Sanford D. Zelnick D.O., M.S.
Member
Lake-Sumter State College Institutional Review Board
The Institutional Review Board (IRB)
Process For Researchers
Why Have An IRB Process?
An IRB process establishes a framework by the federal government to
ensure that activities performed in the name of research are analyzed with
regard to risks, benefits, alternatives and issues of equity to protect the
rights and safety of participants. It also affords an ethical framework for
researchers and our institution.
How Is Research defined?
45FCR 46.102 (d) defines research as “a
systematic investigation, including research
development, testing and evaluation, designed to
develop or contribute to generalizable
knowledge”.
Types of Research Categories
For the purposes of IRB review, research falls into
two categories:
Exempt
Non-exempt
Exempted Research 45 CFR Part 46 .102 (b) covers exempted research categories:
Educational Settings: 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
Exempted Research
Educational Tests: 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.
Exempted Research
Educational Research on candidates, public officials or
other confidential covered entities:
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
Exempted Research
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
Exempted Research
Public Benefit programs: 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
Exempted Research Food: 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.
Exempted Research (Conclusions)
If the proposed study meets the definition
of research (defined earlier) and does not
fit into one of the exempted categories just
discussed, the study is non-exempt and
must be reviewed by the Institutional
Review Board.
Non-Exempt Research
If your research is non-exempt, two categories of IRB review
are possible:
Expedited IRB Review
Full IRB Review
Expedited review means that the IRB chair alone or designate
will review the study, as opposed to the whole IRB board; you
should receive a quicker response.
Expedited IRB Review
Research activities that (1) present no more than minimal risk to human
subjects (defined in the next slide), and (2) involve only procedures listed in
the slides after that, may be reviewed by the IRB through the expedited
review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110
Research in these categories just make them eligible for review for an
expedited approval procedure. It does not mean they are automatically
approved as expedited (it depends on the specifics of the research proposal
under review).
Definition: Minimal Risk
Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests (45 CFR.46.102 (i))
Studies Which May Receive Expedited
Review
Drugs and Medical Devices
Research on drugs for which an investigational new drug application (21
CFR Part 312) is not required
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
Studies Which May Receive Expedited
Review
Studies Involving Blood Collection 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
from other adults and children*, 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.
*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).
Studies Which May Receive Expedited
Review
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.
Studies Which May Receive Expedited
Review
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.)
The points to keep in mind here are non-invasive means and minimal harm…
Examples of Possible Approvals For Expedited Reviews;
Non-invasive Testing
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.
....these (above) are examples of minimal risk types of analyses….
Studies Which May Receive Expedited
Review
Research involving materials (data, documents, records, or specimens) that
have been collected, or will be collected solely for non-research 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.)
Collection of data from voice, video, digital, or image recordings made for
research purposes
Studies Which May Receive Expedited
Review
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.)
Again, the decision of the IRB will depend on the specifics of the proposed
study and whether the study involves more than minimal risk…remember only
no more than minimal risk can be considered for expedited review….
Studies Which May Receive Expedited
Review Continuing review of research previously approved by the convened
IRB as follows:
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
Where no subjects have been enrolled and no additional risks have been identified; or
Where the remaining research activities are limited to data analysis.
….when your study is approved, you should request (and we will approve) a start date and a completion date…if you need an extension, you must re-apply to the board.
Other Issues To Consider…. Protection of Vulnerable Populations:
Specific sections of 45CFR46 and/or applicable state regulations deal with
research on prisoners, pregnant women, fetuses, fetal tissues, neonates,
children, wards of the state, traumatized or comatose patients,
institutionalized or cognitively impaired elderly, the mentally ill and minorities.
Read carefully the relevant sections pertaining to your project (if applicable)
Central issues concerning these subjects are:
Is free and informed consent being obtained or is there an inducement of such
magnitude that it might interfere with free judgment to participate?
Are the benefits and risks equitably shared?
Would a person not categorized as vulnerable agree to participate?
Policy Statement
Animal Research
While the Lake Sumter College IRB primarily concerns
itself with human research, the college will not approve
of any animal testing/research on its campuses or
engage in any partnership to conduct animal research
Policy Statement
Tobacco-Related Research
Lake Sumter College will not conduct any research
involving the consumption of tobacco products (in any
of its forms), nor will it conduct any research whose
aim is to enhance the sale of tobacco products
Funding of Research by Registered
Lobbyists
Conflicts of interest may arise in research situations where a registered
lobbyist is receiving state-support (use of state college resources).
