RESEARCH COMPLIANCE NEWSLETTER

SUMMER 2016

 

Financial Conflict of Interest (FCOI)

Important About Financial Conflict of Interest (FCOI) Requirements

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Federal regulations and KP policies have several important requirements relating to Financial Conflict of Interest (FCOI) training and disclosures for researchers.  The following are timely reminders about key aspects of these requirements:

  1. Researchers are required to complete FCOI training through the CITI system every four years.

This requirement originated in summer 2012, so many KPNW researchers are coming due for training this summer and fall.  CITI will send you an automated reminder when it is time to renew your training.  Double-check your spam filter — although we believe the issue has since been resolved, we’ve had some reports of messages not getting through.  Principal investigators and co-investigators must be up-to-date with FCOI training in order to obtain IRB approval for any study or study modification.

If you do not anticipate ever being involved in a federally funded research project, you can complete the abbreviated one-module version of the training.  All others must complete the three-module version.  Both are available in CITI.

  1.  The FCOI training requirement now includes most study staff in addition to investigators.

FCOI training is a federal requirement, and it applies to all researchers who are involved in the design, conduct, or reporting of the research.  That includes many study staff in addition to the PI and co-investigators.  CHR has created a Research Specific Training Requirements Matrix that lists the roles and job titles for which this training is required.

This list of personnel has been expanded since the FCOI regulations took effect in 2012.  Research Compliance, along with COG, recently decided to expand the requirement for training after careful consideration of the applicable federal regulatory requirements.

Because the RSPO has noticed that many study staff being added to eIRB protocols have not completed FCOI training, the IRB will not withhold approval due to missing FCOI training for study staff.  This exception applies only to study staff, not to co-investigators, and it applies to items submitted through October 31.  All investigators and study staff still must have up-to-date human subjects training.

After October 31, all study staff listed in eIRB must have completed FCOI training in order for the IRB to approve submissions for that project.

  1. Sponsor-paid study expenses = FCOI?  No.

The new eIRB system has a question that asks whether each study-team member has a financial interest related to that study.  We have received questions about whether financial interests include expenses paid by the sponsor as part of the study budget, such as travel to study-training meetings.  Any money paid to the institution (CHR/KPNW) to cover the conduct of the study is not considered an FCOI for study-team members.  That means there is no FCOI for grant money awarded to a PI or for expenses reimbursed by the sponsor as part of the study budget.  However, you must disclose a potential FCOI if money (or travel, etc.) is paid by the sponsor or other outside entity directly to you as an individual, outside the scope of the study (e.g., for consulting).  See the help text in the eIRB for additional guidance on this, including dollar amounts that trigger the disclosure requirements.  CHR/KPNW policies prohibit many of the typical activities that may result in an FCOI.

 

 

Tool for Mobile Health Apps

The Federal Trade Commission (FTC) recently released a guidance titled “Mobile Health App Developers: FTC Best Practices” that provides tips to developers about data security. 

 

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The FTC also released an accompanying online tool to assist developers in determining the federal laws that apply to their mobile apps. The guidance and interactive tool were developed in collaboration with the Food and Drug Administration (FDA), the Department of Health and Human Services Office for Civil Rights, and the Office of the National Coordinator for Health Information Technology.

The tool consists of a series of high-level “yes” or “no” questions to be answered by the app developer. The answer to any individual question directs the user to a subsequent question, and ultimately informs the user as to the applicability of HIPAA, the FTC Act, and/or the federal Food, Drug, and Cosmetic Act (FDC Act).

The tool is fairly straightforward and provides basic information to a novice developer. What it fails to do is explain how an app should comply with the law, should it potentially apply to a particular app, and what the relationship is between the laws. For example, Questions 5, 6, and 7 help the user determine whether the app is a mobile medical app and, if so, whether it is the type of app over which the FDA intends to exercise its regulatory authority. Regardless of the applicability of the FDC Act to the app, the tool then asks whether the app developer is a nonprofit organization. If the answer is “no,” the tool states that the FTC Act likely applies, and that the FTC Act “prohibits deceptive or unfair acts or practices,” meaning that the developer “cannot make deceptive or misleading claims to consumers about things that are important to them,” and “cannot engage in acts or practices that cause, or are likely to cause, substantial injury to consumers that they cannot avoid, and that do more harm than good.”

Stating that the FTC Act “may apply” even to regulated medical devices is an interesting perspective, given the broad regulatory authority of the FDA over regulated medical devices with respect to claims made about the product. Although the FDA technically has authority only over the “labeling” of a medical device, and the FTC over the advertising (with certain exceptions), courts and FDA have broadly interpreted the meaning of labeling such that it includes nearly all promotional activity of a manufacturer. Therefore, even if the FTC Act were to apply to a regulated mobile app, it is far more likely that the FDA, rather than the FTC, would take action against a company for false or misleading claims. Neither the tool nor the guidance provides insight regarding precisely how, if at all, the FTC Act, rather than the FDC Act, would govern misleading promotional claims about a mobile app. Developers of mobile medical apps over which FDA will exercise its regulatory authority should assume that their promotional claims will be subject to oversight by FDA, rather than FTC.


 

Continuing Review Summary

The continuing review summary required in § 6 of the Continuing Review form must provide a brief synopsis of findings or results, if any. A short paragraph or a few sentences in lay language may suffice. A synopsis of findings or results must be provided even if a publication or report to the sponsor is uploaded with the continuing review.

The summary should not just duplicate information provided on the continuing review form or merely inform the IRB that the study is being kept open for analysis and paper writing. The IRB wants to know what has been learned.


