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Stony Brook University

 

What's New in Research Compliance


2006/12/19

2006/12/07

  • A new update has been posted for SBU's Human Subjects Protection Program. It is extremely important that you review this information with all members of your study team.

2006/11/07

  • The Health and Risk Assessment Survey for staff with animal contact has been updated as of 9/06. Please download and begin using this newly revised form.

2006/11/01

  • The Applications for Human Subjects Research (Main application and 5 Year application) have been updated. Please download and use these revised applications.

2006/10/30

  • The Standard Procedures for Animal Research have been updated. Please review these revised procedures before beginning your research.

2006/10/25

  • The Applications for Continued Approval of Human Subjects in Research and 5 Year Continued Approval have been updated. Please download and begin using these revised applications.
  • Sections 14 and 15 of the Handbook for Investigators have been updated. Please review these sections prior to conducting research.
  • The PDF version of the Handbook for Investigators has been updated. Please download the latest version.

2006/09/13

2006/08/16

  • Section 24 of the CORIHS Handbook for Investigators has been updated. Please review this section and/or download the updated PDF version of the Handbook.
  • Fill-in PDF forms and Word documents have been updated for certain Compliance and Sponsored Programs documents. Please review the Campus Forms page and begin using these new forms.
  • Links on the Responsible Conduct of Research page have been updated.
  • The Initial Application for Recombinant DNA Activities has been updated (IBC Application). Please visit the Recombinant DNA/Biosafety page to download the revised form.

2006/08/01

  • A new option for IRB review has been established: National Cancer Institute's Central IRB Adult and Pediatrics Initiative. For application instructions, see SBU - NCI Central IRB.

2006/07/20

  • A new Standard Procedure has been added to the Laboratory Animals section under Appendix III: In Vivo Micro MRI of Rats/Mice.   Please review this procedure before beginning research.

2006/06/28

2006/06/12

  • The website for the Office of Research Compliance experienced technical difficulties from June 9th to June 12th. If you accessed this website during this period, please review the site again for updated information. Thank you!
  • The Standard Procedures for Laboratory Animal Research [Appendix III] have been updated. Please review these procedures prior to beginning research.

2006/05/22

2006/05/09

  • Sections 2, 12, 14, 15 and 25 of the Handbook for Investigators have been updated. Please review these sections for updated information.

2006/03/28

2006/03/07

  • The Standard Procedures for Laboratory Animal Research have been updated. Please review the Forms page for additional information which may be pertinent to your research.
  • The Application for Approval of Animal Use in Research has been updated. Please download and begin using the latest version.

2006/02/14

  • Sections 16 and 23 of the Handbook for Investigators have been updated. Please review the sections for pertinent information.

2006/01/25

2006/01/18

  • The animal approval and animal renewal applications have been updated. Please download and start using these forms immediately.

2006/01/13

  • Section 14 and Section 15 of the Policies and Procedures Handbook for Investigators have been updated. The Alternative Treatments section is now mandatory to include on the consent form.
  • The Exempt Category Review application has been updated. Additional information has been added to Exempt Category 46.101.b.2.
  • Section 11 of the Policies and Procedures Handbook for Investigators has been updated. The IRB is now capable of reviewing research involving prisoner subjects.

2005/12/23

  • The IBC Application (Institutional Biosafety Committee) has been updated. Please download and start using this newly revised form.

2005/12/14

  • The Human Subjects' Exempt Project Review Application has been updated. Please download and start using this newly revised form.

2005/12/02

  • The CORIHS Policies and Procedures Handbook for Investigators has been posted in PDF for investigators who wish to print the manual in its entirety. You may download the manual or print it but check back to the website often as the policies are updated regularly.

2005/12/01

  • The Annual Renewal Application Involving Animals in Research and Education has been updated. Please download and start using these revised versions.
  • Instructions for using CRRI services for industry-sponsored, industry-generated studies have been updated. Visit CRRI Option for specific information.
  • The confidentiality sections of Sections 14 and 25 of the CORIHS Policies and Procedures Handbook have been updated. Please review these sections before creating your consent forms.

2005/11/16

  • For industry-sponsored, industry-generated studies: If you wish to use the services of Chesapeake Research Review, Inc., the forms can now be downloaded directly from their site. This will ensure SBU investigators are using the most current forms available. Visit CRRI Option for more information.

