Filling out new IRB applications is like reinventing the wheel. Attachments for this page are examples of approved applications and templates for different parts of the application.

Informed Consent

Many studies require comprehensive written informed consent from participants. IRB requires that we use Merge Fields in informed consent documents so they can add approval numbers, etc. to our documents. See attachments below for some examples. The template link here goes to IRB's page to get the latest template.
Merge fields template from IRB (.doc)
Example consent form from RideNow
More example consent forms on the DSO Ctools site (must be registered doctoral student to access).

Notes from the Doctoral Development Seminar Novermber 16, 2007 on IRB
Presenters: Marianne Ryan and Libby Hemphill
Marianne Ryan- has worked for IRB for 18 months and became an expedited reviewer 8 months ago. IRB boards at U-M are: medical, health (nursing, dental, public health schools), and behavioral science (the board Marianne is on).
When IRB application is first submitted, it goes to a staff reviewer who reviews it to identify any potential issues.
Staff reviewers:
Look for PEER certification (last 3 years, online cert.)
Will hold up app for 2 weeks if you don’t have
Make initial determination:
1. Exempt (minimal risk to people, anon surs or interviews)
2. Expedited- looking at aggregate data- groups or children or prisoner populations- these are seen as vulnerable
3. Full Board
Board meets once a month
Site approval letter
Consent/ assent forms for parent/ student
Look for inconsistencies

Student project for a class where you DON’T think you will publish doesn’t need IRB approval. But you can’t get it retroactively. Weeds out undergrad research, looks at year or longer projects usually. Web publishing is considered publishing.

Staff review takes less than 1 week, can figure out questions, problems within 2 weeks

Research design should be very clearly described, or IRB will send back- don’t assume prior knowledge

Moderate risk- exposes people to potential psych harm. Ex: talking to undocumented workers—linking back to a person could cause a lot of trouble for them.

Researcher should take on reducing risk, since they know the research design. IRB would have to change design. Should work with IRB before submitting!

Marianne looks at informed consent form. (She spends the most time on this part of the application). Merge fields- IRB staff put approval data on forms—this needs to also be on any recruitment documentation. Consent forms should be at an 8th grade reading level. Use Word feature to check reading level. IRB can decide to issue a waiver of documentation of consent (for undocumented workers or online research—fed gov doesn’t see clicking on a screen as consent) or a waiver of consent- if someone tells you about their friends in a social network study., friends become data points. Need to get waiver of consent before hand. Can get a verbal recording of consent - doesn’t have to be in writing.

Deceptive study- for reasons of avoiding bias you don’t want them to know what you are doing (say its about decision making but don’t tell them about all factors). Say upfront, this is a deceptive study but I will debrief people at the end- can hand out a debriefing sheet including a list of references. May need to ask subjects not to tell others about the study, you may not want to debrief them in this circumstance, so they don’t tell others.

If Marianne isn’t comfortable about approving an app, she will send it to the full board. If a cert of confidentiality is involved, goes to the full board to be granted. So if a 3rd party wants you to turn over data, you can use the cert in court to deny release of the data.

The Board only looks at 10-12 applications per month. Applications have to go the full board if you're collecting very sensitive data.

Sometimes IRB enlists consultants and/or faculty advisors for feedback about applications —when an approach may be specific to a discipline, or culturally sensitive.

College students- sensitive when the students own prof wants to study them, could be subject to coercion

13 board members- must include a non-scientist (a librarian in this case), a community member (not from U-M) a prisoner rep, in charge of knowing the regs on working with prisoners and speaking up for them

Every app gets a primary and secondary reviewer. Primary rev writes a review to the board for things they deny (as does the secondary rev). they recommend approving it, app with contingency, defer (to talk with PI)

Usually say app with cont- change a few little things- IRB prefers to do this.

Try to make a unanimous decision

Two votes if it involves children because of risk level.

Can abstain (rare) if you don’t want to vote

Has legal council at meeting to review legal issues, may ask a PI to come to do a presentation and clarify

Amendment to app: be explicit about changes. Comes up with large fed funded projects. What happens in phase 1 effects phase 2. IRB will approve phase 1 and ask for an amendment for phase 2.
Doesn’t have to be all on one IRB, but it might help funding. Talk to IRB before submitting

Continuing Review - Required when 1 year has passed since approval. You need to provide IRB with an update. You will get 90-day, 60-day, and 30-day reminder notices. # recruits, how many ineligible, drop outs, make up of recuits. Don’t miss deadline or else study has to stop on the day IRB expires.

If you are still working on data analysis, have to get review- even if data collection is done. If you think you will publish in the future, should still keep it open (easy to renew—you never know when you’ll want to publish).

Sometimes faculty try to switch an IRB to a new institution (if you leave U-M and nobody from project is still here).

Adverse event ORIO: other reportable incident or occurrence. Have to report if something bad happens. Call and ask to find out if you need to report

AE- involves physical or pysh harm from study. (example- a kid was hit by a car after leaving a study on campus. Accident wasn’t due to the study, but the kid was here because of the study) IRB may change risk level or requirements for disclosure of risk.

ORIO- something like missing a filing deadline but not stopping the research. IRB will figure out what to do. Or if a subject dies (unrelated to study) may change study. Protocol deviation (IRB approves face to face interview but you have to do one by phone). Anticipate potential problems and put them in the application.

