NEWSLETTER

WINTER 2021

Breaking Down Continuing Review

I think the number one question we get at the IRB is about the annual review/check-in process for minimal risk projects and how to handle an approaching expiration or “Next Report Due” date. Here are some things to bear in mind:

  1. There have been a few changes to both regulations and IRB procedure in the last year, so we understand current expectations may be different from what you’re used to.
  2. Brooke Wainwright has been helping the IRB to keep on top of expiring studies, so you may be hearing from her if you need to act on your study.
  3. Automated emails regarding ‘Next Report Due’ from IRBNet are inaccurate for ceded studies. We regret the confusion and are working with our national KP partners to get these revised to differentiate between ceded studies and those that do not require action.

Generally, minimal risk studies fall into one of three categories that affect the annual review/check-in process:

  • Expedited studies with an expiration date – Prepare an IRBNet package and create a Continuing Review Form from the Designer page. The package should be submitted 4-6 weeks prior to the study expiration date.
  • Exempt and expedited studies with no expiration date - If no changes to study or staff are requested, no action is required by study staff. The study team only needs to update the IRB regarding proposed changes to the approved study plan. After three years, the IRB will check in with the study team to make sure that the study is still active and unchanged.
  • Ceded studies overseen by an external IRB - Upon receipt of the continuing review approval letter from the reviewing IRB*, prepare a package in IRBNet and upload the approval letter. If the protocol or any other locally relevant documents were also modified in the last year, include the most recent versions of the revised materials in the package. If the reviewing IRB does not issue approval letters (this is rare), a screen shot of the new expiration date will suffice.

*We realize that in certain situations the CR approval letter may not be available until close to or even after the ‘Next Report Due’ date. If you anticipate a delay in making the submission deadline, please contact the IRB to make them aware.

Consent Information Sheet Template Now Available

We’ve developed a Consent Information Sheet Template for study teams to use in many situations that do not require documentation of consent (physical or electronic signature). A consent information sheet is most useful when you are collecting verbal or passive consent for surveys, interviews, and other minimal risk activities. The template makes it easy to develop a consent document and ensures that all elements of consent are included. It even has HIPAA authorization language in it in case you are collecting PHI! I know, I’m excited too.

Note that the information sheet is not suitable for use with studies that involve complex study designs, investigational agents/devices, or a risk of harm that is greater than minimal.

Inquiring minds want to know – Tips on Submitting an Inquiry

The Inquiry Form captures a lot of information for a wide variety of activities, which can sometimes make it feel overwhelming. We’ve done our best to refine the form to make it more user-friendly. You’ll see that we’ve made the different sections collapsible so if you know a section doesn’t apply to you, you can just leave it collapsed. If you’re not sure, it’s important to read each section carefully and provide the requested information when applicable. Here’s a quick summary of the information we’re looking for in each section:

  1. Summary – This is your chance to explain to us in lay language the purpose of your project and how you will accomplish your aims.
  2. Research or not research – Certain activities (quality improvement, public health surveillance, case studies) do not meet the definition of research, so the IRB doesn’t need to oversee them. Activities like public health surveillance and case studies are usually pretty cut and dried, but QI can overlap with research in ways that can be tricky to tease apart. Be sure to clearly describe any elements of QI and/or research in the project summary in section one.
  3. Human subjects – If your project doesn’t involve identifiable data or interacting with participants (even an anonymous survey would constitute an “interaction”), it qualifies as ‘not human subjects research’ and the IRB doesn’t need to oversee it.
  4. Engaged in research – If KPNW employees are not consenting, collecting data, or performing analysis of identifiable data, we may not be engaged. Do your best to answer the questions and provide any clarifying information that would delineate how KPNW is (and is NOT) involved in the study.
  5. Genetic information – The state of Oregon has special protections in place regarding the use of genetic information for research. If your project uses genetic specimens or data, the IRB will want to know the level of identifiability and how the project will comply with the Oregon Genetic Privacy Law (detailed in Section 5.3 of the Inquiry Form).
  6. Protected Health Information – This section is designed to help the IRB understand whether PHI is being used/disclosed for research or purposes other than research. The majority of inquiries fall into the first three selections, but read carefully to make sure it matches the information provided in prior sections. If no selection describes your project, use the ‘other’ field to tell the IRB if the data is health information, if it could be used to identify an individual, and if you are using it for research or non-research purposes.

Policy Updates

No substantive changes since the last newsletter.

Mark Mac’s Media Corner

*Sarcasm Alert* While we’re all working hard trying to solve the global pandemic crisis, it’s important to remember who the real unsung heroes of this crisis are. Day in and day out, rain or shine, conspiracy theorists are in the basement of their parents’ homes, tirelessly weaving the kind of nightmares that would make Phillip K. Dick blush. Did you know that COVID-19 is spread by 5G cell phone towers? Me neither!!! For your consideration, a round-up of the Top 10 COVID-19 conspiracy theories brought to you by Cornell University’s Alliance for Science.

Mark Mac’s Contest Corner

Thanks to everyone who participated in last quarter’s contest. We had such a great response that we’ve decided to repeat it again this winter. The winner of the winter contest will receive a hand carved apple wood soup spoon. Send your entries to mark.j.mcnamara@kpchr.org. All correct entries will be entered into a drawing to win the spoon! Here’s your question:

The Common Rule for research outlines ‘basic’ and ‘additional’ Elements of Consent. Basic elements are required and the additional elements are added as appropriate. Which of the following is NOT a basic element of consent?

  1. A description of the purpose of the research
  2. A description of any foreseeable risks or discomforts to the subject
  3. The expected duration of a subject’s participation
  4. The approximate number of subjects involved in the study
  5. None of the above