Understanding myIRB and Human Research

Wajeeh Bajwa, PhDResearch Regulatory Manager

Presentation Version: 2017-11-20

Learning Objectives• Overview of the Research Landscape at UF• What is myIRB• Registration and training requirements for submitting a study

to myIRB• Create a new study, effectively navigate SmartForms, and

appropriately handle attachments• Different review types and how they are submitted to myIRB• Quality Improvement (QI) vs. Research• Clinical Trials

RESEARCH LANDSCAPE AT UF

Office of Research

Vice President for Research

Div. Sponsored Programs

Div. Research Compliance

Div. Research Program

Development

Div. Research Operations

and ServicesInstitutes and

Center

USDA FDA

CDC

DOT

NASA

HHS

HIPAA

OHRP

HIPPA

ITAR

DHS

EAR

NSF

OMBOSHA

FERPA

DOJ

ADA

IRS

OLAW

Cleary Act

FOAG

BOG

DSS

UF

OFAC

NRC

AHCA

FDOH

2012 FDP Survey: PIs spend 42% of research time on “administrative duties”Florida Sunshine Law

OIG

Lots of Rules!

UF

Research Compliance

• High priority at UF; taken seriously• Promoted and supported at all levels• Team effort

o Note: FL Sunshine Law§ Noncompliance can become headline news

Research Compliance Areas

• Human subjects -IRB

• Animals - IACUC• RDNA, BSL3, SA - IBC• Export Controls• Conflict of Interest

• Research Misconduct• NIH Public Access Policy• Fiscal compliance

• Cost Principles

• Effort reporting

What to Remember?• Network, find out who can help you

o Use them• Engage early

o Reach outo Ask questionso We have regulatory expertiseo Can help guide you

MYIRB

• What is myIRB?• Get your team registered in myIRB • Ensure the PI and study staff have completed their

required trainingo PRV801 HIPAA & Privacy – Research o IRB800 IRB01 Local Trainingo H70 CITI Mandatory IRB Trng-Biomedo IRB820 How To Manage a Tissue/Data Bank

myIRB• It’s a web of SmartForms capable of electronic completion,

dynamic sections, database calls, and electronic submission.

Branching Logic• Branching logic makes the forms “smart”; forms present only those

questions that are relevant to your study based on your previous responses.

REGISTRATION AND TRAINING REQUIREMENTS

1. myIRB is located at: https://my.irb.ufl.edu/uflirb/

2. Go to Login link in the upper right corner.3. If registering for the first time when you click Login you will be taken to the myIRB

registration page. If you are a VA user registering for the first time, use the link on the left on a non-VA computer.

Registration and Login

• myIRB is behind a firewall -> need to use VPN if connecting from outside of the Health Science Network.

• http://ufhealthjax.org/employees/

Accessing myIRB

Required Training• HIPAA for Researchers (UF_PRV801v_OLT) (1 hr) Privacy

Requirement – Yearly (http://mytraining.hr.ufl.edu/)• NIH Extramural Education (2 hrs)

http://phrp.nihtraining.com/users/login.phpOr CITI IRB-01 Mandatory training (modules: Basic IRB Regulations, Informed Consent, History/Ethical Principals): “Group 1: IRB-01 Mandatory Training” at CITI through myUFL.

• Local IRB video (once) (UF_IRB800_OLT) and then refresher (UF_IRB802_OLT) – Every 3 years

CREATING A NEW STUDY

Study Staff• Make sure that one member of the study team

(mentor) is designated as the “PI Proxy”

Inbox / Workspace

Study Workspace

Agree to Participate

Attachments

The Navigation Bar

Tools: Hide/Show Errors

Click to turn on, click to toggle off

Tools: Smart Form Progress• Access from the Study Workspace:

Finished is not submitted

Email Notifications

Study Staff& PI

“Ancillaries”

IRB Staff ApprovedIRB Board

Approval Process is Flexible:set by policy rather than hardwired by programming

Workflow

IRB Staff

REVIEW TYPES

Review Types• Non-human• Retrospective Data/Chart Review• Exempt• Expedited• Full Board• Banks

o Each selected review type alters branching of SmartForms.

Non-Human Research• Is the activity a systematic investigation designed to develop

or contribute to generalizable knowledge? [45 CFR 46.102(d)]• Does the research involve obtaining information about living

individuals? [45 CFR 46.102(f)]• Does the research involve intervention or interaction with the

individuals?[45 CFR 46.102(f)(1), (2)]• Study is conducted or supported by HHS? [45 CFR

46.101(a)(1)]

Non-Human Research (cont.)• Non-Human (must meet 4 criteria):

1. No interventions or interactions with a living person.2. No identifiable data or information, you are receiving de-

identified samples or data for analysis.3. No individuals who become participants. If the person

providing the data or specimens has a code or identifiers, a Confidentiality Agreement will need to be obtained.

4. The study does not involve an investigational device that uses human specimens.

Retrospective Data/Chart Review• Existing records, data, or specimen (on the shelf when

submitting the study to the IRB)o Exempt data/chart review§ Cannot maintain a link to any identifier

– Ages/time periods instead of dates– Cannot re-access information or use multiple sources– Cannot record any identifiers

o Expedited data/chart review§ A link to identifiers is allowable

– Multiple sources is allowable§ De-identification plan and timeframe § Full Waiver of Consent and HIPAA Waiver of Authorization

Exempt CategoriesSix Categories: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.

