HIV and the IRB

1
HIV and the IRB

• Christopher S. Murrill, PhD, MPH
• Director of Research
• HIV Epidemiology Program
• New York City Department of Health and Mental
  Hygiene
• September 10, 2004

2
Special Populations

• 45 CFR 46 does not formally designate persons
  with HIV and AIDS as a special population.
  HOWEVER,
• Local, state and federal law build in special
  protections for persons with HIV and persons at
  risk for HIV.
• Almost 90,000 persons have been diagnosed and are
  known to be living with HIV and AIDS in NYC. A
  cumulative total of 143,000 persons has been
  diagnosed with AIDS since the epidemic began in
  1981.

3
Why Do PLWHA Merit Special Consideration?

• They are vulnerable to
• StigmaMSM, IDU
• Mental Health problemspre-existing morbidity or
  reaction to diagnosis of fatal disease
• Risk factors are sensitive, private behaviors
• Sex
• Drugs
• They are at risk for
• Domestic violence or abandonment if risk behavior
  or serostatus disclosed (teens, women, MSM)
• Discrimination re jobs, housing, insurance
• Coercion re vaccine and treatment trial
  participation, undue enticement from incentives
  
• Many are poor, already marginalized

4
IRBs should be vigilant that

• Research protocols demonstrate knowledge of state
  law re confidentiality and nondisclosure of HIV
  serostatus and HIV-related information
• Research protocols demonstrate understanding of
  why HIV serostatus and related risk behaviors are
  so sensitive and HIV at-risk populations so
  vulnerable
• Researchers understand their reporting
  responsibilities to the NYC and NYS Departments
  of Health
• Research protocols incorporate comprehensive
  training and supervision protocols

5
New York State Public Health LawArticle 27F

• Article 27F, Section 2782 protects confidential
  HIV-related information and defines the limits of
  disclosurewho, when, what, and under what
  circumstances HIV information can be disclosed.
• Section 2783 provides for civil penalties for
  violation of 2782 if willful disclosure of
  protected information is found.
• Penalty is levied per case, not per eventso if
  somebody steals 500 surveys with individually
  identifiable information on them out of a
  researchers backpack and sells them to Act Up or
  the Daily News, the researcher is liable for 500
  disclosures
• Make sure that the protocol demonstrates
  knowledge of the law and adequate data security
  measures

6
HIV Research and Human Subjects Protection
Special Considerations

• Under NY State Public Health Law, HIV infection
  is a reportable disease.
• HIV research involves the collection of highly
  sensitive information (HIV status, sexual
  behaviors, illicit drug using behaviors).
• Strict rules apply to the disclosure of such
  information.
• Maintaining the confidentiality of such
  information must be adhered to and is the
  responsibility of the entire research team.

7
HIV Surveillance vs. HIV Research

• HIV is a reportable condition in NY State
• AIDS has been reportable since 1983
• HIV has been reportable since June 1, 2000
• Distinction between public health practice
  (surveillance, outbreak investigation) and public
  health research can sometimes be difficulte.g.,
  a case control study that is part of an outbreak
  investigation, or a follow-up study to a risk
  factor group identified in surveillance
• Behavioral risk data that are not required for
  surveillance fall into the category of research

8
Public Health Research is Public Health, but it
is still Research!

• Public health research is an activity that is
  designed to answer an important question or test
  a hypothesis or intervention that may have broad
  public health significance.
• It does not directly benefit the patient or
  participant. It may benefit others in the long
  run.

9
Who Must Comply with Public Health Research
Activities?

• EVERYONE must comply with reporting,
  surveillance, and outbreak investigations
• NO ONE is compelled to comply with any research
  activity.
• All participation in research is voluntary.
• Consent must be freely given by the participant
  after he or she is completely informed about the
  purpose, methods and activities involved in the
  study.
• Patients must be given ample opportunity to weigh
  and discuss the risks and benefits of
  participation.

10
Examples of Low Risk HIV Research

• Anonymous survey
• Confidential survey
• Chart review (common form of epi research)
• Anonymous or confidential blood draw plus survey
• Participation in a behavioral intervention trial
  (may not be low risk!)
• Testing of blinded blood remaining from a
  diagnostic blood test (common form of
  epidemiologic research)

11
Examples of Greater than Minimal Risk HIV
Research

• Randomized controlled trial of a multi-drug
  treatment regimen for primary HIV infection
• Randomized placebo controlled trial of an
  experimental HIV vaccine
• Randomized controlled trial of a genetically
  engineered CD4 blocker
• Randomized controlled trial of PI vs. non-PI
  containing multi-drug regimen

12
Protection of Privacy and Confidentiality

• The confidentiality of all persons whose
  individually identifiable health information is
  collected by routine reporting or public health
  research is protected by
• Law
• Ethics
• Professional Standards

13
Confidentiality in Research General Principles

• All research data are considered confidential
• Research data are collected to benefit society or
  to provide non-surveillance-related public health
  information. The patient does not benefit
  personally from the research.
• Part of our respect for the patient in this
  situation derives from his willingness to
  participate despite the lack of personal benefit.
  
• An incentive is not a benefitit is a
  reimbursement for time and effort.

14
The Trust of the Research Participant General
Principles

• Research participants trust that we collect these
  data for a legitimate public health or research
  purpose.
• They are doing us a favor by agreeing to
  participate and allowing their medical and
  behavioral information to be entered into the
  study.
• Research participants entrust us with maintaining
  the confidentiality of their data.
• This is a sacred trust that can never be
  violated.

