KENYA STANDARD  
KS 1954:  2019  
ICS 13.280  KS 1954:2019   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical research — Administration of 
ionizing radiation to human subjects — 
Requirements  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© KEBS 20 19                                                                                                           First Edition 20 192 © KEBS 2019 — All rights reserved   
  
TECHNICAL COMMITTEE R EPRESENTATION  
 
The follow ing organ izations were represented on the  Technical C ommittee:  
 
Eastern Africa A ssociation f or Radiation Prote ction (EAARP)  
Kenya Airways - Non Destructive Testing Department  
Kenya Industrial Research and Development Institute - Energy Division  
Kenya National Accreditation Service  
Kenyatta National Hospital -Radiation Safety Department  
Kenya Nuclear Electricity Board  
Kenyatta University - Department of Applied Physics  
Ministry of R oads and Publ ic Works — Materials Testing and  Research D epartment  
National Commission for Science, Technology and Innovation  
Non Destructive Testing Society of Kenya  
Radiation Pr otection Bo ard 
SGS limited Kenya  
Kenya Bure au of Standar ds — Secret ariat 
 
 
 
 
 
 
REVISION OF KEN YA STANDARDS  
 
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for improv ements to publ ished st andards, address ed to the Mana ging Direct or, Kenya Bure au of Standar ds, 
are welcome.  
 
 
 
 
 
© Kenya  Bureau  of Standards,  2019 
 
Copyright. Users  are reminded  that by virtue  of Section  25 of the Copyright Act,  Cap.  12 of 2001  of the Laws of Kenya,  copyright subsists  
in all Kenya Standards  and except  as provided under  Section 26  of this Act, no Kenya Sta ndard produced  by Kenya Bureau of Standards  
may be reproduced, stored  in a retrieval  system  in any form or transmitted by any means  without  prior permission  in writing from the 
Managing  Director.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ISBN 9966 -19-758-3 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical research — Administration of 
ionizing radiation to human subjects — 
Requirements  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KENY A BUREA U OF STANDARD S (KEBS)  
 
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© KEBS 20 19 — All rights reserved                                                                                                                  iiiKS 1954:  2019  
4 © KEBS 2019 — All rights reserved   
  
 
Foreword 
 
The Radiation  Protection  Act governs  the use of ionizing radiation  in Kenya .  Internati onal consensus  requires 
that in all cases of exposure  to ionizing radiation, doses to persons and critical  organs be kept as low as 
reasonably achiev able, ec onomic and  social cons ideratio ns taken into account. 
 
During the preparation of this Stand ard refere nce was made to the  following publicatio ns: 
 
 
 
IAEA Safety  Series No. 115 ‘International Bas ic Safety Standards for Protection against Ionizing 
radiati on and  the Safety of  Radiation S ources  
 
ICRP  Publication  62 Radiological  Protec tion in Biom edical Research, Annals of the ICRP  
RPS 14, Code of Practice for Radi ation Protection in the Medical Applications of Ionizing Radiation 
(2008) , Radiation Protection Series  
 
The R adiation Protecti on Act, CAP 243 Laws of Kenya, 1985 (Revised)  
The Sci ence and T echnology Act, Cap 250, Laws of Kenya  
WHO, International Ethical Gui delines for Biomedical Research Involving Human Subjects  1993 , 
World Health Organization  
 
 
Acknowledgement is h ereby made for the assist ance derived from the above  sources. 
 KENYA  STANDARD                                                                KS 1954:  2007  
 
Medical  research  — Administrati on of ionizing radiation  to human 
subjects  — Requirements  
 
1        Scope  
 
This stan dard sp ecifies the requ irements to be met when  administering  ionizing radiati on to human s ubjects 
for purp oses of medical  research. This  standard applies to the  clinical tria ls sta ge of research  only.  
 
