Ethics  of  Na,onal  and  Interna,onal  Epidemiological  HIV  

Preven,on  Research  

Lloyd  A.  Goldsamt,  Ph.D.  Na,onal  Development  and  Research  

Ins,tutes,  Inc.  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Confiden,ality  

•  Review  of  Confiden,ality  •  Consequences  of  Viola,ng  Confiden,ality  •  Special  Topics  in  Confiden,ality  •  Confiden,ality  for  Special  Popula,ons  •  Confiden,ality  Issues  for  Different  Types  of  Data  Collec,on  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Review  of  Confiden,ality  

•  Confiden,ality  vs.  Anonymity  •  Iden,fying  Informa,on  

•  Federal  Cer,ficate  of  Confiden,ality  •  Viola,ons  of  Confiden,ality  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Iden,fying  Informa,on  

•  It’s  more  than  just  a  name  •  “Iden,fying”  depends  on  who  has  the  informa,on  

•  Computer  based  iden,fiers  –  IP  addresses  – Data  mining  

•  DNA  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Federal  Cer,ficate  of  Confiden,ality  

•  Legal  protec,on  •  No  protec,on  from  harassment  by  police  

•  No  protec,on  for  social  consequences  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Viola,ons  of  Confiden,ality  

•  Almost  always  well-­‐inten,oned  – To  help  a  research  par,cipant  in  distress  – Out  of  concern  for  a  research  par,cipant’s  well-­‐being  

– To  further  the  aims  of  an  important  research  study  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Consequences  of  Viola,ng  Confiden,ality  

•  Arrest  •  Physical  harm  (even  death)  

•  Shame/Emo,onal  Distress  

•  Rela,onship  Distress  •  Harm  to  the  Par,cipant-­‐Researcher  Rela,onship  – For  specific  study/researcher/ins,tu,on  – For  research  in  general  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Special  Areas  of  Concern  

•  Illegal  Behaviors  •  S,gma,zed  Behaviors  

•  Disease  Status  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Injec,on  Drug  Users  

•  Illegal  Behaviors  (not  only  drug  use)  •  Capacity  for  consent  when  using  –  Is  an  addicted  drug  user  more/less  able  to  consent  when  high  or  when  in  withdrawal?  

•  Compensa,on  – Paying  for  drugs  – Preven,ng  other  money-­‐raising  prac,ces  

•  HIV  risk  for  par,cipant  and  others  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Youth  

•  Parental  Consent/Assent  •  Youth  Consent/Assent  •  Emancipated  Minor  Status  

•  Risks  in  geang  consent  from  parents/guardians  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

MSM  

•  LGBTQ  is  really  L,  G,  B,  T  and  Q  •  S,gma  (including  internalized  s,gma)  

•  HIV  risk  for  par,cipant  and  others  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Individual  Interviews  

•  Interviews  in  public/semi-­‐public  loca,ons  •  Interviews  in  private  loca,ons  iden,fied  with  specific  popula,ons  – Health  clinics  (including  specialized  clinics)  – Research  field  sites  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Focus  Groups  

•  Confiden,ality  among  par,cipants  •  Group  composi,on  

•  Power  dynamics  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Ethnography  

•  Par,cipant-­‐Observa,on  •  Boundaries  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Clinical  Chart  Reviews  

•  Iden,fica,on  of  individuals  with  study  topics  •  Disclosure  of  research  informa,on  to  clinic  staff  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute  

Case  Studies  

•  IDUs  •  Youth  •  MSM  

©    Lloyd  Goldsamt,  July  2011  for  the  Fordham  HIV  Preven,on  Research  Ethics  Training  Ins,tute