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Research Involving
Adolescents as Participants

RESEARCH

Today’s presentatio= n

Slide 4

Title 45 CFR Part 46
Protection of Human Subjects

45 CFR 46 Subpart D
Additional Protections for Children

45 CFR 46 Subpart D
Additional Protections for Children

45 CFR 46 Subpart D
Additional Protections for Children

45 CFR 46 Subpart D
Additional Protections for Children

45 CFR 46.402 Defin= itions

45 CFR 46.102 Defin= itions

45 CFR 46. 408 (c)
Requirement for Parental Permission

45 CFR 46. 408 (c)
Requirement for Parental Permission

45 CFR 46. 408 (c)
Requirement for Parental Permission

45 CFR 46.116(d)  Waiver of requirement for informed cons= ent

How to apply the CF= R

Factors Influencing= IRB Decisions Not to Waive Parental Permission

Points to Consider<= /a>

Attitudes of IRB Me= mbers

45 CFR 46.107 (f)
IRB Membership

Expertise:IRB Membe= rship

Attendance at Revie= w

Burden of Proof=

HIV Research as a S= pecial Case

Youth as a Vulnerab= le Population

Newer Understanding= s: Vulnerability

Categories of Vulnerability

The condition of vulnerability need not be a “red light”,  it can be a “flashing yellow light” that requires the investigator to take extra steps.

Addressing Specific Vulnerabilities

Recap: Useful Steps=

Special Cases

If a subject brings= sex partners
into the discussion…

If a subject brings sexual abuse or suicide ideation into the discussion…

Suggested language:=

If you’ll be conduc= ting
focus groups

If you’re using the Internet for recruitment

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Research Involving
Adolescents as Participants
Audrey Smith Rogers= , Ph.D., M.P.H.

RESEARCH

Today’s presentatio= n
Present Code of Fed= eral Regulations (CFR) for Protection Human Subject
Explain how to appl= y the CFR
Discuss special cas= es

Slide 4

Title 45 CFR Part 46
Protection of Human Subjects
Subpart A app= lications, definitions, IRBs, IRB reviews, procedures, records, consent issues, special conditions
Subpart B: Fetuses,= Pregnant Women
Subpart C: Prisoner= s
Subpart D: Children=

45 CFR 46 Subpart D
Additional Protections for Children
Categories of Resea= rch
*-Not involving gr= eater than minimal risk
*-Involving greate= r than minimal risk but presenting the prospect of direct benefit to the individ= ual
   *-Involving greater than minimal ris= k and no prospect of direct benefit to the individual, but likely to yield generalizable knowledge

45 CFR 46 Subpart D
Additional Protections for Children
Category One Resear= ch
*-Not involving gre= ater than minimal risk
- parental permi= ssion - child assent

45 CFR 46 Subpart D
Additional Protections for Children
Category Two Resear= ch
*-Involving greate= r than minimal risk but presenting the prospect of direct benefit to the individual - parental permission - child assent - risk justified by potential benefit
- risk:benefit ra= tio at least as favorable as alternatives

45 CFR 46 Subpart D
Additional Protections for Children
Category Three Rese= arch
   *-Involving greater than minimal ris= k and no prospect of direct benefit to the individual, but likely to yield generalizable knowledge - parental permission - child assent - risk is minor increase over minimal risk - measures reasonably commensur= ate - generalizable knowledge vitally important

45 CFR 46.402 Defin= itions
“Children” are pers= ons who have not attained the legal age for consent to treatments or procedures involv= ed in the research, under the applicable law of the jurisdiction in which the research will be conducted.

45 CFR 46.102 Defin= itions
“Minimal Risk” mean= s that the probability and magnitude of harm or discomfort anticipated in the resear= ch are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

45 CFR 46. 408 (c)
Requirement for Parental Permission
If an IRB determine= s that a research protocol is designed for conditions or a subject population for which parental permission is not a reasonable requirement to protect subj= ects (e.g. neglected or abused children) it may waive the consent requirements= …..

