Title: Research That Does Not Need Ongoing Review by a Research Ethics Committee
1Research That Does Not Need Ongoing Review by a
Research Ethics Committee
- Henry Silverman, MD, MA
- Nahed Moustafa, MD
2Important Definitions
- Human Subject Research
- Exempt Research
- Expedited Research
PricewaterhouseCooper
3First Question to AskDoes the study
involveHuman Subjects?
4Definition of Research
- a systematic investigation
- research development,
- testing, and
- evaluation
- designed to
- develop or to contribute to generalizable
knowledge
5Definition 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
6Definition 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
7Non-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)
9Definition 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
10Minimal Risk
- If human subjects cannot be identified or the
data cannot be linked to subjects, then there
are no risks to human subjects.
11Case 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
12Case 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
13Case 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.
14Case 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
-
15What 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.
16Case 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
17Case 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.
18Definition 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
19Research 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
20Case 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
21Case 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
22Case 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
23Case 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
24Case 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.
25Case 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?
26Exempt 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.
27Who Determines Exemption Status?
PI makes the request but final decision lies with
the REC
28Exemption 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.
29Exempt 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
30Exemption 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.
31Exempt Category 1
- But what does established or commonly accepted
educational settings mean?
32Exempt 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.
33Exempt Category 1
- But what does normal educational practices
mean?
34AIDS 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.
35AIDS 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
36Exempt 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
37Does 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
38Exempt 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
39Exempt 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
40Exempt 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)
41What 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.
42Case Studies
43Case 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.
44Case 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.
45Case 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
46Case 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
47Case 2 Does this survey study meet Exemption
criteria 2?
Yes
48Case 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.
49Case 3 Does this survey study meet Exemption
criteria 2?
No
50Case 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.
51Case 4 Does this survey study meet Exemption
criteria 2?
Yes
52Case 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.
53Case 5 Does this survey study meet Exemption
criteria 2?
NO
54Case 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.
55Case 6 Does this survey study meet Exemption
criteria 2?
NO
56Summary
- 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
57Thank you!