University of Charleston’s

Institutional Review BoardAnd how it affects you.

To ensure the institution is in compliance with the HHS Protection of Human Subjects (Federal Regulation 45 CFR part 46).

To be eligible for a Federalwide Assurance (FWA), a commitment that we will comply with this regulation.

To be eligible for grant money.

Why do we need an IRB?

A review committee established to help protect the rights and welfare of human research subjects.

Research is a systematic investigation designed to contribute to generalizable knowledge.

Human subjects are those about whom an investigator obtains data, or from whom identifiable private information is obtained.

What is an IRB?

Approve / disapprove research

Modify research

Hold continuing reviews

Observe / verify changes

Suspend / terminate approval

Observe the consent process and research procedure

Require collaborating outside agencies to have an FWA

Authority of the IRB

Five members minimum

Both sexes must be included

Varied Professions: 1 non-science,

1 science, 1 not affiliated with

the institution.

Composition of the IRB

Additionally, the board must be culturally diverse, be sensitive to community issues, and have members that understand the research being done.

Juliana Serafin, Chair Brad Deel Debra Mullins Stephen Cook Dean Reardon Jennifer Pack Lynn Gunnoe * Diana Long *Nonvoting Members: Marea Dodd, Assistant to the Board and

Recordkeeper Dennis Flaherty, ad hoc

UC’s IRB Board

* Denotes an outside representative who is not affiliated with UC

The IRB meets quarterly to complete full reviews: August November February MayCheck with Marea Dodd for specific dates.

The IRB may hold additional, Special Meetings, based on need.

IRB Meetings

Application for initial review

Application for Annual Renewal/Progress Report

Amendments or modifications

Reports as indicated by the IRB

Closure Report

Reports to other agencies may also be required.

Types of IRB Submissions

Forms and instructions are on the UC website (Faculty and Staff)

The primary investigator for research involving human subjects

must submit an IRB application.

The investigators must have the appropriate NIH training or their application will not be reviewed.

Faculty Information

Investigators must have current Training in

Protecting Human Research Participants or applications

will not be reviewed.

• Training is found at: phrp.nihtraining.com

• PI is responsible for submitting a copy of their current certificate with EACH application.

Training is good for 3 years from the date of

certification.

• Plan to renew your training before it expires, to avoid delays with your project.

PI Certification Expires before project is complete, the project is suspended

until:

• The PI renews training certification, or

• An application for change in PI to another PI who has training certification, is approved.

NIH Training – Protecting Human Research Participants

Application Preparation

NOTE: Our process has changed for issuing application numbers. You will NOT be issued an application numbers, until the project has been approved.

Submit (Choose a Method)Signed & Scanned Electronic to:

irb@ucwv.edu OR Signed Paper Copy to: Marea Dodd, SOP-304

Save Electronic Copy of All Completed Forms

CompleteForms (All appropriate)

ChooseForms (All appropriate)

ReviewInstructions Forms

Full Committee Review

Expedited Review

Exempt Review

Annual Review

Types of IRB Reviews

Full Review

IRB will go over the application at a formal meeting.

Modifications may be requested by the IRB before approval is given

There must be a quorum present for the IRB to vote and each member will

vote to approve or disapprove the project.

Expedited Review

Risk Level

• Minimal

Falls into one of nine specific categories

(Refer to Instructions for detail):

• Noninvasive Sample Collection

• Blood Samples• Studies with approved

drugs/devices• Data that has already

been collected or will be collected for non-research purposes

Review

• Two IRB Members are chosen to review.

Exempt Review

Risk Level

• No Risk• Minimal Risk

Falls into one of six categories:

• Educational Research

• Educational Tests• Educational Research involving public officials or candidates for office

• De-identified existing records

• Research conducted by heads of government department

• Taste and Food Quality Evaluations

Review

• IRB selects one IRB Member to review

Exemptions Do Not Apply To Prisoners

Surveying or

Interviewing Children

Observations of public behavior

when investigator participates

Joint Studies

CAMC’s IRB actions will be

accepted in lieu of UC’s IRB

Other Institutions

involved in a study must

have a FWA and obtain approval from UC’s IRB

Select Application Type:

Save a Copy of All Completed Forms:

Print Copy & Obtain All Required Signatures:

Submit Signed Application:

•See www.ucwv.edu/IRB/

•You will need this for the next two steps.•You will also want a copy for your records.

•Primary Investigator •Other Investigator•School/Division Chair

•Electronically to: irb@ucwv.edu (Scan entire application and attachments as one inclusive pdf)

•OR•Mail Hard Copy to: Marea Dodd, SOP-304, Charleston Campus

Submission of Application

Approval

If there are changes to the project, such as, PI, PI’s NIH Certification Expires, or Circumstances or situations arise that were not previously know. You MUST notify the IRB.

You may NOT begin your project, until you receive written approval from the IRB.

Once approved, it is good for one year from date of approval. If you wish to continue beyond one year, you must seek approval through the Renewal Process.

RenewalsA project must stop at the end of the approved year;

unless you have applied for and received approval.

Apply at least 60 days before the expiration of

your approval.

NIH Training Certification must remain current.

Complete Closure Report

At Project Termination

• Project Completed• Funding Ended• PI Left University

At end of Approved

Year• Unless completing

a Renewal Application

Timeline for IRB Decision

• Four Weeks

Exempt

• Six Weeks

Expedited

• Eight Weeks

Full Review

• Submit 60 days prior to expiration of the approved year.

Annual Renewal / Progress Report

• No approval required, due upon the completion or termination of project or suspension of approved year; unless, applying for renewal.

Closure

Questions?

For Additional Assistance, Please Contact:

Dr. Juliana Serafin, IRB Chair OR Ms. Marea Dodd, IRB Asst./RecorderCharleston Campus, CTB-716 Charleston Campus, SOP-304304-357-4939 304-357-4354