Changes to IRB: formal accreditation review in June- oversight group audited U-M IRB. If accredited, IRB will have more flexibility. 2 demonstration projects- testing it on a couple apps- a new category for exempt research - 7th category is about using identifiable data (linked to someone’s identity) that is not restricted (if minimal risk, doesn’t involve children or prisoners). Right now, can’t apply for this. Other project- a 2 year approval period (can’t involve prisoners, … (one other characteristic), can't have federal funding or possibility of federal funding). This 2-year approval period is great for students -- it means they don't have to tell IRB what's going on after 1 year.

New reporting guidelines for ORIOs and adverse events to match other U-M IRBs.

Add application to e-research guidelines….

They're integrating Proposal Management into eResearch so everything will be in one system.

Dana Boyd blogged about frustration with IRB blocking- is planning to give up academia for industry to avoid IRB.
SO, to avoid frustration apply early, Aug/Sept, Dec/Jan IRB is most busy. Get things done ahead of time.
Check Behavioral Sciences IRB website, may answer many questions. Has a template for informed consent guidelines—follow this, and you’ll be in good shape.
Try to anticipate potential reviewer’s questions and address them in narrative. Have a friend from another discipline look over your application before you submit it.
Faculty advisor needs to be on your application. He/she should look carefully at application, will catch things. They must have PEERS certification as well. Ask them to get certification now (lasts 3 years).
Proofread document. If there are typos, they will make you edit it before approving.
Ask the IRB questions! This is why they do the IRB on the road thing, to be accessible. They want to make things flow as smoothly as possible. You can also e-mail them or phone them.
Keep data for as long as you think appropriate, but you have to tell IRB and potential participants. Can be explicit about when you will strip identifiers, unlinking parts of data, deleting audio files, etc.

Libby Hemphill:
Things to have ready for doing the IRB:
Research design (template)
Informed consent documents
Papers (with lit reviews)
Old approved IRBs
IM client/ email
Funding app.
CV
Recruitment documents

Jude and Libby have an exempt IRB to look at public areas of SI wikis. Don’t look at private areas of wiki. They are writing a new IRB since it was an exempt study and this one will not be—want to talk to people about their wiki behaviors.
Eresearch.umich.edu- where you fill out apps
Takes Libby 3.5 hours to do the whole process including advisor sign off.
Eresearch.umich.edu> new study, give a title, you are listed as PI but must add a faculty advisor. At SI, add Ann Verhey-Henke as a staff member on all apps.
Give faculty adviser edit access, yes on “all communications” for advisor. Anne doesn’t care if she gets edit rights but does want all communications. If you get any funding, Anne has to be on there.
LH makes start date a couple of weeks after submitting, to last 1 year.
Be sure to put something in for fields with the red asterisk.
Emilee sometimes does her IRBs at 5 am since it's so slow, traffic is lighter then.
1-1.7 (has scientific merit been peer reviewed). Libby says no for her project, because it was not officially peer reviewed (although peers did review it at a conference). Grant funded (like NSF) projects are peer reviewed, put those orgs in 1-1.71.
Rakham discretionary funds count as internal sponsorship—scan and upload doc to application. Advisor’s research incentive account counts here. So does your own incentive account. Federal funding is very relevant info here (can’t get 2 year approval with fed funding)
If data are public, you’ll be applying for an exemption and have a whole different application. Reviewer will look at the data and assess the risk to people of using it.
Non-technical study abstract (if you applied for NSF funding, reuse what you submitted). Make this very informative, very simple- what you are going to do, why, and what information you think you will get from it.
Go to the wiki and use “research design document for IRB application” a Word template made by Libby with the 6 questions you need to answer (Objective; Specific Aims; Background; Expertise and Qualifications; Methodology; and Statistical Design). Easy for a group to collaborate with a text rather than online doc. Checks for typos, etc.
Mary Kenke (sp?) is Libby’s favorite IRB resource- she calls her with questions and she is very helpful.
Yong-Mi found the IRB on the Road really helpful- she had face to face feedback which speeded up the process a lot.
6 questions have a lot of overlap with other parts of the application.
“specific aims” is NIH terminilogy- means “what’s the point”- Libby uses bullet points.
Background is a brief lit review with references. 5000 character limit- highlight section in Word and do a word count- will show characters.
Q4. special expertise and qualifications—Libby says how these people have done this stuff before and gives the IRB numbers. On her first IRB, she said she took a class on it.
Q5. methodology- give research design- less technical then for a publishable paper- can’t say “I’m using standard protocol from so-and-so”. Might upload interview protocol- if open ended or semi-structured, tell them the kind of information you want and the best methods to get it (like observe, interrupt work and ask questions).
Q6. statistical design- frustrating for qual researchers. Libby assumed the question referred to data analysis methods
Q7. references- sometimes put this in lit review section as well

Should have this all worked out before applying
Email you send people to be in study, fliers, text of phone calls all count as recruitment documents
Informed consent document/s- Emilee’s example is on the wiki
Template on eResearch has boxes on the bottom (Emilee’s does too)
Section headings (e.g., Purpose, Data Collection, Participant Rights, Risks & Benefits, Confidentiality, Consent, Optional Consent (for recording), and For Questions contact...) are good for readability.
Confidentiality section has IRB boilerplate. IRB has examples to use.
Optional consent section for recording subjects (NOT optional to have two signatures for recording subjects- one to be in the study and one to be recorded)
Use a “print name” line so you can read names to match consent to survey, etc.
What to do if you have questions (your and IRB contact info) must be on there
In recruitment materials, incentive text can’t be larger than the words “research study”
Before you click submit, ask someone to be sure you put the docs in the right place.