Changes to Consent Form May 2014

Changes to Consent Form May 2014

Institutional Review Board (IRB) News Changes to Consent Form May 2014

Changes to Consent Form May 2014

​The following are changes to the Sample Consent Form, version 05/29/14

  • Font has been changed to Calibri to comply with Institutional style guidelines.
  • Header:  The header has been updated to include Sponsor Protocol No., when applicable.
  • Risks and Discomforts:  Clarification to instructions in Randomization section and revisions to the example paragraph have been made.
  • Confidentiality:  
    • Change in language regarding publishing results of research
    • Updated Billing Compliance language
    • Addition of clinical trials indicator in medical records
  • Voluntary Participation and Withdrawal:  Instructions have been updated.
  • Cost of Participation:  Addition of sample language regarding Category B medical devices.
  • Signatures:  Several changes in the guidance.
  • HIPAA Authorization Form:  Revision to consent cancellation language.

Click here for a more detailed summary of the changes.

The sample consent form is available online by clicking this link.

Additional News and Announcements

  • NIH Notices - September 19, 2016

    Notices:
    • Policy on Funding Opportunity Announcement (FOA) for Clinical Trials
      (NOT-OD-16-147) National Institutes of Health
    • Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
      (NOT-OD-16-148) National Institutes of Health
    • NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
      (NOT-OD-16-149) National Institutes of Health
    See the full web version of these notices and more here.
    Posted by Office of Sponsored Programs | 09/19/16
  • Joint Symposium on HIV Research in Women

    The goal of the Inter-CFAR collaborative symposium on HIV in Women is to share cutting edge research, extend knowledge and foster action to address gaps toward understanding the complex clinical, biological and social aspects of HIV in women. This meeting will be held in conjunction with the 2016 Women’s Interagency HIV Study (WIHS) EC meeting to allow for joint activities with WIHS investigators. The meeting will consist of three sessions:
    • Vulnerable Populations
    • Microbiome in HIV-Infected Women and its Impact on Health Outcomes
    • The HIV Continuum of Care Across the Lifespan of Women
    We are currently soliciting abstracts for posters and oral presentations from investigators in relevant areas until Oct 2, 2016.
    Posted by Center for AIDS Research | 09/15/16
  • Research Administration Announces Melinda Cotten as Assistant Vice President for Sponsored Programs

    ​Dr. Richard Marchase, Vice President for Research and Economic Development, is pleased to announce the appointment of Melinda Cotten as Assistant Vice President of Sponsored Programs. She will be starting on September 19, 2016. Ms. Cotten will be working with her staff in assisting UAB researchers in their efforts to secure and fulfill extramurally funded sponsored programs by performing pre-award and non-financial post-award administration. With a focus on customer-centric approaches for continuously improving UAB’s processing of submissions, Cotten’s extensive experience will be critical to ensuring the continued success of the UAB research community, and maintaining UAB’s national position as a top research university.
    Posted by Office of the Vice President for Research and Economic Development | 09/12/16
  • NIH Notices – September 12, 2016

    Notices

    • Optional Electronic Method to Request Withdrawal of Applications from Consideration for Funding
      (NOT-OD-16-143) National Institutes of Health
    • Notice of Correction to PA-16-309 "Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)"
      (NOT-OD-16-146) National Institutes of Health
    • AHRQ Retires Policy on Post-Submission
      (NOT-HS-16-017) Agency for Healthcare Research and Quality
    Posted by Office of Sponsored Programs | 09/12/16
  • National Science Foundation (NSF) System Shutdown on September 17-18, 2016

    All National Science Foundation (NSF) systems, including the NSF websiteResearch.gov and FastLane, will be unavailable from 5:00 PM on Saturday, September 17, until 4:00 PM on Sunday, September 18. This downtime is scheduled to coincide with repairs to the Foundation's electrical systems. Affected deadlines that fall on Monday, September 19, are extended to Tuesday, September 20, submitter's local time. See the attached NSF downtime notice for more information on affected solicitations.

    Attachments:
    Posted by Office of Sponsored Programs | 09/09/16
  • eRA Enhancements – September 9, 2016

    Effective September 8, 2016, Signing Officials have the ability to electronically request the withdrawal of an application through eRA Commons. A Signing Official has two business days after successfully submitting an error-free application to reject the application. If more than two business days have elapsed, the Signing Official must contact the Division of Receipt and Referral (DRR) to request an application be withdrawn. Contacting DRR directly may now be done electronically. Requesting the withdrawal of an application will remain available while the application has not undergone review and the summary statement posted.

     

    Features

    • The initiation of a withdrawal request can be done by the Signing Official or Principal Investigator.
    • A new navigation tab, Prior Approval, was added to Commons.
    • Signing Officials have the ability to search for requests.
    • Automated notifications are generated on submission and on approval of DRR withdrawal requests.

     

    For more details on the features listed above, please review the original announcement. For more information concerning Prior Approval for Withdrawals, please see Guide Notice NOT-OD-16-143 and the Prior Approval section in the eRA Commons online help.

    Posted by | 09/09/16
  • National Heart, Lung, and Blood Institute (NHLBI) Years of Support Clarification for K24 Funding

    The National Heart, Lung, and Blood Institute (NHLBI) have announced an important clarification impacting years of support for both new and renewal K24 funding. The maximum years of support is capped at 10 years. Review the full notice for more details.

    Posted by Office of Sponsored Programs | 09/08/16
  • NIH Extramural Nexus Updates - August 2016

    The NIH Extramural Nexus Updates for August 2016 are now available. Some highlighted stories include:

    • NIH Support for Model Organisms, Parts Two and Three
    • National Research Service Awards (NRSAs) Postdoctoral Stipend Guidelines for Fiscal Year 2017
    • NIH Loan Payment Programs (LRPs) Accepting Applications from September 1 through November 15
    • Changes to Post-submission Materials and Appendix Policies Take Effect January 25, 2017
    • Withdrawing Applications Electronically in eRA Commons, Available on September 8, 2016
    • FAQ: How May a PI Check Their Eligibility for a Continuous Submission?
    • NIH Closed for Federal Holiday: September 5, 2016 (Labor Day)
    • See the original digest or attachment for more information.
    Posted by Office of Sponsored Programs | 09/02/16
  • Marilyn Hilton Award for Innovation in MS Research

    The Conrad N. Hilton Foundation is announcing the release of two new Request for Proposals (RFP) for its Marilyn Hilton Award for Innovation in MS Research which aims to stimulate innovative and paradigm-shifting research on progressive MS.  Recognizing the current challenging fiscal environment, particularly for those at the beginning of their careers, these two RFPs are calibrated to support the work of young investigators at this critical time. For more information, please view the Foundation's webpage.
    Posted by Office of Sponsored Programs | 08/30/16
  • National Heart, Lung, and Blood Institute (NHLBI) Notice of Changes Impacting Clinical Trials

    The National Heart, Lung, and Blood Institute (NHLBI) have announced important changes impacting the acceptance, review, and funding of investigator-initiated single-site clinical trials (Phase II and beyond). These changes will affect applications with a due date on or after January 8, 2017. Review the full notice for more details on the changes.
    Posted by Office of Sponsored Programs | 08/30/16
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