MOOCs and Human Subjects Research

Rebecca Armstrong, Director of Research Subject Protection at UC Berkeley, has published an article on the Public Responsibility in Medicine and Research (PRIM&R) blog, Ampersand.

The article, Getting ahead of the wave: MOOC’s and human subjects research, discusses the issues of massive open online courses (MOOCs), educational research, and, by extension, human subjects research and IRB review.

USDA Creating New Foundation for Food and Agricultural Research

The U.S. Department of Agriculture has announced the creation of a new Foundation for Food and Agricultural Research (FFAR), that will “leverage public and private resources to increase the scientific and technological research, innovation, and partnerships critical to boosting America's agricultural economy.”

FFAR was authorized by Congress as part of the 2014 Farm Bill and will operate as a non-profit corporation seeking and accepting private donations to fund research activities that focus on problems of national and international significance. Congress provided $200 million for the foundation which must be matched by non-federal funds.

FFAR will fund research in areas that include plant and animal health; food safety, nutrition and health; renewable energy, natural resources, and environment; agricultural and food security; and agriculture systems and technology.

AAAS: Federal Budget Process 101

The American Association for the Advancement of Science (AAAS) has published The Federal Budget Process 101. The article, written by Matt Hourihan, Director of the AAAS R&D Budget and Policy Program, provides a step-by-step summary of the complicated annual budget cycle, from the President’s budget formulation, through Congressional appropriations, then to the execution of the budget by federal agencies starting October 1, the beginning of the federal fiscal year.

The AAAS R&D Budget and Policy Program provides detailed and timely analyses of federal research and development funding trends, including, for example, Research and Development Funding in FY 2015 Appropriations.

OACU/ACUC to Launch eProtocol July 2014

The UC Berkeley Office for Animal Care and Use (OACU) and the Animal Care and Use Committee (ACUC) are transitioning from a paper-based protocol submission and review process to a web-based system called Berkeley eProtocol in July 2014. This is the same system that has been in use by the UCB Office for Protection of Human Subjects (OPHS) and the Committee for Protection Human Subjects (CPHS) since 2009. Within eProtocol, the two different protocol systems are designated as eProtocol IACUC (animals) and eProtocol IRB (humans subjects).

eProtocol is a proven system that has not only been in place at Berkeley since 2009, it’s also in use at many other academic institutions, including Stanford University, University of Texas (Austin), Colorado State University, Harvard University, and University of Minnesota, to name a few.

How does this impact you?

• Effective July 1, 2014, all new protocols must be submitted online via eProtocol.
  
  • eProtocol will be available for submissions starting July 30, 2014.
  • New submission received prior to August 25, 2014, will be reviewed at the October 8th ACUC meeting. See the ACUC web site for submission deadlines.
• Protocols due for their de novo (three-year) review in October 2014 must be submitted online via eProtocol.
• Revisions to existing “electronic” protocols (“eProtocols”) will be made using the eProtocol system.
• Annual reviews and revisions to existing “paper” protocols can continue to use the paper-based process up until the protocol’s de novo submission.
• Investigators may opt to submit a revision as a new electronic eProtocol and they are strongly encouraged to contact the OACU Director regarding this possibility.

What are the benefits of eProtocol?

• eProtocol will be a “one-stop shop” for investigators submitting both human and animal research protocols (one PI dashboard to navigate from).
• PIs can designate up to two other people to have “editing” access to the protocol.
• Protocols will be readily accessible online for all team members through “view only” access.
• eProtocol sends automatic email reminders to the PI, Lab Contact and third designated individual on protocol for protocol annual renewals and three-year de novo reviews.
• eProtocol sends automated emails acknowledging receipt of submission, when review questions from ACUC/OACU have been sent to the PI, and when the protocol action has been approved.
• PIs can “clone” (i.e. copy) a protocol and edit from that point or they can choose to cut and paste from a Word document into the text fields in answering questions. Or, both strategies can be used when writing/developing a new protocol submission.
• eProtocol provides secure, worldwide access (where the internet is available) for the PI to work on documents and even submit them.
• Because documents (animal use protocols, review questions, attachments) reside within the web-based system, there are no version control issues.
• After initial protocol submission, annual reviews and subsequent de novo submissions will be greatly simplified.
• eProtocol simplifies the process of revision submission and we anticipate it will speed the approval process along.
• eProtocol will help the PI and ACUC ensure compliance more efficiently and effectively, particularly for USDA-regulated species.