NEWSLETTER

WINTER 2018

 

Have You Heard About the New NIH Single IRB Mandate?

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The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies involving multiple institutions to use one designated IRB to accomplish oversight and approval.

What does this mean for you?

Regardless of who will be the prime awardee and/or IRB of record, the KPNW IRB must acknowledge and agree to their involvement. To request an acknowledgment, use the “Request IRB Acknowledgment” link on the new RSPO Reliance website located at: https://research.kpchr.org/research-compliance/For-Researchers/Reliance  Once you click on the link you will be asked to enter basic information regarding the proposal and then be prompted to upload the following documentation.

  • Copy of the sIRB Plan that will be included in the grant submission; and
  • Summary of proposed research as it relates to human subjects, including activities that will occur at KPNW.

Start early in the grant proposal stage. For multisite studies where KPNW is the prime awardee, you must identify who will be the IRB of record. Then, work with your Sponsored Projects Administrator (SPA) to ensure that you write the single IRB Plan (sIRB) according to NIH instructions and that your budget reflects any additional costs associated with the sIRB.

Although this step is pre IRB submission, you will want to consult with the IRB as early as possible to avoid complications, especially if requesting that KPNW IRB act as IRB of record for all sites

For more information about KPNW policy and guidance located at: https://research.kpchr.org/research-compliance/For-Researchers/IRB-Process-and-Submissions#Collaborate

 

Emailing for Recruitment Purposes

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Recently, Research Compliance has received questions regarding the use of study titles and acronyms in recruitment emails to potential participants.  We are currently updating our guidance document on Best Practices for Emailing Research Participants and Recruits to better address this and related issues.  In the meantime, please keep reading for interim guidance…

Because an individual’s email address is an identifier under HIPAA, any associated health information is considered PHI.  Any email containing PHI should be encrypted.  However, recruitment emails are often sent without encryption because potential participants are unlikely to open an encrypted email when they are not expecting one.  Therefore, when sending a recruitment email without encryption, it is important to ensure that no part of the email contains health information about the recipient.

Even a study title or acronym is considered health information if it provides information about the recipient’s health status.  The key questions to ask are:

  • Does the study include only people with a particular health condition or characteristic?
  • Could someone find that out by reading the email or searching the internet for the study title/acronym?

If yes to both questions, you must ensure that your recruitment email does not include any details about the study, including the title/acronym, that reveal information about the recipient’s health.

It is okay to use the study title, acronym, or other descriptors in recruitment emails if study recruitment is not based on a particular health condition or characteristic.  This is still true if the study recruits based on other criteria such as age, geographic location, occupation, or KP member status.

Examples:

J Do J

L Don’t L

New Research Opportunity for KP Members

New Research Opportunity for KP Members who have High Blood Pressure

KP Center for Health Research Survey

MyPlan Study Survey (where ClinicalTrials.gov indicates that MyPlan includes only patients at suicide prevention clinics)

We are writing to let you know about a study on ADHD that includes adults over age 50 with and without ADHD.

We are contacting you because you were recently diagnosed with ADHD.

Based on your medication history, we think you may be eligible for a study at KP Center for Health Research.

We think you may be eligible for this study because you were prescribed antibiotics five or more times in the past year.

If you’d like to participate, please contact the study team at STUDY@kpchr.org. (where STUDY is an acronym for a study that recruits any college student)

If you’d like to participate, please contact the study team at START@kpchr.org. (where an internet search for “START study” reveals that it includes only HIV-positive people)

 

We are here to help!  Please email (CHR_ResCompTeam), call, or stop by the RSPO if you need assistance in modifying your recruitment emails to meet these standards.

 

Policy Updates
 

NWRC.RIM.03 – Quality Improvement Monitoring. This policy was revised to incorporate our region’s use of the KFRI shared service model for clinical trials monitoring in addition to our local monitoring program.

NWRC.HRPP.102 – Collaborative IRB Reliance Arrangements. This is a new policy to address how Research Compliance will evaluate requests from investigators to rely on an external IRB, or to serve as the IRB of record for another site. This new P&P will be the foundation for a collection of procedures and guidance materials, currently being developed by the RSPO team, that will help Research Compliance facilitate single IRB review arrangements. These arrangements are becoming more common and will eventually be required for certain federally funded studies.

NWRC.HRPP.02 – Continuing Review of IRB Approved Research. This policy was extremely outdated and was revised to reflect our current review process.

NWRC.PRIV.04 – Privacy Rule Documentation for Research. This policy was revised as part of a routine review to include several clarifications and corrections. The table in Appendix A is a particularly useful summary of agreement and other requirements for different types of data sharing.


IRB Announcements

Customier Service Survey

The Research Compliance team would like to hear your thoughts about our customer service. Responding should only take about 8 minutes. Your responses can help us improve our customer service, so we appreciate any feedback you provide!

You may open the survey in your web browser by clicking the link below:
Research Compliance Customer Satisfaction Survey

If the link above does not work, try copying the link below into your web browser:
https://redcapint.chr.or.kp.org/redcapint/surveys/?s=DCEXN384FL

Who to Contact in RSPO

Got an IRB-related question? For general IRB questions, using the CHR_ResCompTeam@kpchr.org is still the preferred method. However, if you need to contact someone directly please be aware that some contacts have changed. Melinda Allie is now the Quality Improvement and Compliance Coordinator and should be contacted for issues related to the new QI Monitoring Program. AndrĂ©a “Drea” Volz and Kathrynn Mosley are the new IRB Coordinators and can field your IRB questions. For a breakdown of roles, and additional contact information please see the CHR Compliance CenterNet page located at:  https://centernet.chr.or.kp.org/cnetcms/departments-teams/compliance

IRB Humor

We all make mistakes and sometimes our mistakes make us laugh. Here are a few examples pulled from actual consent forms submitted to the IRB.

Your study doctor will give you a reminder car with instructions for when you should take the second weekly dose.

After completing these procedures, you will be given breakfast prepared from normal foods. 

You will be provided with a cool bag to store the study drug.

This ferally funded study . . .

You may already have tenderness in your area.