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Research That Does Not Need Ongoing Review by a Research Ethics Committee

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Case #1: Research with autopsy specimens ... An investigator receives autopsy specimens from a pathologist at the same institution. ... – PowerPoint PPT presentation

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Title: Research That Does Not Need Ongoing Review by a Research Ethics Committee


1
Research That Does Not Need Ongoing Review by a
Research Ethics Committee
  • Henry Silverman, MD, MA
  • Nahed Moustafa, MD

2
Important Definitions
  • Human Subject Research
  • Exempt Research
  • Expedited Research

PricewaterhouseCooper
3
First Question to AskDoes the study
involveHuman Subjects?
4
Definition of Research
  • a systematic investigation
  • research development,
  • testing, and
  • evaluation
  • designed to
  • develop or to contribute to generalizable
    knowledge

5
Definition of a Human Subject
  • a living individual
  • about whom an investigator conducting research
    obtains
  • (1) data through intervention or interaction
    with the individual, or
  • (2) identifiable private information

6
Definition of a Human Subject
  • a living individual
  • about whom an investigator conducting research
    obtains
  • (1) data through intervention or interaction
    with the individual, or
  • (2) identifiable private information

7
Non-Human Subject Research
  • Researches that does not
  • Involve an intervention/interaction
  • Obtain identifiable private information
  • No review by the full board of the REC
  • No informed consent
  • Chair or vice-chair makes the determination, not
    the PI

8
  • Identifiable
  • Subjects identity is associated with the
    information or may readily determined by the
    investigator through identifiers linked to the
    subjects.
  • 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 that it will
    not be made public (e.g., academic records,
    medical records)

9
Definition of Obtain
  • To receive or access individually identifiable
    human data or specimens
  • Includes an investigators use, study, or
    analysis of human data or specimens already in
    investigators possession

10
Minimal Risk
  • If human subjects cannot be identified or the
    data cannot be linked to subjects, then there
    are no risks to human subjects.

11
Case 1 Research with autopsy specimens
  • An application describes the following proposed
    research activities
  • An investigator receives autopsy specimens from a
    pathologist at the same institution.
  • The investigator will receive and record
    identifiable private information about the
    individuals from medical records

12
Case 1 Is the investigator conducting human
subjects research?
  • No
  • Research involving only specimens and data from
    deceased individuals is not human subjects
    research
  • Investigator is neither interacting nor
    intervening with living individuals for research

Definition of human subject is not met
13
Case 2 Discarded Tumor Specimens
  • An application describes the following proposed
    research activities
  • Investigators will obtain human specimens for
    basic research from a pathologist who has
    previously collected tumor specimens from cancer
    patients.
  • The pathologist will de-identify the data so that
    he/she and the investigators will not know the
    identities of the samples.

14
Case 2 Is the recipient investigator conducting
human subjects research?
  • No
  • The recipient investigators are not conducting
    human subjects research, because
  • They have received de-identified data
  • There is no way they can ever access the
    identities of the samples
  • Data have been anonymized

15
What is meant by existing data?
  • Data have already been collected at the time the
    proposal has been conceived
  • Existing data had been collected for purposes
    other than the proposed research
  • Applies to retrospective studies involving
    already collected data where data must be on the
    shelf when the protocol is initiated.

16
Case 3 Discarded Surgical Specimens
  • An application describes the following proposed
    research activities
  • Investigators will obtain human specimens for
    basic research from a surgeon.
  • The surgeon will collect surgical specimens, at
    the request of the investigators, that would
    otherwise be discarded and provide them in a
    coded fashion.
  • The surgeon will have no other involvement in the
    proposed research.

Not Existing Data
17
Case 3 Is the recipient investigator conducting
human subjects research?
  • Yes
  • The recipient investigator is conducting human
    subjects research, because
  • an investigator involved in the research (the
    surgeon) is collecting specimens from living
    individuals for the specific study, and
  • the recipient investigators can readily link the
    specimens to the living individuals.

