What You Can Do To Facilitate Efficient IRB Review
Columbia University
Institutional Review Board
(212) 870-3585
1) Definition of Human Subjects Research
2) Tips to facilitate efficient IRB review
3) IRB Terminology Related to Data Collection
4) Criteria for IRB Approval
5) Categories of Exempt Research
6) Categories of Expedited Review
7) Criteria for Waiver of the Elements of Informed Consent
8) Criteria for Waiver of the Written Documentation of Informed Consent
If you have questions about IRB review or procedures,
contact the IRB office at (212) 870-3481.
If you have technical questions, contact the RASCAL help
line
In
accordance with the terms of the Federalwide
Assurance (FWA) that
Research is defined as a systematic
investigation, including research development, testing and evaluation, designed
to develop or contribute to generalizable knowledge.
Activities, which meet this definition, constitute research for purposes of
this policy, whether or not they are conducted or supported under a program, which
is considered research for other purposes.
For example, some demonstration and service programs may include
research activities.
Human subject is defined as a living individual about whom an
investigator (whether professional or student) conducting research obtains:
(1) data
through intervention or interaction with the individual, or
(2) identifiable private information.
Federal
regulations permit exemption from IRB review for research with human subjects
that involve only procedures in one or more of six specific categories
(http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101). While review of such proposals by the convened
IRB is not required, in accordance with the FWA the determination of
eligibility for exemption must be made by the IRB. Therefore, all requests for exemption must be
submitted via RASCAL for the appropriate determinations.
Proposals
for all investigative activities that involve the use of humans or human
specimens should be submitted to the IRB via RASCAL, even if the definitions of
“research” and/or “human subject” may not appear to be met. In some cases, a determination of “not human subjects research” will be made; funding agencies and/or
research sites may require documentation from the IRB of such a determination. A designation of “not human subjects research” does not imply that other institutional
or agency approvals are not required, or that methods routinely employed in the
ethical conduct of human subjects research should not be utilized.
The IRB encourages
investigators, faculty, and staff to call the IRB office for consultation
regarding whether or not an activity requires IRB review.
Tips To Facilitate
Efficient Protocol Review
Initial Submission
Resubmission (in
response to Correspondence)
1.
Respond
via correspondence; be sure to address all
questions and concerns.
2.
Revise
the protocol, consent forms, or other documents as necessary.
3.
Reattach
all consent forms built in RASCAL that were detached for editing.
4.
Archive
any superceded attached documents.
5. Remember to approve and resubmit the protocol in addition to answering correspondence.
1.
Submit
a modification request if there will be any change to an approved
protocol. A request via correspondence
does not change the protocol.
2.
Explain
why the modification is requested.
3.
Modify
relevant fields and documents.
4.
Attach
new documents.
5.
Review
personnel section to ensure that the list is still current.
1.
Validate
far enough in advance to avoid expiration.
Expired protocols cannot be reactivated; a new protocol, with a new number,
must be submitted if the study is to continue.
2.
The
IRB can assist with scanning of documents if necessary. Allot enough time for documents to be scanned
and returned.
3.
Attach
the latest versions of all relevant material, e.g., funding proposal (grant or
contract), the complete protocol, study instruments [i.e., questionnaire(s) or survey(s)],
and non-CU site approvals (e.g., permission to conduct the
study).
4.
Be
aware that a pending modification may impede the submission of a renewal
request. Withdraw pending modifications if submitting a renewal and incorporate the changes in the study description. Be sure to explain the changes, either in the
study description, or in a cover letter.
5.
Submit
the renewal sufficiently in advance of the expiration date to allow processing
time. If the renewal is submitted, the
protocol will not expire.
6.
Understand
the validation process and the “history” entry.
Renewal of a RASCAL
Protocol
Submissions to the IRB are often returned to the
investigator for clarification of the nature of data collection. The IRB must be able to determine whether the
data are:
a)
Anonymous – the identity of the respondent cannot be
determined; no links exist between the data and the individual about whom the
data are recorded;
b)
De-identified – identifiers have been removed from
the dataset under consideration; links between the data and the individual
about whom the data are recorded exist but are not readily accessible to the
researcher at CU;
c)
Coded – identifiers have been removed from the
dataset under consideration but can readily be replaced through the use of a
master list that is accessible to the investigator;
d)
Identifiable or non-coded – the identity of the
subject is documented, linked or associated with the data.
The manner in which data are recorded and maintained
influence the decisions of the IRB, particularly determination of risk level
and type of review required. To avoid
delay in the review process, investigators should clearly state whether data
are anonymous, de-identified, coded, or identifiable. A description of the data to be recorded is
particularly helpful.
Criteria for IRB Approval of Research (45 CFR 46.111)
(a) In order to approve
research covered by this policy the IRB shall determine that all of the
following requirements are satisfied:
(1)
Risks to subjects are minimized: (i) by using
procedures which are consistent with sound research design and which do not
unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using
procedures already being performed on the subjects for diagnostic or treatment
purposes.
(2)
Risks to subjects are reasonable in relation to anticipated benefits, if any,
to subjects, and the importance of the knowledge that may reasonably be
expected to result. In evaluating risks and benefits, the IRB should consider
only those risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subjects would receive even
if not participating in the research). The IRB should not consider possible
long-range effects of applying knowledge gained in the research (for example,
the possible effects of the research on public policy) as among those research
risks that fall within the purview of its responsibility.
(3)
Selection of subjects is equitable. In making this assessment the IRB should
take into account the purposes of the research and the setting in which the
research will be conducted and should be particularly cognizant of the special
problems of research involving vulnerable populations, such as children,
prisoners, pregnant women, mentally disable persons, or economically or
educationally disadvantaged persons.
(4)
Informed consent will be sought from each prospective subject or the subject's
legally authorized representative, in accordance with, and to the extent
required by §46.116.
(5)
Informed consent will be appropriately documented, in accordance with, and to
the extent required by §46.117.
(6)
When appropriate, the research plan makes adequate provision for monitoring the
data collected to ensure the safety of subjects.
(7)
When appropriate, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.
(b) When some or all of the
subjects are likely to be vulnerable to coercion or undue influence, such as
children, prisoners, pregnant women, mentally disabled persons, or economically
or educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these subjects.
Categories of Exempt Research (45
CFR 46.101(b))
(b) Unless otherwise
required by Department or Agency heads, research activities in which the only
involvement of human subjects will be in one or more of the following
categories are exempt from this policy:1
(1)
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (i)
research on regular and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
(2)
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation
of public behavior, unless:
(i) information obtained is
recorded in such a manner that human subjects can be identified, directly or
through identifiers linked to the subjects; and
(ii) any disclosure of the human subjects' responses outside the
research could reasonably place the subjects at risk of criminal or civil
liability or be damaging to the subjects' financial standing, employability, or
reputation.
(3)
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or observation
of public behavior that is not exempt under paragraph (b)(2) of this section,
if:
(i)
the human subjects are elected or appointed public officials or candidates for
public office; or
(ii)
Federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and
thereafter.
(4)
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.
(5) Research
and demonstration projects which are conducted by or subject to the approval of
Department or Agency heads, and which are
designed to study, evaluate, or otherwise examine:
(i)
Public benefit or service programs;
(ii)
procedures for obtaining benefits or services under
those programs;
(iii)
possible changes in or alternatives to those programs
or procedures; or
(iv)
possible changes in methods or levels of payment for
benefits or services under those programs.
(6) Taste and food quality evaluation and consumer
acceptance studies, (i) if wholesome foods without
additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or
agricultural chemical or environmental contaminant at or below the level found
to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection Service of
the U.S. Department of Agriculture.
Categories of Research That May Be
Reviewed by the
Institutional Review Board (IRB)
through an
Expedited Review Procedure1
Applicability
(A) Research activities
that (1) present no more than minimal risk to human subjects, and
(2) involve only procedures listed in one or more of the following categories,
may be reviewed by the IRB through the expedited review procedure authorized by
45 CFR 46.110
and 21 CFR 56.110. The activities listed should not be deemed to be of minimal
risk simply because they are included on this list. Inclusion on this list
merely means that the activity is eligible for review through the expedited
review procedure when the specific circumstances of the proposed research
involve no more than minimal risk to human subjects.
(B) The categories in this
list apply regardless of the age of subjects, except as noted.
(C) The expedited review
procedure may not be used where identification of the subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or
be damaging to the subjects= financial standing, employability, insurability,
reputation, or be stigmatizing, unless reasonable and appropriate protections
will be implemented so that risks related to invasion of privacy and breach of
confidentiality are no greater than minimal.
(D) The expedited review
procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that
the standard requirements for informed consent (or its waiver, alteration, or
exception) apply regardless of the type of review--expedited or
convened--utilized by the IRB.
(F) Categories one (1)
through seven (7) pertain to both initial and continuing IRB review.
Research Categories
(1)
Clinical studies of drugs and medical devices only when condition (a) or (b) is
met.
(a) Research on drugs for which an investigational new drug
application (21 CFR Part 312) is not required. (Note: Research on marketed
drugs that significantly increases the risks or decreases the acceptability of
the risks associated with the use of the product is not eligible for expedited
review.)
