an and d th through rough the IRB Mary R. Lynn - - PowerPoint PPT Presentation

Getting to an and d th through rough the IRB

Mary R. Lynn (Mary_Lynn@unc.edu) Professor, School of Nursing Previously - Assistant Director Office of Human Research Ethics University of North Carolina at Chapel Hill

Your IRB experience or thoughts …

Which studies are reviewed by IRB?

Those studies classified as human subjects research (HSR).

Which studies are HSR?

• 1. Human Subject(s)
• 2. Research

Neither may be what you think!

What is a Human Subject?

 First must be alive  Then information must be ABOUT them (not just

FROM them)

 Interviews of “key stakeholders” ABOUT

something is generally not human subject research

 “Interaction with“ and “identifiable data” are

considerations

 HSR includes when data about someone are

collected through interaction OR is identifiable

 The question always is …

Is there someone to protect?

What is research?

 Systematic investigation, including research

development, testing and evaluation

 Designed to develop or contribute to generalizable

knowledge

 Interaction with individual (or their data)  Many examples of “research-like” activities that are

not

 QI/QA  Case Studies  Program evaluation  Etc.

The part that matters (HSR)

Is the activity a systematic investigation designed to contribute to generalizable knowledge Activity is research Does the research involved obtaining information about living individuals? Does the research involve intervention or interaction with the individuals? Activity is research involving human subjects

YES YES YES

So if my study is HSR?

If you will be interacting (directly or indirectly) with a living human being (or their identifiable data) for any activity related to research (which includes those aspects some call “preparatory to research”) you need to either submit an application to the IRB for approval before the interaction or clarify with the IRB in advance if an IRB application is required.

Examples of NHSR

 Secondary analysis of de-identified data from

a local business about the unpaid invoices from the last year

 Interviews of university administrators about

the cost of college athletics

 Examining soap consumption when different

signs are used to remind employees about hand washing

 These are all likely research but are also

NHSR!

Who decides?

The IRB makes determination not the researcher (or for students … not a student or their advisor). The online application will screen for “NHSR” for all

• studies. If it is “NHSR” the application will be very

short.

How to succeed

 Follow the directions  Inconsistencies across

various parts of the application is one of the biggest issues in having the “opportunity” to address concerns after the IRB has reviewed it.

And where are the directions?

irb.unc.edu One website for all of the campus IRBs (one entry place as well)

What will you find there?

 Application (submission instructions)  Regulatory documents and other

information for researchers

 Deadlines & meeting dates (Only matter

if you have a “full board” study which few students have)

 Lots of additional information

Where do you start?

 Start with the online application … answer

any and all questions you are offered. It is a “smart application” and should tailor what is asked to the kind of study you are proposing

 Ask your advisor for help with the application  Your consent form will be “templated” as you

complete the application. Once the application is done fill out the “individualized” aspects of the template.

Where do you start? (cont)

 Call the IRB if you still have questions: 966-

3113.

 Can make an appointment with an “IRB

Analyst” if have more questions.

It all starts here, logging in using your onyen and password

Do students have additional requirements?

 Students must have their materials

reviewed and “co-signed” (by certifying when the application is routed) by their faculty advisor who is assuming responsibility with/for the student

Routing of IRB Submissions

PI and/or Study Staff Drafts Application Certification by PI (and Faculty Advisor if Student PI)* PI’s Home Department (Chair or Dept Review Committee) Administering Department (if any) Oncology PRC or CTSA- CTRC (if relevant) IRB

Non-IRB Issues (if any)

*Note that student research will follow same routing process as any project

Speaking of proposals

All relevant proposals (1 copy) if one exists must be submitted with the IRB

• application. This applies to all

researchers, whether students or faculty.

Anything Else?

 Complete the required IRB education at

https://about.citiprogram.org/en/series/human- subjects-research-hsr/. Advise – do it in a few sessions rather than one; it will take you several hours to do! Be sure to print a copy of your certificate you get at the end of the program for safekeeping in case the automatic “transfer” of your completion record does not work right away.

