Compliance and Research Protection News

Winter 2007

The number of state and federal regulations that lab researchers have to comply with is mind-boggling, and the administrative structures that grow up around regulatory compliance and oversight are almost as complicated. Don Robinson, Director of EH&S, has created a set of flow charts and matrices for animal use, biosafety, radiation safety, chemical safety and human subjects research. They diagram who does what, who is responsible for what, and illustrate how compliance review and oversight flows from proposal or protocol, through training, review, approval, reporting and post-approval monitoring. They are on the EH&S website at http://www.ehs.umass.edu/Research-Safety.htm.

We spent many frustrating months in the spring of 2006 trying to find an electronic protocol system for UMass to streamline our oversight of research using human or animal subjects. In August 2006 the campus signed an agreement with Key Solutions to purchase their "eProtocol" system. Key Solutions' process for writing and submitting protocols, and reviewing and overseeing them, is very similar to our present paper-based system. To date, we have completed the "train the trainer" phase of implementation and are in the process of tailoring the human subjects and animal use protocol forms to our needs.

In the next few months we will be looking for volunteers to test drive the e-protocol forms. Please contact the IACUC or IRB offices if you are willing to be a guinea pig. You will have all the assistance you need in preparing your eprotocol and we guarantee your eprotocol review will not take longer than it would if you submitted it on the old form.

In October 2006 the Animal Care program welcomed a new Animal Care Supervisor, Alison Bardwell. She will be paying close attention to post-approval monitoring to ensure there is no "protocol drift", and will help us stay on top of items that are common citations by USDA inspectors such as expired medications. The Animal Care Offices are now located in Blaisdell House.

If you have a topic for future newsletters please contact Hilary Woodcock at:

email: hilaryw@ora.umass.edu

______________________________________________________ IACUC

The third IACUC/NSB Roundtable sponsored by the VPR is scheduled for May 2, 2007. Dr Martha McClintock from the University of Chicago will be the speaker, hosted by Dr. Jeff Blaustein in the Psychology Department. Her visit will feature discussions hosted by the IACUC and a research seminar. Dr. McClintock's research focuses on the behavioral control of endocrinology and the hormonal and neuroendocrine mechanisms of behavior, especially the evolutionary function of hormone-behavior interactions. Her data show that, for example, singly housing rats has a negative effect on their immune system and longevity. On the strength of her findings the University of Chicago has implemented major changes in the way her animal care facility is run. This event is still in the planning stage but we anticipate it will follow the same format as previous events with an IACUC Round Table in the morning, lunch with graduate students, lab visits in the afternoon and a seminar at 4 p.m. We expect her seminar to feature her work on the effects of stress on the immune system and longevity. You can find more about Dr. McClintock's research at http://www.hsus.org/web-files/PDF/ARI/pd_reports/PDReport_9_06.pdf.

OLAW has a new brochure titled, "What Investigators Need to Know about the Use of Animals," which provides a quick overview of the requirements and expectations governing animal research funded by the Public Health Service. Because of the terms of our Animal Use Assurance with PHS the information in this brochure is pertinent to all use of vertebrate animals in research at UMass. Barbara will be happy to send you a copy if you call her at 7-0387. You can also order free copies by emailing OLAW at olaw@od.nih.gov.

Relatively new on the OLAW web site is a link to Frequently Asked Questions (with answers) at http://grants.nih.gov/grants/olaw/faqs.htm. These FAQs provide guidance for institutions and IACUCs in implementing the PHS Policy.

