1 Developed by: U-MIC To start the presentation, click on this button in the lower right - PowerPoint Presentation

342 views
Uploaded On 2020-06-15

1 Developed by: U-MIC To start the presentation, click on this button in the lower right - PPT Presentation

enter IRB oversight for data andor biospecimen repositories Developed by UMIC University of Michigan IRB Collaborative IRB oversight for research repositories 3 Developed by UMIC ID: 777340

research irb oversight repositories irb research repositories oversight developed data application rep repository hum regulatory micrepository biospecimens umich management

Link:

Copy

Embed:

<iframe width="560" height="315" src="https://www.docslides.com/embed/777340" frameborder="0" allowfullscreen></iframe>

Download Presentation from below link

Download The PPT/PDF document "1 Developed by: U-MIC To start the prese..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Presentation Transcript

Slide1

Developed by:U-MIC

To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

Slide2

IRB oversight for data and/or

biospecimen repositories

Developed by:U-MICUniversity of Michigan IRB Collaborative

Slide3

IRB oversight for research repositories

Developed by:U-MICResearch repositoryalso called a

ata and/or biospecimens for future researchstoresmaintains

distributesm

aximizes data/specimens’ utility to overall community

increasingly a priority

ational level

nstitutional level

research

data

tissue bank

Slide4

IRB oversight for research repositories

Developed by:U-MICResearch repositoryIRBs oversee

repositories that hold

individually identifiable dataindividually identifiable biospecimens

OHRP (“Issues to Consider the Research Use of Stored Data or Tissues”):

“The

IRB should review and approve a protocol specifying the conditions under which data and specimens may be accepted and shared, and ensuring adequate provisions to protect the privacy of subjects and maintain the confidentiality of data

.”

Slide5

IRB oversight for research repositories

Developed by:U-MICRepository oversight at UMf

ormerly tracked in

eResearch Regulatory Management through traditional application type (HUM)now tracked through a repository application type (REP)information required for IRB oversight

information required for compliance with UM policies on

ata and physical security

epository governance

Slide6

IRB oversight for research repositories

Developed by:U-MICSubmitting a repository application to UM IRBNewly established repositories should request approval through REP application for data and/or biospecimens

ntakestorage

maintenancedistribution

In certain cases, REP replaces HUM application.

In other cases, REP is an adjunct of one or more HUM “collection applications.”

Currently, no requirement to transition HUM applications to REP applications

IRB staff will encourage transition case by case.

Slide7

IRB oversight for research repositories

Developed by:U-MICResearchers obtaining data and/or biospecimens

Indicate a REP as data/specimen source in a HUM application.

One REP can be expected to distribute to multiple HUMs.

eResearch