Date of publication: 2017-08-29 10:26
While NIH requires some documentation in the application, it varies by institute as to whether to include other items, such as the protocol and informed consent document. At NIAID, requirements also vary by division, so talk to a program officer to find out when you must submit required documents.
Here we offer advice and information to help you determine whether your research is considered human subjects, and if it is, how to understand and comply with regulations at all phases of application and award, including NIAID requirements.
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 7 weeks.
Applications must be submitted electronically following the instructions described in the SF979 (R&R) Application Guide. Paper applications will not be accepted.
If the IRB or IEC determines that you need informed consent, it must approve the informed consent form. For details, read 95 CFR , 95 CFR , and 95 CFR . Also visit the Informed Consent section of Human Research Questions and Answers from the Office for Human Research Protections.
Your research may fall under the umbrella of human subjects even if you aren't working on humans directly. For example, some basic research on samples would be considered human subjects, while research taking a different approach would not. This is a complicated topic with many rules and regulations, so tread carefully and read on to learn more.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Earth Floor. Site includes information on commonly found Biomes: Arctic Tundra Biome, Mid-Latitude Deciduous Forest Biome, Desert Biome, Tropical Rainforest Biome, Tropical Savannah Biome, and Taiga Biome. A map shows the locations of these biomes in different colors.
To determine whether your research is exempt, go to OHRP Is an Activity Research Involving Human Subjects ? If you still think your research may be exempt, contact your program officer.
For more information, go to the NIH Office of Biotechnology Activities website and the NIH Guidelines for Research Involving Recombinant DNA Molecules.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Temperate Forests occur in eastern North America, northeastern Asia, and western and central Europe. Well-defined seasons with a distinct winter characterize this forest biome.
Tsunami Safety Rules from International Tsunami Information Center, Honolulu, HI. See also Tsunami Library - includes Overviews, Glossary, Great Waves, Historical Events, Online Documents, FAQs, Fact Sheets, Research Efforts, Tsunami Links, Videos Available for Order, Pacific Tsunami Warning Center Bulletins for current tsunami events.