On November 9 the NIH announced the "Notice of a Report on the Review of Responses to the National Institutes of Health Request for Information (RFI): Standards for the Care and Use of Laboratory Animal" available at: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-016.html. This informs the research community of the NIH review of submissions to its "Request for Information (RFI): Standards for the Care and Use of Laboratory Animals" to explore whether an update to the Guide for the Care and Use of Laboratory Animals is warranted. After reviewing the submissions the working group found no evidence that the performance standards of the 1996 Guide need revising. However, some submissions recognized areas for improvement which resulted in recommendations for how the Guide might be enhanced for better utilization by NIH-supported investigators. They include:

Make the Guide a living, web-based document and
- Periodically, e.g. every 3-5 years, revise Appendix A with current references;
- Include new references after critical review for scientific validity;
Include updated science-based, peer-reviewed guidelines and reports from scientific and professional societies, e.g. the Report of the AVMA Panel on Euthanasia, and
As information for a component of science increases, new reports, e.g. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (National Research Council, 2003) may be advantageous.

A copy of the group's report to the NIH is at: http://grants.nih.gov/grants/olaw/rfi_lab_animal_standards/RFI-Report.pdf.

______________________________________________ Human Subjects

Federal regulations guiding human subject protection leave much room for interpretation and the Office of Human Research Protections and other sources are continually developing new guidance materials. Check out the OHRP's latest FAQs at http://www.hhs.gov/ohrp/policy/index.html#faq which break down the federal regulations into more manageable bites.

New resources for researchers and people contemplating participating in research that involves human subjects are continually popping up on the web. The University of Southern California has a useful booklet titled "Is Your Project Human Subject Research?" which you can find at http://www.usc.edu/admin/provost/oprs/private/docs/oprs/NHSR_3_6_06_WEB.pdf. It provides some initial guidance about whether human subjects review board approval is necessary. However if you are uncertain about whether your work with human subjects does or does not need IRB review you should also consult with the IRB Human Research Protection Office at 545-3428 or humansubjects@ora.umass.edu, or check with a member of your local Human Research Protection board if there is one that serves your department or college.

Guidelines especially designed for investigators in the social and behavioral sciences and education include "Research Involving Audio, Video or Digital Recordings of Research Participants" and "Subject Recruitment and Advertising". These provide useful guidance for developing appropriate informed consent materials. These and many other resources are at: http://www.umass.edu/research/comply/Guidelines/index.htm.

Another useful new resource, "Students in Research", provides on-line training for student investigators, students who are study subjects, and the investigators who support them. It includes the history of ethical regulations, helpful tips on the IRB review process, what to expect as a subject, and the role of the faculty advisor. This new guidance has been added to the Collaborative Institutional Training Initiative (CITI), the web-based educational program located at https://www.citiprogram.org/default.asp. Also for students, or anyone else contemplating volunteering as a research subject, OHRP has a pamplet titled "Becoming a Research Volunteer: It's Your Decision". You can download it at http://www.hhs.gov/ohrp/outreach/ or get free copies by calling 1-800-444-6472 and pressing 1.

We have used CITI for some time to provide the training to meet the campus requirement for Human Subject ethics training. Recently CITI has added several new modules to their web page including expanded information on the security of health information, good clinical practices and on human subject research in an international setting. The new courses, which have been added to the main course site at http://www.citiprogram.org, include an 18-module "Health Information Privacy and Security (HIPS)" course and a 12-module "Good Clinical Practice (GCP)" course.

The CITI International Training Platform provides basic, foundational information for researchers, research staff, and research ethics committee members involved in international research. The modules provide a general overview of the ethical issues central to conducting human subjects research internationally. Specific discussions include international research ethics, US government guidelines, and international guidelines. It also includes a listing of ethical review links for countries or regions of the world. It is intended to help researchers and their staff identify ethical requirements of their global research partners. Access this information by registering at http://www.irbtraining.org. Topics include:

History and Ethics
Research Review Processes
Informed Consent
International Studies (Resource information/country specific information)
Course Documents (Ethical guidance documents and links to research compliance information)

____________________________________________________ Biosafety

On September 19, 2006 Boston's Public Health Commission voted to adopt new "Biological Laboratory Regulations" requiring research laboratories obtain a permit from the Commission in order to operate a laboratory at biosafety levels 3 or 4 and to register BL2 labs. IBCs must file an annual report with the Commission and the Commission may conduct inspections. Classified research is prohibited if its classification would prohibit the BPHC's complete knowledge of the research. Also prohibited is any research with the potential to enable the use of a high risk agent to serve as a principle component of the biological weapon. These regulations became effective in December 2006.

