Exempt Research and Waiver of Informed Consent

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Exempt Research and Waiver of Informed Consent

• Henry Silverman, MD, MA
• Professor of Medicine

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Definitions

• Research
• Methodical investigation into a subject to
  discover facts, establish a theory, or develop an
  action plan based on facts discovered
• Investigation, study, exploration, examination,
  inquiry

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Regulatory Definitions (DHHS)

• Research
• Systematic investigation designed to develop or
  contribute to generalizable knowledge
• Human subject
• Living individual about whom an investigator
  obtains
• - Data through intervention or interaction
• - Identifiable private information

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Regulatory Definitions

• Individually identifiable
• Participants identity is or may readily be
  ascertained by the investigator or associated
  with the information
• Private information
• Individually identifiable information about
  behavior with reasonable expectation that no
  observation or recording is taking place
• Identifiable information provided for specific
  purposes with reasonable expectation will not be
  made public (e.g., academic records)

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Review Algorithm

• Questions
• Is the project research?
• If research, does it involve human subjects?
• If human subjects research, is it exempt from IRB
  review?
• - Investigators may not make determination
• If research is not exempt, is expedited review
  possible?
• - Minimal risk of damage to financial standing,
  employability, insurability or reputation

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Exempt Research (DHHS)

• 1) Conducted in educational settings involving
  normal educational practices
• 2) Involving educational tests, survey
  procedures, interview procedures, or observation
  of public behavior
• Without identifiers or responses do not place
  subjects at risk
• 3) Existing data, records, specimens
• - Publicly available or without identifiers
• 4) Federal public benefit or service programs

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Exceptions

• Greater than minimal risk
• Prisoners
• Involving deception
• Surveys, interviews with children
• - Unless observation of public behavior
• Conducted outside United States

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Case Study

• A traffic department wants to obtain information
  regarding the effects of weaker streetlights at a
  certain intersection. Researchers who work in
  the department takes shifts recording information
  regarding accidents at the intersection. At the
  intersection, there is a nearby drive-in
  Starbucks, where drivers frequently go through to
  get coffee. Accordingly, the researchers
  administers a survey to drivers who pass through
  the Starbucks. Drivers receive a free coffee if
  they complete the survey. Drivers names are not
  recorded on the survey.
• Questions
• Is this study considered research?
• Is private identifiable information being
  obtained?
• Should informed consent be obtained?

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Case Study

• A traffic department wants to obtain information
  regarding the effects of weaker streetlights at a
  certain intersection. Researchers who work in
  the department takes shifts recording information
  regarding accidents at the intersection.
• Questions
• Is this study considered research?
• Is identifiable private information being
  obtained?
• Should informed consent be obtained?

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Case Study

• A traffic department wants to obtain information
  regarding the number of people speeding through a
  red light at a certain intersection. Cameras are
  set up with the intent to obtain how frequently
  cars speed through the intersection and during
  which times during the day. While the drivers
  cannot be identified in the photos, license
  plates are captured.
• Questions
• Is this study considered research?
• Is identifiable private information being
  obtained?
• Should informed consent be obtained?

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Projects that may collect or analyze private,
identifiable information

• Marketing or consumer preference surveys
• Program evaluations
• Quality assessment / improvement
• Performance appraisals
• Analysis of health care outcomes

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Projects that may collect or analyze private,
identifiable information

• Examples
• Door-to-door voter registration survey
• Secondary analysis of existing data set
• Telephone survey of teenagers to determine radio
  station preferences
• Quality of life questionnaires in adults with
  arthritis

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Exempt Category 1

• Many studies conducted by students and faculty
  are exempt from review because they involve
  research conducted in established or commonly
  accepted educational settings involving normal
  educational practices
• According to guidelines, this falls under exempt
  status.
• But what does established or commonly accepted
  educational settings mean?

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Exempt Category 1

• Established or commonly accepted educational
  settings means K-12 and college classrooms. This
  term may also apply to after school programs,
  preschools, day care centers, vocational schools,
  alternative education programs, etc. which are
  affiliated with K-12 schools or colleges.
• Laboratory settings would not be included in this
  category.
• Other educational settings need to be considered
  case by case by the IRB.

