NEWSLETTER

FALL 2017

 

Most Published Research Findings Are False

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For an enterprise engaged in research, this provocative headline is virtually existential. How is it possible the product of our work, all our careful planning, is ultimately misleading? This assertion would be dismissed out of hand if it hadn’t been objectively proven that studies testing established medical practice were confirmatory of such in just over one-third of instances.

The threats to research integrity are diverse and span the gamut from the innocent to the insidious. Many common features of research design conspire to reduce the reliability of findings — inadequate power, failures of randomization, lack of blinding, composite outcomes, assumptions and imputations in statistical models, and multiple hypothesis testing. 

Other problems with research findings, unfortunately, result from explicit design decisions and enrollment exclusions. Frequently, these decisions are made with the unstated intent to test a narrow cohort for maximum effect size, then apply the findings generally to maximize revenue (e.g., “indication creep”). Even more common is use of disease-oriented surrogate endpoints, rather than patient-oriented outcomes —  progression-free survival, for example, rather than overall survival, in oncology studies.

Given these threats to validity, it seems reasonable to wonder whether any findings are reliably true by design or just by chance — and it reminds us of our responsibilities as researchers to do our utmost to honor our societal contracts in the creation of generalizable knowledge.

Citations:

Ionnidis JP. Why Most Published Research Findings Are False.
https://www.ncbi.nlm.nih.gov/pubmed/16060722

Prasad V, et al. A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices.
https://www.ncbi.nlm.nih.gov/pubmed/23871230

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New Common Rule: Benign Behavioral Interventions

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With the rollout of the new common rule comes an exempt category that will be of interest to any investigator conducting behavioral research. The category is called “Benign Behavioral Interventions” (BBI). BBI involves the collection of data from adults and is defined as “being brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.” The exemption for BBI research is intended to cover research for which IRB review is likely to add little additional protections because the risk of harm is low and subject autonomy is respected. However, it is important to remember that only the IRB can make the final determination as to whether research fits the criteria for exemption for Benign Behavioral Interventions. Also, certain research that does not meet the requirements for this exemption may be eligible for expedited review.

Additional points to consider when determining whether research is a Benign Behavioral Intervention:

  • Does the research involve only adults? [If no, not exempt BBI]
  • Do the participants have adequate decision-making capacity? [If no, not exempt BBI]
  • Are vulnerable populations excluded? [If no, not exempt BBI]
  • Does the research enable prospective agreement to participate by subjects? [If no, not exempt BBI]
  • If the research involves planned deception, it is included in the prospective agreement by the subjects? [If no, not exempt BBI]
  • Is the research limited to: communication or interpersonal contact, the performance of a cognitive, intellectual, educational or behavioral take and/or manipulation of the subject’s physical, sensory, social, or emotional environment? [If no, not exempt BBI]
  • Is the collection of data limited to: verbal or written responses, data entry by subject or observation of the subject including audiovisual recording? [If no, not exempt BBI]

For more information regarding Benign Behavioral Interventions, go to:
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-august-2-2017.html

 

NIH Releases Updated Policy on Certificates of Confidentiality

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Certificates of Confidentiality (CoCs) help protect the privacy of research participants by allowing researchers to refuse to disclose identifiable participant information in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding — for example, in response to a criminal investigation or court subpoena. A CoC does not prevent researchers from complying with public health reporting requirements or disclosing information pursuant to a participant’s consent. CoCs are issued by the NIH, but may be issued to both NIH-funded and non-NIH-funded studies. The IRB may require researchers to obtain a CoC when a study involves particularly sensitive participant information, such as information about criminal behavior or genomic information.

To further ensure the privacy of research participants and their information, the 21st Century Cures Act mandated that the NIH issue CoCs automatically for research in which identifiable, sensitive information is collected. On September 7, 2017, the NIH issued a policy to comply with this requirement. Effective October 1, 2017, all NIH-funded research that was commenced or was ongoing on or after December 13, 2016, and fits any of the following categories is deemed to have a CoC:

  • Research involving the collection or use of individually identifiable information or biospecimens;
  • Research involving the collection or use of biospecimens or information that carries at least a “very small risk,” as determined by current scientific practices or statistical methods, that some combination of the information and other available data sources could identify the individuals; or
  • Research involving the generation of individual level human genomic data from biospecimens, or the use of such data, regardless of identifiability.

