Registration Projects

MCW as an institution has chosen to limit the scope of its Federal Wide Assurance (FWA) to apply to federally funded and/or FDA-regulated research. Effective 01/27/2017 certain research projects not funded by federal sources, and/or not regulated by the FDA, and so fall outside of the scope of the FWA, may qualify to be reviewed under institutional equivalent protections consistent with the Belmont Report. 

IRB SOP: Registration Projects: Human Subject Research Projects which Qualify for FLEX Review defines the criteria and MCW's process with Registration projects.  This policy is limited to projects which meet the following criteria:

  1. All project activities are no greater than minimal risk.
  2. There is no/ has never been federal support for this project or study team members including: projects where a student/fellow is supported via a federal training grant or other federal funding including support from Faculty Advisor’s federal funding
  3. Projects with contractual obligations or restrictions that preclude eligibility with this policy.  For example: the sponsor’s contract requires the project to be reviewed under FDA or HHS regulations.
  4. Project does not involve prisoners as subjects
  5. Project does not have an executed Inter-Institutional Reliance Agreement in place
  6. Project is not a local bank
  7. Project may not include international site(s) under the supervision of the PI
  8. Project is limited to activities that will occur solely at MCW, a Froedtert Health entity and/or BloodCenter of Wisconsin (BCW)

 

Under no circumstances will federally funded or FDA regulated research projects qualify for review under this policy.

 

Registration Categories

Projects which qualify for registration will be reviewed under newly defined MCW-specific registration categories which have been modeled from the currently defined federal cateorgies of activities for exempt and minimal risk research projects. 

These categories will only be applied to research projects which qualify for FLEX review and are considered registration projects.

Category 1: Evaluation or comparison of educational techniques or instructional curriculum
Category 2: Conducting surveys, questionnaires, focus groups, or interviews
Category 3: Use of specimens that has been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)
Category 4: Taste and Food Quality evaluations
Category 5: Blood draws via venipuncture, finger, heel or ear stick*
Category 6: Prospective collection of biospecimens via non-invasive procedures
Category 7: Prospective collection of data via non-invasive procedure
Category 8: Research involving materials (i.e. data, documents, or records) that has been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
Category 9: Collection of images, video or recordings for solely for research
Category 10: Psychosocial interventions

*This category has specific criteria which must be met to qualify under this category such as limits on amount of blood collected depending upon the subject population to be included.

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  Change: Funding Revisions

Addition of a new funding source requires an amendment

  • If federal, for-profit, or CTSI funding is added, the project may no longer qualify for registration
  •  

Advice:  Include all pending funding at initial submission.  Funding types that require additional IRB review (federal and for-profit) would indicate that a project likely does not qualify for Registration, so please update as your project as soon  as possible whether these types of funding might be involved in the project.

  Change: Revised dates of record/specimen review
  • You are limited to the range of dates proposed in your initial submission.
  • The retrospective/prospective line is drawn at the date of IRB approval.  All material created after the date of IRB approval is considered prospective per IRB definitions.

Advice: You do not need to limit yourself to purely retrospective or prospective data.  If you are seeking material from a finite range (e.g. 1/1/2012 – 12/31/2013), then by all means submit that.  However, if a wider range of dates fits with your project purpose, you can submit a more open-ended retrospective/prospective review with a broader limit on the end date of records reviewed.

  Change: Adding new data/specimen sources to review
  • If you are adding new internal data sources equivalent to original sources (e.g. You were accessing clinical EPIC records and now you seek to add some clinical, departmental records that are kept separate from EPIC).   Internal data is that data which is owned by an institution overseen by the FH/MCW IRB.
    • OCRICC review is needed for any further access to Froedtert-owned records.
    • You must always acquire permission from the owner of the records for research access.
    • Note that this refers to clinical data only.  The IRB does not allow the free exchange of data across research projects. 
  • If your original application was not clear that you wanted to access the Clinical Data Warehouse, an amendment may be needed.  CTSI expects the IRB to be able to verify that any project seeking identified data is explicit in the IRB application even for use of the Warehouse.
  • If you are adding the collection of external records for comparison (i.e records from outside of the institutions covered by the MCW/FH IRB):
    • Further IRB review is likely needed if this activity adds a further purpose, e.g. comparison versus another site.
    • If the reason for gathering further records is primarily to increase your n and no further purposes are being added:
      • Contact MCW IRB Reliance staff at MCWIRBReliance@mcw.edu with a brief description of your addition so they can assess whether or not a reliance agreement is needed.  
      • Complete a data use agreement as required by the owner of the data, and keep these signed agreements in your study records.  It is the prerogative of the site owning the data as to the data use agreement requirements.  The IRB does not need to be informed of every new instance of receiving data if, at original submission, a clear plan for the collection of equivalent data from multiple external sources is presented approved.

Advice:  Consider all possible data sources, both internal and external, that you might seek access to in order to acquire the material you need.  If you plan to acquire data/specimens from external sources, describe your process for executing data use agreements with those sites and preserving those agreements in your records. 

  Change: Revised study population
  • If you are adding a whole new class of subjects, an amendment is likely required.  Examples include:
    • Adding healthy controls to a project that did not have a control arm.
    • Adding a new language population, as the IRB will have to review your translation plans.
    • Adding subjects with a significantly different medical history.
  • Always consult OCRICC if revised populations involve Froedtert inpatients or outpatients.

Advice:  Study teams often find that their targeted population is too small or difficult to recruit, so consider upfront what other subjects classes you might expand to and include those at original submission.  Brainstorm circumstances that might lead you to approach further populations beyond your initial target.  Think at original submission about whether you will want a control group.  

  Change: Revising activities that involve non-invasive procedures (e.g. blood draw, MRI, 10-minute walk test, etc.)
  • If adding new procedures, an amendment is required.
  • If increasing the frequency of procedures, an amendment is required.
  • If changing the amount/frequency of blood drawn, contact the IRB.  There are specific regulatory thresholds (Expedited Category 2) for blood draws that impact whether or not they can even be considered minimal risk.

Advice:  Include in your original application all activities that you are considering including in your project.  “Non-invasive procedures” constitutes a broad category of activities so contact the IRB for specific advice.

  Change: Revised study activity schedule
  • If you are changing the dates of your research procedures (e.g. changing the dates of focus groups) and these dates are not directly related to medical procedures or the subjects’ clinical schedule, an amendment is not necessary.

Advice:  Allow yourself some flexibility in the schedule.  Propose a more general schedule as opposed to hard dates/times, and make clear how your proposed schedule relates to other non-research activities, especially clinical activities.

  Change: Additional focus group/interview/survey sessions
  • If adding one or two further sessions operating under the approved protocol (e.g. offering another night of focus groups to accommodate subject interest or collect more data), an amendment may not be required.
  • If adding sessions with different procedures, an amendment is required.

Advice:  The IRB does ask for an estimate as to the number of research sessions you will hold in the original application, and a range will be accepted.  

  Change: Revised surveys, focus group/interview guides
  • The IRB is most concerned with:
    • The identification level of the questions.
    • The risk at which answers recorded with identifiers would put subjects.
    • Whether the questions could put subjects in uncomfortable/stressful situations, regardless of identification.
  • If planned changes would impact any of this, an amendment is likely required.
  • If revisions are purely editorial/grammatical, an amendment may not be needed.  However, please do be conscious of every change, as even one word can significantly affect risk.
  • If adding or revising questions that are of equivalent risk (i.e. they are the same kinds of questions in terms of the topics/themes being asked), no new submission is likely needed.  You can contact an IRB Coordinator for their feedback as to whether they agree new questions are equivalent.

Advice:  When adding/revising the questions you would ask subjects, think about how you, your family members, or friends might respond to the questions.  Consult your colleagues and the IRB for feedback as to whether they believe changes might impact risk.

  Change: Sending data out to other institutions
  • If a plan to send data off-site was not included in your original application, an amendment is required.
  • Data agreements are needed to send data off-site, and the IRB needs to review the data points you plan to send away to ascertain the level of agreement needed.
    • If sending completely de-identified data, local PI and off-site collaborator should sign and provide our De-identified Data Agreement.
    • If any of the 18 HIPAA identifiers are included in your data set, a more robust agreement brokered by the Grants and Contracts Office is likely needed.

Advice:  If you know you will want to send data off-site, before you send any data, provide the IRB with the data points you would send away so that we can confirm the level of data agreement needed.  If you do not know the exact sites to which you would plan to send data, but you have included a specific plan to send out data, then a new submission may not be needed; individual data agreements could be completed as proposed and saved in study files without further review.

Registration Projects Frequently Asked Questions

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  Why has the MCW/FH IRB implemented a registration process?

The reasons for implementing these new procedures are twofold. First, these updates are to keep in line with new federal regulations governing the IRB oversight of minimal risk projects. Second, the MCW/FH IRB hopes these procedures will simplify the application process for investigators as well as reduce the length of time the IRB requires to review new projects.

  What types of projects can be registered?

Registration only applies to projects which meet all of the following criteria:

  • All activities are no greater than minimal risk
  • No federal support for the project, present or past
  • Projects with no contractual obligations or restrictions that would preclude eligibility with this policy
  • Project is not subject to FDA regulation
  • Project does not involve prisoners as subjects
  • Project does not have an executed Inter-Institutional Reliance Agreement in place
  • Project is not a local bank
  • Project does not include international site(s) under the supervision of the PI
  • Project is limited to activities that will occur solely at MCW, a Froedtert Health entity and/or BloodCenter of Wisconsin (BCW)
  What is the difference between registration and approval?

Projects which are determined to be eligible for FLEX review will undergo a streamlined review process.  MCW's FLEX review process and a registration determination is an institution-specific research review process for eligible minimal risk projects. Further, registered projects will not require Continuing Progress Reports (CPRs).

  What will happen to my currently approved project(s)?

If a project meets the criteria for registration, projects will be re-classified at the time of the next amendment.

  Can I choose whether my project is registered or approved?

The IRB will determine whether a project should be registered or approved based on the inclusion and exclusion criteria for registration.

  Do I have to complete Continuing Progress Reports (CPRs) for my registered project?

No, Continuing Progress Reports (CPRs) are not required for registered projects and will not be accepted.

  Will my registered project be subject to QA/QI review by the MCW/FH IRB?

Registered projects will be subject to the same QA/QI review as approved projects. 

  Is my registered project subject to review and approval by OCRICC?

If your registered project involves the use of any Froedtert Health resource such as, space, staff services, supplies/equipment or any ancillary services - lab, pharmacy, radiology, protected health/billing information or specimen requests, OCRICC approval is required before beginning any research activity at those sites. It is recommended that you contact OCRICC before registration with the IRB

  Who can I contact if I have further questions

Should you have questions regarding project registration, please contact the MCW/FH IRB Office at (414) 955-8422 or IRBOffice@mcw.edu.

Additional information can also be found on the MCW/FH IRB website 

HRPP Contact Information

(414) 955-8422
(414) 955-6575 (fax)

IRBOffice@mcw.edu (for general IRB questions)
MCWIRBReliance@mcw.edu (questions about reliance agreements/deferral requests)

Location:  MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI 53226-0509

HRPP Staff Contact Info

HRPP Organizational Chart

Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

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