Human Subjects Research: The DePaul IRB Process and Protoco - PowerPoint Presentation

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Human Subjects Research: The DePaul IRB Process and Protocol Preparation Guidance

Susan Loess-Perez, MS, CIP, CCRC

Director of Research Compliance

Office of Research Services

Graduate Thesis and Dissertation Conference

February 6, 2016Slide2

Purpose of IRBWhat Requires Review

Levels of Review

Non-ReviewableExemptExpeditedFullShort Summary of DePaul ProcessGuidelines for submissionCommon General ProblemsCommon IRB ConcernsConsent Principles and ConcernsContact InformationQ &A

TopicsSlide3

A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the

aim to protect the rights and welfare of the research subjects.

Has authority to approve, require modifications, or disapprove researchThe Purpose of the IRBSlide4

The IRB and the Human Subject Protections Program

Researchers

FWA InstitutionOffice of Research ServicesLocal Review Boards/Departmental ReviewSupport Offices ORS-Grants and ContractsComplianceBilling

General Counsel

Institutional Review Board

Human Subjects Protection ProgramSlide5

All human subject research conducted by DePaul faculty, staff, or students, whether conducted at DePaul or in other locations.

Activities must meet the definition of research contained in the

federal regulations.Activities must involve human subjects as defined in the federal regulations.What Requires IRB Review?Slide6

Is what I am doing research?Does this activity involve a systematic investigation designed to develop or contribute to generalizable

knowledge?

Am I using a systematic approach, such as scientific methods, to collect and analyze data?Is the primary goal or intent to disseminate the information or apply it to persons outside the individual or group involved in the activity?Will the activity result in knowledge expressed in theories, principles, and statements of relationships that can be applied to others’ experiences?Where to Start?Slide7

Does my research involve Human Subjects?Human subject means a

living individual

about whom a researcher obtains:(1) Data through intervention or interaction with the individual, or(2) Identifiable private informationIf it is “Research,” What’s Next? Slide8

Non-ReviewableNot researchNot involving human subjects

Exempt

ExpeditedConvened or FullResourcesDePaul website: Levels of reviewhttps://offices.depaul.edu/ors/research-protections/irb/Pages/default.aspx OHRP decision trees: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html Levels of ReviewSlide9

Projects that do not involve “research” and/or “human subjects”

Non-

generalizable survey/interview research, such as:Surveys/interviews for internal program evaluationSurveys/interviews conducted by students for a class project & that will not be used outside of the classJournalism interviewsMost Oral history projectsResearch utilizing information about deceased personsResearch using archival or currently existing data, when:

Data accessed or used by the researcher are permanently de-identified or coded

and the PI will not have the key to link the data to the person

What research is non-reviewable?Slide10

Submit information to the Office of Research Services, Research Protections at ORP@depaul.edu

Receive a letter with Non-Reviewable Determination

Why might you want this?Funding agencyJournal publicationPersonal recordsNon-Reviewable Determination ProcessSlide11

Little or no risk (benign)

Must fall within one or more of the exemption categories (6)

Cannot involve prisonersCannot involve survey or interview research with children or observation of children when the investigator takes part in the activity being observedMust be someone with institutional authority that makes the exemption determinationExemption DeterminationsSlide12

In-depth IRB reviewMay be reviewed administratively

Informed consent

DePaul requires an information sheet or processContinuing ReviewExempt from What?Slide13

Research conducted in established or commonly accepted educational setting, involving normal educational practices, such as research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior

unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside of 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 categoriesSlide14

3. Research as per category 2 that is not exempt under category 2, if the human subjects are elected or appointed public officials or candidates for public office…

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if the sources are publicly available

or if the information is recorded by the investigator so that the subjects cannot be identified, directly or through identifiers linked to the subjects.Research and demonstration projects, which are designed to study, evaluate, or examine public benefit or service programs…Taste and food quality evaluation and consumer acceptance studies…Exempt Categories (cont.)Slide15

Initial Review

Does not mean fast review

Minimal risk-i.e. probability and magnitude…not greater than daily life …or routine examinationsReviewed by one or more IRB membersSpecific categories (7 initial, 2 for continuing review)Is assigned an approval period Most often 364 daysCan be any time period assigned by the IRB