What is changing for researchers?

  • NIH-funded studies meeting the above criteria no longer require an application for a CoC because they are automatically issued one. Non-NIH-funded research can still obtain a CoC through the existing application process, and must do so if required by the IRB.
  • Starting October 1, 2017, the IRB will determine and note on initial and continuing approval letters if the study is covered by an “automatic” CoC.
  • Studies with a CoC, including an “automatic” CoC, must include consent form language (if consent is obtained) that explains the CoC to participants. See the Research Compliance Recruitment and Consent website for template language. This will be required of new submissions received after October 1. Existing studies that fall within the new NIH policy and are still recruiting participants should update their consent forms at the next modification or continuing review; however, re-consent of already enrolled participants is not required.

Regardless of whether a study is covered by a CoC, researchers who receive a request to release participant information to someone who is not associated with the study or otherwise approved by the IRB to receive such information should contact Research Compliance immediately before responding to the request.

 

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

Research Compliance Staff Updates

RSPO would like to extend a warm welcome our two new IRB coordinators, Andréa Volz and Kathrynn Mosley.

If you recognize the name Andréa “Drea” Volz, it’s true, you’ve likely seen it before! Drea worked as a project manager at CHR from 2015 to early 2017, when she left to pursue a position as a medical writer for industry. While she knew she loved writing, analysis, and interpreting complicated information, Drea discovered that she missed the structure and pace of working in a busy office environment as part of a physical (rather than virtual) team.

Along with her stellar analytic and regulatory capabilities, Drea possesses project management experience, which we know will help inform the RSPO team with a more in-depth understanding of the “research side” of IRB work. Drea’s organizational abilities and attention to detail have been noted by her previous employers and led to her to creating style and data collection manuals: skills we look forward to utilizing as RSPO updates our processes to stay current with the regulatory tides. Drea was hired for the position previously held by David Matthews, who retired in August.

Our new IRB coordinator/trainer, Kathrynn Mosley, has many years of regulatory research experience, most recently with the VA. . She worked at the OHSU IRB as an analyst, then transitioned to a research associate/lead regulatory coordinator position (similar to a project manager) with the OHSU Peds Hematology/Oncology department, where she managed over 112 studies! She returned to the IRB world when she was hired as an IRB analyst for the VA, where she quickly was promoted to team lead.

Kathrynn brings a wide array of experience training different types of groups, including study teams, potential researchers, and IRB members. She served on the VA Preventive Ethics Committee and was appointed issues lead for opioid treatment management, which involved identifying the quality gaps related to long-term opioid treatment, conducting analysis of the data and processes, and training others on those findings. Kathrynn lives on a century-old farm with her husband, Doug, where they enjoy herding their eight rescued cats and perfecting homemade pizza recipes. Kathrynn assumed the position previously held by Melinda Allie.

Melinda Allie has transitioned to a new position as quality improvement compliance coordinator and will be doing full-time quality improvement work, building upon the existing Quality Improvement–Monitoring program to further our compliance partnerships with the research community. She will keep her work space in the RSPO office and will support the IRB team on an as-needed basis. 

 

Research Compliance Manager on Leave

Research Compliance Manager Andrea Seykora will be on parental leave from early October to early January. In her absence, please refer to the following chart for assistance:

Topics

Contact

Email

Phone

IRB review or eIRB system

Kaija Maggard, IRB Manager

Kaija.H.Maggard@kpchr.org

503-335-6699

Data/specimen sharing (including agreements and compliance manager access); FCOI; QI Monitoring Program

Melinda Allie, Quality Improvement and Compliance Coordinator

Melinda.J.Allie@kpchr.org

503-335-6753

Unauthorized disclosures of PHI; other compliance questions

Research Compliance Committee

CHRCompliance or

CHR_Compliance2@kpchr.org

 

 

IRB Humor

Quote from a reviewer of a study regarding a statement in the consent form: “This sounds so much like Dr. Seuss. Please tell me Dr. Seuss is the P.I. Your PHI from A-Z, we will retain indefinitely.”