Recently Filed Comments
The PRIM&R Public Policy Committee oversees the development of oral or written comments on particular policies that it determines are relevant to PRIM&R's mission and warrant PRIM&R's input. PRIM&R's most recent comments are listed below.
April 2013 – In March 2013, the National Science Board, the policy and advisory board of the National Science Foundation, issued a request for information (RFI) titled Reducing Investigator’s Administrative Workload for Federally Funded Research. The RFI sought input from principal investigator’s on Federal policies and institutional requirements that increase the administrative workload of investigators. In their response, PRIM&R advocated that any attempts to reduce administrative workload should remain directed at protecting research subjects.
October 2012 - PRIM&R submitted comments to Congressman Edward Markey, (D-MA), on a bill titled “Trial and Experimental Studies Transparency (TEST) Act of 2012”, which sought to increase transparency of clinical trials by expanding reporting and registration requirements for ClinicalTrials.gov. PRIM&R expressed support for increasing transparency of clinical trials, but cautioned that preliminary steps should be taken to analyze the efficacy of the current process before attempting to expand its requirements.
October 2011 – Following the July 26, 2011 publication of the Advance Notice of Proposed Rulemaking on human subjects research protections, the OHRP solicited feedback on the questions posed in the notice. PRIM&R responded with specific recommendations on the broad spectrum of topics put forward in the notice, including informed consent, privacy, centralized review, calibrating level of review to level of risk, and post-IRB human subjects protections.
August 2011 - PRIM&R submitted a request to the Department of Health and Human Services’ Office of Human Research Protections (OHRP) that the comment period for the Advance Notice of Proposed Rulemaking proposing changes to the “Common Rule” published July 26, 2011, be extended from 60 days to 120 days.
April 2011 - PRIM&R drafted these comments in response to the Request for Comments on Human Subjects Protections in Scientific Studies by the Presidential Commission for the Study of Bioethical Issues. In their response, PRIM&R urges the Commission to consider, and address, the current regulatory requirements for obtaining and documenting informed consent.
July 2011 – The American Psychological Association put out a request for comments regarding the revised Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research. PRIM&R responded by commending the APA for their commitment to ethical conduct and making a suggestion for the further clarification of the Guidelines.
June 2011 – In response to a request for comments on the revised International Guiding Principles for Biomedical Research Involving Animals, PRIM&R submitted comments to CIOMS/ICLAS. PRIM&R supports the guidelines, which they describe a morally comprehensive, but would like to see explicit requirements for education for research personnel.
March 2010 - PRIM&R developed these comments in response to the FDA's proposed rule on informed consent. PRIM&R supports efforts to fully inform potential research subjects of the risks, benefits, and alternatives potentially encountered as a result of participating in research. However, PRIM&R has two serious concerns with this proposed rule.
January 2010 - PRIM&R filed comments in response to OHRP’s Draft Guidance on IRB Approval of Research with Conditions. PRIM&R believes this draft guidance document is helpful, but has a few questions to further clarify the guidance.
Similarly, PRIM&R commented this month on OHRP’s Draft Guidance on IRB Continuing Review of Research.PRIM&R asserted that the draft guidance was helpful in clarifying ambiguities and had several suggestions to make the document clearer.
July 2009 - The Association for the Accreditation of Human Research Protection Programs (AAHRPP), of which PRIM&R is a founding member, recently issued a request for public comment on its "Proposed Revised Accreditation Standards." PRIM&R issued comments, along with those submitted by La Cesta Consultants, LLC and HRP Associates, LLP.
June 2009 - PRIM&R filed comments in response to OHRP's request for public comment on IRB accountability. PRIM&R expressed support of the general proposal to hold institutional review boards (IRBs) and the institutions or organizations operating the IRBs, directly accountable for meeting regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects. However the comments state that "PRIM&R would not however, support a regulatory change primarily promulgated to reduce institutional administrative burdens, if they might diminish protections for human subjects. Cooperative review agreements should not be used to waive, transfer or weaken the responsibility of the institution or investigators conducting the research to protect human subjects and to comply with the federal regulations and ethical principles that govern human subjects research."
January 2009 - OHRP recently invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.
PRIM&R's Public Policy Committee developed comments that request further clarification about the ongoing responsibilities of the investigator and IRB toward subjects who's participation in a study has terminated. Please review PRIM&R's comments.
September 2008 - PRIM&R's board chair in 2008, Leonard Glantz, JD, responded to a request for information from the Office for Human Research Protections (OHRP) on Human Subjects Protection Training and Education. In his comments, Mr. Glantz stated that it is not necessary for an education requirement to "prescribe in detail the process, content, or evaluation" of an educational program. He instead proposed a framework for education regulation based on institutional discretion.
June 2007 – In June 2007, the Food and Drug Administration (FDA) issued a guidance document titled Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting. The guidance document was based on the agency's request for information on adverse event reporting in March 2005, upon which PRIM&R commented. In this response, PRIM&R urges the FDA to provide addition guidance as outlined in their previous set of comments.
April 2007 - PRIM&R board chair in 2007, Pearl O'Rourke, MD, responded to an article titled "As Ethics Panels Expand Grip, No Field is Off Limits," that was published in the New York Times. In her response, Dr. O'Rouke stressed the need for and value of the work of institutional review boards (IRBs) in justifying and minimizing risk whenever possible.
January 2007 - In January 2007, the Office for Human Research Protections (OHRP) released Draft Guidance on Engagement of Institutes in Human Subjects Research. In their comments, PRIM&R commended OHRP for their efforts to clarify the current policy and suggested two points of clarification.
November 2006 - In response to the release of the Food and Drug Administration's (FDA's) Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research, PRIM&R proposed several sections that could use further clarification, including the study design and IRB requirement sections.
January 2006 - PRIM&R responded to the Office for Human Research Protections (OHRP) Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others in January 2006 by providing recommendations in three general categories: harmonization of Food and Drug Administration (FDA) and OHRP/National Institutes of Health (NIH) guidance, reporting requirements, and reformatting of the draft guidance.
May 2005 - The Applied Research Ethics National Association (ARENA), PRIM&R's former membership arm, responded to questions put forth by the Office for Human Research Protections (OHRP) on the Proposed Criteria for Determination of Equivalent Protections, drafted in May 2005.
April 2005 - The Applied Research Ethics National Association (ARENA), PRIM&R's former membership arm, responded to the Food and Drug Administration's (FDA's) request for comments on adverse events. The topic of institutional review board (IRB) review of data and safety monitoring plans was also addressed.
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