how to successfully apply to the irb richard gordin, irb chair true rubal, administrator / director...

How to Successfully Apply to the IRBRichard Gordin, IRB ChairTrue Rubal, Administrator / Director

For the Protection of

Human Participants

in Research

IRB Reviews Research Conducted with Human Participants

Purpose: to determine if the rights and welfare of human participants are adequately protected.

Documents must be provided that contain enough information to allow valid judgments about the science and ethics of research

How do you know if you’re doing research?

A systematic investigation designed to develop or contribute to generalizable knowledge or to contribute to the general body of knowledge.

How do you know if you are using human participants?

Living individuals about whom an investigator…conducting research obtains:

A. Data through intervention or

interaction with the individual, or

B. Identifiable private information

What does the IRB look for in a research project?

Risks minimized (coercion?) Risk vs. Benefits ratio Equitable participant selection Informed Consent process appropriate Privacy, confidentiality, safety - maximized Safeguards for vulnerable subjects Research design - scientifically sound

What Guides the Inclusion of Human Participants?

Respect for PersonsInformed consent BeneficenceDo no harmMust be some benefit to society Justice Equitable and fair

Who submits application to the IRB?

o Responsibility of principal investigator (PI),

prior to implementation (includes pilot studies)o previously collected data must be submitted to the IRB

What are the deadlines? Full-board review meetings

held 1st Tuesday of the month

Submit two weeks before for review at that month’s meeting

Exempt and expedited proposals reviewed as received – generally takes 2 / 3 weeks respectively

Meeting dates listed at: Http://irb.usu.edu/htm/deadlines

What do I need to submit? Online application: Protis.usu.edu Scientific Validity Form Copy of proposed informed consent, assent,

Letter of Information or cover letter Proposal that includes the research design Copies of instruments, surveys,

questionnaires Advertising used for recruitment

What happens after that?

Contacted by e-mail Final approval for 1

year; when all info is received / reviewed

Continuing Review:

yearly status update

What else do I need to know?

You must contact the IRB whenever there are any changes in:

methods/objectives population used Unanticipated problem

- adverse event

Training Required

PIs and any research personnel who will be in contact with HS must receive IRB training

CITI training modules (www.citiprogram.org)

Many agencies require all researchers working with people to be formally trained.

USU has a Federal Wide Assurance (FWA) with OHRP

Common Mistakes by Applicants

Talk to the IRB: Does your study qualify as research? Which application do I complete? What’s the deadline submission? How long for a response from the IRB? What other requirements are needed?

Common Mistakes… Not enough information Answer every question fully Follow directions, please No handwritten documents Upload supporting documentation Complete CITI online training modules

Common Mistakes…Create informed consent (and assent) document Write in language understandable to the

subject (6th grade level) Follow template on web page!! PLEASE Include timeline for procedures – duration of

each visit and total duration. Use proper grammar, spell

check, local phone number

Common Mistakes… Information in the Informed Consent must

match the application and proposal IRB web page: irb.usu.edu/htm/consent-forms Address HIPAA authorization

agreements if applicable, in

the IC or separately

Common Mistakes…

Submit materials to the IRB on time Response to reviewer comments within 48 hrs

assures your place in the queue. Respond promptly to IRB requests for info Don’t start the study until

you have IRB approval letter

in hand

Common Mistakes…After IRB approval: Implement the study according to the

approved protocol and IRB conditions Get prior approval for changes (amendments) PIs must complete the Continuing Review

Status Report form on the IRB website Tell the IRB when the study is completed Retain records according to federal/state reg’s

Online Resources…

Checklists: http://irb.usu.edu/htm/guidelines IRB Handbook & SOPs

Office of HS Protections http://www.hhs.gov/ohrp Office of Research Integrity

http://ori.dhhs.gov

Institutional Review Board

Contact: Richard Gordin (Rich.Gordin@usu.edu) or True Rubal at 7-0597 (True.Rubal@usu.edu)