Consenting Process for Radiation Facilities - Atomic Energy ...
Consenting Process for Radiation Facilities - Atomic Energy ...
Consenting Process for Radiation Facilities - Atomic Energy ...
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should be volunteers drawn from a large population, after obtaining their<br />
in<strong>for</strong>med consent. Any biomedical work involving radiation should serve a<br />
useful purpose and the results should be applied <strong>for</strong> beneficial knowledge in<br />
the subject. It is also important that such results are not already available.<br />
Any unnecessary exposure to individuals should be avoided. An Ethical<br />
Review Committee of the hospital should review all the proposed biomedical<br />
procedures, be<strong>for</strong>e Approval of AERB is sought.<br />
3.16.3.2 Commissioning and Operation<br />
The AERB shall review applications <strong>for</strong> approval of a procedure <strong>for</strong><br />
biomedical research. Such studies shall be undertaken in laboratories having<br />
AERB approval <strong>for</strong> handling radioisotopes in unsealed <strong>for</strong>m (eg. nuclear<br />
medicine laboratory)<br />
The applicant should establish the procedures through animal studies, prior<br />
to seeking permission <strong>for</strong> biomedical programme on humans. The report along<br />
with details of the biomedical programme should be submitted to the Ethical<br />
Review Committee of the institution. The Ethical Review Committee’s<br />
recommendation that the procedure adopted might have beneficial results is<br />
an essential requirement <strong>for</strong> carrying out the programme. The applicant should<br />
follow the Helsinki Declaration (18 th World Medical Assembly, Helsinki,<br />
1964) in selecting the human subjects <strong>for</strong> the biomedical research.<br />
Based on the inspection and assessment of facilities and availability of trained<br />
manpower to carry out the required research work, AERB may grant<br />
Registration <strong>for</strong> the said biomedical research with certain stipulations on<br />
radiation safety. The Consentee should follow the stipulations and report to<br />
AERB on the safety aspects of the research.<br />
The application <strong>for</strong>mat <strong>for</strong> obtaining the Registration <strong>for</strong> the biomedical<br />
research/studies is given in Annexure 45.<br />
3.16.3.3 Lead Time <strong>for</strong> Submission/Availability of Documents<br />
The lead time <strong>for</strong> submission of documents at any stage of consenting process<br />
is 30 days be<strong>for</strong>e the desired date of consent and the documents should be<br />
complete in all respects <strong>for</strong> review by AERB.<br />
3.17 Radio-Immuno Assay (RIA)<br />
3.17.1 General<br />
Radio-immuno assay (RIA) is an in-vitro procedure in which radioactivity is<br />
not administered directly to patients. Tests are carried out by adding<br />
radioactivity to blood samples drawn from patients. Since RIA is a laboratory<br />
process, the source storage, assay and waste handling areas need to be<br />
demarcated and contamination prevented, contained or controlled.<br />
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