Ethical issues related to the National Longitudinal Survey of Adolescent Health Add Health

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Ethical issues related to the National
Longitudinal Survey of Adolescent Health (Add
Health)

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Survey Objectives

• To collect data on health-related behaviors of
  adolescents, beginning in grades 7-12.
• To explore the causes of these behaviors with an
  emphasis on the influence of social context.
• To explore the transition from adolescence into
  young adulthood.

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The StudyA School Based Survey
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Sensitive and Confidential Information

• According to the DHHS, sensitive information
  consists of (but is not restricted to )
• Information regarding sexual practices or
  preferences
• Information regarding the use of alcohol, illegal
  drugs, or other addictive products
• Information concerning illegal behavior
• Information that can be destructive to the
  subjects financial standing, employability or
  reputation within the community or might lead to
  disgrace or prejudice
• Information regarding the subjects psychological
  state or mental health and generic information
  or tissues samples.
• Add Health collects all of the above!

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Add Health The promise made to participants

• At no time will Add Health respondents
  identity or identifying information be linked to
  their responses. In addition, strict measures
  will be taken to protect respondents information
  from the risk of deductive or indirect
  disclosure.

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Informed consent

• School
• Written parent/guardian consent for minors, with
  assent from youths (lt18)
• Written consent for participation of adults (18)
• Separate consent for questionnaire and biological
  specimen collection
• Separate consent for partner recruitment

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Privacy-sensitive data collection methods

• Interviewers sign confidentiality pledge
• Use of CASI to collect data and ACASI to collect
  sensitive information
• Careful training of interviewers

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Privacy-sensitive data handling methods

• Link between respondents name and data is broken
  immediately after data entry
• data is stored with ID only
• name- ID link is maintained by a security
  manager outside of the US, and is not available
  to researchers

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Privacy-sensitive data handling methods the ID
system

• Security manager gets name, address file of
  participants, associated with a roster ID from
  each school
• Security manager creates an altered
  identification number (AID) using an algorithm
  known only to him, and survey data are sent to
  investigators only with AID
• investigator can never link AID with name/address

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Privacy-sensitive data handling methods
biospecimens

• Subjects given containers for specimen
  collection, labeled with UID (different from
  AID).
• Lab analysis results sent to security manager
  only with UID. Security manager associates data
  with AID, and send to investigators. Neither
  the lab, nor the in investigator can ever link
  AID with name/address

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Privacy-sensitive data handling methods data
maintenance and use

• All people associated with project sign a
  confidentiality pledge
• Data are maintained on a secure, password
  protected system, with limited user access
• Distribution of data is subject to tight data use
  agreements

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Balancing privacy and public use

• NIH data sharing policy vs. need to protect
  confidentiality A conflict???
• Conditions for data use
• Public use data set, widely available without
  restriction includes wave I and II respondents,
  1/2 of core (nationally representative) sample
  chosen at random and 1/2 of special African
  American oversample

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Balancing privacy and public use

• Contractual data sets
• Available to researchers with IRB approved plan
  for protecting data
• Romantic pairs data set, because of its even more
  sensitive nature, is available only for
  restricted on-site use at UNC Chapel Hill

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Privacy-sensitive data handling methods extra
precautions

• Certificate of confidentiality, issued by the
  Department of Health and Human Services
• This certificate requires that there be no
  disclosures of identifying characteristics of
  research subjects in any Federal, State, or local
  civil, criminal, administrative, legislative or
  other proceedings to compel disclosure of the
  identifying characteristics of research subjects

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Risk of deductive disclosure

• If you
• knew that someone was an Add Health Participant
  AND
• you knew as few as 5 non-sensitive
  characteristics, you could deduce identity

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Deductive disclosure example

• An X year old white male in grade Y, attends an
  urban public school in region C of the US, plays
  football and runs track.
• X years old 14,575
• male 7,423
• grade Y 2,606
• white 1,497
• born in US 1,386
• sports 79
• region C 16
• public school 13
• urban 1

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What would you do?

• Many states mandate reporting of STDs. Add
  Health collects biospecimens for gonorrhea.
  However, reporting STD status would violate
  confidentiality. If subjects are informed that
  their results must be reported, and that partner
  notification would ensue, they may be less likely
  to provide a specimen, and then the
  representativeness of the sample, and thus
  scientific merit of the study is jeopardized.

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What would you do?

• You want to collect information from the sexual
  partners of participants in the survey.
• How can you ethically recruit the partners and
  maintain privacy?

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What would you do?

• You establish a special call in method to
  provide results of STD tests. A subject with a
  positive, treatable, and highly communicable
  disease does not call in for her results. Should
  you contact that subject or does she have the
  right not to know? Is the answer different for
  HIV?

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Add Health Website

• www.cpc.unc.edu/addhealth