18
Definition of Coded Data
  • Identifying information has been replaced with a
  • number,
  • symbol, and/or
  • letter and
  • A key to the code exists that links information
    to an individual
  • The key enables the investigator to readily
    figure out the identity of the individual

19
Research With Coded Information
  • Research with coded human data/specimens does not
    involve human subjects if
  • Data/specimens not collected specifically for
    proposed study and
  • Investigators cannot readily ascertain the
    identities of donors because
  • Key to code destroyed before research begins
  • Non-disclosure agreement between provider and
    investigator
  • Other legal requirements prohibit release of
    key to code

20
Case 4 Research using human blood
  • An application describes the following proposed
    research activities
  • An investigator will obtain blood from the Red
    Cross for basic research

21
Case 4 Is the investigator conducting human
subjects research?
  • No
  • Data/specimens not collected specifically for
    proposed study and investigators cannot readily
    ascertain identities of donors because
  • Red Cross is prohibited by law from disclosing
    identities of donors

22
Case 5 Discarded Human Specimens
  • An application describes the following proposed
    research activities
  • Investigators will obtain human specimens for
    basic research from a surgeon.
  • The surgeon has IRB approval to collect specimens
    that would otherwise be discarded and provides
    them, in coded fashion, to any investigator upon
    request.
  • The surgeon requires that recipient investigators
    enter into a written agreement prohibiting the
    release of the key to the codes to the
    investigators under any circumstances.
  • The only involvement of the surgeon in the
    proposed research is to provide the specimens to
    the investigator.

Not Existing Data
23
Case 5 Is the recipient investigator conducting
human subjects research?
  • No The investigator is not conducting human
    subjects research because
  • the private information or specimens were not
    collected specifically for the proposed research
    through an interaction or intervention with
    living individuals and
  • the investigator cannot readily figure out the
    identity of the individuals to whom the coded
    private information or specimens pertain because
  • the investigator and the holder of the key enter
    into an agreement prohibiting the release of the
    key to the investigators under any circumstances
  • there are IRB-approved written policies and
    operating procedures for a repository or data
    management center that prohibit the release of
    the key to the investigators under any
    circumstances

24
Case 6 Retrospective Record Review
  • An application describes the following proposed
    research activities
  • An investigator obtains individually identifiable
    information on treatment outcomes of patients
    treated with two different approved drugs by
    accessing medical records.
  • The investigator records the treatment outcomes
    in a coded manner.

25
Case 6 Is the investigator conducting human
subjects research?
  • Yes
  • the investigator is conducting human subjects
    research because
  • the investigator obtains individually
    identifiable private information about living
    individuals and
  • The investigator records the data in a coded
    manner allowing the subjects to be identified via
    the code.

If the investigator does not record the data in a
coded manner
How could this study be considered exempt from
ongoing ethics review?
26
Exempt Research
  • Exempt research involves human subjects
  • The Chair of the REC or his/her designated
    individual will decide whether a protocol
    qualifies for exemption.
  • Research is exempt from full board review of the
    REC and future review by the REC.
  • The determination of exempt status must be made
    in advance of the research activity, not
    retroactively
  • Individual countries/institutions should define
    how it determines which research can be exempt.

27
Who Determines Exemption Status?
PI makes the request but final decision lies with
the REC
28
Exemption Categories
  • Research conducted in established or commonly
    accepted educational settings involving normal
    educational strategies
  • The research is limited to survey procedures or
    interview procedures, UNLESS
  • The information obtained is recorded in such a
    way that human subjects can be identified -- AND
  • Disclosure of the human subjects responses
    outside the research would reasonably place the
    subjects at risk of criminal or civil liability,
    or be damaging to the subjects financial
    standing, employability, or reputation.
  • Research involves the collection of existing data
    or tissue specimens and either the data are
    publicly available or the information is recorded
    by the investigator in such a manner that
    subjects cannot be identified.