Continuing review, amendments, Final reports, Unanticipated problems/adverse events

Expedited ReviewSlide16

5) Research involving data, documents, records, or specimens that have been collected, or will be collected

(6) Collection of data from voice, video, digital, or image recordings for research purposes

(7) Research on individuals or groups or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Most Common Expedited Categories at DePaulSlide17

Greater than minimal risk or Minimal risk research that doesn’t fit into one or more of the expedited categories

Protocol receives a review by the convened Board, rather than a subcommittee review

Is assigned an approval period No categoriesConvened or Full ReviewSlide18

Summary of DePaul ProcessSlide19

Materials Required for Exempt Projects

Materials Required for

Expedited or Full ProjectsExempt applicationExpedited/full applicationExempt info sheet or processConsent, parent/guardian permission, assent forms, as appropriateMeasures or data collection toolsMeasures or data collection toolsRecruitment materials (e.g. scripts, flyers)Recruitment materials (e.g. scripts, flyers)Collaborative IRB approval*

Collaborative IRB approval*

Letters of collaboration or support*

Letters of collaboration or support*

Grant application, if federally funded

Grant application, if federally funded

CITI training completion for PI and Faculty Sponsor

CITI training completion for PI and Faculty Sponsor

Guidelines for SubmissionSlide20

Before beginning the IRB process-PLAN YOUR RESEARCH PROTOCOL!Proof read your materials for typos, incoherent or confusing language, and inconsistencies

Avoid scientific jargon, write as if explaining to someone not in your field of study

Ensure the application matches the consent documents regarding risks, benefits, and limits of confidentialityMake sure the info sheets or consent documents are written at a 6th-8th grade reading level, or at a level appropriate for the target populationMore information is better than too littleCommon General ProblemsSlide21

RecruitmentSnowball recruitmentPrivacy issues

How contact information is obtained

Engagement of othersHow it is used, in final formatOnline surveysWhen and how is the information sheet or consent presented to subjects?Active consent or agreement process?Can they skip questions?Will payment be offered? If so how is contact information gathered?Anonymous or confidential?Common IRB ConcernsSlide22

Data collectionHow is data recorded?De-identified, coded, with identifiers.

What procedures or method of data collection will be used?

Surveys (anonymous or confidential), questionnaires, interviews, record reviews, collection of artifacts.Measures to protect confidentiality of data once collectedWhat happens to data when research is completed?Audio or video recordingHow will these be used in the research?Will they be used outside of the research?Archived, documentary, teaching/training Is appropriate language included in the consent or information sheet?When are these destroyed?State law (see guidance document)Common IRB ConcernsSlide23

Consent processIs a process, it is not about signing a form.

Involves providing information in an understandable way, assessment of understanding through discussion with the subject, and ongoing assessment and affirmation.

Begins with initial contact with the participant (recruitment). It is ongoing, particularly for longitudinal research.Can be written, verbal, or elements or entire process can be altered or waived.General Principles of ConsentSlide24

Missing elements or informationInaccurate or incomplete informationReading level and vocabularyAge appropriate assent

Does the subject have the capacity to provide consent?

Not obtaining signaturesNot obtaining appropriate Legal Guardian permissionUsing the currently approved documentCommon Consent ConcernsSlide25

Susan Loess-Perez, MS, CIP, CCRC

Director of Research Compliance

Phone: 312-362-7593Email: sloesspe@depaul.eduDiana Alfaro, MSAssistant Director of Research CompliancePhone: 312-362-7592Email: dalfaro@depaul.eduJessica Bloom, MPHResearch Protections CoordinatorPhone: 312- 362-6168Email: jbloom8@depaul.edu

Richard Mulnix, II, MS

Research Protections Coordinator

Phone: 312-362-7497

Email:

rmulnix@depaul.edu

Office of Research Services

DePaul University

1 East Jackson Blvd.

Chicago, IL 60604

Office Location: 14 E. Jackson, Suite 1030

Fax: 312-362-7574

General Research Protections Email box:

ORP@depaul.edu

IRB Webpage:

https://

offices.depaul.edu/ors/research-protections/irb/Pages/default.aspx

Contact InformationSlide26

Questions?Q and A