NEWSLETTER

FALL 2016

Involving Pregnant Women in Research

 

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Determining whether or not pregnant women are involved in research can seem complicated. However, by answering a few questions, the process to determine inclusion of this population under the regulatory requirements of 45 CFR 46 Subpart B is relatively simple.

One of the first questions to ask is whether pregnant women will be included in the anticipated subject population (either specifically or incidentally). If not, Subpart B does not apply.

If pregnant women could be subjects because of the age range of the population, etc., the next question to resolve is whether their pregnancies will be revealed through the screening procedures.. Now keep in mind this applies either incidentally, through taking part in open-ended study procedures like focus groups or interviews where a participant may volunteer this information, or by asking explicitly, testing, or checking medical records for pregnancy.

If you identify that a women is pregnant as part of the screening process, the next question to ask is whether she will be removed from the study because of her pregnancy. If yes, you are not including pregnant women. If no, pregnant women will be included, and Subpart B does apply to the research project.

With a retrospective data-only project, pregnant women are considered to be included only if they are pregnant at the time of data collection. Thus, if the date range for the project is not prospective or you have to wait until post-pregnancy to collect the information, pregnant women would not be considered part of the research.

We have created a decision chart for pregnant women. The chart also includes prisoners. It can be found on our website on the Recruitment and Consent Page under Research Involving Vulnerable Populations.

As always, if you need assistance determining whether pregnant women are included in your study, please contact RSPO, we are always glad to help!

 

Researcher Training – Financial Conflicts of Interest, Human Subjects, and Good Clinical Practice

 

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Wait, again? Now what? Over the past few months, you may have noticed a lot of information swirling around regarding research-related training. Earlier this year, Research Compliance published a new Researcher Training Policy and Matrix that expanded and clarified training requirements for research teams. Then, many researchers were due to renew their research Financial Conflict of Interest (FCOI) training this fall. And then, NIH published a new policy regarding Good Clinical Practice (GCP) training, so we revised the training policy once again.

If you’re feeling a little lost, you are not alone! Research Compliance has created a comprehensive summary of what you need to do to get caught up with the policy and the new requirements. Our goal is to get everyone in compliance by the end of the month.

CLICK HERE for the Ultimate Guide to Research-Related Training!

You can also find this guide and more information on the Research Compliance Training and Education website.

So, what’s actually new?

Per NIH policy, Good Clinical Practice (GCP) training is now required for researchers involved in the conduct of Clinical Trials as defined by NIH. This includes clinical trials of behavioral interventions.  Biomedical clinical trial staff have likely already completed GCP training and don’t need to do anything else right now, but all clinical trial staff should verify their requirements and make sure they are up to date. Review the Research-Related Training Requirements Matrix to determine whether this requirement applies to you, and check with your supervisor to determine which GCP training modules you should complete in CITI.

CHR managers and supervisors will also be receiving an email with an updated list (current as of November 21) of their direct reports’ CITI training records. Note that this list shows courses that have been completed and when they expire — it does not flag employees who need to take a new course but have not done so. Therefore, managers need to refer to the Research-Related Training Requirements Matrix to identify which courses each of their employees needs to complete, and then check the CITI list to see if they have done so.

 

 

Policy Updates

•             NWRC.HRPP.32, IRB Review of the Informed Consent Process – Minor changes to clarify certain regulatory requirements, include instructions for documenting consent for participants with physical disabilities that preclude them from signing, and bring procedures in line with current practices.

 •             NWRC.SEC.03, Disclosing Information about New Industry-Sponsored Research Proposals and Grants to the RFTC – Scope clarified to reflect the goal of avoiding inappropriate disclosures of confidential KP pharmacy information to prospective funders. Procedures revised to include greater detail on how the RFTC receives the required information.

 

 

IRB Tips and New Information

Tips

Waiver of consent not allowed for FDA regulated studies

When research is FDA-regulated, there are no provisions for an IRB to approve a waiver or alteration of informed consent. Therefore, the consent procedure must include all required elements of informed consent and be communicated by the investigator or designee to each participant or legally authorized representative.

The regulations do allow for a waiver of signed consent, and there are provisions for a waiver in emergency situations when a participant is in a life-threatening situation. For additional information on these requirements, please contact the RSPO.

IRB review of research conducted at external collaborating sites

The External Sites page of the IRQ will ask you to identify each external site that is engaged in the research in collaboration with KPNW.

Questions 5 and 6 (see Fig. 1 below) relate to IRB review of research conducted at an external site:

5. Will the external site’s IRB review the research?

6. Will the external site rely on this institution's IRB?

Select “No” for question 5 and “Yes” for Question 6 if you want the external site to rely on the KPNW IRB for review of the study (other site cedes). Select “Yes” for Question 5 and “No” for Question 6 if there is no ceding request.

Please contact RSPO if there is a situation where you believe the correct answer to both questions would be “Yes” or if you believe both should be “No.”

Fig. 1. Add an external site

Fig. 2. External Sites page of the IRQ listing an external site