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…