Sunday, January 7, 2018

Single IRB policy for multi-site trials

By Metropolitan Transportation Authority of the State of New York (Blizzard of 2015: Empty Grand Central Terminal) [CC BY 2.0 (], via Wikimedia Commons
The new policy requiring a single IRB for multi-site clinical trials goes into effect on January 25th, 2018.  All of your IRB approvals will now need to be routed through one IRB that will serve as a central hub.  For details, including links to the many previous NIH notices regarding this change, visit this page.

Friday, January 5, 2018

New changes to human subjects mean updated review criteria

NIH has released updated review criteria that will be used to evaluate grant applications proposing clinical trials.  According to NIH, the purpose of the expanded criteria is "to ensure that key pieces of clinical trial-specific information are submitted with each application and that reviewers appropriately consider this clinical trial-related information. Implementing new and more rigorous review criteria for evaluating clinical trial applications will ensure the highest likelihood of translating research results into knowledge that will improve human health."
The full description of the updated clinical trial-specific review criteria and rationale can be accessed here. 

Thursday, December 7, 2017

Is my grant a clinical trial?

It can be very confusing to determine whether your project meets the NIH definition of a clinical trial.  Given the new Forms-E that will be effective starting with January submission deadlines, it is now more important than ever to correctly characterize your project. 
NIH has provided investigators with a useful tool in order to make this determination.  This series of questions will help you to ascertain whether your proposed project meets the NIH definition of a clinical trial, which will help to guide you as you complete all of the newly required Human Subjects attachments.

Monday, November 27, 2017

Your final report will now be public

In a recently-released notice, NIH announced that all Project Outcomes sections from interim and final RPPR reports will be made public.  This applies to all submissions starting October 1, 2017.  The reports will be available in the NIH RePORTER.  This is an important step toward showing transparency in publicly-funded research.  It will be interesting to see how it is received by the public.  There has been considerable outcry in the past over NIH-funded research, including studies of sexy goldfish, origami condoms, and poop-throwing monkeys. Although this new policy is based on good intentions, I can't help but wonder if it will hurt scientists whose potential research impact is not obvious to those without particular scientific knowledge.  To help prevent this type of scrutiny, it is important to write your Project Outcomes section in clear language that can be easily understood by the public.

Monday, November 20, 2017

New NIH Research Program - All of Us

NIH is currently beta testing a new initiative called All of Us that is designed to engage 1 million or more volunteers in research.  The All of Us website describes the initiative as follows:
"Creating the right health approaches and care for the right person is called precision medicine. Getting the right information to make that happen is the goal of the All of Us Research Program from the National Institutes of Health (NIH).  To get there, we want to create the largest health data resource ever. By understanding people’s health, neighborhood, family, and lifestyle, researchers will have information to better understand health and disease. This information is essential to create a healthier future for generations to come."
By taking part in this initiative, participants will help to advance the field of precision medicine.  They will take part in activities such as providing blood or urine samples, answering surveys, and allowing access to medical records.  Anyone can join who is not in prison, unable to consent on their own, or younger than 18.
For more information, view the recent press release from NIH here

Tuesday, November 7, 2017

A recent update in the fight against caps on indirect costs

Although it has not been a top news story as of late, there is still an undercurrent of discussion surrounding limiting the indirect costs paid on federal grants.  As previously mentioned, a cap of 10% indirect costs on all NIH and other federal awards would decimate the research infrastructure of most academic institutions.  In a recent move, an important legislator began to lay the groundwork for prevention of indirect cost limits in 2018.  You can read the full article here.

Sunday, November 5, 2017

Planning to apply to NIOSH in February or March? Not so fast...

In a series of recent notices, the Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH) has closed all February and March 2018 application deadlines.  It is anticipated that they will begin accepting R01 and R21 applications again in June and July of 2018.  However, if you are planning a grant proposal submission, it is important to watch this closely, monitor for any new updates, and stay in close contact with NIOSH program staff.

Saturday, October 21, 2017

Sample successful R01 and R03 grant applications

If you are looking for more sample NIH R01 and R03 applications, there are several located on the NCI website.  The proposals are all focused on cancer epidemiology, but even those in other fields can benefit from seeing the structure and flow of a successful application.  The sample grant proposals are located here.

Monday, October 16, 2017

New NIH criteria for review of clinical trial applications

Beginning with the January 25, 2018 deadline, NIH will instruct reviewers to use additional criteria in the evaluation of grant applications that propose clinical trials.  The full policy change notice is located here.

The additional review criteria are as follows:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Does the application adequately address the following, if applicable?
Study Design 
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis 
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?  Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?