OFFICE OF RESERCH SERVICES HUMAN SUBJECTS

Education Research and Social & Behavioral Science Institutional Review Boards (IRB)

Welcome to the presentation “Education and Social & Behavioral Science Institutional Review Boards (IRB).”

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Lil Larson, IRB Director, presented this information on November 29,2012, and it has been modified into a self-paced presentation. It is part of a series or seminars coordinated by L&S Administration, intended to connect L&S faculty and staff with topics and information that may be helpful in their positions. More presentations and information about this series of trainings can be found at https://kb.wisc.edu/ls/page.php?id=25131

For new faculty and staff:

Human subject research activity taking place while employed by UW-Madison requires review by a UW-IRB.

Ongoing research approved at a previous institution will likely require review by a UW-Madison IRB.

If a previously approved project will now become collaborative, the IRB must approve that collaboration.

A faculty member who completed research at another institution and is only writing at UW-Madison may be an exception from this. However, this exception should be confirmed in writing with the IRB office.

For new faculty and staff:

In addition to the federal regulations, IRBs are governed by institutional policies, which may vary.• For example: Per campus policy, the IRB must make

a determination if a research study is Exempt. This is not a federal requirement, but UW-Madison (and most peer institutions have determined that PIs cannot determine if their project is exempt.)• PI should be tenured or tenure-track faculty

Dates and deadlines are available on the IRB website. The committee conducting full reviews meets once a month. A full review is usually only required with complex studies that need faculty expertise, or in situations where federal guidelines require a full review (e.g. when subjects are prisoners or persons with disabilities).

Proposals that do not need a full committee review are considered on a rolling basis; a response can be expected from us in 7 to 10 days. Most protocols require some revision, so additional time for this should be built into your timeline.

For funded research, RSP must be able to verify human subjects (IRB) approval before funds will be released. • Adding a funding source requires a Change of

Protocol. Dates and deadlines are important only if a

project is likely to require full committee review.• Turnaround times

For new faculty and staff:

If you haven’t received a response in 7-10 days please check in with us in case there is an issue (the most common issue is that the protocol wasn’t successfully submitted by the proposer!)

For new faculty and staff:

Personnel:• Anyone taking part in recruitment, consent, data

collection or data analysis is considered engaged in the research and must take human subjects training and be listed as key personnel.• For some labs/departments it is a good idea to list

support staff as the Point of Contact or personnel; however that means the staff member must complete human subjects training as well.

This includes any students involved in projects; they must all be listed on the protocol and show evidence of human subjects training before they can be engaged in the research.

Undergraduate student research projects can be a grey area, per our campus policies. If a student research project is solely for a class grade or course credit (no intention to publish or to disseminate beyond campus), it likely does not involve IRB approval.

However, in some cases, a student’s research could be substantial and built upon for future publishable or presentable research. We rely on faculty to help identify those types of projects so they can go through IRB approval at the onset. More information about student research policies can be found on the IRB website.

It’s a great place to find ARROW assistance as well….

Please use our webpage as a resource! It includes links to human subjects trainings, guidance documents on topics such as research with social media, research at international sites, and other resources.

Introduction to ARROW

Huron/Click Commerce Product• 8 of top 10 NIH funded institutions

Campus-wide system• Health Sciences IRBs since November 2010

• Animal Care & Use Committees

• Biosafety Fully compatible with all computers and web browsers

We have recently transitioned to a new platform for IRB proposals, called ARROW. The older platform, WebKit, is no longer accessible for submitting protocols. It will still be available read-only through next year so you can access documents previously submitted through the older platform.

ARROW is customizable, and has been designed to fit the nuances of UW Madison policies, AAHRPP accreditation (Association for the Accreditation of Human Research Protection Programs), and other needs specific to our campus.

Register a NetID

All Registered Users have access to ARROW To gain access, ask your PI or other study team member

to register your NetID in the ARROW system The Register a NetID activity can be found in any

protocol application workspace

Add NetID to the ARROW System or use Look Up provided

In the older system, every person needing access had to request authorization through our office. Now, the PI (or someone else registered as part of the team team) can register a staff or faculty NetID in the ARROW system to authorize access. Once an individual’s NetID is registered in ARROW, they may be added to any study team.

Since individuals are added to a protocol in ARROW by their NetID, a NetID must be requested for any non-UW collaborator. PIs (or other team members) can then add the individual to their ARROW protocol by their NetID, just as they would with any other UW personnel.

The extra step of requesting a NetID may take several days; so when you have external collaborators, it’s important to plan ahead.

Non-UW Personnel Obtain a UW-Madison NetID for all members of the

study team• Non-UW-Madison personnel

that need to obtain a NetID should request one through the web form: http://www.gradsch.wisc.edu/arrow/access/request.pl

Once the external collaborators receive their NetID, they may also complete human subjects training online at UW. (All of your team members must complete training.) If your collaborator is from another institution they may complete their human subjects training at their home institution instead.

Non-UW individuals engaged in your research project must be listed on the protocol application, if our campus is serving as the IRB of record. This includes collaborators from other universities, unless they have submitted protocols to the IRB at their home institution. Everyone included in the research project must be covered by one IRB approval.

Special Considerations & Procedures Use of new media (Facebook, Twitter, blogs, etc.)

• Will likely require review by the Full IRB

• Provide Privacy Statement/Terms of Use and explain how research is in compliance with site’s policies

Sensors or monitors applied to subjects

• Include description in the Research Design & Procedures section

DNA

• Explain how samples will be collected, stored, and protected

Not Applicable

• Very few projects should select this option

The Special Considerations & Procedures area of the protocol should be attended to closely. If proposers do not check the boxes that relate to their study or interview questions, they will not be prompted for additional required information. This can hold up the review process.

When a research project includes social media (for reasons other than recruitment postings), the proposer must provide assurance their research falls within the site’s privacy policies. Because the area of social media is changing so rapidly, research involving it will likely require a full IRB review. If you’d like to know whether a project will require full review before you submit a protocol, please contact our office.

Special Considerations & Procedures Research activities occurring in an educational setting

• Research activities taking place in schools, classrooms, etc.

• Site permission will be needed (likely from district or principal)

Review of records/data/images

• Includes reviewing databases, registries, existing data, etc.

Watching or listening to materials that subjects might consider offensive, threatening, or degrading (e.g., pictures, videos)

• Ensure the consent form adequately prepares participants for participation

Community-based research

• Includes any sites where additional permission may be required (Community Centers, etc.)

If researchers are using any existing data, they must provide information about it, including what data points they will be using, if a data use agreement in place, and how the researcher got access to that data.

Special Considerations & Procedures Creation of audio or video recordings or photographs

• Explain how recordings/photos will be used and stored

Collection and/or use of biological specimens for research purposes

• SBS IRB can only review non-invasive measures and/or one venipuncture

Deception

• Provide debriefing

• May require Full review

Interviews, focus groups, surveys, questionnaires, assessments

• Most ED & SBS researchers will include this option

Most common errors: Inconsistencies

• Protocol description says something different than consent forms or instruments

• Risks

• Identifying risk does not mean the study cannot be approved—only that steps to mitigate risk are included.

• Most research is confidential– not anonymous

• Academic jargon – study description and abstract should be written in layman’s terms, not copied and pasted from a grant application.

Identifying no risks is often an error. A breach of confidentiality is often a potential risk. Most risks will be minimal, and will not affect approval of the study; but the IRB office will want to see how researchers plan on mitigating those minimal risks (such as how data will be protected to minimize a breach of confidentiality).

Another common error is misidentifying research as anonymous. If the study includes interviews, collects names, email addresses, or even if a web survey collects IP addresses, the study is not truly anonymous. The review is not affected if there are direct or indirect identifiers, but the IRB office will look to see how that identifying information will be protected.

Finally, keep in mind that the reviewers will likely not have a background in your particular research area. Explain your project in layman’s terms to ensure readers understand what your project is.

An example inconsistency is when a protocol outlines five potential risks, but the consent form only includes two. All provided documents should be consistent with the protocol.

A protocol cannot be submitted if it’s missing required information. The most common missing components are:

(1) Missing answers to required questions. You can run a validation of the protocol before submitting; it will show you any required questions missing an answer.

(2) Missing human subjects training of a team member. The activity area shows individuals included on the protocol that indicates the team members and whether they have completed the training. All individuals must have their training indicated here before the protocol can be submitted.

If an attempt is made to submit an incomplete protocol, the submission will be blocked, and an error message will appears with the reason.

… and finally

Remember to SUBMIT!

The ARROW system will indicate the protocol was successfully submitted. Nevertheless we run into situations where proposers thought they submitted the protocol when they did not actually do so. Double-check the history area to ensure it has been submitted, and check in with our office if you have not received a response to your protocol within 7 to days of submission.

Questions?

Contact the IRB Office:http://www.irb.wisc.edu/

(608) 263-2320310-322 Lathrop Hall