45 CFR 46. 408 (c)
Requirement for Parental Permission
…provided  an appropriate mechanism for protectin= g the children who will participate as research subjects is substituted and provided the waiver is not inconsistent with Federal, State, or local law= .

45 CFR 46. 408 (c)
Requirement for Parental Permission
The choice of an ap= propriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the resear= ch subjects, and their age, maturity, status, and condition.

45 CFR 46.116(d)  Waiver of requirement for informed cons= ent
Involve no more tha= n minimal risk
Waiver will not adv= ersely affect rights or welfare of subjects
Research cannot be = practicably done without the waiver
When appropriate, s= ubjects will be provided with additional information after participation

How to apply the CF= R

Factors Influencing= IRB Decisions Not to Waive Parental Permission
Increased subject r= isk
Perceived legal pro= hibitions
Concern for institu= tional liability
Risk aversion
Precedent in past I= RB decisions “We just always require parental permission”

Points to Consider<= /a>
Attitudes of IRB Me= mbers
Expertise in IRB Me= mbership
Attendance at Revie= w
Burden of Proof

Attitudes of IRB Me= mbers
Attempt to Influence -Provide IRB with copies of Society Position Papers
Guidelines: Positio= n Paper Santelli, Rosenfeld, DuRant, et al. JAH 1995; 17:264-9
Code of Research Et= hics: Position Paper Rogers, Kinsman, Santelli, Silber. JAH 1999; 24: 277-83=

45 CFR 46.107 (f)
IRB Membership

Expertise:IRB Membe= rship
Review the credenti= als of the IRB members
If experience in re= search with adolescents is lacking, respectfully cite the CFR and request that the expertise be added for the review of your application

Attendance at Revie= w
Request so that you= might hear and apply the discussion of safety concerns
Request to improve = efficiency in that you may be able to clarify
What is the worst t= hat can happen? - You do not attend!

Burden of Proof=

HIV Research as a S= pecial Case
Most IRBs view all = HIV-related research, including survey research, as a special case because of the stigmatization and discrimination issues that have been attached to HIV infection

Youth as a Vulnerab= le Population
Full cognition and = reasoning capacity by age 15, what youth may lack is judgment based on experience
Perceived as vulner= able by most IRBs and parental permission for participation in “not greater than minim= al risk” research is rarely waived

Newer Understanding= s: Vulnerability
Current approach: = Names classes of people as vulnerable subpopulations (pregnant women, prisone= rs, children)
Possible new approach: Vulnerability is a condition of the candidate subject that calls into question the efficacy of consent in effecting the permissibi= lity of the research

Categories of Vulnerability
Cognitive limitatio= n- mental illness, retardation
Juridic subordinati= on- liable to another’s authority
Patterns of deferen= ce- intimidated
Medical duress- ver= y ill with few options
Resource disadvanta= ge – need goods, care, money

The condition of vulnerability need not be a “red light”,  it can be a “flashing yellow light” that requires the investigator to take extra steps.

Addressing Specific Vulnerabilities
Limited cognition
Juridic subordinati= on
Deference
Resource Disadvanta= ge
Medical exigency
Plain language, ext= ra education, advocates
Insulate from syste= m,                 use ombudsman
Devise process to eliminate   social pressure
Ensure exchange is = fair             and not exploitive<= /td>
Avoid unreasonable<= span style=3D'mso-spacerun:yes'>      expectation of success

Recap: Useful Steps=
Learn the 45 CFR 46=
Request waiver of p= arental permission based on 45 CFR 46.116(d)
Justify minimal ris= k nature
Provide extra safet= y measures
Check IRB membershi= p; request ad hoc member if necessary 46.107(f)
Ask to attend the I= RB review

Special Cases

If a subject brings= sex partners
into the discussion…
The study is offeri= ng HIV CTS to subjects and promoting their engagement into care if HIV+
Make provisions for= referral if subject wants -partner notification (M+F) -partner HIV CTS (M+F) -partner health care (M+F)