(b)
Research on medical devices for which (i) an
investigational device exemption application (21 CFR Part 812) is not required;
or (ii) the medical device is cleared/approved for marketing and the medical
device is being used in accordance with its cleared/approved labeling.
(2) Collection of blood
samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a)
from healthy, nonpregnant
adults who weigh at least 110 pounds. For these subjects, the amounts drawn may
not exceed 550 ml in an 8 week period and collection may not occur more
frequently than 2 times per week; or
(b)
from other adults and children2, considering the age, weight, and
health of the subjects, the collection procedure, the amount of blood to be
collected, and the frequency with which it will be collected. For these
subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in
an 8 week period and collection may not occur more frequently than 2 times per
week.
(3) Prospective collection
of biological specimens for research purposes by noninvasive means.
Examples:
(a) hair and nail clippings in a nondisfiguring
manner;
(b) deciduous teeth at time of exfoliation or if routine patient
care indicates a need for extraction; (c) permanent teeth if routine
patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat);
(e) uncannulated saliva collected
either in an unstimulated fashion or stimulated by
chewing gumbase or wax or by applying a dilute citric
solution to the tongue;
(f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor;
(h) supra-
and subgingival dental plaque and calculus, provided
the collection procedure is not more invasive than routine prophylactic scaling
of the teeth and the process is accomplished in accordance with accepted
prophylactic techniques;
(i) mucosal and skin cells
collected by buccal scraping or swab, skin swab, or
mouth washings;
(j) sputum collected after saline mist nebulization.
(4) Collection of data
through noninvasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving x-rays
or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and
effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
Examples:
(a) physical sensors that are applied either to the surface of the body or at a
distance and do not involve input of significant amounts of energy into the
subject or an invasion of the subject=s privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, doppler blood flow, and
echocardiography;
(e) moderate exercise, muscular strength testing, body
composition assessment, and flexibility testing where appropriate given the
age, weight, and health of the individual.
(5) Research involving
materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes
(such as medical treatment or diagnosis). (NOTE: Some research in this category
may be exempt from the HHS regulations for the protection of human subjects. 45
CFR 46.101(b)(4). This listing refers only to
research that is not exempt.)
(6) Collection of data from
voice, video, digital, or image recordings made for research purposes.
(7) Research on individual
or group characteristics or behavior (including, but not limited to, research
on perception, cognition, motivation, identity, language, communication,
cultural beliefs or practices, and social behavior) or research employing
survey, interview, oral history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies. (NOTE: Some research in this
category may be exempt from the HHS regulations for the protection of human
subjects. 45
CFR 46.101(b)(2) and (b)(3). This listing refers
only to research that is not exempt.)
(8) Continuing review of
research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of
new subjects; (ii) all subjects have completed all research-related
interventions; and (iii) the research remains active only for long-term
follow-up of subjects; or
(b) where
no subjects have been enrolled and no additional risks have been identified; or
(c) where
the remaining research activities are limited to data analysis.
(9) Continuing review of
research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do
not apply but the IRB has determined and documented at a convened meeting that
the research involves no greater than minimal risk and no additional risks have
been identified.
_______________________
1 An expedited review procedure
consists of a review of research involving human subjects by the IRB
chairperson or by one or more experienced reviewers designated by the
chairperson from among members of the IRB in accordance with the requirements
set forth in 45
CFR 46.110.
2 Children are defined in the HHS
regulations as "persons who have not attained the legal age for consent to
treatments or procedures involved in the research, under the applicable law of
the jurisdiction in which the research will be conducted." 45
CFR 46.402(a).
Source:
63 FR 60364-60367, November 9, 1998.
Waiver of
Elements of Informed Consent (45 CFR 46.116)
(c) An IRB may approve a consent procedure
which does not include, or which alters, some or all of the elements of
informed consent set forth above, or waive the requirement to obtain informed
consent provided the IRB finds and documents that:
(1) the research or demonstration project is to be
conducted by or subject to the approval of state or local government officials
and is designed to study, evaluate, or otherwise examine: (i)
public benefit or service programs; (ii) procedures for obtaining benefits or
services under those programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs; and
(2) the research could not
practicably be carried out without the waiver or alteration.
(d)
An IRB may approve a consent procedure which does not include, or which alters,
some or all of the elements of informed consent set forth in this section, or
waive the requirements to obtain informed consent provided the IRB finds and documents
that:
(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.
Waiver of Written Documentation of Informed Consent (45 CFR 46.117)
(c) An IRB may waive the requirement for the investigator
to obtain a signed consent form 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 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) 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.
In cases in which the documentation requirement is
waived, the IRB may require the investigator to provide subjects with a written
statement regarding the research.