses 

to other organs, when respective data is available. These dose estimates must 

take into account the contribution of any significant radionuclide contaminant(s) 

present in the final project. 

• Specify the literature reference from which the biodistribution data for calculation 

of the radiation absorbed dose estimates were obtained; or, if not published, 

provide a summary of the biodistribution data and identify the laboratory and 

personnel involved in its collection. 

• Specify the individual or entity responsible for calculation of the radiation 

absorbed estimated and the methodology (e.g., MIRD or ICRP absorbed fraction) 

utilized; or, if taken from a published source, include a copy of the respective 

reference. 

b. Method of radioassay: 

• Specify the method by which the radioactive drug will be assayed prior to use so 

as to ensure that the administered radioactivity dosage and corresponding 

absorbed dose estimated are as stated in the research protocol. 

c. Assay instrumentation quality control: 

• Indicate the procedures that will be performed to ensure accurate operation of the 

instrumentation used to assay the radioactive drug. 

4. Pharmacological Dosage of Active Ingredient 

a. For an FDA-approved (i.e., NDA) radiopharmaceutical prepared using a nonapproved 

method and/or administered by a non-approved route: Provide supporting 

statements to address the requirement that deviation(s) from the approved product 

labeling will not significantly increase the risk to the research subject. 

b. For a radioactive drug prepared and administered under the authority of 21 CFR 

361.1; provide data, based on the published or other valid human studies, 

(1) In support of the requirement that the amount of active ingredient/carrier in the 

proposed dosage of the final radioactive drug will not cause any clinically 


10

detectable pharmacological effects. (Append copies of key referenced 

publications or cited human studies.) 

(2) Maximum mass dose level at which no clinically detectable pharmacological 

effects are known to occur. 

5. Quality of the Radioactive Drug 

a. Method of preparation/dispensing: 

• Identify the individual(s) or entity that will be responsible for the preparation, 

repackaging, and/or dispensing of the radioactive drug. 

• Describe, in detail, the procedures that will be used in the preparation, 

repackaging, and/or dispensing of the radioactive drug. (May be appended in the 

form of a master formula card.) 

b. Minimum acceptance criteria: 

• Delineate minimum acceptance specifications for the final radioactive drug, 

addressing which of the criteria listed below: 

c. Preclinical validation studies: 

Visual appearance 

pH 

Radiochemical purity 

Chemical purity 

Specific activity 

Radionuclide purity or identification: 

Pyrogens or bacterial endotoxins (limited to parenteral 

administration) 

Sterility (limited to parenteral administration) 

• Summarize the outcome of any preclinical validation studies that have been 

performed to confirm that the final radioactive drug will meet the designated 

minimum acceptance criteria when prepared/repackaged according to the 

indicated procedures. Such validation studies may include procedures performed 

on site and/or obtained from the supplier of the radioactive drug. 

d. Routine quality control procedures: 

• Indicate the testing procedures that will be performed on each batch of the 

radioactive drug to ensure that it meets the designated minimum acceptance 

criteria. 

(Note that because of test complexity it may not be possible or practicable to 

address each of the designated minimum acceptance criteria on each batch of the 

radioactive drug. In such an event, compliance of the radioactive drug with the 


11

applicable minimum acceptance criterion should be addressed in the preclinical 

validation studies. For certain criteria (e.g., sterility, pyrogens/ bacterial 

endotoxins), it may be a requirement (i.e., based on the physical half-life of the 

radionuclide) that testing be completed following release of the radioactive drug 

for human use.) 

• Indicate the individual(s) or entity that will be responsible for routine quality 

control testing of the radioactive drug. 

e. Expiration dating: 

6. Labeling 

• Specify an expiration period, post preparation or repackaging of the radioactive 

drug, wherein there is evidence that each of the designated minimum acceptance 

criteria will be retained. Summarize the studies that have been performed or 

provide a literature reference justifying this expiration period. 

a. For an FDA-approved (i.e., NDA) radiopharmaceutical prepared using a nonapproved 

method and/or administered by a non-approved route: Specify how the 

immediate container (e.g., vial syringe) shielding of the radiopharmaceutical will be 

labeled so as to address the identity of the responsible research area or investigator, 

the identity of the radiopharmaceutical, the total quantity of contained radioactivity at 

a designated assay time/date, the total contained volume or mass, the expiration 

time/date, and (if applicable) a lot or control number that will permit reference to the 

procedure/reagents involved in the non-approved method of preparation. 

• Note that if the radiopharmaceutical is to be distributed outside of the responsible 

research area, the information listed above must appear on the primary label 

attached to the immediate container or shielding. If the radiopharmaceutical is 

not distributed outside of the responsible research area, the information included 

on the primary label may be limited to the identity of the radiopharmaceutical and 

an identifier (e.g., lot number or batch number) that permits immediate access to 

the other information specified above. 

• Note that if the primary label is attached to the shielding, the immediate container 

of the radioactive drug must be labeled to include, at a minimum, the identity of 

the radiopharmaceutical. 

b. For a radioactive drug used under the authority of 21 CFR 361.1: Specify how the 

immediate container (e.g., vial, syringe) or shielding f the radioactive drug will be 

labeled so as to comply with the requirements of 21 CFR 361.1 (available from the 

Radiation Safety Unit). 