 

Announcements

eIRB Upgrade Brown Bag

Join the RSPO team for an eIRB upgrade discussion.

September 15 2016, noon
3800 Boardroom

We will provide an overview of the new eIRB, offer guidance about common errors and points of confusion, and discuss upgrade ideas and possible improvements. Please bring your lunch, questions, and feedback.

If you cannot make it to the Brown Bag, it will be available on WebEx. We will record the session and post it on our website. 


 

IRB Tips and New Information

Inquiries and Exempt Research

Inquiry

If you are not sure whether your project is one that must meet human subjects or research requirements, you should submit an inquiry.  The new eIRB does not include an inquiry pathway, but we do have a new Inquiry Form, which can be found on our website and in the eIRB. The form will walk you through the determinations for engaged in research, human subjects, and research. The form must be uploaded as your protocol.

The Code of Federal Regulations defines Research as:

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR 46.102(d)]

and defines Human Subjects as:

” living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” [45 CFR 46.102(f)(1-2)]

Exempt research

Exempt research is a category or type of human subjects research that does not require ongoing oversight by an IRB. The new eIRB does not have a separate pathway for exempt research, so you will have to fill out the full application.

The IRB must determine if a research project fits one of the six exempt research categories. Below is a summary of the most common exempt categories:

 (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices.

(2) Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified and (ii) any disclosure could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

For more information see HHS Regulations.

NIH Requirement for Single IRB Review

You may have heard that NIH released a policy to require single IRB review for many multi-site studies receiving NIH funding.  This means that sites involved in the research will need to select a single IRB to serve as the IRB of record, and all other sites will cede review to that IRB.  While this will help reduce duplicative IRB reviews, there is typically a fair amount of administrative work upfront to get a ceding agreement and review procedures in place with the reviewing IRB.  Researchers planning to ask KPNW to cede to another IRB should work with the RSPO early in the process to ensure these administrative tasks are completed and do not delay study start-up.  The policy takes effect for proposals submitted on or after May 25, 2017.  Read more details here.

Final Report for Migrated Study

In some cases the final report may be the first submission after a study has been migrated to the new eIRB system. If that is the case, select the "Continuing Review" option on the first page of the Modification/CR form (do not also select "Modification"). You will not need to make any other updates to your study information.

Updating eIRB account information

Need to change your name or update other information in your eIRB account? Email ResCompTeam@kpchr.org.

Wondering if you need to keep a study open?

Check out the Winter 2016 newsletter article “When Can I Submit a Final Report to Close My Study?” for guidance about when you can close a study.

Naming Documents in the eIRB

When uploading a document in the eIRB system, please use the Name field to name the document in accordance with IRB requirements. This is the easiest way to name your document. The system will default to the file name if the Name field is left blank. You do not need to change the file name to conform with IRB naming requirements unless you wish to have it serve as the default name in the eIRB system.

For additional guidance, see the eIRB Help Center document “Naming Study Documents in the eIRB” or the Spring 2016 newsletter article “Naming Study Documents in the Upgraded System.”

Whom to notify when you comment in the eIRB

When you add a comment in the eIRB, you have the option of notifying the PI/proxy/primary contact, study team, or IRB coordinator. If you select  PI/proxy/primary contact, emails will go to your PI and whomever is assigned as the primary contact on the project. The study team option will result in emails to the study team in its entirety. And of course, if you select IRB coordinator, a notification will go to the IRB team member assigned to the study. If an IRB coordinator is not yet assigned, all RSPO staff are notified of comments.

Please keep in mind that IRB coordinators do not need to be included on certain notifications. Most specifically, when a submission is ready for PI notification, the IRB coordinator should NOT be included in that email. IRB coordinators should only be cc’d on and notified of comments when you have a direct question or are documenting information such as responding to a question from the IRB coordinator or making a comment that the PI has accepted requested changes, etc. For internal notifications of the PI; however, the IRB coordinator should be left of this correspondence.

Full Board Review of Modifications

The RSPO sees many modification submissions at the beginning of each month. Some of these end up requiring review by the full board; however, most meet the criteria for minimal risk, expedited review. The first of the month is a busy time for RSPO staff because we are preparing for the IRB meeting. Thus, we encourage project teams to submit minimal risk modifications whenever they are ready. Please do not feel obligated to shoot for the deadline since it is likely the modification will not be taken before the board.

Also, it is important to keep in mind that if your study was originally reviewed and approved as minimal risk under an exemption or expedited criteria, it is likely that the modification will be reviewed under those same criteria. As a rule of thumb, the following types of modifications DO NOT need full board review:

  • Minor edits to the consent form and study materials to correct spelling, update contact information, and revise formatting.
  • Adding a new questionnaire or measure that is in keeping with the approved methodology of the study.
  • Adding a new recruitment document such as a flier or phone script.
  • Revising a process that is not more than minimal risk (such as requesting to contact subjects over the phone instead of via email).

 
 

Research Compliance Policy Updates

Researcher Training (NWRC.RIM.05) – New, 5/31/2016.

Policies and Procedures for the KPNW Institutional Review Board for the Protection of Human Subjects (NWRC.HRPP.01) – Revised.  Minor updates throughout.

Physically Moving Research-Related Data (NWRC.SEC.02) – Revised. Clarified scope, harmonized with regional Information Security policies, and simplified requirements for physical security (aka “red bag” procedures).

Guidance on Surrogate Consent in Research – Revised from Policy.  Determined this was a better fit as a guidance document than as a policy.  Addresses what the IRB evaluates when reviewing a study involving adults who lack decisional capacity and how to obtain valid consent from a surrogate decision-maker.