2        Approvals  
 
Any admin istration of  ionizing r adiation to human sub jects for the purposes  of diagnostic or therapeutic 
research involving  external irradiation, brachyther apy or the adminis tration  of radionuclides,  shall be 
undertaken  only after approval  by the Natio nal Commission for  Science, Technology &  I n n o v a t i o n  
Ethics  Committee.  The ethics  comm ittee shall ob tain advice from a person experienced  in radiation prot ection 
and safety  before granti ng approval.  The r esearch prop osal shall co mply with regulatory require ments relati ng 
to the use of ioniz ing radiation. 
 
3        Requirements  
 
The ethics  committee shall  have reg ard to: 
 
3.1      The gu idelines of the National Commission for Science, Technology & Innovation Ethics in Medical 
Research. 
 
3.2      The gu idelines of the W orld Health Organization on  Ethics and Res earch on Human  subjects 1993. 
 
3.3      A detailed  protocol  for the research project that shall include estimat es of the radiati on doses 
expect ed to be delivered and  the individual  and collective  risks associated with these  doses. A competent 
person  not assoc iated with the project, such  as the institution’s  radiation safe ty officer  or an experi enced 
medical phys icist a nd rad iation oncolog ist, shall verify these estima tes. 
 
3.4 The manner in which the project is to be expla ined to the subjects and the informed consent 
obtain ed. 
 
3.5 The measures to be taken  during the project to assess  the radiation doses deliver ed, and to keep 
them to a minimum; As L ow As Re asonably Achiev able (AL ARA). 
 
3.6 The review  of the radiati on doses actually deliver ed to the subjects as soon as reliab le data are 
available, to validate predictions.  
 
4        Patients  
 
Where the person  irradiated is a pat ient who may benefit  from the procedure,  the justification  for the irr adiation 
shall be the s ame as for other medical exposur es. Neverthel ess because of the exper imental nature of the  
procedure, it  shall still be subj ect to thorough r eview by the ethics  committee.  
 
5        Non-patients  
 
No ion izing radiation (IR) shall be adm inistered to no n-patien ts for res earch p urposes. 
 
Where the irradiation  is not desig ned to benefit  the person irradiat ed, subjects shall  be selected according to 
the following criteria:  
 
5.1      Age 
 
Because  of the possibility  of hereditary  effects  and also  becau se of the long latent  periods  associated with 
certa in soma tic effec ts of radiation, sub jects shall, where practicab le, be aged over 40 years, and preferably 
over 50.  
 
 
 
© KEBS 20 19 — All rights reserved                                                                                                                   1KS 1954:  2019   
  
5.2      Number  of individuals  
 
The number of subjects irradiat ed shall be  restrict ed to the minimum necessary  to acquire the informati on 
needed with  suffici ent accur acy. 
 
5.3      Exclusions  
 
Children and pre gnant w omen shall be exclu ded as sub jects except when pr oblems sp ecific to those gr oups 
are being investigat ed. Research involv ing administration of ionizing radiation  to those  groups shall only be 
performed  when the infor mation s ought cannot be ob tained by oth er mea ns, and  the risks are  minimal.  
 
5.4      Radiation  doses  
 
The radiati on doses  to sub jects shall be kept  to the minimum  level practicable, and the accu mulated  effective 
dose  equiva lent to any individual subj ect in any year shall not exceed 5  millisievert*, except with  the a pproval 
of the re gulatory authority respo nsible for rad iation control.  In the c ase of  irradiation  of chi ldren or  of other 
perso ns incapable  of giving inform ed consent,  approval  of the regulatory  authority shall be obtained  where 
estimat es of effective  dose  equivalent exce ed 0.5 millisiev ert*.  For babies, infants or fet uses, approval  of the 
regulatory au thority shall be obtain ed where estimat es of effective dose equiva lent exce ed 0.1 millisiev ert*. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* Excludi ng normal natural  back ground radiation and exposure fr om diagn ostic or therap eutic proced ures. 
 
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