- Post-Proposal Timelines/Milestones:
- Sponsor Review (Score/Summary Statement/Intent to Fund)
- Just-in-Time
- Award
- Potential Action Items:
- Early Accounts
- IACUC Protocol Approval for Animal Research
- IRB Protocol Approval for Human Subjects Research
- Tutorial (Human Subjects Research Protection)
- Scientific Review Committee (SRC) Protocol Approval for Cancer Center Research
- Stem Cell Research Oversight (SCRO) Protocol Approval
- PI Training
- Conflict of Interest Training (NIH/PHS Agency Awards)
- Conflict of Interest Declaration (NIH/PHS Agency Awards)
If a sponsor notifies you that your proposal may or will be funded, this is the time that the PI and/or Department Administrator need to prepare to respond to the sponsor’s pre-award action items.
NIH requests pre-award materials at Just-in-Time (JIT). We often have little time to respond to these requests completely. Protocol reviews and approvals takes time. If we are not able to provide protocol approvals to NIH, NIH may issue awards with restrictions. This practice has become more and more common. RMG must hold these awards until the restriction is lifted and this has caused delays in the release of awards.
Other federal sponsors will simply hold the award until they have reviewed and approved our protocol and approval.
RMG must hold awards until Stanford &/or sponsor approval of protocols are in place. Even with an early account in place, no protocol-related research or spending can start.
- Early Accounts
- IACUC Protocol Approval for Animal Research
- IRB Protocol Approval for Human Subjects Research
- Tutorial (Human Subjects Research Protection)
- Scientific Review Committee (SRC) Protocol Approval for Cancer Center Research
- Stem Cell Research Oversight (SCRO) Protocol Approval
- PI Training
- Conflict of Interest Training (NIH/PHS Agency Awards)
- Conflict of Interest Declaration (NIH/PHS Agency Awards)
If the department agrees that protocol-related work will not begin until the protocol is approved, the department (at its own risk) may request an Early Account (for the award on hold), so non-protocol related work and spending can start. Early accounts allow for spending against an award prior to receipt or release of an award. Expenses, that benefit the project, can be charged at the PIs risk. A guarantee account is requested from PIs/Department’s unrestricted funds to cover the costs in the event that the award does not materialize.
There may be times when an early account may be requested:
- An award is anticipated to be funded.
- An award has been issued by the sponsor, but RMG must hold award because of pending compliance issues (any of the above or other issues).
Pending Protocols
If required protocols have not been approved for an award an early account can still allow non-protocol related work to start while the protocol is under review.
Early Account Requests
1st early account request (for 1st year of award segment) is approved for 90 days (applicable protocols must be submitted & a meeting date set).
2nd extended account request (for 1st year of award segment) is approved for an additional 90 days (Protocols must be
approved).
Resources Early PTA: https://doresearch.stanford.edu/taxonomy/term/448
SeRA User Manuals Guide: webpage >>
It’s our practice to submit proposals with IACUC protocols marked as pending approval.
The reason for this is because each research plan in each proposal needs to be individually reviewed against a protocol and will receive a separate approval, if appropriate.
Important: In addition to any other required items, be sure to add the Stanford SPO # & Sponsor Reference # (if applicable) under the Funding – Grants/Contracts section of the appropriate protocol. Protocols will be required for subawards engaging in these activities.
Please inform RMG when your protocol is approved.
General Information & FAQs: https://labanimals.stanford.edu/resources/faq/index.html
IACUC, IRB & Other Panel Meeting Dates & Deadlines:
http://researchcompliance.stanford.edu/rco/documents/panel_schedule/RCO_Meeting_Schedule_2015_2016.pdf
Please contact the appropriate APLAC staff member for assistance:
https://labanimals.stanford.edu/schedules_contacts/contacts/index.html
It’s our practice to submit proposals with IRB protocols marked as pending approval.
The reason for this is because each research plan in each proposal needs to be individually reviewed against a protocol and will receive a separate approval, if appropriate.
Important: In addition to any other required items, be sure to add the Stanford SPO # & Sponsor Reference # (if applicable) under the Funding – Grants/Contracts section of the appropriate protocol. Protocols will be required for subawards engaging in these activities.
Please inform RMG when your protocol is approved.
Does My Project need IRB Review?
http://humansubjects.stanford.edu/research/documents/HSresearch_if_IRB_review_neededFLW03H04.pdf
Determination of Human Subjects Research:
http://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.docx
Some faculty obtain this before submitting the proposal, so ensure this is established up-front.
