Applied he alth care research test 2
Terms in this set (29)
Assent Agreement to particip ate in a study of a subject who cannot legally consent
Confidential ityAssur ance, on the p art of the in vestigator, that no one other than the resear ch
team can ha ve access to a respondent' s info unless those who see the data
are identified to the per son be fore particip ation (inf o can't be linked to an
identity )
An independent group of experts who review
and appr ove all study procedur es, pr ovide
oversight procedur es regarding the sa fety of
human subjects and ethical resear ch pr actices,
including r eviewing the in vestigators appr oach
to recruitment in the inf ormed consent process,
determine whether and when a study shoul d be
termina ted because of adverse events that can
be attribut ed to study procedur es, and if interim
analyses shoul d be conduct ed to evaluate study
outcomes and if the s tudy shoul d be s topped
because it is either overwhel ming bene ficial or
harmfulDSMB (Data Safety Monit oring Bo ard)
Full Discl osureAdequa cy of informa tion pr ovided to resear ch particip ants; necessar y for
them to mak e informed decisions about the degr ee of their particip ation in
the s tudy
HIPAA (Heal th Insur ance P ortability and
Account ability Act)Feder al privacy policy and rul ing which manda tes personal privacy of
individual heal th inf orma tion
Human subject protectionLegisl ated metho ds to reduce harm and pr eserve priv acy of human r esear ch
particip ants
Informed consentOfficial statement developed by the resear cher that informs study
particip ants of the purpose and scope of the s tudy
IRB (Institutional Review Board)Board of experts that mus t be es tablished at each ins titution in volved in a
resear ch pr ocess to oversee the ethical conduct of resear ch
Voluntary Particip ation Informed decision to be a subject or study particip ant
Terms in this set (29)
Assent Agreement to particip ate in a study of a subject who cannot legally consent
Confidential ityAssur ance, on the p art of the in vestigator, that no one other than the resear ch
team can ha ve access to a respondent' s info unless those who see the data
are identified to the per son be fore particip ation (inf o can't be linked to an
identity )
An independent group of experts who review
and appr ove all study procedur es, pr ovide
oversight procedur es regarding the sa fety of
human subjects and ethical resear ch pr actices,
including r eviewing the in vestigators appr oach
to recruitment in the inf ormed consent process,
determine whether and when a study shoul d be
termina ted because of adverse events that can
be attribut ed to study procedur es, and if interim
analyses shoul d be conduct ed to evaluate study
outcomes and if the s tudy shoul d be s topped
because it is either overwhel ming bene ficial or
harmfulDSMB (Data Safety Monit oring Bo ard)
Full Discl osureAdequa cy of informa tion pr ovided to resear ch particip ants; necessar y for
them to mak e informed decisions about the degr ee of their particip ation in
the s tudy
HIPAA (Heal th Insur ance P ortability and
Account ability Act)Feder al privacy policy and rul ing which manda tes personal privacy of
individual heal th inf orma tion
Human subject protectionLegisl ated metho ds to reduce harm and pr eserve priv acy of human r esear ch
particip ants
Informed consentOfficial statement developed by the resear cher that informs study
particip ants of the purpose and scope of the s tudy
IRB (Institutional Review Board)Board of experts that mus t be es tablished at each ins titution in volved in a
resear ch pr ocess to oversee the ethical conduct of resear ch
Voluntary Particip ation Informed decision to be a subject or study particip ant
