Source: http://www.aspirusgrandview.org/Main/Institutional-Review-Board-IRB.aspx?srcaud=Main
Timestamp: 2017-03-24 12:05:55
Document Index: 118573760

Matched Legal Cases: ['art 46', 'art 46', 'arts 50', 'art 160', 'art 164', 'art 46', 'art 50', 'art 56', 'art 312', 'art 812']

Aspirus Wausau Hospital utilizes the internet to submit applications to the IRB through the use of a new program, "CyberIRB." This program is accessible from any computer at any site.
Access CyberIRB If you are a new Investigator or an investigator who has previously submitted a paper IRB submission form please contact the IRB Office at 715.847.2569 to receive instructions, a USER ID and Password to access CyberIRB.
IRBFAQLinksReference Manual Meeting DatesExcellence AwardEducationRegulations & PoliciesInstitutional Research Review Board (IRB)
Community members (not affiliated with Aspirus Wausau Hospital) IRB members serve on a voluntary basis, for a two-year term, meeting once a month to review research for physicians & medical staff who are engaged in research.
Email: Deb.Block@aspirus.org IRB Chair: Kevin O'Connell, MD
IRB Coordinator/HRP Administrator: Deb Block, BSFrequently Asked Questions about Research Participation
It is also often helpful to talk to a physician, family members, or friends about deciding to join a study. Synonyms Used in Research
Clinical Research Study or Trial Likewise, individuals volunteering to be in a research study are referred to by many names:
Research or Clinical Subject (Please note: Research professionals do not refer to human subjects as "guinea pigs"; unfortunately, this term is often refered to when individuals think of research participation.) What is a clinical trial /study?
What is an "expanded access" protocol? Participation in Clinical Trials
Can a participant leave a clinical trial after it has begun? In addition: If you have a child considering participation in a clinical trial, the following online video by Children's Hospital Boston is worth viewing Interactive Parents' Guide to Medical Research
Aspirus Research Institute Cancer Prevention & Treatment Trials ­ Aspirus Langlade Hospital, Antigo
Aspirus Grand View Eye Center Aspirus Wausau Hospital
National Institute of Nursing Research (NINR) NINR Division of Intramural Research Online Developing Nurse Scientist
SUNY Downstate Medical Center Evidence Based Medicine Tutorial Statistics
http://www.telecompricer.com/article/statistics-at-square-one.html Other Research - Human Protection Links
National Reference Center for Bioethic Literature Information for Investigators, research staff, and IRB members
Journal of Clinical Research Best Practices - Hundreds of free articles Investigator Reference Manual & FAQ for Researchers
Download the Investigator Manual in PDF format. You may review the manual online or print it out. If you do not have access to the Aspirus Onbase Policy System please contact the IRB Office at (715) 847-2569 to acquire a supplemental CD of all applicable research policies and procedures for your review.
The final report FAQ
Types of IRB review include convened full board, expedited, and exempt review. All applications are submitted through CYBERIRB, the on-line electronic application submission system.
Aspirus Wausau Hospital has transitioned into utilizing the internet to submit applications to the IRB through the use of a new program, "CYBERIRB". This program is accessible from any computer at any site through this website address link.
If you are a new Investigator or an investigator who has previously submitted a paper IRB submission form please contact the IRB Office 715-847-2569 to receive instructions, a USER ID and Password to access CYBERIRB.
All requests to the IRB for review should be submitted electronically through the CYBERIRB program.
Deb.Block@aspirus.orgMeeting Dates 2015
Institutional Review Board Timeline for Agenda Items IRB Meeting Date:
Please contact Deb Block at Deb.Block@aspirus.org or 715-847-2569 if you have any questions or requests.Dr. Charles Shabino Excellence in Research Award
To annually recognize an individual who has made significant contributions to excellence in research at Aspirus. Definition
Nominations may be sent to the HRPC Manager throughout the year. The nominations will be reviewed by a small group (IRB Chair, IRB Coordinator, IRB Community Member, Institutional Official, and the Executive Director of Aspirus Health Foundation) following the October IRB meeting. Award Presentation
Dr. Charles Shabino receives the inaugural award that is named in his honor in December 2015. Also pictured with Dr. Shabino is Deb Block, IRB Coordinator (left), and Lisa Opatik, IRB Chair.
http://phrp.nihtraining.com/users/login.php This free, web-based course from NIH Office of Extramural Research. Please note that this is a NEW course, with new content. This course replaced the previous Protecting Human Research Participants (PHRP) course as of March 1, 2008. To take the new course, please register by clicking on the Register button below presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds. You will have the option of printing a certificate of completion from your computer upon completing the course. OHRP Educational Materials
These videos are also listed on the OHRP YouTube Playlist. Research Use of Human Biological Specimens and Other Private Information
Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. He discusses the differences between adverse events and unanticipated problems and appropriate responses for investigators, IRBs, and institutions when encountering an unanticipated problem. He also discusses prompt reporting requirements and the difference between external and internal unanticipated problems, what to do in the case of multi-center research, and what information that should be reported to OHRP. This video is also available in RealPlayer format at http://videocast.nih.gov/ram/ohrp_carome.ram General Informed Consent Requirements
The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have passed regulations regarding human subjects research (45 CFR Part 46 and 21 CFR Parts 50 and 56). DHHS, through its Office for Human Research Protections (OHRP), and the FDA also issue periodic guidance documents for institutions and investigators. Sections of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Part 160 and Part 164 are also relevant to IRB review of research. Questions regarding the regulations or guidance documents may be directed to (715) 847-2569. *Department of Health and Human Services Office for Human Research Protections (OHRP)
Regulation - Title 45, Part 46 [45 CFR 46] Protection of Human Subjects OHRP Policy & Guidance Library Guidance - Categories of Research That May Be Reviewed by the IRB Through Expedited Review
OHRP IRB Guide Book *Food and Drug Administration (FDA) Code of Federal Regulations (FDA)
Title 21, Part 50 [21 CFR 50] -- Protection of Human Subjects Title 21, Part 56 [21 CFR 56] -- Institutional Review Boards Title 21, Part 312 [21 CFR 312] -- Investigational New Drug Application Title 21, Part 812 [21 CFR 812] -- Investigational Device Exemptions Guidance - Informed Consent ICH Guidelines - Good Clinical Practice
Scientific Misconduct #5738 IRB Standard Operating Procedures (SOPs)
IRB of Record #12858 Aspirus Inc. Policy
Corporate Signature Authority #6553 Federal-Wide Assurance (FWA)