We all love hearing about changes to the federal register, amirite? Well celebrate, one and all: last week, a new final version of the “Common Rule” for the protection of human subjects was published by fifteen federal agencies (including DHHS and NSF) in effort to strengthen the Federal Policy for the Protection of Human Subjects. The intent is to both enhance protections and reduce administrative burden(!), and here’s what it means to you:
- Consent forms are required a better understanding to provide potential research subjects of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- A single institutional review board (IRB) for multi-institutional research studies is required in many cases. (There is substantial flexibility in now allowing broad groups of studies, instead of just specific studies, to be removed from this requirement; this provision is delayed until 2020.)
- Studies on stored identifiable data or identifiable biospecimens allow 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. Aside: if you’ve been following along, you’ll note that this is a change of course from earlier intent to apply the principles of informed consent to all biospecimens.
- New exempt categories of research are established based on the level of risk posed to participants. (For example, there is a new exemption for secondary research involving identifiable private information as regulated by and participants protected under HIPAA; the intent is to reduce regulatory burden to allow IRBs to focus their attention on higher risk studies.)
- Continuing review of ongoing research studies is no longer required in instances where such review does little to protect subjects.
- Consent forms for certain federally funded clinical trials are required to be posted on a public website.
The general effective/compliance date of the final rule is January 19, 2018; all studies without initial IRB review as of 1/20/18 will be subject to the new requirements. Any ongoing research at that time (i.e. studies with IRBs approved under the current version of the Common Rule) will continue to be subject to the current, pre-2018 version of the rule unless the university chooses to mandate compliance with the final version. For more on the transition provisions, check out the final rule preamble, as well as Section 101(l) of the regulatory text.
Stay tuned for further guidance; HHS intends to issue direction on specific provisions of the rule changes in the near future.
For fiscal year 2016, the Division of Mathematical Sciences at the National Science Foundation will be piloting a just-in-time (JIT) system. The intent of the pilot is to allow NSF reviewers to focus on the science and to reduce PI workload by requiring only basic budget justifications; think along the lines of the impetus behind NIH modular budgets. If a proposal is recommended for award, NSF staff will request full budgets and associated justifications at that time (hence the term).
Here’s where it gets a little sticky: during the initial proposal submission stage, NSF is requesting a blank FastLane budget (listing zero dollars). Since FastLane prepopulates fields for senior personnel, there is a work-around to erase those fields in Section A if senior personnel are on the project (here’s a hint: they probably are). Here’s what NSF wants you to do:
- Go the Budget;
- Click Funds (or Add a Year, if appropriate, then click Funds);
- Delete the Senior Personnel from Budget Section A (by clicking on ‘Add/Remove Senior Personnel’) and then click Save; and
- Click to the Bottom of Page, click Calculate and Save and Go Back.
The budget justification will include resource details, but not dollar amounts (except for large equipment). If they are being requested, information must be provided for:
- Total number of person-months of Senior Personnel salary for the entire project (such as 3 months, 6 months, etc.);
- Number of postdoctoral scholars, graduate or undergraduate students, administrative and clerical staff, and a brief overview of their respective roles in the project;
- Equipment purchases, including estimated cost;
- Number of domestic and foreign trips anticipated, their necessity for the project, as well as the number of travelers and the location of the trip, if available;
- Number of project participants for whom travel, stipend, etc., support is requested;
- Pertinent materials and supplies to be purchased, consultant services, etc.; and
- Any subawards, to whom, and a brief description of the work to be performed.
As you can see, the new NSF JIT framework is a bit nuanced. Make sure you read the pilot announcement to fully understand the JIT implementation if you are planning to submit a DMS NSF proposal in FY2016. This is also worth a read if you plan to submit to any NSF division in the future 😉
For those of you unable to attend the Tips & Tools meeting last week, Kathryn Wrench’s presentations slides are available HERE. If you were a part of the discussion, a couple of corrections were subsequently made to the information presented:
- Resubmissions to NSF Programs: Resubmissions are considered new submissions by NSF, if substantially revised. If not substantially revised, the investigator risks return without review, or the Program Official may be kind enough to suggest that the proposal be withdrawn so that NSF does not need to take an adverse action. Some NSF Directorates explicitly prohibit resubmission within 1 year of the original submission, others do not. There is no formal standardized process for the entire organization. The NSF Proposal Review Process is accessible here. The Non-Award Decision actions are accessible here.
- Salary Cap: NSF removed their statutory salary cap around 1990. Keep in mind, however, that NSF has a general limit of 2 month’s pay for Senior Personnel. Although that rule is general, we go by it in budgeting unless the program would justify deviation with permission (there are some exceptions permitted to the 2 month limit). Apparently, the agencies that impose a cap are certain components of DHHS, including NIH $183,300, and DOD $952,308. The DOD and other cap provisions outside of DHHS apply to contracts only (more on that here).