Proposed state legislation for Massachusetts, currently titled "An Act Promoting Safe Biological Research and Protecting the Public Health and Safety and the Environment", would, if passed, put in place requirements for oversight similar to Boston's for communities statewide. This would add, after Chapter 17 Section 17 of the General Laws, a "Section 18. Biological Agents Registry Program" and "Section 19. High Containment Biological Research Laboratory Health and Safety Program". The December 2006 draft would, among other things, require local boards of health to be informed of the location and nature of select agents and toxins located within local jurisdiction, and require that facilities with a high containment (BL3 or BL4) research laboratoty to obtain a permit from the MA Department of Public Health. If enacted this legislation as drafted will put an additional administrative burden on the compliance offices in EH&S and Research Affairs.

On the topic of state and local oversight of biosafety in research, on November 30th NEBSA (Northeast Biosafety Association) met on the UMass campus hosted by our Biosafety Officer, Maureen O'Leary. The agenda included "The Impact of the Connecticut State Regulations on Biosafety Program Management" presented by Ben Fontes, Yale, and Leslie Delpin, UConn, and "Interpreting the NIH Guidelines" presented by Andy Braun, Harvard Medical School. These were timely topics in light of the pending MA legislation. In general, the Connecticut speakers said that being regulated by the state has added value to their programs by providing them with firm procedures and guidelines. Their interaction with state inspectors has been generally helpful in improving their programs.

If you have been waiting (and waiting) for the 5th edition of BMBL to come out the latest news was that it would come out in January 2007 but it looks as though we will have a bit longer to wait. In the mean time used copies of the 4th edition, now out of print, are selling for over $100 on the internet.

Jump down to contents:

