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Final NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research (June 30, 2016)

The National Institute of Health (NIH) published its Final Policy on the Use of a Single Institutional Review Board for Multi-Site Research on June 30, 2016.  The NIH's stated goal with this new policy is to streamline and enhance the ethical review process.  While some multi-site research is conducted at the University of Richmond, the impact of this policy could facilitate more participation in multi-site studies by UR researchers.  For a review of this policy (to be effective on May 25, 2017) see the Quorum Review's article.

AY 2016 - 2017 IRB actions will use irb@richmond.edu

IRB actions are conducted through the email account of the IRB,  irb@richmond.edu .  New proposals, correspondence with the Chair, and other IRB activities can be conducted through this account.   If you have any questions on the use of this account, please feel free to address them to irb@richmond.edu.

The 2016 International Compilation of Human Research Standards is Now Available

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 120 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.  The 2016 edition was released on November 5, 2015 and is now accessible in both Word and PDF formats:http://www.hhs.gov/ohrp/international/index.html .  The updated edition includes hundreds of updates from the previous edition. Seven new countries are included in the 2016 edition: Burkina Faso, Cote-d’Ivoire, Cuba, Sri Lanka, Trinidad and Tobago, United Arab Emirates, and Uzbekistan.  As in the past, the new edition updates the human research standards based on information provided by in-country experts.

Embrace of Deception in Experiments Puts Social Scientists in an Ethical Bind

This article by Paul Basken from September 14, 2015 issue of the The Chronicle of Higher Education raises questions about the ethics of deception in research.

Substantial Changes to the "Common Rule" proposed by the U.S. Department of Health and Human Services.

In the September 8, 2015 edition of the Federal Register, the U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  The NPRM can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf.  Action on these proposals is expected during September 2016.  For information on these proposed changes visit http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.

 

UR IRB Schedule for Academic Year 2016 to 2017 Approved

The University of Richmond IRB approved a new meeting schedule for AY 2016 to 2017.  Dates for these meetings can be found under the schedules section of this website.

Notice of Memorandum of Understanding Between NIH and NSF Concerning Laboratory Animal Welfare  (Notice Number: NOT-OD-15-139)

As of August 10, 2015 "NIH and NSF operate under a MOU to ensure consistent and effective oversight of the welfare of animals used in activities funded by the NSF. The agreement provides a framework to enhance communication and harmonize the agencies' efforts while reducing regulatory burden to supported institutions. The MOU is posted at http://grants.nih.gov/grants/olaw/references/mou_nsf.htm."

Article available on the risks and benefits of qualitative research.

The August 2015 edition of The PRIM&R Research Ethics Digest was published on August 15.  The digest features an interesting article on the benefits of qualitative research.  The article, titled "Considering the Risk/Benefit Ratio of Qualitative Research" is available HERE.

Book criticizes the IRB system in the United States. 

A book by Carl Schneider, "The Censor’s Hand", targets the Institutional Review Board (IRB) system in the United States.  Schneider argues that -- on the whole -- IRBs do more harm than good.  The book reflects views somewhat similar to those expressed in Zachary M. Schrag's 2010 book "Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009".  Institutions such as the University of Richmond are required by the federal government to have an IRB and operate in accordance with an institution-specific Federalwide Assurance (FWA) agreement.  Without an IRB or FWA, University of Richmond scholars would be ineligible for federal (and some other) funds.  Some journals also require IRB action on research contained in article submissions.

Weighing Benefits and Risks in a Drug Trial

This March 2, 2015 Wall Street Journal article explores the benefits and risks of a drug trial where the subjects, who are children, many not entirely benefit from a new drug.  Access the article HERE.

Human-Subject Researchers Wait in Vain for New Rules

By Christopher Shea (Chronicle of Higher Education, November 4, 2014)

"Many social scientists, like anthropologists and oral historians, argue that the rules should not apply to them." However, as this Chronicle of Higher Education article points out, there has been no action on a 2011 report that urged streamlining of IRB procedures. 

Harvard Researchers Used Secret Cameras to Study Attendance. Was That Unethical?

Cited by some as an innovative way to measure attendance, by others as an intrusion on privacy.  This November 6, 2014 article from the Chronicle of Higher Education cites IRB approval although the actual determination was that the procedure was "not human subjects research."

"The curious state in which survey research finds itself"

An article from the August 28, 2014 Chronicle of Higher Education discusses the imperfect state of survey research and the risks associated with online and other surveys.