Submitting a Protocol:
https://eprotocol.stanford.edu/help
IACUC, IRB & Other Panel Meeting Dates & Deadlines:
http://researchcompliance.stanford.edu/rco/documents/panel_schedule/RCO_Meeting_Schedule_2015_2016.pdf
Please contact the appropriate IRB staff member for assistance:
http://researchcompliance.stanford.edu/hs/new/schedules_contacts/contacts_irb.htm
RMG follows NIH Guidelines on this requirement:
NIH website: Frequently Asked Questions: Human Subjects Research - Requirement for Education
1. Who Must Comply with the Policy
A. [Expanded] Who needs to receive required education on the protection of human subjects?
Individuals who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the education requirement. These individuals are considered to be "Key Personnel" on NIH awards and contracts that include research involving human subjects, this includes the Principal Investigator(s), all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites.
Your RPM will confirm all Key Personnel have taken training. Please notify your RPM if any of the the Key Personnel listed are NOT involved in the conduct and design of Human Subjects Research.
This differs from Stanford’s Research Compliance Office requirement which requires ALL staff & third party (subcontract) personnel, responsible for designing and/or conducting research, performing data analysis or reporting activities complete training and that they are required to take refresher courses in order to obtain protocol approval.
TUTORIAL: Stanford’s Collaborative IRB Training Initiative (CITI) Training:
This required tutorial covers both IRB Training* and Good Clinical Practices (GCP) Training**.
Required Tutorial on Human Subject Research Protection
Research Policy Handbook (RPH) 5.7-Training in the Protection of Human Subjects
webpage
*IRB training: Human subjects: Stanford University requires that all individuals working with human subjects in either medical or nonmedical research complete an instructional program in the protection of human subjects. Training must be completed before the University will approve a project protocol or release project funds. This requirement reflects the University's commitment to the protection of the rights and welfare of human subjects in research, and incorporates the requirements of the National Institutes of Health (NIH).
**Good Clinical Practices Training: On September 16, 2016, NIH issued a policy establishing the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials as defined by NIH should be trained in Good Clinical Practice (GCP),
The NIH policy is effective January 1, 2017. As a result, the Institutional Review Board (IRB) will require assurance that GCP training will be completed. Your institutional official in RMG or OSR also will require verification that GCP training has been completed before sponsored project awards are issued.
For Qualifying Cancer-Related Human Subjects Research, Scientific Review Committee (SRC) is required.
More about the SRC and what studies require SRC review:
http://med.stanford.edu/cancer/research/trial-support/src.html
Please inform RMG when your protocol is approved.
It’s our practice to submit proposals with SCRO protocols marked as pending approval.
The reason for this is because each research plan in each proposal needs to be individually reviewed against a protocol and will receive a separate approval, if appropriate.
Important: In addition to any other required items, be sure to add the Stanford SPO # & Sponsor Reference # (if applicable) under the Funding – Grants/Contracts section of the appropriate protocol. Protocols will be required for subawards engaging in these activities.
Please inform RMG when your protocol is approved.
Do I need to submit a SCRO Protocol?
https://scro.stanford.edu/docs/flow_chart/SCRO_Review_Categories_Flowchart.pdf
How do I submit a SCRO Protocol?
https://eprotocol.stanford.edu/scro
IACUC, IRB & Other Panel Meeting Dates & Deadlines:
http://researchcompliance.stanford.edu/rco/documents/panel_schedule/RCO_Meeting_Schedule_2015_2016.pdf
Please contact the appropriate SCRO staff member for assistance:
https://scro.stanford.edu/schedules_contacts/contacts.html
Every PI (by virtue of Academic Council, MCL faculty appointment or PI Waiver) at Stanford must complete a one-time course:
PI Training: Stewardship and Compliance for Principal Investigators
Stanford requires principal investigators to complete a brief online course to help them carryout the responsibility for protecting individuals and the University, and for compliance with laws and regulations that touch on all aspects of the research enterprise.
Go to: http://doresearch.stanford.edu/training/piship
Scroll down to bottom of page and click on:
PI Training: Stewardship and Compliance for Principal Investigators
Or
Log in.
Scroll down to bottom of page.
Click Start Course.
Course is comprised of the following modules:
1. Research and Scholarship
2. Financial Management
You must certify your completion of the course:
3. Certify Completion
This certification should automatically link to SeRA and appear in the University database
http://doresearch.stanford.edu/pi-training-certification-database
Stanford University Outside Professional Activities Certification System (OPACS)
PHS Conflict of Interest Training
It is available to all members of the Stanford community with SUNet IDs through this SeRA webpage >>.
Who should take this training?
If you receive PHS funding, you must complete this training before a PHS award can be accepted on your behalf. Your certification is valid for four years. You must retake this training when your certification expires.
In addition to those faculty support with PHS funding, Stanford requires all newly-hired faculty to complete this training.
If Pending, please take the following actions:
1. Go to your OPACS Dashboard: https://sera.stanford.edu/pls/apex/f?p=opacs:dashboard
2. Under “Faculty Action Items” a list of records appear requiring you to re-declare COI.
3. Click on the record(s) to complete your COI declaration.
Proof of completion should be reflected in SeRA.