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• But what does normal educational practices
  mean?

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Exempt Category 1

• Normal educational practices means research on
  regular and special education instructional
  strategies, or research on the effectiveness of
  or the comparison of instructional techniques,
  curricula, or classroom management methods.
• Normal educational practices include
  curriculum/instruction that is planned and
  implemented by the classroom teacher. This might
  also include surveys or tests that teachers
  commonly give to measure the effectiveness of an
  educational practice.
• Any material, intervention, activity, etc.
  suggested or implemented solely by the researcher
  is NOT considered to be a normal educational
  practice.

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• Some kinds of descriptions will indicate that
  practices do not indicate normal educational
  practices.
• Examples
• The researcher will implement a social skills
  role play.
• The researcher will conduct a body image
  interview.
• The researcher will administer a survey about
  bullying and being victimized.
• These descriptions do not indicate normal
  educational practices and indicate neither
  teacher participation nor the teachers planned
  curriculum. Further, these descriptions are vague
  and suggest potential personal or sensitive
  topics.

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• Some kinds of description that will show clearly
  that you are doing studies involving normal
  educational practices.
• Examples
• The researcher (who is the teacher in this
  classroom) will implement a social skills role
  play.
• The researcher (who is helping the teacher
  implement her physical education curriculum) will
  conduct a body image interview.
• The researcher will administer a survey about
  bullying and being victimized. This survey is
  being used by the teacher as part of a school
  wide program to prevent bullying. This survey is
  similar to a survey previously used by the
  teacher and its administration has been requested
  by the teacher.

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Exempt Category 2

• Research involving use of educational tests,
  survey procedures, interview procedures or
  observation of public behavior, unless
• a) Information is recorded in such a manner that
  human subjects can be identified, directly or
  through identifiers linked to the participant
  and
• b) Any disclosure of the responses outside the
  research could reasonably place the participants
  at risk of criminal or civil liability or be
  damaging to the participants financial standing,
  employability, or reputation.

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Category 2 Example

• Survey of individuals about their health status,
  use of tobacco products, and effect of the
  smoking ban in a certain location
• Information is recorded without identifiers or
  codes that could link data to participants
• If identifiable, disclosure of responses would
  not place participants at risk
• - Content of questions, data security important
• Children may not participate

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Educational/Survey Practices

• An HIV/AIDS referral center accepts patients for
  counseling and distribution of educational
  materials regarding the illness and prevention
  strategies. An investigator would like to access
  a new brochure detailing safer sex strategies
  that contains pictures of male and female
  genitalia.
• The research will randomize patients to receive
  the new brochure or the old brochures.
• Before leaving the clinic, patients will be asked
  to complete a survey regarding their reactions to
  the brochure and their knowledge about the
  information in the brochure. Surveys will not
  contain names, but will be coded and hence,
  linked to names.
• Is this considered human subjects research?

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Issues in Survey Research

• Types of Risk
• Breach of confidentiality
• Violation of privacy
• Presentation of results, harm to others
• Dignitary harms
• Recruitment and Informed Consent
• Re-contact
• Waiver of written consent
• Incentives

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Privacy and Confidentiality Issues

• How subjects are identified and contacted
• Randomly selected or targeted
• Reasonable access to information
• How data are stored during study
• Will data be de-identified? Coded?
• Who will have access?
• How long will data be stored? When and how will
  it be destroyed?

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Waiver of Consent Documentation

• 45 CFR 46.117(c)
• (1) The only record linking the subject and the
  research would be the consent document and the
  principal risk would be potential harm resulting
  from a breach of confidentiality. Each subject
  will be asked whether the subject wants
  documentation linking the subject with the
  research, and the subject's wishes will govern
  or
• (2) 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

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Waiver of Consent Process

• 45 CFR 46.116(d)
• (1) The research involves no more than minimal
  risk to the subjects
• (2) The waiver or alteration will not adversely
  affect the rights and welfare of the subjects
• (3) The research could not practicably be
  carried out without the waiver or alteration and
• (4) Whenever appropriate, the subjects will be
  provided with additional pertinent information
  after participation.

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Questions ?