• Note that if the radioactive drug is to be distributed outside of the responsible 

research area, each of the applicable information/statements listed in 21 CFR 

361.1 must appear on the primary label attached to the immediate container or 

shielding. If the radioactive drug is not distributed outside of the responsible 

research area, the information statements included on the primary label may be 


12

limited to: 1) the statements, “Caution: Federal law prohibits dispensing without 

a prescription,” and “To be administered in compliance with the requirements of 

Federal regulations regarding radioactive drugs for research use (21 CFR 361.1)”; 

2) the identity of the radioactive drug; and 3) an identifier (e.g., lot number, batch 

number) that permits immediate access to the other information listed in 21 CFR 

361.1. 

• Note that if the primary label is attached to the shielding, the immediate container 

of the radioactive drug must be labeled to include, at a minimum, the identity of 

the radioactive drug and an identifier (e.g., lot number or batch number) that will 

permit correlation with the primary label. 

P. Special Conditions for the Research Use of a Radioactive Drug That Is Not F.D.A. Approved 

(21 CFR Part 361.1) 

1. Definition of “research use” 

Radioactive drugs or compounds are generally recognized as safe and effective when 

administered to human research subjects during the course of a research project intended to obtain 

basic information regarding the kinetics (including distribution and localization) and metabolism 

of the radioactive drug or regarding human physiology, pathophysiology, or biochemistry; but 

not when intended for immediate diagnostic, therapeutic, or similar purposes or to 

determine the safety and effectiveness of the drug in humans for such purpose (i.e., to carry 

out a clinical trial). 

2. Human research subjects: 

Research subjects shall be at least 18 years of age and legally competent. Exceptions are 

permitted only in those special situations when it can be demonstrated that the study presents a 

unique opportunity to gain information not currently available, and that the study requires the use 

of research subjects less than 18 years of age. 

The number of subjects included in the research study shall be sufficient but no greater than 

necessary to achieve the objective(s) of the study (i.e., to obtain basic research information). 

Inclusion of more than 30 subjects or subjects less than 18 years of age in the research study 

requires advanced notification of the F.D.A. and must be scientifically rationalized. 

3. Limit on radiation dose 

The amount of the radioactive drug administered shall be such that the subject receives the 

smallest radiation dose with which it is practical to perform the study without jeopardizing the 

benefits to be obtained from the study. 

Under no circumstances may the radiation dose to an adult research subject from a single study 

exceed 3 rems to the whole body, active blood-forming organs, lens of the eye, or gonads; or 5 

rems in a single study to any other organ. (A “single study” is defined as all procedures 

performed on a subject during a single study session). The total dose commitment from multiple 

studies (by all investigators) performed on the same subject within 1 year may not exceed 5 rems 

to the whole body, active blood-forming organs, lens of the eye, or gonads; or 15 rems to any 

other organ. 


13

• Radiation doses from x-ray or other procedures that are part of the research study (i.e., would 

not have occurred but for the research study) shall be included when determining the single 

study radiation absorbed doses and total dose commitments. 

• For research subject under 18 years of age at his/her last birthday, the radiation dose shall not 

exceed 10% of the limits described above. 

• Numerical definitions of the radiation dose shall be based on an absorbed fraction method of 

calculation such as the system set forth by the Medical Internal Radiation Dose Committee 

(MIRD) of the Society of Nuclear Medicine or the International Commission on Radiological 

Protection (ICRP). 

4. Limit on pharmacological dose 

The amount of active ingredient (or carrier) per administered dose of the radioactive drug shall be 

known, based on published or other valid studies, not to cause any clinically detectable 

pharmacological effect. 

5. Quality of the radioactive drug 

The radioactive drug must appropriate chemical, pharmaceutical, radiochemical, and radionclidic 

standards of identity, strength, quality and purity as needed such uniform and reproducible 

quality as to give significance to the research study conducted. Radioactive drugs for parenteral 

use must be prepared in sterile and pyrogen-free form. 

6. Labeling 

The final container the radioactive drug shall be labeled to include the following: 

• The statement “Caution: Federal law prohibits dispensing without a prescription.” 

• The statement “To be administered in compliance with the requirements of Federal 

regulations regarding radioactive drugs for research use (21 CFR 361.1).” 

• Identity of the radioactive drug to include the name and half-life of the radionuclide. 

• The identity and quantity of the active ingredient. 

• The total quantity of radioactivity within the immediate container at a designated reference 

time. 

• The amount of radioactivity per unit volume or unit mass at a designated reference time. 

• The net quantity of contents. 

• The route of administration if it is for other than oral use. 

• An identifying lot or control from which it is possible to determine the complete 

preparation/repackaging history of the batch of radioactive drug. 

• The name and address of the manufacturer, preparer, repackager, or distributor. 

• The expiration date 


14

• If the drug is intended for patrenteral use, a statement as to whether the contents are sterile. 

• If the drug is for other than oral use, the identity of all inactive ingredients. 


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