Preparing IRB Submissions for Human Subjects Research Tips for Preparing IRB Protocols IRB Educational Session-Psychological Sciences September 15, 2017 Post Approval Monitor-Joan Levine, MPH, CIP Research Compliance Services
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 post- doctoral 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? research.uconn.edu
Level of Review cont. 1. Exempt research is considered “less than minimal risk” and fits into one of six categories. Most of the research here at UConn falls under Category 2: anonymous survey research. These applicaCons are accepted on a conCnual basis. The IRB Chair or designee reviews and approves. IRB-5 ApplicaCon and Protocol Examples: anonymous surveys collected through Qualtrics/Survey Monkey-many studies use Mechanical Turk, or the Psychology ParCcipant Pool to collect data. The data are not linked to any idenCfiers. 2. Expedited studies involve no greater than minimal risk and fit into one of 9 categories. IRB-1 ApplicaCon and Protocol Examples: Survey research with idenCfiable data, focus groups, collecCon of data through non-invasive procedures or means (MRI, EEG, buccal swab), secondary data analyses of idenCfiable datasets . One IRB member reviews this research. Typically, an IRB member will review protocols at least once per week. research.uconn.edu
Level of Review cont. 3. Full commi`ee research is considered to be more than minimal risk. These studies include research that involves physical or psychological risks, or the collecCon of idenCfiable data considered to be sensiCve in nature. The full board reviews these studies at a fully convened meeCng. MeeCngs once every 3 weeks. Dates are listed on the IRB web-site. These protocols are due 3 weeks prior to the IRB meeCng date. This provides Cme for a RCS member to pre-review the study to ensure all of the documents have been submi`ed, and for the IRB members to read through and be prepared for discussion during the meeCng. IRB-1 ApplicaCon and Protocol Examples: research with drugs/supplements, biologics, many devices protocols, research that includes psychological, physical, or legal risk. At Cmes, researchers are invited to the IRB meeCng to clarify procedures. * Call RCS prior to submiBng your protocol to ensure that you are submiBng under the correct category and have all necessary forms completed. Common Finding-protocols submi7ed under incorrect category-exempt vs. expedited research.uconn.edu
IRB Criteria for Approval 45 CFR 46 1. Risks to subjects are minimized 2. Risks to subjects are reasonable in relaCon to anCcipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. 3. SelecCon of subjects is equitable. 4. Informed consent will be sought from each prospecCve subject or the subject's legally authorized representaCve, in accordance with, and to the extent required by §46.116 5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. 7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidenCality of data. 8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educaConally disadvantaged persons, addiConal safeguards have been included in the study to protect the rights and welfare of these subjects. research.uconn.edu
Forms • Complete the IRB-1 or IRB-5 (if Exempt) electronic applicaCon in InfoEd. • Complete the corresponding IRB-1 or IRB-5 Study Protocol and upload to Infoed • Include an Appendix A form (personnel form) if you have addiConal “key personnel” that will be working on your study. Each person listed on Appendix A must complete the required CITI courses prior to IRB approval. If a person has not completed the training, this will hold up IRB approval. Common Finding-personnel have not completed CITI • Please be sure that the protocols and other forms, such as the consent form, parental permission form, informaCon sheet, etc., are the most recently updated forms that are on the IRB web-site. Sugges?on: create folder on your computer with all necessary forms. When complete, upload to InfoEd. research.uconn.edu
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