15
IRBs need to ensure that research protocols cover
these principles, and that field and interview
personnel are trained and supervised

• The only relationship between the research staff
  and participant is a professional one.
• Field staff cannot use survey activities to meet
  people socially.
• When encountering participants in public, field
  staff must wait for them to acknowledge the staff
  person.
• Field staff must refrain from showing any
  personal interest in a participant.
• Field staff must learn to show empathy during
  study activities but maintain the professional
  relationship.

16
Recruitment Issues

• Field staff must maintain the professional
  boundary between the participant and researcher
  by NOT recruiting friends and colleagues
• When approaching someone or when sending out
  letters/placing phone calls field staff must not
  advertise the study as an HIV study. Use the
  term health survey instead.
• Special considerations apply for more
  vulnerable population groups such as gay youth,
  illicit drug users, sex workers, etc.

17
Informed Consent Standard Principles ApplyMake
Sure They are Incorporated!

• Informed consent must be obtained from the
  recruited participant prior to the administration
  of a survey, specimen collection, and/or HIV
  testing.
• Consent is a process, not a rubber-stamp
  signature on a form.
• Purpose, methods and activities of the study must
  be explained and the person must be provided the
  time to think carefully and ask questions before
  having to decide whether or not they want to
  participate.
• New York State requires an additional consent for
  HIV testing.

18
(No Transcript)
19
Consent Forms Standard Principles Apply

• Must include the following items at or below 8th
  grade reading level
• Purpose of the study
• Description of study procedures
• Confidentiality
• Risk and Benefits to the individual
• Reimbursement of time
• Participation and withdrawal is voluntary
• Alternatives to being in the studyno penalty for
  not participating
• Contact information of lead scientist and local
  IRB chair or designee.
• Signature lines

20
Additional Considerations re Consent

• Additional consent is required for the storage of
  HIV specimens for future testing purposes.
• Individuals whose HIV results are associated with
  personal identifiers MUST be informed of their
  test results and provided appropriate counseling.
• Subjects should be assured that any genetic
  testing is for HIV subtype and resistance and NOT
  for testing of their own genes

21
Waiver of Signed Informed Consent

• Anonymous surveys may request a waiver on the
  requirement for written informed consent. Under
  Federal Regulations Title 46, Section 117,
  Documentation of Informed Consent, paragraph (c)
• An IRB may waive the requirement for the
  investigator to obtain a signed informed consent
  for some or all subjects if it finds either
• (1) That the only record linking the subject and
  the research would be the consent document and
  the principal risk would be the potential harm
  resulting from a breach of confidentiality. Each
  subject would be asked whether the subject wants
  documentation linking the subject with the
  research, and the subjects wishes will govern
  or
• That the research presents no more than minimal
  risk of harm to subjects and involves no
  procedures for which written consent is normally
  required outside of the research context.
• Only under very unusual circumstances should an
  IRB waive the need for written informed consent
  (e.g., anonymous street survey)

22
Teenagers and HIV

• Teens may be sexually active without their
  parents knowledge
• Gay and TG teens may not be out to their
  parents or guardians
• Disclosure of their behavior or serostatus may
  put them at risk for violence or abandonment
• Asking parent for consent for survey
  participation can become problematic
• In New York State, teens can consent to an HIV
  test, an STD exam, and a pregnancy test--but this
  is consent for medical care, not research
• Assess each research application on its own
  meritsbalance need for adequate protection for
  the teenage subject (including assessment of
  capacity to consent) and adequate respect to the
  rule of parental consent

23
Ethics of HIV ResearchNew Standards

• HIV research should give something back to the
  consenting participant, I.e., dont just take the
  data or blood and run!
• Build into the protocol adequate resources to get
  test results back to the participant
• Build into the protocol adequate resources to
  provide active referrals to appropriate community
  based services (primary care, prevention, and
  partner notification referrals)
• Be ready to provide crisis intervention if field
  staff identify a MH problem during an interview
  or after a test result is received
• Reimburse subjects for the time they have given
  to the research project

24
Participant Follow-up

• Maintaining contact with participant may be
  necessary for the provision of HIV test results
  and follow-up interviews (intervention trials or
  cohort studies).
• Provide appointment cards with study name (no
  reference to HIV)
• Use available contact information (phone number,
  mailing address) for reminder letters or calls

25
Protocols Must Incorporate Measures to Ensure
Data Security

• Physical security of laptops, PDAs, and paper
  forms, that go into the fieldNO NAMES!
• Screen saver on all CASI terminals
• Screen saver on all workstations
• Secure data entry rooms
• Double passwords on databases
• Separate names files survey and serostatus data
  identified ONLY by study ID
• Specify how long identifiers will be retained and
  why, and approximate date when all links will be
  destroyed

26
Summary

• ConfidentialityNew York State law officially
  designates HIV serostatus and related data as
  protected health information. Make sure this is
  clear in the protocol.
• Data securityall protocols must incorporate
  adequate physical and electronic means to secure
  data researchers should use common sense about
  what can go wrong.
• Protocol must show respect for the patients
  vulnerabilitystigmatized disease, stigmatized
  risk behaviors.
• Training and ongoing supervision of staff are
  critical elements of any research protocol.