IACUC

Human Subjects

Biosafety




Research Home Compliance Home Animal Use Biological Safety Feedback Forms Human Subjects Research Policies Responsible Conduct Staff	Compliance and Research Protection News Winter 2007 The number of state and federal regulations that lab researchers have to comply with is mind-boggling, and the administrative structures that grow up around regulatory compliance and oversight are almost as complicated. Don Robinson, Director of EH&S, has created a set of flow charts and matrices for animal use, biosafety, radiation safety, chemical safety and human subjects research. They diagram who does what, who is responsible for what, and illustrate how compliance review and oversight flows from proposal or protocol, through training, review, approval, reporting and post-approval monitoring. They are on the EH&S website at http://www.ehs.umass.edu/Research-Safety.htm. We spent many frustrating months in the spring of 2006 trying to find an electronic protocol system for UMass to streamline our oversight of research using human or animal subjects. In August 2006 the campus signed an agreement with Key Solutions to purchase their "eProtocol" system. Key Solutions' process for writing and submitting protocols, and reviewing and overseeing them, is very similar to our present paper-based system. To date, we have completed the "train the trainer" phase of implementation and are in the process of tailoring the human subjects and animal use protocol forms to our needs. In the next few months we will be looking for volunteers to test drive the e-protocol forms. Please contact the IACUC or IRB offices if you are willing to be a guinea pig. You will have all the assistance you need in preparing your eprotocol and we guarantee your eprotocol review will not take longer than it would if you submitted it on the old form. In October 2006 the Animal Care program welcomed a new Animal Care Supervisor, Alison Bardwell. She will be paying close attention to post-approval monitoring to ensure there is no "protocol drift", and will help us stay on top of items that are common citations by USDA inspectors such as expired medications. The Animal Care Offices are now located in Blaisdell House. If you have a topic for future newsletters please contact Hilary Woodcock at: email: hilaryw@ora.umass.edu ______________________________________________________ IACUC The third IACUC/NSB Roundtable sponsored by the VPR is scheduled for May 2, 2007. Dr Martha McClintock from the University of Chicago will be the speaker, hosted by Dr. Jeff Blaustein in the Psychology Department. Her visit will feature discussions hosted by the IACUC and a research seminar. Dr. McClintock's research focuses on the behavioral control of endocrinology and the hormonal and neuroendocrine mechanisms of behavior, especially the evolutionary function of hormone-behavior interactions. Her data show that, for example, singly housing rats has a negative effect on their immune system and longevity. On the strength of her findings the University of Chicago has implemented major changes in the way her animal care facility is run. This event is still in the planning stage but we anticipate it will follow the same format as previous events with an IACUC Round Table in the morning, lunch with graduate students, lab visits in the afternoon and a seminar at 4 p.m. We expect her seminar to feature her work on the effects of stress on the immune system and longevity. You can find more about Dr. McClintock's research at http://www.hsus.org/web-files/PDF/ARI/pd_reports/PDReport_9_06.pdf. OLAW has a new brochure titled, "What Investigators Need to Know about the Use of Animals," which provides a quick overview of the requirements and expectations governing animal research funded by the Public Health Service. Because of the terms of our Animal Use Assurance with PHS the information in this brochure is pertinent to all use of vertebrate animals in research at UMass. Barbara will be happy to send you a copy if you call her at 7-0387. You can also order free copies by emailing OLAW at olaw@od.nih.gov. Relatively new on the OLAW web site is a link to Frequently Asked Questions (with answers) at http://grants.nih.gov/grants/olaw/faqs.htm. These FAQs provide guidance for institutions and IACUCs in implementing the PHS Policy. On November 9 the NIH announced the "Notice of a Report on the Review of Responses to the National Institutes of Health Request for Information (RFI): Standards for the Care and Use of Laboratory Animal" available at: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-016.html. This informs the research community of the NIH review of submissions to its "Request for Information (RFI): Standards for the Care and Use of Laboratory Animals" to explore whether an update to the Guide for the Care and Use of Laboratory Animals is warranted. After reviewing the submissions the working group found no evidence that the performance standards of the 1996 Guide need revising. However, some submissions recognized areas for improvement which resulted in recommendations for how the Guide might be enhanced for better utilization by NIH-supported investigators. They include: Make the Guide a living, web-based document and Periodically, e.g. every 3-5 years, revise Appendix A with current references; Include new references after critical review for scientific validity; Include updated science-based, peer-reviewed guidelines and reports from scientific and professional societies, e.g. the Report of the AVMA Panel on Euthanasia, and As information for a component of science increases, new reports, e.g. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (National Research Council, 2003) may be advantageous. A copy of the group's report to the NIH is at: http://grants.nih.gov/grants/olaw/rfi_lab_animal_standards/RFI-Report.pdf. ______________________________________________ Human Subjects Federal regulations guiding human subject protection leave much room for interpretation and the Office of Human Research Protections and other sources are continually developing new guidance materials. Check out the OHRP's latest FAQs at http://www.hhs.gov/ohrp/policy/index.html#faq which break down the federal regulations into more manageable bites. New resources for researchers and people contemplating participating in research that involves human subjects are continually popping up on the web. The University of Southern California has a useful booklet titled "Is Your Project Human Subject Research?" which you can find at http://www.usc.edu/admin/provost/oprs/private/docs/oprs/NHSR_3_6_06_WEB.pdf. It provides some initial guidance about whether human subjects review board approval is necessary. However if you are uncertain about whether your work with human subjects does or does not need IRB review you should also consult with the IRB Human Research Protection Office at 545-3428 or humansubjects@ora.umass.edu, or check with a member of your local Human Research Protection board if there is one that serves your department or college. Guidelines especially designed for investigators in the social and behavioral sciences and education include "Research Involving Audio, Video or Digital Recordings of Research Participants" and "Subject Recruitment and Advertising". These provide useful guidance for developing appropriate informed consent materials. These and many other resources are at: http://www.umass.edu/research/comply/Guidelines/index.htm. Another useful new resource, "Students in Research", provides on-line training for student investigators, students who are study subjects, and the investigators who support them. It includes the history of ethical regulations, helpful tips on the IRB review process, what to expect as a subject, and the role of the faculty advisor. This new guidance has been added to the Collaborative Institutional Training Initiative (CITI), the web-based educational program located at https://www.citiprogram.org/default.asp. Also for students, or anyone else contemplating volunteering as a research subject, OHRP has a pamplet titled "Becoming a Research Volunteer: It's Your Decision". You can download it at http://www.hhs.gov/ohrp/outreach/ or get free copies by calling 1-800-444-6472 and pressing 1. We have used CITI for some time to provide the training to meet the campus requirement for Human Subject ethics training. Recently CITI has added several new modules to their web page including expanded information on the security of health information, good clinical practices and on human subject research in an international setting. The new courses, which have been added to the main course site at http://www.citiprogram.org, include an 18-module "Health Information Privacy and Security (HIPS)" course and a 12-module "Good Clinical Practice (GCP)" course. The CITI International Training Platform provides basic, foundational information for researchers, research staff, and research ethics committee members involved in international research. The modules provide a general overview of the ethical issues central to conducting human subjects research internationally. Specific discussions include international research ethics, US government guidelines, and international guidelines. It also includes a listing of ethical review links for countries or regions of the world. It is intended to help researchers and their staff identify ethical requirements of their global research partners. Access this information by registering at http://www.irbtraining.org. Topics include: History and Ethics Research Review Processes Informed Consent International Studies (Resource information/country specific information) Course Documents (Ethical guidance documents and links to research compliance information) ____________________________________________________ Biosafety On September 19, 2006 Boston's Public Health Commission voted to adopt new "Biological Laboratory Regulations" requiring research laboratories obtain a permit from the Commission in order to operate a laboratory at biosafety levels 3 or 4 and to register BL2 labs. IBCs must file an annual report with the Commission and the Commission may conduct inspections. Classified research is prohibited if its classification would prohibit the BPHC's complete knowledge of the research. Also prohibited is any research with the potential to enable the use of a high risk agent to serve as a principle component of the biological weapon. These regulations became effective in December 2006. Proposed state legislation for Massachusetts, currently titled "An Act Promoting Safe Biological Research and Protecting the Public Health and Safety and the Environment", would, if passed, put in place requirements for oversight similar to Boston's for communities statewide. This would add, after Chapter 17 Section 17 of the General Laws, a "Section 18. Biological Agents Registry Program" and "Section 19. High Containment Biological Research Laboratory Health and Safety Program". The December 2006 draft would, among other things, require local boards of health to be informed of the location and nature of select agents and toxins located within local jurisdiction, and require that facilities with a high containment (BL3 or BL4) research laboratoty to obtain a permit from the MA Department of Public Health. If enacted this legislation as drafted will put an additional administrative burden on the compliance offices in EH&S and Research Affairs. On the topic of state and local oversight of biosafety in research, on November 30th NEBSA (Northeast Biosafety Association) met on the UMass campus hosted by our Biosafety Officer, Maureen O'Leary. The agenda included "The Impact of the Connecticut State Regulations on Biosafety Program Management" presented by Ben Fontes, Yale, and Leslie Delpin, UConn, and "Interpreting the NIH Guidelines" presented by Andy Braun, Harvard Medical School. These were timely topics in light of the pending MA legislation. In general, the Connecticut speakers said that being regulated by the state has added value to their programs by providing them with firm procedures and guidelines. Their interaction with state inspectors has been generally helpful in improving their programs. If you have been waiting (and waiting) for the 5th edition of BMBL to come out the latest news was that it would come out in January 2007 but it looks as though we will have a bit longer to wait. In the mean time used copies of the 4th edition, now out of print, are selling for over $100 on the internet.	Jump down to contents: IACUC Human Subjects Biosafety


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