Document 13495370

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Eastern  Michigan  University  

Instruc3ons  for  accessing  CITI  

Training  for    

Human  Subjects  

     

•   The  first  step  is  to  establish  an  account  with  

CITI  Training.    This  is  a  user-­‐defined  system,   much  like  seFng  up  an  account  with  

Facebook,  and  doesn’t  require  CITI  to  issue   any  thing  to  you.  

•   hJps://www.ci3program.org/  

CITI  Login  

New  Users  

Register  Here  

CITI  Set-­‐up  

Select  EMU  

Create  a  

Username  

Create  a  

Password  

Set-­‐up  Con3nued  

Create  a   security   ques3on  

Enter  your  name  and   email  address  

Set-­‐up  Con3nued  

Select  “No”  

Choose  whether  or   not  to  par3cipate   in  a  survey  about  

CITI’s  training   program  

Personal  Informa3on  

Complete  at  least  the   three  required  items  

 The  next  step  is  to  enroll  in  a  learners’  group.    

Please  see  the  following  slides  for  informa3on  on   the  various  learner  groups  for:  

1.

  Responsible  Conduct  of  Research  (RCR),  which   includes  a  general  overview  module  on  human   subjects  research  and  care  and  use  of  animals;   and  

2.

  Human  Subjects   Research  training,  which  is   required  by  the  University  Human  Subjects  

Review  CommiJee  for  faculty  and  students   working  with  human  subjects  

See  following   slides  for   further   informa3on  on   the  group   selec3ons  

Training  Op3ons  

RCR  versus  Human  Subjects  

•   If  you  need  to  do  Responsible  Conduct  for  

Research  training  for  a  class  assignment  or  to   meet  funding  source  requirements,  select  op3on   for  item  1.  You  may  also  select  an  op3on  for  item  

2,  if  the  research  involves  human  subjects.  

•   If  you  are  working  with   Human  Subjects ,  skip   item  1  (RCR)  and  select  your  researcher  category  

(what  is  your  role?)  in   sec3on  2 .  For  item  1,   choose  “ Not  at  this  3me .”  

Human  Subjects  Research  

Human  Subjects  

•   For  Item  2:  determine  your  role  and  make  a   selec3on.  Mark  Item  1,  “Not  at  this  3me”   unless  the  above  men3oned  RCR  situa3ons   apply  to  you.    

•   Most  Research  Methods  courses  will  only   need  to  require  Item  2:  Inves3gator,  Student   and  Faculty  Mentor  training.  (Note:  item  1   training  offers  many  more  case  studies  and   op3onal  modules.)  

You  are  ready  to  complete  your   registra3on  

Select  No,  you  are   not  affilia3ng  with   a  VA  Medical  

Center  

This  is  your  individualized  learners’   menu  

By  selec3ng  the  “Incomplete/Re-­‐ enter”  link,  you  will  be  taken  to  the   module  menu  

First,  complete   the  “Integrity  

Assurance  

Statement”  

Then,  select  

“incomplete”   to  enter  the   individual   lessons  for  this   module  

Comple3ng  the  module  

•   The  first  item  you  will  need  to  complete  is  the  

“Integrity  Assurance  Statement.”  

•   Once  that  is  complete,  you  will  be  able  to   select  the  individual  lessons  within  the   module  by  selec3ng  the  red  “Incomplete”  link   to  the  right.  

•   Complete  the  module  including  all  quizzes.    

Quizzes  in  the  CITI  training  program  scored.  

Human  Subject  topics  

•   Complete   The  Integrity  Assurance  Statement  before  beginning  the  course.  

•   Belmont  Report  and  CITI  Course  Introduc3on  

•   Students  in  Research  –  SBR    

•   History  and  Ethical  Principles  –  SBR    

•   Defining  Research  with  Human  Subjects  –  SBR  

•   The  Regula3ons  and  The  Social  and  Behavioral  Sciences  -­‐  SBR  Basic  

•   Ins3tu3onal  Review  Board  (IRB)  Regula3ons  and  Review  Process  

•   Assessing  Risk  in  Social  and  Behavioral  Sciences  -­‐  SBR  Informed  Consent  

•   Privacy  and  Confiden3ality  -­‐  SBR    

•   Research  With  Protected  Popula3ons  -­‐  Vulnerable  Subjects:  An  Overview    

•   Research  with  Children  –  SBR    

•   Research  in  Public  Elementary  and  Secondary  Schools  -­‐  SBR    

•   Conflicts  of  Interest  in  Research  Involving  Human  Subjects    

•   EMU  Page  

Elec3ve  Topics  

•   Records-­‐Based  Research    

•   Interna3onal  Research  –  SBR    

•   Vulnerable  Subjects  -­‐  Research  Involving  Pregnant  Women  and  

Fetuses  in  Utero  

•   Internet  Research  –  SBR    

•   Group  Harms:  Research  With  Culturally  or  Medically  Vulnerable  

Groups  

•   Gene3c  Research  in  Human  Popula3ons    

•   Research  with  Prisoners  –  SBR    

•   HIPAA  and  Human  Subjects  Research    

•   FDA-­‐Regulated  Research    

•   Human  Subjects  Research  at  the  VA    

•   Workers  as  Research  Subjects-­‐A  Vulnerable  Popula3on  

Verifica3on  of  Comple3on  

•   Each  CITI  program  learner  can  print  out  their  learners’   menu  at  any3me  and  provide  as  verifica3on  of   comple3on.  

•   While  a  minimum  score  on  quizzes  has  not  been   determined  by  the  University  for  most  modules,  your   faculty  member  may  require  a  certain  score.    Quiz   scores  are  also  indicated  on  the  learners’  menu.  

•   If  a  CITI  program  learner  leaves  EMU,  or  is  working   with  another  ins3tu3on,  he  or  she  can  affiliate  with  the   new  ins3tu3on  and  his/her  training  record  transfers.  

Contact  Informa3on  

•   Ques3ons  related  to  Human  Subjects  Training,   or  Human  Subjects  Training  requirements   should  be  directed  to  the  University  Human  

Subjects  Review  CommiJee:   human.subjects@emich.edu  

•   Ques3ons  related  to  RCR  training  should  be   directed  to  the  Office  of  Research  

Development:   ord_dept@emich.edu

 

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