June 2007 Important Updates to SBU's Human Subject Protections Program (HSPP)
Released June 12, 2007
Our Human Subject Protection Program (HSPP) has many active participants, including Principal Investigators and their study teams, staff of the Office of Research Compliance (ORC), and the membership of our Institutional Review Boards (IRBs). Our combined efforts continue to help ensure that our HSPP is solid and effective in keeping safe those individuals who volunteer to participate in our research activities at SBU.
The ORC and the IRBs are constantly evaluating the program to assess the need for clarifications of current SBU policies and procedures, promulgation of new policies and procedures, and dissemination of new federal guidance and regulations. The following is a summary of such actions that have been taken or proposed over the past year, including some clarifications of unchanged policies and procedures, since our last update in December 2006.
It is extremely important that you review this information with all members of your study team.
I. Establishment of the Human Radiation Research Committee (HRRC)/ New Radiation Risk Language Required for Informed Consent Documents
The ORC (Office of Research Compliance) and the CORIHS committees announce the establishment of the Human Radiation Research Committee (HRRC). The HRRC is a sub-committee of, and reports to, the CORIHS committees. Current membership includes Dr. Nand Relan (Chair; Medical Physicist), Mr. Edward O’Connell (SBU’s Radiation Safety Officer), and Dr. Cora Cabahug (Chief, Nuclear Medicine).
All research procedures involving ionizing and non-ionizing radiation (radioactive materials) must be reviewed and approved by the HRRC prior to commencement. The only exceptions are BNL studies, which undergo a distinct review through that entity.
The ORC will review all submitted IRB proposals for use of radiation/radioactive use and will forward copies of applicable studies to the HRRC for review. HRRC findings will be sent by the ORC to the investigator for appropriate action. IRB and HRRC modifications must be satisfied in order to secure IRB approval for the activity in question.
Specifically, the HRRC will:
- review and assess dosimetry calculations and risk associated with diagnostic and therapeutic procedures specifically conducted for research purposes (e.g., radiographs, CT scans, fluoroscopy, DEXA scans, PET/SPECT scans or radio-isotope administration etc).
- ensure that the risk from radiation in research procedures is acceptable based on scientific value of the procedure, and based upon the subject population being studied. The goal is to minimize the risk from radiation as much as possible.
- provide information necessary to ensure that the subject’s informed consent document and consent process is accurate, valid, and relayed to the subject in lay language.
Effective July 1, 2007, all consents for activities involving ionizing and non-ionizing radiation/ radioactive material use must contain the boilerplate text available here:
http://www.sunysb.edu/research/humans/policies/HRRC%20RADIATION%20RISK%20STATEMENT.pdf
II. New Confidentiality/Privacy Section Language for Informed Consent Documents
The language in the confidentiality/privacy sections of consent has been simplified to the 7th-8th grade reading level, according to the Flesch-Kincaid Readability Scale (which is an MS Word ‘tool’—use it in drafting your consent forms!).
The final boilerplate language, available through the link below, must be included in all consent documents received/reviewed on or after July 1, 2007:
http://www.sunysb.edu/research/humans/policies/FinalConfidentialityPrivacySection.pdf
Directions are provided that address the need to include or exclude certain subsections because ‘one size may not fit all’ for a particular study.
III. Hospital QA/QI vs. Research Activities: Which is which?
Policy and guidance has been formulated by the ORC, SBUMC’s Division of Medical and Regulatory Affairs, and other key hospital officials to distinguish between QA/QI initiatives and research activities.
QA/QI initiatives are a mandated function of our hospital. Some of these initiatives are implemented after thorough evidenced-based best practices are identified, in response to an identified safety issue, or to improve the delivery of care and avoid potential safety issues. The overarching intent of the initiatives is continuous monitoring of hospital operations and improved care of our patients here at Stony Brook University Medical Center.
Pending issuance of definitive policy or guidance from the federal level, please review the new “Quality Assurance/Quality Improvement (QA/QI) Activities vs. Research Activities (Policy and Guidance)” , available at http://www.sunysb.edu/research/humans/policies/QA-QI%20vs%20Research%20FINAL%20051807%20AMEND1.pdf for assistance in determining if the activity you propose to conduct falls under the jurisdiction of the IRB, or the Division of Medical and Regulatory Affairs.
IV. You know that copy of the consent document you give to each research subject?
The document that you give the subject to keep should be (and for studies under FDA jurisdiction, must be) a copy of the consent form that has been signed by the subject and the person obtaining consent!
Please e-mail me at jmatuk@notes.cc.sunysb.edu if you would like to see a particular topic covered in future updates. We will do our best to comply!
As always, the ORC Website has all the current information and current applications you need:
http://www.stonybrook.edu/research/humans/humansubjects.html
Our Human Subject Protection Program (HSPP) is always undergoing review and is frequently updated. . When you need to complete an application or form, always download it directly from the web, to ensure you are using the most current version. The best way to stay up to date with changes made to our HSPP is to visit the website often.
If you have any questions about any of the information above, please feel free to contact me at jmatuk@notes.cc.sunysb.edu, phone (631) 632-9036.