irb's workflow get to know the

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Get to know the IRB's workflow RESEARCH WITH US! What kind of research are you doing? Is it non-human subjects research (NHSR)? Does it use secondary data or biospecimens? Is there human interaction? Do you plan to generalize and disseminate the data/findings? Based on the type of research you're doing, you'll want to complete and email to the IRB a completed Request for Waiver IRB Application for Class Projects form or a completed IRB's Request for Protocol Review form. (For NHSR, use the protocol review form, noting you're conducting NHSR.) Once we receive the requisite form, the IRB will review your documentation/wavier/protocol. Protocol reviews will be determined as exempt (IRB approval not necessary), expedited (limited committee review necessary), or full board (extensive IRB review necessary. necessary changes/clarifications to your protocol (if any), a letter acknowledging your NHSR, recommendation to use the class projects waiver, or IRB protocol determination with assigned protocol number. The IRB will log your documents and follow up as needed. Kinds of follow-up: NHSR, class projects waiver, and exempt protocols: 14 days Expedited protocols: 3-7 weeks, based on project level of complexity Full board review protocols: Depends on volume of submissions; agenda space is first-come, first-served; keep IRB meeting dates in mind (no full board reviews during summer months). Review timelines (ideally): Rolling submissions, no deadlines Once we go through 1-3 rounds of changes, we finalise your project, send you the invoice and hand over the finalised files ready for you to use! All done! [email protected] 1 2 3 4 5 6

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Page 1: IRB's workflow Get to know the

Get to know theIRB's workflow

RESEARCH WITH US !

What kind of research are you doing? Is it non-human subjects research(NHSR)? Does it use secondary data or biospecimens? Is there humaninteraction? Do you plan to generalize and disseminate the data/findings?

Based on the type of research you're doing, you'll want to complete andemail to the IRB a completed Request for Waiver IRB Application for ClassProjects form or a completed IRB's Request for Protocol Review form. (ForNHSR, use the protocol review form, noting you're conducting NHSR.)

Once we receive the requisite form, the IRB will review yourdocumentation/wavier/protocol. Protocol reviews will be determined asexempt (IRB approval not necessary), expedited (limited committee reviewnecessary), or full board (extensive IRB review necessary.

necessary changes/clarifications to your protocol (if any), a letter acknowledging your NHSR, recommendation to use the class projects waiver, or IRB protocol determination with assigned protocol number.

The IRB will log your documents and follow up as needed. Kinds of follow-up:

NHSR, class projects waiver, and exempt protocols: 14 daysExpedited protocols: 3-7 weeks, based on project level of complexityFull board review protocols: Depends on volume of submissions; agendaspace is first-come, first-served; keep IRB meeting dates in mind (no fullboard reviews during summer months).

Review timelines (ideally): Rolling submissions, no deadlines

Once we go through 1-3 rounds of changes, we finalise yourproject, send you the invoice and hand over the finalised filesready for you to use! All done!

[email protected]

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Page 2: IRB's workflow Get to know the

Exempt

Presents no more than minimal risk to participants, andInvolves any of the following:

Research that involves normal educational practices thatare not likely to adversely impact students Research that only includes interactions involvingeducational tests, survey procedures, interview procedures,or observation of public behavior* Research involving benign behavioral interventions inconjunction with the collection of information from an adultsubject through verbal or written responses or audiovisualrecording*Secondary research uses of identifiable private informationor identifiable biospecimens*Research and demonstration projects that are conductedor supported by a Federal department or agency, orotherwise subject to the approval of department or agencyheads, and that are designed to study, evaluate, improve, orotherwise examine public benefit or service programsTaste and food quality evaluation and consumeracceptance studiesStorage or maintenance of identifiable private informationor identifiable biospecimens for potential secondaryresearch useResearch involving the use of identifiable privateinformation or identifiable biospecimens for secondaryresearch use*

Still considered human subjects research!Eligibility:

* = specific criteria must be met

ONE FORM...ONE FORM...ONE FORM...3 REVIEW TYPES3 REVIEW TYPES3 REVIEW TYPES

Full BoardIf the proposed research does not qualify for Exempt or Expedited review, itwill be subject to a Full Board review. Also if it involves any of the following: Children under the age of 18;Prisoners; Individuals with impaired decision-making capacity;Economically or educationally disadvantaged persons; Procedures thatmight cause physical harm; Procedures that might cause significantpsychological/emotional distress; Collection of information about highlysensitive topics; Collection of information about illegal behavior;Collection of information that could seriously harm the participantlegally, socially, financially etc. if other people could identify them.

Expedited

Presents no more than minimal risk to participants, andDoes not involve any vulnerable populations (i.e., children,prisoners, individuals with impaired decision-makingcapacity, and/or economically or educationallydisadvantaged persons), and Involves any of the following:

Collection of data from voice, video, digital, or imagerecordings made for research purposesResearch on individual or group characteristics orbehavior, or research employing survey, interview, oralhistory, focus group, program evaluation, humanfactors evaluation, or quality assurance methodologiesResearch involving materials that have been collected,or will be collected, solely for non-research purposesCollection of data through noninvasive proceduresroutinely employed in clinical practice (not X-rays)*Clinical studies of drugs and medical devices*Collection of blood samples by finger stick, heel stick,or venipuncture*Prospective collection of biological specimens forresearch purposes by noninvasive means

Minor changes to research previously approved by the IRBmay also qualify for expedited review

Studies that involve no more than minimal risk but which do notmeet any of the criteria for exempt status may be eligible forExpedited Review.

Eligibility:

* = specific criteria must be met

More on IRB Requestsfor Protocol Review

Adapted from Lafayette College, Institutional Review Board for Human Subjects.

[email protected]