29
Exempt Research
  • Exceptions
  • Greater than minimal risk research
  • Prisoners and pregnant women
  • Children
  • except for research involving educational tests
    or
  • observations of public behavior when the
    researcher(s) do not participate in the
    activities being observed.
  • Use of Deception

Not all research that is minimal risk qualifies
for exempt status
30
Exemption Category 1
  • Research conducted in established or commonly
    accepted educational settings involving normal
    educational strategies, such as
  • Research on regular and special educational
    strategies, or
  • Research on the effectiveness of or the
    comparison among instructional techniques,
    curricula, or classroom management methods.

31
Exempt Category 1
  • But what does established or commonly accepted
    educational settings mean?

32
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 REC.

33
Exempt Category 1
  • But what does normal educational practices
    mean?

34
AIDS Educational 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.

35
AIDS Educational Practices
  • Is this considered human subjects research?
  • Yes
  • it involves an interaction with individuals
  • Can this study be considered EXEMPT, as it
    involves educational practices?
  • No
  • Clinic not considered normal educational setting
  • Study might be considered greater than minimal
    risk as the pictures in the brochures might
    invoke strong negative reactions

36
Exempt Category 2
  • Interviews, questionnaires, surveys, and focus
    groups
  • The research is limited to educational tests,
    survey procedures, interview procedures, or
    observation of public behavior (no other data)
    UNLESS
  • The information obtained is recorded in such a
    way that human subjects can be identified
    (directly or through identifiers or through
    codes) -- AND
  • Disclosure of the human subjects responses
    outside the research would reasonably place the
    subjects at risk of criminal or civil liability,
    or be damaging to the subjects financial
    standing, employability, or reputation.

only applies to research with children for
observations of public behavior when the
investigators do not participate in the
activities being observed
37
Does Not Qualify for Exempt
  • Identifiers are with data
  • Directly
  • Can be linked through a code
  • Identifiers names, birthdates,
  • medical record numbers, etc.

AND
Subjects could possibly be harmed if the
information were made public
38
Exempt Category 2 Example
  • Anonymous survey, returned via mail
  • Subjects are not likely to be at risk when data
    cannot be linked to the subject in any way

39
Exempt Category 2 Example
  • Survey of individuals about their health status,
    use of tobacco products, and effect of the
    smoking ban in their city
  • 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 are not gt minimal risk
  • Children may not participate

40
Exempt Category 3
  • "Research involving the collection or study of
    existing data, documents, records, pathological
    specimens, or diagnostic specimens, if these
    sources are publicly available or if the
    information is recorded by the investigator in
    such a manner that subjects cannot be identified,
    directly or through identifiers linked to the
    subjects."
  • In order to be exempt from the requirement of
    ongoing REC review and approval under exemption
    3, researchers must propose the use of data or
    samples that are either
  • - existing and publicly available
  • OR
  • - existing and unidentifiable (recorded)

41
What is meant by existing data?
  • Data have already been collected at the time the
    proposal has been conceived
  • Existing data had been collected for purposes
    other than the proposed research
  • Applies to retrospective studies involving
    already collected data where data must be on the
    shelf when the protocol is initiated.

42
Case Studies
43
Case Study 1 Archived Human Specimens
  • An application describes the following proposed
    research activities
  • An investigator is using archived, individually
    identifiable specimens from an previous clinical
    trial.
  • The investigator removes identifiers from the
    specimens and does not maintain links to
    identifiers.
  • The investigator then conducts research on the
    anonymized specimens.

44
Case 1 Is the investigator conducting human
subjects research?
  • Yes
  • If the individuals from whom the specimens were
    obtained are living, then obtaining individually
    identifiable specimens is human subjects
    research.

45
Case 1 Does removing identifiers from existing
specimens meet the criteria for Exemption 3?
  • Yes
  • If all specimens are existing at the time the
    research is proposed to an REC for a
    determination of whether or not the research is
    exempt
  • If the investigator collects the specimens and
    then removes links to identifiers from the
    specimens then this research activity meets the
    criteria for Exemption 3.
  • Existing
  • Publicly Available
  • or
  • Unidentifiable