Exempt Categories (cont.)2. Research involving the use of educational tests

(cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

o 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.

Exempt Categories (cont.)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.

Exempt Categories (cont.)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.

Exempt Categories (cont.)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.

Exempt Categories (cont.)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

What is Human Research• Research is considered to involve human subjects

when an investigator conducting research obtains:o Data through intervention or interaction with a living

individual, or o Identifiable private information about a living individual.

(45 CFR 46)

Expedited Review• Must meet all 3 criteria:

1. Minimal risk to subjects (The regulatory definition of “minimal” risk is: The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 45 CFR 46. 102 (i))

2. Identity of subjects does not put them at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, reputation or stigmatizing

3. The research is not classified• There are 9 categories of Expedited Research

Categories of Expedited Research1. 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.

Categories of Expedited Research (cont.)2. Collection of blood samples by finger stick, heel stick, ear stick, or

venipuncture as follows: (a) from healthy, non-pregnant 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 children [2], 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

Categories of Expedited Research (cont.)3. Prospective collection of biological specimens for research purposes by

noninvasive means. Examples: (a) hair and nail clippings in a non-disfiguring 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 gum base 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.

Categories of Expedited Research (cont.)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.

Categories of Expedited Research (cont.)5. 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.)

Categories of Expedited Research (cont.)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.)

Categories of Expedited Research (cont.)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;

orb. where no subjects have been enrolled and no additional risks have been

identified; orc. where the remaining research activities are limited to data analysis.

Categories of Expedited Research (cont.)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.

Full Board Review• Greater than minimal risk studies• Studies involving sensitive information or data

collection• Study that do not fit in any expedited category

Banking Only Review• This type of a review is for any local bank (tissue,

data, contact registry) and any nonlocal bank that is not part of another study. o At UF, all local banks must be submitted as stand-alone

projects.

QUALITY IMPROVEMENT (QI) VS RESEARCH

What is QA/QI?• There is no regulatory definition but often QA/QI is described as

“systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery”1, and the combined efforts of everyone to make changes that will potentially lead to better patient outcomes, better system performance, and better professional development.2 In medical institutions, QA/QI is a necessary, integral part of hospital operations and is not subject to review as research, as defined under federal regulation. Rather, it is governed by Joint Commission and hospital standards. Human Subject Research (HSR) is governed by federal regulation, under IRB oversight.

• 1. Lynn J, et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007:146:666-674 • 2. Lo B, Field MJ, eds. Conflict of Interest in Medical Research, Education, and Practice, National Academies Press,

2009.http://www.nap.edu/catalog.php?record_id=12598, p. 29.

What are some differences between QA/QI and Research?

Points toconsider

Research QA/QI

Purpose To test a hypothesis OR establish clinical practice standards where none are accepted

To assess or promptly improve a process, program, or system; OR improve performance as judged by accepted/established standards

Starting Point

To answer a question or test a hypothesis

To improve performance

Design Typically a fixed protocol with fixed interventions that are not revised as data is collected.

Typically interventions are adjusted based on data collected if quality goal is not being attained.

What are some differences between QA/QI and Research?

Points toconsider

Research QA/QI

Benefits Designed to contribute to generalizable knowledge and may or may not benefit Subjects

Designed to promptly benefit a process, program, or system and may or may not benefit patients

Risks/Burdens

May place subjects at risk and stated as such

By design, does not increase patient’s risk, with exception of possible privacy/confidentiality concerns

DataCollection

Systematic data collection Systematic data collection

What are some differences between QA/QI and Research?

Points toconsider

Research QA/QI

End Point Answer a research question Promptly improve a program/ process/system, typically has a quality goal to measure improvement.

Testing/Analysis

Statistically prove or disprove a hypothesis

Compare a program/ process/system to an established set of standards.

QI/QA Project• https://qipr.ctsi.ufl.edu/approver/

What is a clinical trial• NIH Clinical Trial:

o Does the study involve human participants?o Are the participants prospectively assigned to an intervention?o Is the study designed to evaluate the effect of the intervention on the

participants?o Is the effect that will be evaluated a health-related biomedical or

behavioral outcome?• If the answer to all four questions is yes, then we consider

your research a clinical trial.

Clinical Trial – NIH Definition

Resources• Protocol Development Assistance

o The Center for Health Equity and Quality Research (CHEQR) is an important research resource for the UF Health Jacksonville. One of the primary goals of CHEQR is to provide research design and analysis consultation services to faculty, residents and fellows including help with IRB preparation and submission, development of protocols, grant development, data collection, data analysis and report generation.

Resources (cont.)• IRB-03:

o http://hscj.ufl.edu/research/institutional-review-board/FormsAndRelatedLinks.aspx

• Researcher Manualo http://irb.ufl.edu/ppt/myIRBprintversion.pdf

• Trainingo http://hscj.ufl.edu/research/institutional-review-board/newforms/required-

training.pdf• IRB-03 researcher listserv

o Subscribe to the listserv (JAXRESEARCHINFO-L@LISTS.UFL.EDU) by sending email to: Laura Viafora at Laura.Viafora@jax.ufl.edu

• Contact Information:Wajeeh Bajwa, Ph. D.o E-mail: wajeeh.Bajwa@jax.ufl.eduo Phone: (904) 244-9427