 The training database will verify that you have done

the required education when you submit your application

 Be sure your advisor (at a minimum) has also done

the required education

Data Security Levels

Subject IDs Sensitive Questions Security Level Requirements*

• I

Password protection YES

• II

Level I plus secure network

• YES

II Level I plus secure network YES YES III Level II plus encryption, vulnerability scans, security audits

* Note: There is an IT person designated for this role in the School of Nursing it is Jan Blue, email address is: jhblue@email.unc.edu

Risk dictates LEVEL of review

“Exempt” Expedited Full Board Minimal Risk RISK NHSR

Types of Review

 Exempt  Expedited  Convened Committee (“Full Board”) Are reviewed by IRB staff/Chairs and do not go to the full committee

Are all applications handled in the same time frame?

 No

 Exempt and expedited - submit ANYTIME

(there are no deadlines that apply), expect feedback in ~ 7 business days

 Full board* – submit at least 2 weeks

before a scheduled meeting (check deadlines), expect feedback within 3 days after the meeting

* These are rare for researchers outside the biomedical realm

Feedback?

 Indeed

 Rare is the application that makes it

through the first time with no issues to be resolved

 The purpose of the feedback is either to

get clarification or the submission has not exactly conformed to the requirements (remember, follow the directions!)

What do I do with the feedback?

 Whine and moan  All interactions are online but you can,

• f course, call with any questions about

the feedback

 Address the issues and resubmit what

is asked for in the feedback you receive

Within a few days of the resubmission . . .

You will usually receive an approval memo which includes information related to the IRB and it’s ongoing role with you and your research study

With your approval you’ll also have access to . . .

 Consent forms, flyers, recruitment materials, etc.

 Note if you have been involved with IRB

previously:

 All materials that remain with a submission have

been reviewed

 Materials from “wherever” you might be

Modification

 Modification – any change in the study

requires IRB review and approval before being implemented

 Submitting a modification will allow you

access to your application to alter it in line with the proposed changes

 Continuing review (aka “renewal”)

 At least annually  Includes the addition of questions

about what occurred since the last review and what will occur during the next period.

How will I know when to renew?

 Your approval (or renewal) will include the

date for renewal.

 The IRB will notify you at least two months in

advance of the renewal date and again 30 days before the expiration date.

 But it is ultimately your responsibility to have

the study renewed on time --- make a note of the renewal date and plan ahead for it.

And after I submit the renewal?

 If it’s “full board” it is reviewed by the

whole committee at the next meeting, after which you’ll receive feedback – changes may be needed so be sure to plan time before your approval expires

 If it’s expedited, you should hear about

the renewal in a few days after it is submitted

How long must studies stay “active”?

 The general rule is as long as there are

human subjects to protect. Once a study is in data analysis only and there is no chance you will re-contact the subjects, it is possible to close the study.

If I close it, can it be reopened?

 Not really  You’ll likely need to submit a new

application, which is easy in the online system … you can clone studies.

What about student’s studies?

 Students should close their studies online

before they graduate. If they do not do so the faculty advisor will be responsible for the closure.

 Exempt studies are never really “opened”

since the IRB doesn’t maintain contact with those projects. However, an email to the IRB when the study has ended helps the IRB with record keeping.

Miscellaneous questions

 Must I submit an IRB application* for

secondary analysis of another researcher’s data?

 Yes, even if that researcher’s IRB approval is

current, because you are likely asking new

• questions. But in submitting the application you

should be screened to a very short application to

• complete. There are some exceptions related to

identifiablility of the data.

 Or you can be added to the study team and your

research question(s) added to the study protocol

 If I am doing a secondary analysis and

the researcher’s IRB approval is not current, does that protocol have to be reopened?

 No, your online application will be

sufficient.

 I have not received any feedback from

the IRB or I have not received my approval memo or I did not get my renewal email notice.

 Check with the IRB to make sure all your

contact information (surface mail and email addresses) is correct

Important contact information

Webpage: ohre.unc.edu or

irb.unc.edu

Phone: 966-3113 Mailing address: CB# 7097, UNC-

Chapel Hill, Chapel Hill, NC 27599- 7097

Location: 720 Martin Luther King

Blvd, Second Floor.