10 CFR 35.6, Provisions for the Protection of Human Research Subjects

Provisions for the protection of human research subjects

a

(a) A licensee may conduct research involving human research subjects only if it uses the byproduct materials specified on its license for the uses authorized on its license.

b

(b) If the research is conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy for the Protection of Human Subjects (Federal Policy), the licensee shall, before conducting research--

(1) Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and

(2) Obtain "informed consent," as defined and described in the Federal Policy, from the human research subject.

c

(c) If the research will not be conducted, funded, supported, or regulated by another Federal agency that has implemented the Federal Policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its NRC medical use license. The amendment request must include a written commitment that the licensee will, before conducting research--

(1) Obtain review and approval of the research from an "Institutional Review Board," as defined and described in the Federal Policy; and

(2) Obtain "informed consent", as defined and described in the Federal Policy, from the human research subject.

d

(d) Nothing in this section relieves licensees from complying with the other requirements in this part.

Federal Register

67 FR 62872, Oct. 9, 2002]

External Links

NRC website 10 CFR 35.6

v t e Code of Federal Regulations
Title 10 Part 35 - MEDICAL USE OF BYPRODUCT MATERIAL
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, General Information, Purpose and scope 2, Definitions 5, Maintenance of records 6, Provisions for the protection of human research subjects 7, FDA, other Federal, and State requirements 8, Information collection requirements: OMB approval 10, Implementation 11, License required 12, Application for license, amendment, or renewal 13, License amendments 14, Notifications 15, Exemptions regarding Type A specific licenses of broad scope 18, License issuance 19, Specific exemptions 24, General Administrative Requirements, Authority and responsibilities for the radiation protection program 26, Radiation protection program changes 27, Supervision 40, Written directives 41, Procedures for administrations requiring a written directive 49, Suppliers for sealed sources or devices for medical use 50, Training for Radiation Safety Officer 51, Training for an authorized medical physicist 55, Training for an authorized nuclear pharmacist 57, Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist 59, Recentness of training 60, General Technical Requirements, Possession, use, and calibration of instruments used to measure the activity of unsealed byproduct material 61, Calibration of survey instruments 63, Determination of dosages of unsealed byproduct material for medical use 65, Authorization for calibration, transmission, and reference sources 67, Requirements for possession of sealed sources and brachytherapy sources 69, Labeling of vials and syringes 70, Surveys of ambient radiation exposure rate 75, Release of individuals containing unsealed byproduct material or implants containing byproduct material 80, Provision of mobile medical service 92, Decay-in-storage 100, Unsealed Byproduct Material-Written Directive Not Required, Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required 190, Training for uptake, dilution, and excretion studies 200, Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required 204, Permissible molybdenum-99, strontium-82, and strontium-85 concentrations 290, Training for imaging and localization studies 300, Unsealed Byproduct Material-Written Directive Required, Use of unsealed byproduct material for which a written directive is required 310, Safety instruction 315, Safety precautions 390, Training for use of unsealed byproduct material for which a written directive is required 392, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries) 394, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries) 400, Manual Brachytherapy, Use of sources for manual brachytherapy 404, Surveys after source implant and removal 406, Brachytherapy sources accountability 410, Safety instruction 415, Safety precautions 432, Calibration measurements of brachytherapy sources 433, Decay of strontium-90 sources for ophthalmic treatments 457, Therapy-related computer systems 490, Training for use of manual brachytherapy sources 491, Training for ophthalmic use of strontium-90 500, Sealed Sources for Diagnosis, Use of sealed sources for diagnosis 590, Training for use of sealed sources for diagnosis 600, Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units, Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit 604, Surveys of patients and human research subjects treated with a remote afterloader unit 605, Installation, maintenance, adjustment, and repair 610, Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 615, Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 630, Dosimetry equipment 632, Full calibration measurements on teletherapy units 633, Full calibration measurements on remote afterloader units 635, Full calibration measurements on gamma stereotactic radiosurgery units 642, Periodic spot-checks for teletherapy units 643, Periodic spot-checks for remote afterloader units 645, Periodic spot-checks for gamma stereotactic radiosurgery units 647, Additional technical requirements for mobile remote afterloader units 652, Radiation surveys 655, Five-year inspection for teletherapy and gamma stereotactic radiosurgery units 657, Therapy-related computer systems 690, Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 1,000, Other Medical Uses of Byproduct Material or Radiation From Byproduct Material, Other medical uses of byproduct material or radiation from byproduct material 2,024, Records, Records of authority and responsibilities for radiation protection programs 2,026, Records of radiation protection program changes 2,040, Records of written directives 2,041, Records for procedures for administrations requiring a written directive 2,060, Records of calibrations of instruments used to measure the activity of unsealed byproduct material 2,061, Records of radiation survey instrument calibrations 2,063, Records of dosages of unsealed byproduct material for medical use 2,067, Records of leaks tests and inventory of sealed sources and brachytherapy sources 2,070, Records of surveys for ambient radiation exposure rate 2,075, Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material 2,080, Records of mobile medical services 2,092, Records of decay-in-storage 2,204, Records of molybdenum-99, strontium-82, and strontium-85 concentrations 2,310, Records of safety instruction 2,404, Records of surveys after source implant and removal 2,406, Records of brachytherapy source accountability 2,432, Records of calibration measurements of brachytherapy sources 2,433, Records of decay of strontium-90 sources for ophthalmic treatments 2,605, Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 2,610, Records of safety procedures 2,630, Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 2,632, Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations 2,642, Records of periodic spot-checks for teletherapy units 2,643, Records of periodic spot-checks for remote afterloader units further results Appendices:

10 CFR 35.6, Provisions for the Protection of Human Research Subjects

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10 CFR 35.6, Provisions for the Protection of Human Research Subjects

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