If a subject brings sexual abuse or suicide ideation into the discussion…
Anticipate and plan= for this
Know your state law= or regulations on reporting child sexual abuse
If you are required= to report, this must be in the consent form
You must be prepare= d to intervene for suicide ideation and this, too, must be in the consent form=

Suggested language:=

If you’ll be conduc= ting
focus groups
Script the facilita= tor
Set ground rules for confidentiality
If you will be tapi= ng, disclose in consent and instruct no names to be used
Decide on chain of = custody if transcribing is planned
Include plans for t= he destruction of tapes

If you’re using the Internet for recruitment
Include procedures = in protocol appendix for IRB to review (IRBs must review all material promoting studi= es)
Information goes on= ly one way from study staff to chat room participants
Script the study st= aff to set confidentiality boundaries in chat rooms
Never permit identi= fying information to be exchanged in chat room

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<= /td> =
Research Involving
Adolescents as Participants
Audrey Smith Rogers, Ph.D., M.P.H.
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RESEARCH
= =
…a systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable knowledge.
Activities which meet this definition constitute
research for purposes of this policy, whether or not
they are conducted or supported under a program
which is considered research for other purposes. For
example, some demonstration and service programs
may= include research activities.
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= Today’s presentation
=
http://www.hhs.gov/ohrp
Sidebar:  <click> Regulations
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<= /td> =
Title 45 CFR Part 46
Protection of Human Subjects
<= /td> = = <= /td> <= /td>
• Su= bpart A
   applications, definitions, IRBs, IR= B
   reviews, procedures, records,
   consent issues, special conditions<= /font>
• Su= bpart B: Fetuses, Pregnant Women
• Su= bpart C: Prisoners
• Su= bpart D: Children
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=
= 45 CFR 46 Subpart D
Additional Protections for Children
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= 45 CFR 46 Subpart D
Additional Protections for Children
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=
= 45 CFR 46 Subpart D
Additional Protections for Children
<= /td> = <= /td> = <= /td> <= /td> <= /td>
• Ca= tegory Two Research
   *-Involving greater than minimal risk but
pr= esenting the prospect of direct benefit to
th= e individual
   - parental permission
   - child assent
   - risk justified by potential benef= it
     - risk:benefit ratio at least as favorable as
   alternatives
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=
= 45 CFR 46 Subpart D
Additional Protections for Children
<= /td> = = <= /td> <= /td>
• Ca= tegory Three Research
     = *-Involving greater than minimal risk and=
no= prospect of direct benefit to the individual,
bu= t likely to yield generalizable knowledge
   - parental permission
   - child assent
   - risk is minor increase over minim= al risk
   - measures reasonably commensurate<= /font>
   - generalizable knowledge vitally
   important
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45 CFR 46.402 Definitions
<= /td> = <= /td> <= /td>
“Children” are persons who have not
at= tained the legal age for consent to
tr= eatments or procedures involved in the
re= search, under the applicable law of the
ju= risdiction in which the research will be
conducted.
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45 CFR 46.102 Definitions
= <= /td> <= /td>
“Minimal Risk” means that the
pr= obability and magnitude of harm or
di= scomfort anticipated in the research
ar= e not greater in and of themselves
th= an those ordinarily encountered in
da= ily life or during the performance of
ro= utine physical or psychological
examinations o= r tests.
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= =
45 CFR 46. 408 (c)
Requirement for Parental Permission
= = <= /td> <= /td>
If= an IRB determines that a research
pr= otocol is designed for conditions or a
su= bject population for which parental
pe= rmission is not a reasonable requirement
to= protect subjects (e.g. neglected or
ab= used children) it may waive the consent
requirements….= .
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= =
45 CFR 46. 408 (c)
Requirement for Parental Permission
<= /td> = <= /td> <= /td>
…provided  an appropriate mechanism
fo= r protecting the children who will
pa= rticipate as research subjects is
su= bstituted and provided the waiver is
no= t inconsistent with Federal, State, or
local law.
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= =
45 CFR 46. 408 (c)
Requirement for Parental Permission
= <= /td> <= /td> <= /td> <= /td>
Th= e choice of an appropriate
me= chanism would depend upon the
na= ture and purpose of the activities
de= scribed in the protocol, the risk and
an= ticipated benefit to the research
su= bjects, and their age, maturity,
status, and co= ndition.
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<= /td> =
45 CFR 46.116(d)  Waiver of=
requirement for informed consent
<= /td> = <= /td> = <= /td>
• In= volve no more than minimal risk
• Wa= iver will not adversely affect rights
or= welfare of subjects
• Re= search cannot be practicably done
wi= thout the waiver
• Wh= en appropriate, subjects will be
pr= ovided with additional information
af= ter participation
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How to apply the CFR
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=
Factors Influencing IRB Decisions
= Not to Waive Parental Permission
<= /td> = <= /td> <= /td> <= /td> <= /td>
• In= creased subject risk
• Pe= rceived legal prohibitions
• Co= ncern for institutional liability
• Ri= sk aversion
• Pr= ecedent in past IRB decisions
   “We just always require parental
   permission”
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= Points to Consider
<= /td> = <= /td> <= /td>
• At= titudes of IRB Members
• Ex= pertise in IRB Membership
• At= tendance at Review
• Bu= rden of Proof
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= Attitudes of IRB Members
<= /td> <= /td> = <= /td> <= /td>
• At= tempt to Influence
     -Provide IRB with copies of
     Society Position Papers
• Gu= idelines: Position Paper
     Santelli, Rosenfeld, DuRant, et a= l.
     JAH 1995; 17:264-9
• Co= de of Research Ethics: Position Paper
     Rogers, Kinsman, Santelli, Silber= .
     JAH 1999; 24: 277-83