46
Case 2 Survey data on Quality of Life
  • A study is proposed to measure the Quality of
    Life (QOL) of various groups in the population
    and those with illnesses in order to obtain
    normative baseline data for future studies.
  • The proposal plans to survey at least 3000 of the
    general population, as well as 250 each of
    patients with cancer and epilepsy in communities
    and clinics in all regions of the country with a
    view to achieving the following objectives
  • estimate the reliability and validity of the
    World Health Organizations QOL Instrument, the
    26-item WHOQOL-Bref
  • establish the general population subjective QOL
    domain score norms for various age and sex
    groups and
  • compare the normative values with those
    ascertained in previous WHO studies
  • Identifying data will be kept

47
Case 2 Does this survey study meet Exemption
criteria 2?
Yes
48
Case 3 Survey on Substance Abuse
  • A study is proposed to assess the presence of an
    etiological correlation and interconnection of
    risk factors among abuses of different
    psychoactive substances.
  • The study will enroll students between the ages
    of 13-19, who will be asked to complete a survey
    during a single school class.
  • The survey will ask questions regarding measures
    of substance abuse, family relations and presence
    of past abusive behavior by parents, substance
    use by family members, satisfaction with teachers
    and social interactions at school, attitudes
    toward marijuana and knowledge on consequences of
    illicit drug abuse.
  • Surveys will be anonymous.

49
Case 3 Does this survey study meet Exemption
criteria 2?
No
50
Case 4 Qualitative Research on Curriculum
  • A study aims at describing and analyzing the
    situation of current teaching regarding the major
    endemic diseases.
  • The study will address different elements of the
    curricula of schools such as The proportion of
    the curriculum allocated for the teaching of
    major endemic diseases learning objectives and
    content areas covered and methods and tools for
    students' assessment and evaluation.
  • The study will involve review and analysis of the
    curricula (using a checklist) focus group
    discussions with faculty staff, and a
    questionnaire for final year medical students
    (age gt 18 years) that will assess the students
    awareness of major endemic diseases and their
    opinions on currently used educational and
    assessment methods and tools.

51
Case 4 Does this survey study meet Exemption
criteria 2?
Yes
52
Case 5 Survey of Knowledge and Attitudes
toward infection control practices
  • At present there are no clearly defined standards
    for infection control practices in the public
    sector hospitals.
  • The study aims to determine the knowledge and
    attitudes of healthcare workers towards infection
    control practices in the emergency departments
    and the effect of recent In-service training on
    knowledge and attitudes of staff towards
    infection prevention and control.
  • Data will be collected on structured
    questionnaires by the data collection team. The
    Questionnaire contain three portions,
  • Personal demographic information
  • In-Service Training
  • Knowledge Attitude questions.
  • Informed consent will be taken by the study
    subjects and they will be ensured that the
    information will not be leaked to any irrelevant
    person and they will not be made guilty for not
    being knowledgeable.

53
Case 5 Does this survey study meet Exemption
criteria 2?
NO
54
Case 6 Focus Group Discussions Involving
Perinatal Loss
  • Perinatal grief is profound and is among the most
    painful of bereavement experiences, yet society
    has long minimized or ignored it.
  • The aim of the study is to understand and improve
    support available to the bereaved persons from
    within their immediate family and community
  • The specific objectives are
  • To study mourning and death rituals
  • To study gender issues related to the topic
  • To determine inter-spousal support mechanisms at
    the death of unborn, newborn and infant.
  • To recommend strategies for strengthening support
    mechanisms for the bereaved parents and families.
  • Methodology All the families experiencing death
    of (still birth, neonatal
  • death and selected post neonatal deaths) during
    pervious 1 1/2 years
  • would be visited in the study area to conduct in
    depth interviews to
  • understand different support mechanisms available
    for bereaved parents.
  • Three Focus Group Discussions will be conducted
    at each site with elderly
  • women and mothers and fathers who had the
    perinatal loss.

55
Case 6 Does this survey study meet Exemption
criteria 2?
NO
56
Summary
  • Not all research needs to be reviewed by the full
    REC board.
  • Initial determination made by REC Chair or
    someone he/she designates
  • Non-human subjects research
  • Exempt research
  • Enhances efficiency of the REC
  • No need to review by the full board
  • No need for continuing review

57
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