Rickly IRB forms notes

Claim for Exemption
can't start collecting data until claim is approved

Kids are way too hard
box 2: survey
aa: subject cann't be identified directly or through identifiers
box 3 b: they are recorded by investigator so that subjects can't be id

Consent form Example 1
Intro study/ name/ contact
Purpose of study
How it's constructed
question/warning
compensation for study
what happens to data
free will--no obligation
any questions

Consent form Ex 2
invitation/ who's running it/ contact info
purpose
explanation
summary
risks
benefits
confidentiality
rights & consent
contact information
if injury caused

Consent Form Instructions
2 steps: consent process & consent form
must have WHAT they'll be informed of
7th grade reading level
not to protect researcher
written in2nd person
no standard form; whatever format works best for participant's understanding
1 copy must be given to subject & 1 copy kept by researcher for 3 years past end of IRB approval

Cover Sheet
checklist
get PI contact info
Dr. Rickly


Expedited Review Form
minimal risk
1. drugs NOT
2. blood samples NOT
3. bio specimens NOT
4. data via non invasive (sensors, ekg, etc) NOT
5. involving materials (data, docs, records) for non-research purposes like treatment NOT
6. collection of data from voice, dig, vid, image--THINK SO--for res. purposes
7. group behavior using interview, oral, focus group quality assumrance WHAT ABOUT SURVEY?

OHRPR regs
pg 2 how regs apply & to whom
pg 3 46.102 def of research & other terms
pg 4 have IRBs so people follow rules
pg 5 IRB membership, functions, & review of RSRCH
pg 5 process for expedited review & criteria for approval of RSRCH
This IS important
pg 6 cooperative research/ IRB records/ gen req for informed consent
important in terms of structure
looks/reads much like a rules/pattern for writing the doc
pg 7 Doc of informed consent/ apps lacking plans to involve humans
pg 8 Rsrch supported by a Fed Dept/ Agnecy/ Fed Funds
pg 8-10 pregnant women, fetuses, neonates in research
pg 10-11 prisoners
pg 11-12 children

Proposal Format
Rationale
Subjects
Procedures
Adverse events/liability
Consent
Attachments

Required Elements
checklist
specific statements that must be present


Short Form Consent
used when investigator can't be sure that a signed consent is understood well enough
more relevant to complex surveys research and/or ones related to health

Waiver of Written Consent: this seems viable/useful
usable if only record in research is the consent form & greatest potential harm is loss of confidentiality

Waiver or Alteration
waiver/alteration of consent requires specific findings
justification should be self-eficent
1 minimal risk to subjects
2. waiver does not neg impact rights/welfare of subjects
3. research cannot be done without waiver/alteration
4. if pertinent, subs will get more information