2005/11/09

  • New documents (Word and Wordperfect) have been created for entering additional personnel to the Animal Research Application. If you have more than six individuals on your study, please enter additional personnel on this form and submit it with your application. The new forms can be found here: Laboratory Animal Research Forms.

2005/10/20

  • The ORC has updated the Application for Approval for Research Involving Human Subjects, the Application for 5 Year Continued Approval, and the Application for Exempt Category Review. Please download and begin using these revised HS Forms.

2005/10/20

  • The Application for Approval for the Use of Vertebrate Animals in Research and Educational Activities has been updated. Please download and begin using this revised form. The Guidelines for Amendments have also been updated. Please review the Guidelines before submitting new amendments to protocols.

2005/07/20

  • The ORC has updated the Application for Approval of Recombinant DNA Activities. Please download and begin using this revised form.

2005/07/05

  • The following Human Subject Research applications have been updated. Please download and begin using the July 2005 versions below.
    • Approval application
    • 5 Year Continued Approval application
    • Renewal application
    • Exempt application

  • HIPAA forms have been updated. Please visit the Forms page to download the newly revised Limited Data Set, De-Identified, and Waiver of Authorization forms.

  • Section 25 of the CORIHS Policies and Procedures Handbook has been updated. Please review this section for revised information.

2005/05/25

  • The following Human Subject Research applications have been updated. Please download and begin using the May 2005 versions below.
    • Approval application
    • 5 Year Continued Approval application
    • Renewal application
    • UP/USAE application
    • Exempt application

  • Sections 14, 15, and 25 of the CORIHS Policies and Procedures Handbook have been updated. Please review these sections for revised information.

2005/05/23

2004/06/07

2004/05/20

  • The ORC posted revised Animal applications for both New and Renewal submissions. Start using these forms immediately. The revised applications can be found here: Approval for Animal Use and Related Forms

2004/05/03

  • The ORC posted revised applications for Continued Approval and 5 Year Continued Approval. Start using these forms immediately. The revised applications can be found here: Forms for Human Subject Research

2004/04/05

  • The ORC posted a revised application for Exempt Project Reviews. A separate cover letter summarizing the study is no longer required as the questions have been incorporated into this form. The revised application can be found here: Forms for Human Subject Research

2004/03/31

  • The ORC posted a revised application for conducting new research involving human subjects which will become mandatory on May 1, 2004. A separate project description is no longer required. A sample of new sections include: HIPAA, Conflict of Interest, Vulnerable Populations and Consent Procedures. The revised application can be found here: Forms for Human Subject Research
  • Section 3 of the Handbook for Investigators - Materials required for submission, has been updated in reference with the newly revised application
  • Formatting for Sections 14 and 15 of the Handbook for Investigators has been updated.

2004/03/18

  • The ORC revised Section 24 of the online version of the Handbook for Investigators. The policy addressing "possible, significant (personal) financial interest" has been updated.

2004/03/04

  • The ORC revised the Confidentiality/Protecting the Privacy of Your Health Information section of Section 25 of the online version of the Handbook for Investigators. Procedures for creating consent forms as well as Boilerplate language used in consent forms has been updated.

2004/03/03

  • The ORC posts an updated reporting form for Unanticipated Problems involving risks to subjects or others, including Serious Adverse Events. The former Adverse Event Form will no longer be accepted. For additional information, refer to Section 16 of the online version of the Handbook for Investigators for current policies and procedures.

2004/02/16

  • Revised training instructions for the CITI program are posted. Refer to Section 17 of the online version of the Handbook for Investigators for the most current information

2003/12/30

2003/06/27

2003/06/18

2003/05/28

2003/04/20

2003/04/03

2003/03/10

2002/12/26

2002/12/19

2002/12/17

2002/12/11

2002/12/06

  • NEW CORIHS Policies and Procedures Handbook for Investigators (November 2002)

2002/11/21

2002/11/08

2002/10/22

2002/10/08

2002/09/23

2002/09/13

2002/09/08

2002/09/04

2002/08/31

2002/08/20

2002/08/15

2002/08/12

  • IMPORTANT NOTICE. The CITI Course in the protection of Human Research Subjects will undergo a semi-annual upgrade and revision AUG 15, 2002. The course site will be unavailable between Thursday 8-15-02 and Monday 9-03-02. You must finish the course before AUG 15, 2002 or you will be required to re-register after the course comes back on line in September. All quiz scores will be "zeroed' and you will be required to go through the material again at that time.

