Preparing IRB Submissions for Human Subjects Research

[Pages:25]Preparing IRB Submissions for Human Subjects Research

Tips for Preparing IRB Protocols

IRB Educational Session-Psychological Sciences September 15, 2017

Research Compliance Services

Post Approval Monitor-Joan Levine, MPH, CIP

Objectives

You are ready to begin the submission process to the IRB-what do I need to know?

? Describe and give examples of the 3 levels of IRB review. ? Discuss the process for submiBng a protocol to the IRB using

the web-based applicaCon system-InfoEd. ? Protocol submission process; Forms and locaCons. infoed.uconn.edu/ & InfoEd How to Guides ? Common piMalls when compleCng forms/submiBng to IRB.

Tips for compleCng a submission. DRAFT

research.uconn.edu

Is your study human subjects research?

a. Is it research? ? Research means a systemaCc invesCgaCon, including research development,

tesCng and evaluaCon, designed to develop or contribute to generalizable knowledge. AcCviCes which meet this definiCon consCtute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstraCon and service programs may include research acCviCes. b. Is it human subjects research? ? Human subject means a living individual about whom an invesCgator (whether professional or student) conducCng research obtains (1) Data through intervenCon or interacCon with the individual, or (2) IdenCfiable private informaCon. If yes to both A and B, then you will need to submit your research to the IRB.

research.uconn.edu

CITI Training

CollaboraCve InsCtuConal Training IniCaCve (CITI) The web-based training modules in CITI provide basic educaCon on the history and ethical principles of research. All researchers, including students who are working on the study and are considered "key personnel" must complete the online "CITI Training" course for the protecCon of human parCcipants in research BEFORE the IRB will approve a study. Research personnel must renew their training every three years. Key personnel on studies considered to be clinical trials must also take Good Clinical PracCce training. Also, available from CITI.

research.uconn.edu

Additional Training for NIH/NSF Research

The NaConal Science FoundaCon (NSF) requires the responsible conduct of research (RCR) training for all undergraduates, graduates, and postdoctoral fellows who conduct research supported by NSF funds. The NaConal InsCtutes of Health (NIH) requires that all trainees, fellows, parCcipants, and scholars receiving support through any NIH training, career development award (individual or insCtuConal), research educaCon grant, or dissertaCon research grant must receive RCR training. This requirement also applies to all faculty, including new faculty, mid-career faculty and senior faculty, and professional and scienCfic employees receiving funding from these sources. PIs are responsible for ensuring that each undergraduate student, graduate student and postdoctoral researcher who parCcipates in their NSF or NIH funded research completes the training during the course of their parCcipaCon in the project. These RCR modules can be accessed through the CITI training program.

research.uconn.edu

InfoEd

InfoEd is the web based applicaCon system used to develop and submit research protocols to the IRB. InfoEd sessions are offered on a regular basis. The IRB strongly encourages all researchers to a`end a session prior to submiBng a protocol. Students have access to all features in the InfoEd submission system. However, a faculty mentor must be listed as the Principal InvesCgator of the study. The PI is ulCmately responsible for ensuring protecCon of human parCcipants. Tips: Before clicking submit, all studies that are unfunded must be routed to the department head and PI for sign off. For funded studies, rouCng must go to the PI. If you are unsure who your Department Head is, please contact RCS. There are some DHs who delegate this task to others. Don't forget to click "submit"!!

research.uconn.edu

The Common Rule

Office for Human Research ProtecCons (OHRP)-The "Common Rule" is the federal policy for the protecCon of human subjects in research. It was first published in 1991 and known as 45 CFR 46. The Common Rule describes the detail of the IRB operaCons and the types of research that are subject to regulaCon. There are 4 subparts for addiConal protecCons for pregnant women, human fetuses, and neonates, prisoners, and children. UConn requires addiConal protecCons for students who take part in research. Changes to the regulaCons have been approved by the previous administraCon. However, the changes are presently in review by the current administraCon.

research.uconn.edu

Level of IRB Review

What level of review is my study?

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