U-MIC

University of Michigan
IRB Collaborative

 

The University of Michigan's IRBs are committed to providing educational materials online, as well as in the classroom. U-MIC presentations are short videos and voiceover slide shows that address topics relating both to ethics in human subjects research and to IRB procedures.

  • Topic index

A – C

 

A  
Top
Air Force–sponsored research  
agreements  
anonymous  
applications  
approval periods  
apps in research  
Army-sponsored research  
assent  
Association for the Accreditation of Human Research Protection Programs (AAHRPP)  
audits  
B  
Belmont Report  
biospecimen repositories  
blood draws  
C  
Central Biorepository (University of Michigan)  
central IRBs  
Certificates of Confidentiality  
children in research  
ClinicalTrials.gov  
coded  
cognitiive impairment  
collaborator agreements  
Common Rule (45 CFR 46 Subpart A)  
community-based participatory research (CBPR)  
compensation  
concealment  
confidentiality  
conflict of interest  
consent  
consent document version control  
consent templates  
continuing review  
correspondence  

D – G

D  
data management and security  
data repositories  
deception  
de-identified  
Department of Defense  
determinations  
devices  
document review and finalization  
document version control  
documentation of informed consent  
E  
electronic data security  
eligibility  
emergency research  
enrollment  
epidemiological research  
eResearch  
Exception from Informed Consent for Emergency Research  
exempt research  
expedited review  
external IRBs  
F  
Family Educational Rights and Privacy Act (FERPA)  
flexibility initiatives  
Food and Drug Administration (FDA)  
G  
genetics  
good clinical practice  

H – L

H  
Health Insurance Portability and Accountability Act (HIPAA)  
Human Research Protections Program (HRPP)  
human subject enrollment  
Humanitarian Use Devices (HUDs)  
I  
impairment  
incentives  
informed consent  
informed consent document version control  
informed consent templates  
inspections  
International Council on Harmonisation (ICH)  
investigator responsibilities  
IRB applications  
IRB approval periods  
IRB Authorization Agreements (IAA)  
IRB determinations  
IRB Institutional Agreements (IIA)  
IRB meeting minutes  
IRB membership  
IRB oversight of biorepositories  
IRB review  
J  
     
K  
     
L  
laws applicable to research  
legally authorized representatives  
lotteries  

M – R

M  
Marines-sponsored research  
meeting minutes  
minors in research  
mobile medical apps  
monitoring  
multisite research  
N  
National Institutes of Health (NIH)  
Navy-sponsored research  
non-research materials  
nonsignificant risk devices  
notes in eResearch  
O  
one-time blood draw  
P  
parental permission  
posted correspondence  
pregnant women, fetuses, and neonates  
principal investigator (PI) responsibilities  
prisoners  
privacy  
Privacy Rule  
Protected Health Information (PHI)  
protocol addenda  
Q  
quorum  
R    
registries  
regulatory determinations  
regulatory management  
reimbursement  
repositories  
review and finalization  

S – Z

S  
scheduled continuing review  
screening  
secondary use  
security  
significant risk devices  
single blood draw  
single IRBs  
site-specific protocol addenda  
special subject populations  
specialty informed consent templates  
specimen samples  
students in research  
study monitoring  
subject enrollment  
sub-studies  
submission summaries  
T  
templates  
third parties  
two-year approval  
U  
umbrella projects  
unanticipated problems involving risk to subjects or others (UPRISO / UaP)  
V  
version control  
vulnerable subject populations  
W  
waivers  
writing informed consent documents  
X  
     
Y  
     
Z