When Researchers State Goals for Clinical Trials in Advance, Success Rates Plunge, Chronicle of Higher Education, August 5, 2015


The stigma around null and negative findings is discussed in a review of NIH study outcomes.  The article states that before 2,000 "57 percent of large-budget trials for cardiovascular disease attributed a positive effect to a drug or dietary supplement, according to a study published on Wednesday. After the new requirement [that scientists state their objectives ahead of time], the success rate dropped to just 8 percent..." The complete article can be accessed HERE.

Use of Social Media in Research



Two March 24, 2015 IRB Quorum articles discuss the use of social media in research.  The use of Facebook is discussed in Using Facebook to Improve Recruitment and Retention in Clinical Trials.  A more general article on the use of social media is discussed in the article, Research 2.0: Embracing Social Media in Clinical Trials.

Facebook Research in the News


The IRB Chair has received many questions about Facebook's recent revelation that it conducted research on 700,000 of its users without their prior knowledge or consent.  Was Facebook required to submit its proposed research to an IRB?  In a word, "no."

Generally for-profit companies such as Google and Facebook are not required to submit research proposals to an IRB.  Much of the research that the public is exposed to (market research, polls, Facebook trolling of user habits, etc.) has not been, and does not have to be, reviewed by an IRB.

However, if the for-profit company is receiving federal funds, they may be required to have their proposed research approved by an IRB.   OHRP’s regulations principally apply to entities “involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS)”.  That said, many federal agencies have tied themselves to OHRP rules by adopting and adhering to “The Common Rule” which commits the federal agency to comply with Subpart A (the main body) of 45 CFR 46, which are the basic regulations for the protection of human subjects of research.  In addition, thousands of “institutions” (colleges, universities, hospitals, research labs) have signed  voluntary “Federalwide Assurance” agreements with OHRP in which the institution (e.g. the University of Richmond) voluntarily agrees to apply 45 CFR 46 to all of its research, whether or not the research is funded by HHS or another federal agency.  As this is voluntary, the main “enforcement” requiring IRB reviews are the policies of many journals or grantors that refuse to consider human subjects’ research that has not been reviewed by an IRB.

Further complicating things, the FDA, NIH, NSF, UR and others have additional regulations or policies that supplement the basic HHS regulations, which are a ceiling and not a floor.

The bottom line is that what Facebook did is very likely legal and was not reviewed by, or required to be reviewed by, an IRB.

Should Facebook and others be required to submit proposed research to an IRB?  The answer to this question also “depends”.  IRB review unquestionably leads to more ethical research with human subjects.  However, IRB review also poses barriers to research that could not be feasibly conducted if reviewed by an IRB.  Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 by Zachary M. Schrag makes the case that IRBs have greatly overstepped their original purposes.  The fact that virtually every responsible university in the United States has chosen to establish IRBs speaks to the view that IRBs are necessary.

More National News on Human Subjects Protection


The Chronicle of Higher Education reported on May 27, 2014 about tensions between NIH and OHRP. In addition "the OHRP has also acknowledged a sharp drop in the number of formal investigations it has been conducting, from 91 in 2001 to just one last year, leaving even its allies unsure whether it has been slacking off, grown vastly more efficient, or perhaps become paralyzed by the political intrigue.  Better practices by universities and their institutional review boards are the most likely explanation for the declining enforcement rates, said Edward Greg Koski, an associate professor of anesthesia at Harvard University who led the OHRP for its first two years, starting in 2000. But Dr. Koski admitted that, right now, "none of us know truly what is going on" inside the agency."

National Research News


In a June 23, 2014 article titled "Liability in the Lab: UCLA Case Sends a Signal to Universities" the balance between student experience and a professor's responsibility is examined as a lab director chooses a plea agreement by which he avoids jail time but is held responsible for a fatal accident in his laboratory.

Proposed Changes to Simplify Federal Regulations (Proposed in 2011; still no action taken in 2015).

In 2011, The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP)developed and invited comments on the document "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators".  This document and the comment periods that followed led many researchers to expect simplification and clarification of federally required protections of human subjects of research. Action on this proposal has been delayed and there is little indication that action is imminent.  As of August 25, 2015, the regulations in place before 2011 remain in effect.

General News Posting Practices.  The posting of articles on the University of Richmond IRB website does not constitute endorsement by the University of Richmond IRB.  The articles are presented to reflect discussions that are taking place in the realm of human subjects' protection.  Please adhere to the policies of the linked organization(s) should you wish to print or forward the article.