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=
45 CFR 46.107 (f)
IRB Membership
<= /td> =
An IRB may, in its discretion, invite
individuals with competence in special
areas to assist in the review of issues
which require expertise beyond or in
addition to that available on the IRB.
These individuals may not vote with
the = IRB.
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= Expertise:IRB Membership
<= /td> <= /td> <= /td> = <= /td>
• Re= view the credentials of the IRB
mem= bers
• If= experience in research with
ad= olescents is lacking, respectfully
ci= te the CFR and request that the
ex= pertise be added for the review of
yo= ur application
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= Attendance at Review
<= /td> <= /td> = <= /td> <= /td>
• Re= quest so that you might hear
an= d apply the discussion of safety
con= cerns
• Re= quest to improve efficiency in
th= at you may be able to clarify
• Wh= at is the worst that can happen?
       - You do not attend!
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= Burden of Proof
= <= /td> <= /td>
Th= e proposing investigator must
th= ink of the worst case scenario for
ev= ery aspect of the study and have a
plan in place = to ensure subject
sa= fety if that scenario emerges.
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= HIV Research as a Special Case
<= /td> = = <= /td>
• Mo= st IRBs view all HIV-related research,
in= cluding survey research, as a special
ca= se because of the stigmatization and
di= scrimination issues that have been
at= tached to HIV infection
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= Youth as a Vulnerable Population
<= /td> = <= /td> <= /td> <= /td>
• Fu= ll cognition and reasoning capacity by
ag= e 15, what youth may lack is
ju= dgment based on experience
• Pe= rceived as vulnerable by most IRBs
an= d parental permission for
pa= rticipation in “not greater than
mi= nimal risk” research is rarely waived
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= Newer Understandings: Vulnerability
<= /td> = <= /td> <= /td> <= /td> <= /td>
• Cu= rrent approach:
   Names classes of people as vulnerab= le
   subpopulations (pregnant women,
   prisoners, children)
• Po= ssible new approach:
   Vulnerability is a condition of the=
   candidate subject that calls into question
   the efficacy of consent in effectin= g the
   permissibility of the research
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= Categories of Vulnerability
<= /td> <= /td> <= /td> <= /td> = <= /td>
• Co= gnitive limitation- mental illness,
re= tardation
• Ju= ridic subordination- liable to another’s
aut= hority
• Pa= tterns of deference- intimidated
• Me= dical duress- very ill with few options
• Re= source disadvantage – need goods, care,
mon= ey
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<= /td> <= /td> = <= /td> <= /td>
The condition of
vulnerability need not be a
“red light”,  it can be a
“flashing yellow light” that
requires the investigator to
take extra steps.
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= Addressing Specific Vulnerabilities
<= /td> = <= /td> <= /td> <= /td>
• Pl= ain language, extra
ed= ucation, advocates
• In= sulate from system,
us= e ombudsman
• D= evise process to eliminate
so= cial pressure
• E= nsure exchange is fair
an= d not exploitive
• Av= oid unreasonable
ex= pectation of success
Fro= m Kipnis, NBAC, July 2000
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Recap: Useful Steps
<= /td> = <= /td> <= /td> <= /td> <= /td> <= /td>
• Le= arn the 45 CFR 46
• Re= quest waiver of parental permission
ba= sed on 45 CFR 46.116(d)
