Public Policy
OHRP Releases New Guidance for Human Subjects Research
The Office for Human Research Protections (OHRP) has released a new “Guidance on Engagement of Institutions in Human Subjects Research,” which applies to research involving human subjects that is conducted or supported by the Department of Health and Human Services (HHS). The target audience for this guidance document includes institutional review boards, research administrators, and other relevant institutional officials, investigators, and funding agencies that may be responsible for review or oversight of human subjects research conducted or supported by HHS. The new guidance document replaces two previous OHRP guidance documents from 1999.
View the guidance document.
APPI Submits Comments to the FDA
On September 26th APPI submitted comment letters to the Food and Drug Administration (FDA) in response to the public call for comments on “Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions — Statement of Investigator (Form FDA 1572)” and to the Office of Human Research Protections (OHRP) regarding “Implementation of Human Subjects Protection Training and Education Programs.”
The APPI letter on the Form 1572 urges the FDA to acknowledge certification by a recognized professional organization as a standard of Investigator education and a tool for efficiency in FDA review. APPI feels it is particularly important to highlight the utility of capturing certification information on the Form 1572 for assessing the clinical research educational background of Investigators.
In response to OHRP’s request for information and comments on Human Subjects Protection Training and Education Programs, the APPI letter states that Good Clinical Practices (GCP) are essential knowledge for clinical trial physicians. APPI also encourages OHRP recognition of Investigator Certification as the means to ensure physician Investigators have the minimum competence necessary for oversight of clinical trials and the understanding of human research protection and GCPs.
View the comment letters here: APPI FDA 1572 | HDE Guidance Response
APPI, ACRP Launch Grassroots Campaign to Honor Patient Participants in Clinical Trials
APPI and ACRP have launched a campaign to support a federal effort to honor patient participants in clinical trials. The effort is embodied in U.S. House of Representatives Resolution 248, introduced by Congressman Rick Boucher, which encourages public recognition of clinical trial participants and focuses on the importance of educating the public on the many facets of clinical research in the advancement of medicine and what is entailed in study participation. APPI and ACRP staff has met with Congressman Boucher’s office to offer support for the resolution and to offer APPI and ACRP members’ help in contacting their own U.S. Representatives to urge them to cosponsor the resolution.
How You Can Help
Help recognize the contributions of the millions of men, women and children who participate in nearly 80,000 clinical trials in the United Stated every year. Do your part by urging your Congressional Representative to take action by co-sponsoring Resolution 248. Here’s how:
- Visit the U.S. House of Representatives website at www.house.gov and click on “Write your Representative” in the upper left section.
- Enter the requested information, including your ZIP+4 code, and click “Contact My Representative.”
- When prompted, please write a message. We have provided you a template to use here. Don't forget to personalize this message to create more impact.
- Once your email is sent, please provide a copy of the text and your representative’s name to ACRP staff at kate@acrpnet.org so we may follow up with the contact.
Should you have any questions regarding this campaign, please contact Katherine L. Madigan, MHSA, director of ACRP Government Affairs and managing director of APPI.
Academy of Pharmaceutical Physicians & Investigators Policy Proposal Opportunity
One of the high points of the APPI Program at the ACRP Global Conference & Exhibition each year is the "formal" (in name only) meeting of the members. This year’s meeting during our Boston gathering will be on Saturday, April 26, in the Hynes Auditorium, Room HH 202, from noon to 1:15 p.m. During the meeting, we will conduct an Annual Policy Forum, in which we present and gain comment on public policy proposals from you, the APPI membership. What positions would you like to see APPI weigh in on, either in a public arena (such as comment on legislation or regulations or other matters of current public debate) or with the American Medical Association (AMA) in preparation for its House of Delegates resolution process? To get a matter before our APPI leadership, please send us your thoughts, using freehand or the attached form, describing the policy issue you feel we should address, your rationale for suggesting that APPI get involved (or the resolution you feel we should submit to AMA, and why), and of course the position you feel we should take. You should also include some background, facts at hand, references, best arguments, etc. Of course, it would be best if you could be at the session yourself to make the argument, but if you can't, we'll present it on your behalf. So let us know how to reach you to be sure we can represent your concerns accurately. Please fill out the Policy Proposal Form and send it to APPIcomments@acrpnet.org by Friday, April 25.
Congressional Update
The 110th Congress came to a close on December 12 without acting to pass a final food and drug safety legislative package and the stage has been set for the next Congress to revisit this subject and will likely make changes to this measure.
Rep. Henry Waxman (D-CA) defeated long time House Energy and Commerce Chairman John Dingell (D-MI) for control of the panel in the 111th Congress in a vote on November 20. This Committee was the place where the draft food and drug safety legislative package was being debated over the 18 months. Rep. Waxman, the current chairman of the worked with liberal Democrats who are unhappy with Chairman Dingell to build support for the change and he is also working to secure support among the large incoming freshman class. While both Congressman Waxman and Chairman Dingell have been very critical of the Food and Drug Administration and its operations and funding priorities, Rep. Waxman is likely to revise portions of Chairman Dingell’s current drug safety legislation in order to address his priorities and to have a greater effect on the industry and its government watchdogs. He will also be looking to replace key Committee staffers with his own loyalists from the House Oversight & Government Reform Committee.
These developments, combined with the President-elect Obama’s push on health care coverage reform and other issues before the Committee, will affect the course of this legislation. The possibility remains that food & drug safety provisions may be included in larger health care reform bill next year, but passage of any such measure is far from assured. Delays may also spur key Senate leaders to seek a way to jump start a comprehensive legislative effort to address safety concerns in the areas of drugs, food and medical devices.
As always, ACRP and APPI will continue to monitor the actions on Capitol Hill during this transition period and will advise you about progress of relevant legislation as we continue working with key Members and Congressional staff to continue our role in educating them about effects on clinical trials and on our membership. Please also review the “Bills to Watch” Section below for an update on current legislation and their likelihood to be reintroduced next year.
Use the links below for all of your public policy needs: