Copy
Longwood Research Administration Digest 

[RAD]

 January 20, 2017
For a comprehensive overview of news, upcoming training opportunities, deadlines and other events please visit hlcra.harvard.edu

NIH NEWS

Revisions to the Federal Policy for the Protection of Human Subject (Common Rule)

The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.

Highlights of Significant Changes:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project's scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single IRB for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants are protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • The requirement that consent forms for certain federally funded clinical trials be posted on a public website.
Click here to access the final rule.
Click here to access HHS a Press Release about the final rule.


Implementation of the Interim-RPPR while a renewal application is under consideration

Effective February 9 if the recipient organization has submitted a renewal application on or before the date by which a Final-RPPR would be required for the current competitive segment, then submission of an "Interim-RPPR" via eRA Commons is now required. Based on this requirement, the NIH will discontinue the policy for renewal applications whereby, “whether funded or not,” the progress report contained in the renewal application may serve in lieu of a separate final progress report. 

Like the Final-RPPR, recipients will be required to adhere to the new requirement to report on Project outcomes in the Interim-RPPR. This section will be made publicly available, thus allowing recipients to provide the general public with a concise summary of the cumulative outcomes or findings of the project (analogous to the Project Summary/Abstract section of the competing application) at the end of a competitive segment.

 

NSF NEWS


NSF Advisory Announces Upcoming Updates to FastLane

NSF posted an advisory announcing a release of updates to FastLane on January 30, 2017. These changes support the NSF policy updates that will be effective for proposals submitted, or due, on or after January 30. We encourage you to review the changes in the revised Proposal & Award Policies & Procedures Guide (NSF 17-1) as they may impact your proposal development and submission process.

Changes include two new types of proposals incorporated into the PAPPG;  submission of a new Single Copy Document, "Nature of Natural or Anthropogenic Event;" Updated References and Terminology; and enhanced Automated Compliance Checks.

For system-related questions, contact FastLane User Support at 1-800-673-6188 or fastlane@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.
 

Around Harvard


ecrt Q2 dates
FY17 Q2 Quarterly Project Effort Review Period will open next Tuesday, 1/24/2017. Please observe the following dates and facilitate timely PI certifications. All ecrt statements should be reviewed during the Review Period prior to release for PI certification. 

Important Dates
  • Jan 24, 2017 - FY17 Q2 Project Certification Review Period Opens
  • Feb 14, 2017  - FY17 Q2 Project Certification Period Opens
  • Mar 15, 2017  - FY17 Q2 Project Certification Due
Resources can be found on the Office for Sponsored Programs website http://osp.finance.harvard.edu/effort-reporting.  If you have any questions, please contact your Tub Effort Coordinator or email the ecrt help desk at ecrt@harvard.edu.


Joint Research Administrators Open Forum: Washington/Federal Update
Join us on Friday, February 10, 2017, 9:30 am to 11:00 am, to get an inside perspective and update on what’s happening in Washington. Kevin Casey, Associate Vice President for Public Affairs and Communications and Jon Groteboer, Director Federal Relations, Office of Federal Relations, Harvard University, will be our guest speakers. The event takes place in LMA, HMS: Armenise Amphitheater and is sponsored by HMS and the T.H. Chan SPH.

Please RSVP here.
 

Training Opportunities


ecrt Basics Training
Please visit the OSP Calendar to register!
  • January 23 / 1:30 pm to 4 pm / 8 Story Street Room B2, Cambridge
  • January 27 / 9:30 am to 12 pm / Longwood
  • January 30 / 11 am to 12 pm / WebEx (online)

Description: This course will introduce department administrators to effort reporting and the electronic effort reporting and certification system (ecrt), which allows Principal Investigators and Faculty to certify their effort on federally-sponsored projects. This course will cover the following:

  • Introduction to effort and effort reporting 
  • ecrt roles and responsibilities  
  • Workflow for certification by Principal Investigators and/or Faculty  
  • Workflow for Grants Managers to review and monitor and overall management of certifications during certification periods  
  • Best practices during the pre-certification review period 
  • Workflow for Primary Effort Coordinators to monitor the process of certifications in their departments and assign roles and overrides as needed 

*Please note that this session will include system demos that will first cover Grant Manger responsibilities. The last 30 mins of the session will be devoted to Primary Effort Coordinators and will cover the additional aspects of the systems their role needs to utilize.

Intended Audience: ecrt Basics training is intended for Grant Managers with responsibility for assisting their faculty during the effort reporting process as well as anyone in the Primary Effort Coordinator role. This is a great opportunity for new ecrt users as well as for existing users who want a refresher. 

Recommended Pre-Work: Review of the University-wide Effort Reporting Policy


ecrt Report WebEx
Please visit the OSP Calendar to register!
  • January 30 / 11 am to 12 pm / WebEx (online) or in 1033 Mass Ave., 5th Floor, Rm 559, Cambridge
Description: Join us as we explore some of the key reports available in the University’s effort reporting tool, ecrt. This session will focus on several of the most useful reports available to Grant Managers and Primary Effort Coordinators to aide them during the quarterly and annual review and certification cycles as well as throughout the year. This session will be led by members of the University’s Effort Reporting Operations Committee and will be half demo and half Q/A. Please feel free to join in person or through the following WebEx link.


PI Dashboard Introductory Training
  • February 28th / 9:30 am to 12 pm / Kresge LL6
This training introduces new users to the PI Dashboard, a post-award reporting and projections tool.  The training covers navigation, the projections module and the two main dashboard reports (account and root reports).  All new grants managers and ADFs should attend.  This session is also open to existing users who would like a refresher.  Please register here.

 
Harvard Travel Policy Help Sessions
Please visit the OSP Calendar to register!
  • February 15 / 1 pm to 2 pm / Webex or in person in Cambridge, 1033 Mass Ave, 5th floor, Rm 559
 
Please visit the OSP Calendar to register!
 
IRB Clinics
Do you have a question about the IRB process, need submission assistance, or want to know more about how to use ESTR? All members of the Harvard LMA research community are welcome to stop by either the HMS or Harvard Chan School location to consult with members the of QIP team. No need to make an appointment- first come, first served.
  • Tuesday, January 24, 2017 / 2pm-3pm / SPH: Kresge Cafeteria
  • Thursday, February 9, 2017 / 12-1pm / 90 Smith Street, 1st Floor Conference Room
  • Wednesday, March 8, 2017 / 10:30am-11:30pm / HMS: Courtyard Café
  • Tuesday, April 11, 2017 / 2pm-3pm / SPH: Landmark Center (location TBD)
  • Thursday, May 18, 2017 / 11am-12pm / 90 Smith Street, 1st Floor Conference Room
 

SPH NEWS


SPH Job Postings
  • 41280BR Associate Director of Finance - Environmental Health
  • 41290BR Grants Manager - Global Health and Population
  • 41295BR Grants Manager - Global Health and Population
  • 41297BR Grants Manager - Global Health and Population
  • 41307BR Research Administration Manager - Immunology and Infectious Diseases
  • 41491BR Sponsored Research Administrator -Sponsored Programs Administration
  • 41492BR Sr. Grants Manager - Health Policy and Management
  • 41538BR Grants and Projects Manager (Floater) - Sponsored Programs Administration
Open to SPH staff, this incentive provides an opportunity to nominate and external candidate for an open SPH position. If the referred candidate is selected, the SPH employee will receive $500.00 (gross) after the new hire has successfully completed the orientation and review period. Refer candidates to our Recruiters by sending their information in an email to sphhr@hsph.harvard.edu. Questions can also be directed to this email address, or to the HR main line at 617-432-0979.

HMS-HSDM NEWS



HMS Job Postings
  • 39142BR  Grants Manager - Systems Biology
  • 41203BR Sr. Grants Manager Biomedical Informatics
Questions or Feedback about RAD?  Please reply to this e-mail.
Know someone who would like to receive RAD?  Share this link: http://hlcra.harvard.edu/rad
Have content ideas for future RAD editions?  Contact Ivona at ivona@hms.harvard.edu or Christina at christina_kennedy@hms.harvard.edu
Forward
Share
Share
Tweet






This email was sent to <<Email Address>>
why did I get this?    unsubscribe from this list    update subscription preferences
Harvard Longwood Campus · 25 Shattuck Street · Gordon Hall · Boston, MA 02115 · USA

Email Marketing Powered by Mailchimp