• Ju= stify minimal risk nature
• Pr= ovide extra safety measures
• Ch= eck IRB membership; request ad hoc
me= mber if necessary 46.107(f)
• As= k to attend the IRB review
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Special Cases
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file:///C:/2C6446F3/ResearchInvolvingAdolescents_files/v3_slide0035.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Practical Tips When Interacting with the IRB
=
If a subject brings sex partners
= into the discussion…
<= /td> = <= /td> <= /td> <= /td> <= /td>
• Th= e study is offering HIV CTS to
su= bjects and promoting their
en= gagement into care if HIV+
• Ma= ke provisions for referral if subject
wa= nts
     -partner notification   (M+F)
     -partner HIV CTS (M+F)
     -partner health care (M+F)=
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=
= If a subject brings sexual abuse or
suicide ideation into the discussion…
<= /td> = <= /td> <= /td> <= /td> <= /td>
• An= ticipate and plan for this
• Kn= ow your state law or regulations on
re= porting child sexual abuse
• If= you are required to report, this must
be= in the consent form
• Yo= u must be prepared to intervene for
su= icide ideation and this, too, must be
in= the consent form
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Suggested language:
<= /td>
State law requires us to report any information you tell
us that suggests that you might be in danger.  If you tell
us that you plan to hurt yourself or kill yourself, or hurt
or kill someone else, we may be required to report that
information to the appropriate authorities.  If you tell us
that someone is abusing or neglecting you, or even if
abuse or neglect is suspected, we may also be required
to report that information to the appropriate authorities.
Further, if you tell us about circumstances that might
reasonably lead to abuse or neglect, we may be required
to report that as well.  Also, if = you tell us that you are
abusing or neglecting a child, we would need to report
that= .
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<= /td> =
If you’ll be conducting
focus groups
<= /td> <= /td> = <= /td> <= /td> <= /td> <= /td>
• Sc= ript the facilitator
• Se= t ground rules for confidentiality
• If= you will be taping, disclose in consent
an= d instruct no names to be used
• De= cide on chain of custody if
tr= anscribing is planned
• In= clude plans for the destruction of
tap= es
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= =
If you’re using the Internet for
recruitment
<= /td> = <= /td> <= /td> <= /td> <= /td>
• In= clude procedures in protocol appendix for
I= RB to review (IRBs must review all material
pr= omoting studies)
• In= formation goes only one way from study
st= aff to chat room participants
• Sc= ript the study staff to set confidentiality
bo= undaries in chat rooms
• Ne= ver permit identifying information to be
ex= changed in chat room
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Research Involving
Adolescents as Participants
Audrey Smith Rogers, Ph.D., M.P.H.
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RESEARCH
…a systematic investigation, including research development, testing and evaluation, designed to = develop or contribute to generalizable knowledge.= Activities which meet this definition constitute = research for purposes of this policy, whether or = not they are conducted or supported under a program <= /span>which is considered research for other purposes. = For example, some demonstration and service programs = may include research activities.
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