A list of registered lobbyists is available through the link:
http://www.leg.state.fl.us/Lobbyist/index.cfm?Mode=Lists&Submenu=2&Tab=lo
bbyist&CFID=4162228&CFTOKEN=716b37c9f4b0f4e1-6E860577-FBE1-
E4F1-22F0144308F04DC7
Recruitment of Subjects
Media and Memoranda
Prior to the purchase of any advertising dealing with the
recruitment of subjects for research, a copy of the proposed
advertising must be submitted to the IRB for review.
Similarly, any memoranda of understanding or agreement
between a researcher and any outside entity for participation in
a research study must be submitted to the IRB to review.
Funding
If you are applying for a research that is supported or conducted by any
federal agency, 45 CFR 46.103 requires that a letter of assurance be
submitted to Office for Human Research Protections, HHS and that letter is
approved by HHS. This process is referred to as certification (45 CFR 46.102
(j))
Accordingly, if you are applying for a federal grant, please submit a copy of
your grant application to the IRB.
Publications
A copy of any research accepted for publication
will be submitted to the IRB for our files
Informed Consent
The Basic Requirements
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
Informed Consent (Continued) (5) A statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
Informed Consent Under certain circumstances, you may request the informed consent
requirements may be waived or modified. This can be done by the IRB if the
following conditions hold:
(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
The decision regarding this will be communicated to you by the IRB when you
receive our response to approve/certify the research as you submitted.
Adverse Events (CFR Title 21, Vol. 5) Adverse events are defined in federal regulation as “any untoward medical
occurrence associated with the use of a drug in humans, whether or not
considered drug related”. This should be interpreted broadly as an untoward
human response, be that clinical or psychological/emotional.
All adverse events reasonably suspected to have resulted from research
performed at Lake Sumter College, whether or not it is exempted research or
not, will be reported to the institutions’ risk manager with a copy to the IRB
within 1 business day.
The report should include
What happened
What was the outcome, if known
Was an emergency response required
What was the cause, if known
Breaches of Security
A security breach occurs when personal information is released. This can be
medical or financial information, directly traceable to a participant
A brief security plan should be submitted with the research application,
explaining how personal information will be protected
If a security breach occurs, the institutions’ risk manager as well as the IRB
must be notified, whether or not the research is exempt, within 1 business
day.
Similar to the reporting for adverse events, we will want to know:
What happened
How many people were adversely affected
What was the cause
Research: Additional Points
Research must comply with other applicable state and federal laws such as
those concerning privacy (45 CFR Part 160) as well as applicable state laws.
When research involves activities overseas, IRB approval is predicated on
approval at least as protective as the policy recognized by any foreign entity
or institution
IRB Process Map
Non-expedited Reviews
Research Proposal Submitted To IRB
• Start Date
• Completion Date
• Approximate number of subjects
• Approval of research adviser
• Copies of advertisements or MOAs
• Vulnerable populations identified?
• Security plan
• Funding source
• Rationale for exempt research if applicable
• Informed consent document or request for waiver
• Signed terms and conditions document
Research approved as
exempt (with or without
modifications)
Research approved as non-
exempt (with or without
modifications)
Research not approved
(disapproved)
45 days
IRB Process Map
Expedited Review
Does your research proposal qualify for an
expedited review?
Please submit all the other required
documentation mentioned in the previous slide as
applicable along with your rationale for expedited
review
Research approved for
expedited review
Research not approved for
expedited review
21 days
Contacting The Board
Contacts should be made through your faculty adviser
Reasons to contact the board:
You did not hear from us within the timeframes in the previous slides
You need an extension beyond the completion date submitted
An adverse event or breach of security occurred
You do not agree with the decision of the board
In this instance, you may submit a 1 page letter to the board explaining
your position. You should receive a reply within 2 weeks.
The Lake Sumter State College IRB
Our names and photos
We look forward to receiving your
research proposal as well as any
comments you might have that would
improve our process
…we need contact info of someone to
receive this…
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