If you have any questions about submitting an NSF proposal, Kathryn Wrench has indicated that she is happy to take your questions. RAS is also here to help sort out the details!
Coming or going, the transfer of grant awards raises issues of mechanism and ownership (and territoriality!) for many PIs and administrators. When considering grant transfers, it is important to keep in mind one central tenet: awards are made to institutions, not to PIs. Even though the PI applies for the grant and does or directs the research, s/he is doing so on behalf of the institution. Therefore, should a PI decide to change institutions, s/he must have the permission of the institution to take the grant award along (it is, of course, the prerogative of the institution to keep the project and assign new personnel to the research if it so chooses). That’s where the relinquishing statement comes in.
A relinquishing statement is an official statement relinquishing interests and rights in a research grant; different agencies use different mechanisms for generating these statements. For NIH, the process is initiated in eRA Commons by a signing official of the institution holding the award. Other funding agencies who do not use eRA Commons have different mechanisms, so be sure to check for agency-specific guidelines. NSF, for example, requires that the process be initiated by the PI through FastLane once an agreement has been reached by both the current and future grant holders, and requires the FTR (federal cash transactions report) at the time of the request. For detailed instructions on transferring grants from these two federal agencies, check out the NIH transfer guide assembled by NIAMS, and section IIB2h of NSF’s PAPPG.
Our office has shepherded many a transfer, so feel free to reach out if you have any questions on transfer policy or procedure!
The National Science Foundation recently announced their transition of the “Notifications and Requests” function from FastLane to Research.gov. Starting April 27, 2015, recipients can create and submit three new types of budget-related requests on Research.gov: salaries of administrative or clerical staff, travel costs for dependents, and additional categories of participant support costs other than those described in 2 CFR § 200.75 (such as, incentives, gifts, souvenirs, t-shirts and/or memorabilia). All other existing notifications and requests will continue to reside in FastLane and will be migrated in the future. For more information, see the notifications and requests informational page.
This is just one piece of the NSF effort to “modernize FastLane.” It is NSF’s goal to eventually replace FastLane with Research.gov completely, but that is still years away. For more information on the functionality of Research.gov and what you can expect to migrate, take some time with Research.gov’s FAQ page. If you’re not sure if whether you should be using Research.gov or FastLane (or whether it should be you or your GCO), reach out and we’ll give you a hand!
The new NIH biosketch format will be in effect come May 25, but many PIs and administrators* are choosing to make the switch now to avoid crunch-time headaches. We’ve mentioned SciENcv before, and don’t panic if new systems set your heart a-flutter: it’s not required. We do, however, think you should consider the many benefits of using the SciENcv tool:
- Eliminates the need to repeatedly enter biosketch information. The first time you enter your information into the system will likely be the most time you will have to have to spend with SciENcv. That said, did you know that you can automatically import your information from your eRACommons profile (or ORCID, if you have one) directly into SciENcv? It’s true! And it is editable! This will likely save a lot of time, and may even be faster than cutting and pasting text from your old .doc versions of your biosketch into a new template (see below).
- Reduces the administrative burden associated with federal grant submission and reporting requirements. Your biosketch information will always be right where you left it: in the cloud, in your MyNCBI account. Because SciENcv generates and maintains multiple biosketches from your information (including those for NSF and other federal science agencies), you’ll be able to simply tweak any sections you have saved to align more closely with new applications, click a button, and voila! Your biosketch is generated in proper format, tailored to your specifications. You can even keep multiple profile versions to correspond with different projects or research interests, and generate different biosketches from each one at a later time. Additionally, SciENcv allows you to pull your publications directly from your MyNCBI. Your pubs list is generated for you, and you can decide which ones you want to appear in your list.
- Provides access to a researcher-claimed data repository with information on expertise, employment, education, and professional accomplishments. Collaborations, anyone? You can choose whether or which profiles/biosketches are made public to the research community. You will also be provided a unique link to use to direct people to your profile, for your use.
- Allows researchers to describe their scientific contributions in their own language. The new biosketch format includes a description of up to five of your most significant contributions to science; in other words, this is where you get to show off a little. You don’t have to leave your impact open to reviewer interpretation anymore; tell ’em what you’ve done! You also get to use publications in this section to support your affirmations of grandeur; just keep each description to half of a page.
Interested in the power of SciENcv but not sure where to start? Read all about it, check out the YouTube tutorial provided by NIH, or sign yourself up for a free account (either through your eRACommons account or at the SciENcv portal page) and test it out. For a little more one-on-one assistance, Dr. Katherine Akers in the Shiffman Medical Library is happy to come to your department for a presentation or individual assistance. Already started and hit a snag? RAS is always happy to help get you moving again! If you would prefer not to use SciENcv, you can access an editable Word copy of the May25-required biosketch format, provided by the NIH HERE.
*Note: PIs can designate administrators, research assistants, etc. to have access to their biosketches (and publications) through SciENcv, if said PI does not normally assume responsibility for currency his/herself.