Welcome to the Research and Patents section of our webpage. 

This front page will reflect our most current information on sponsored research, technology transfer, patents and related law affecting educational institutions. 

 

Draft Guidance on Institutional Review Board Approval of Research With Conditions, 74 Fed. Reg. 57486, Nov. 6, 2009

The draft document, which is available on the
OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and
others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

 

Draft Guidance on Institutional Review Board Continuing Review of Research, 74 Fed. Reg. 57487 Nov. 6, 2009

the guidance addresses the following major topics: (1) Key IRB Considerations when Evaluating Research Undergoing Continuing Review;   (2) Process for Conducting Continuing Review;  (3) Additional Considerations for Continuing Review of Multicenter Research Projects;  (4) When Expedited Review Procedures may be Used by an IRB for Continuing Review;  (5) Determining the Frequency of Continuing Review;  (6) Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review;  (7) Lapses in IRB Approval;    (8) Communicating the IRB's Continuing Review Determination to Investigators and the Institution; (9) Suspension or Termination of IRB Approval of Research or Disapproval of Research at the Time of Continuing Review; (10) Identifying the Point When Continuing Review is No Longer Necessary; and   (11) Continuing Review is Not Required for Exempt Human Subjects Research Projects.

 

August 28, 2009 NACUANOTE: International Academic Travel and US Export Controls

Short summary paragraph from the NOTE:  Academic personnel must consider the potential effect of each set of U.S. export control regulations on the proposed international travel to assure that both the institution and the individual traveler are in compliance. U.S. export control laws are principally concerned with whether the academic traveler will take and then disclose any controlled technology or other controlled information to non-U.S. persons (e.g., in papers or on their laptop computers) or will export any controlled items (e.g., sensors, test instrumentation, reagents, biological materials or other similar tangible goods) to non-U.S. persons. Generally speaking, the EAR considers the shipment or delivery of a tangible good to a non-U.S. person an “export” and regards the disclosure of controlled information to a non-U.S. person a “deemed export

 

 

Responsible Conduct of Research, 74 Fed. Reg. 42126 (August 20, 2009)
Effective January 4, 2010 each institution that applies for financial assistance from the National Science Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project

 

Final NIH Guidelines on Stem Cell Research: 74 Fed. Reg. 32170 (July 7, 2009)

Effective July 7, 2009. These guidelines apply to NIH funded stem cell research. 

 

Amendments made by the Fraud Enforcement and Recovery Act of 2009
The new amendments make changes to liability provisions in the Act and specifically overrule the Supreme Court decision in Allison Engine (below). The law creates a new liability for knowingly concealing or improperly avoiding an obligation to pay money to the government. This includes retention of an overpayment, and may thus apply to overcharges to federal grants and contracts. The false statement must be *material* to payment of the claim. It is no longer necessary that the statement be made *to get* the claim paid. Claims may now be considered *false* not only if they are made to an officer or employee of the US government, but can also be made to a recipient of federal funds if the $ or property provided will be spend or used on the government's behalf or to advance a government program or interest, and if the government, will reimburse the recipient for any portion of the money requested or demanded. See Fraud Enforcement and Recovery Act of 2009 Increases Risk for Higher Education by Holland and Knight.

 

 

Advance Notice of Proposed Rulemaking, 74 Fed. Reg. 21610, May 8, 2009, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors; Request for Comments; Comments due by July 7, 2009.

Recognition of the growing complexity of biomedical research, the increased interaction between Government and the private sector in meeting common public health goals, and recent public scrutiny have raised the question of whether a more rigorous approach to Investigator disclosure, management
of conflicts, and Federal oversight is required. The possibilty of more comprehensive guidelines based upon five listed principles is being explored.

 

 

NIH Stem Cell Draft Guidelines: The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled "National Institutes of Health Guidelines for Human Stem Cell Research" (Guidelines).

The purpose of these draft Guidelines is to implement Executive Order 13505, issued on March 9, 2009, as it pertains to extramural NIH-funded research, to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.

 

OHRP Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and IRBs Dated March 24, 2009 Intended for Investigators who conduct, and IRBs that review, genetic research involving human subjects that is conducted or supported by HHS. The Guidance states that investigators and IRBs should consider whether and how the protections provided by GINA should be reflected in informed consent documents, and includes sample language that investigators and IRBs could consider including in such documents.

 

Advanced notice of proposed rulemaking; request for comments, 74 Fed. Reg. 9578 (March 5, 2009) The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments on whether OHRP should pursue a notice of proposed rulemaking (NPRM) to enable OHRP to hold institutional review boards (IRB) and the institutions or organizations operating the IRBs, hereafter referred to as the IRB organizations (IORG), directly accountable for meeting certain regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects. Historically, OHRP has only enforced compliance with 45 CFR part 46 through the institutions that were engaged in human subjects research. This has been the case even in circumstances when a regulatory violation was directly related to the responsibilities of an external IRB that was designated on the engaged institution's assurance of compliance with OHRP. OHRP is considering whether to pursue a regulatory change that would enable the Department to hold IRBs and IORGs directly accountable for compliance with the provisions of 45 CFR part 46 that relate to an IRB's or IORG's responsibilities. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review arrangements and to rely on the review of an IRB operated by another institution or organization.

 

 

Institutional Review Boards; Registration Requirements; 74 Fed. Reg. 2399 January 15, 2009

Effective July 14, 2009, with all committees to be registered by Sept. 14, 2009

This rule adds a new subpart E which  requires institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use by OHRP to register with HHS every three years. This is stricter than the voluntary system which is currently in place, and expands the range of information collected.  The registration information includes contact information, approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. Schools will be able to register online, for both the FDA and the US Dept. of Health and Human Services at the same time. For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under this rule by the three-year expiration date
previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson.

 

Proposed Rule: United States Department of Agriculture Research Misconduct Regulations for Extramural Research, 73 Fed. Reg. 70915 (Nov. 24, 2008)

The U.S. Department of Agriculture (USDA) proposes to establish regulations to implement the Federal Policy on Research Misconduct applicable to extramural research. The proposed regulation defines research misconduct and establishes basic USDA requirements for the conduct of fair and timely investigations of alleged or suspected infractions.

 

 

Final Rule: Proposed Rule: Standards Applicable to Generators of Hazardous Waste; Standards Applicable to Academic Laboratories, 73 Fed. Reg. 72911, Dec. 1, 2008

This rule is effective 12-31-08. EPA is adding a new subpart -- Subpart K -- to the Resource Conservation and Recovery Act (RCRA) hazardous waste generator regulatory requirements. The alternative set of regulations allows eligible academic entities the flexibility to make hazardous waste determinations in the laboratory; at an on-site central accumulation area; or at an on-site treatment, storage, or disposal facility (TSDF). Also, this rule provides incentives for eligible academic entities to clean-out old and expired chemicals that may pose unnecessary risk. Further, this rule requires the development of a Laboratory Management Plan (LMP) which is expected to result in safer laboratory practices and increased awareness of hazardous waste management. Eligible academic entities may also choose to remain subject to the pre-existing hazardous waste generator requirements. Eligible academic entities are colleges and universities, and teaching hospitals and nonprofit research institutes that are either owned by or formally affiliated with a college or university.  See the EPA topical page on this subject.