Applications Requesting More Than $500,000 in Direct Costs
NIA adheres to the NIH policy stating that for applications with direct costs greater than $500,000 in any year, the principal investigator (PI) must contact NIA or other NIH Institute or Center staff 6 weeks prior to submission to determine whether the Institute will accept the application.
This policy applies to:
- Amended applications
- Competing renewals of grants
- New applications
After NIA accepts an application requesting more than $500,000, NIA may apply reductions according to the policy described above. In addition, large applications may be delayed in funding when insufficient funds are available at a particular funding cycle.
For more information, see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004 .html.
Data Safety and Monitoring of Clinical Trials
All clinical trials sponsored or conducted by NIH should have an in-place system for appropriate oversight and monitoring to ensure participants' safety and the data's validity.
For more information, see the NIH Policy for Data Safety and Monitoring, as published in the NIH Guide, June 10, 1998: (http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
NIA Requirements for Human Intervention Studies
Similar to NIH, NIA has specific requirements for human intervention studies that must be addressed in the grant application. These requirements are directed toward protecting participants' safety in intervention studies and assuring that trials are conducted and analyzed properly.
For these requirements, see "Implementation of Policies for Human Intervention Studies"
Guidance on Reporting Adverse Events to Institutional Review Boards (IRBs) for NIH-Supported Multicenter Clinical Trials
All data-safety monitoring boards for multisite clinical trials must forward summary reports of adverse events to each IRB involved in the study.
For more information, see: http://grants.nih.gov/grants/guide/notice-files/not99-107.html.
Certificates of Confidentiality
What are Certificates of Confidentiality?
Certificates of Confidentiality protect those with access to research records from disclosing identifying information in any civil, criminal, legislative, administrative, or other Federal, State, or local proceedings. Certificates are issued only when research information is sensitive and protection is necessary to achieve the research aims while protecting confidentiality and privacy.
Certificates of Confidentiality:
- Allow researchers to avoid the involuntary release of any portion of research records containing information that could be used to identify study participants
- Protect those who have access to research records from involuntary disclosure
When are Certificates of Confidentiality Required?
Certificates of Confidentiality are required when the study:
- Involves information collection potentially damaging to an individual's financial standing, employability, insurability, or reputation
- Results in stigmatization or discrimination
- Involves genetic testing for disease predisposition
- Involves information on sexual attitudes or practices, substance abuse, or other illicit behavior
When Should PIs Request Certificates of Confidentiality?
PIs should request Certificates of Confidentiality from their NIA Program Administrator once the award is received, but before the study begins.
For more information on Certificates of Confidentiality, contact:
Dr. Miriam Kelty
Associate Director
Office of Extramural Affairs
National Institute on Aging
National Institutes of Health
Bethesda, MD 20892
Phone: 301-496-9322
mk46u@NIH.GOV
For additional information, see:
