Compliance Hot Topics

Vertebrate Animal Section

Wondering whether you need to complete the vertebrate animal section of an application? The NIH Office of Laboratory Animal Welfare has put together a helpful fact sheet for applicants. Here you will find an overview of the requirements for each of the 5 points of the vertebrate animal section, as well as a clear explanation of who needs to complete this section.

Repeating Initial Consent or Parental Permission

Informed consent and parental permission should be viewed as an ongoing process. The regulations do not explicitly describe all of the circumstances that might require repeating or supplementing the informed consent process.

Protecting Participants in Human Subjects Research

The Presidential Commission for the Study of Bioethical Issues today issued its report, “Moral Science: Protecting Participants in Human Subjects Research," concerning federally-sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk.

Guide for the Care and Use of Laboratory Animals

The NIH has determined that it will adopt the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide) effective January 1, 2012. In OLAW's judgment, the 8th Edition of the Guide empowers continued advancement in the humane care and use of vertebrate animals in research, research training, and biological testing.

Animal Research in Scientific Publications

The publication of research articles involving animal studies is central to many disciplines in science and biomedicine. Effective descriptions in such publications enable researchers to interpret the data, evaluate and replicate findings, and move the science forward.

Exculpatory Language in Informed Consent

On September 7, 2011, the Office for Human Research Protections (OHRP) and the Food and Drug Administration announced in the Federal Register the availability of a joint draft guidance document entitled, “Guidance on Exculpatory Language in Informed Consent,” and are inviting public comments on that document.

Updated Written IRB Procedures Guidance

The Office for Human Research Protections (OHRP) has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP’s January 15, 2007 guidance on this topic.

Guidance of Reporting Incidents to the OHRP

This guidance has been updated to clarify what information regarding serious or continuing noncompliance by the institutional review board needs to be reported, to include an e-mail address to report incidents to OHRP, and to update OHRP's contact information.

Contacts

Denise Ehlen, Director
262.472.5212
ehlend@uww.edu

Erica Johnson, Research Services Specialist
262.472.5212