2002/07/31

2002/07/30

2002/07/20

2002/07/18

2002/07/14

2002/07/12

2002/07/02

  • Updated CORIHS A & B Schedules to move August meeting dates and dates for receipt of materials to one week later
  • Revised Guidelines on the Capacity to Provide Consent for Research (Including Research Involving Subjects with Diminished Capacity) (New - June 2002)
  • Updated Human Subjects Training session to move August 21 session to August 20 - Lecture Hall 2

2002/06/11

2002/05/31

2002/05/16

  • Added section on use of controlled substances in research

2002/05/14

2002/05/09

2002/04/29

2002/04/26

2002/04/20

2002/03/25

2002/03/20

2002/03/14

2002/03/12

2002/02/05

2002/02/05

  • The American Physiological Society in conjunction with the NIH Office of Laboratory Animal Welfare is sponsoring a symposium "Everything You Ever Wanted to Know about the IACUC But Were Afraid to Ask" at the experimental biology meeting EB 2002 in New Orleans from 1-5:00 pm, Sat, April 20. Registration is free, but required. On-line info and registration at http://www.the-aps.org/meetings/eb2002/abs/pa_stallone.htm

2002/02/02

2002/02/01

  • Compliance Web Pages are being reorganized.
    • All Human Subjects information is now available from one page
    All Laboratory Animal information is now available from one page

2002/01/25

2002/01/21

2002/01/25

2002/01/18

  • Updated Outline of Human Subjects Training Course (html) (pdf)

2001/12/22

2001/12/20

  • Posted revised policy for the reporting of Adverse Events

2001/12/10

2001/11/16

  • Holiday Schedule for research-related Offices

2001/11/14

2001/11/08

2001/10/25
  • Policy on Reporting of Adverse Events (Word)  or (pdf)(New, 10/11/2001)
  • Updated all Human Subjects Forms to Reference Federal Wide Assurance instead of Multiple Project Assurance
2001/10/15
  • Human Subjects Adverse Event Report Form (Word) (pdf) - Revised 10/15/2001
2001/10/09
  • Revised Human Subjects Application Form for Exempt Project Review (Word) (pdf)
2001/10/01 2001/09/20
  • Updated Template for Certification of Completion of Human Subjects Training letter to NIH (Word) to reflect CITI training
2001/09/06
  • Campus announces CITI Web-Based Course of the Protection of Human Research Subjects (html or pdf)
2001/08/09 2001/08/06 2001/07/26
Added links to Compliance Page
2001/07/12
Updated IACUC Standard Procedures for:
  • Production of Subcutaneous Tumors in Rodents
  • Retro-orbital Bleeding of Rodents
  • Collection of Oocytes from Frogs
  • Production of Transgenic Animals
  • Gonadectomy in Rats and Mice
2001/07/10 2001/06/19 2001/05/29 2001/05/15 2001/04/27 2001/04/12
  • OLAW has reviewed and approved the renewal of our Animal Welfare Assurance. It remains #A3011-01and is effective 4/5/2001 through 3/31/2006.
2001/04/11
  • Posted April 9, 2001 memo to Human Subjects Investigators et al, on FWA and other changes in Human Subjects Policy Word or pdf
  • Posted April, 2001 memo to Investigators using Animal Subjects (pdf or Word) covering distribution of Policy P-204
2001/03/30 2001/03/29
  • Stony Brook's Federal Wide Human Subjects Assurance(FWA) #FWA00000125 is approved by OHRP (replaces Multiple Project Assurance, #M1036-01)
2001/01/26 2001/01/01 2000/11/07
  • New CORIHS Form - Application for 5 Year Continued Approval of Human Subjects Research
2000/09/29
  • New CORIHS Form - Application forExempt Project Review
2000/09/02
  • Revised Human Subject Guidelines (Word) (pdf)  --  Update of Phone Area Codes and change of individual to contact for subject rights
  • Revised Human Subjects Application to include justification for number of subjects

 

 

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