Notice of Correction to PAR-17-496 "Intervention Research to Improve Native American Health (R01 Clinical Trial Optional)"

Notice Number: NOT-CA-18-001

Key Dates
Release Date:   October 13, 2017

Related Announcements
PAR-17-496

Issued by
National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to correct and clarify the Funding Opportunity Purpose section in the Funding Opportunity Announcement (FOA) PAR-17-496, Intervention Research to Improve Native American Health (R01 Clinical Trial Optional).

The correction in the Funding Opportunity Purpose section is to highlight the primary purpose of the R01 FOA, which is to develop, adapt, and test the effectiveness of (prevention and/or treatment) interventions to improve health outcomes; and (2) to elucidate the difference between the research scope of the companion R21 (PAR-17-464) FOA.

The following sections of the FOA have been corrected:

Part 1. Overview Information

Section I Funding Opportunity Purpose

 

Currently reads:

The purpose of this funding opportunity announcement (FOA) is to encourage exploratory developmental research to improve Native American (NA) health. Such research can include: conducting secondary analysis of existing data (such as databases that the Tribal Epidemiology Centers have collected); merge various sources of data to answer critical research questions; conduct pilot and feasibility studies; and/or assess and validate measures that are being developed and/or adapted for use in NA communities.

For the purposes of this FOA, the term 'Native Americans' includes the following populations: Alaska Native, American Indian, and Native Hawaiian. The term 'Native Hawaiian' means any individual whose ancestors were natives, prior to 1778, belonging to the area that now comprises the State of Hawaii.

Studies should: be culturally appropriate and result in promoting the adoption of healthy lifestyles; improve behaviors and social conditions and/or improve environmental conditions related to chronic disease; prevent or reduce the consumption of tobacco, alcohol, and other drugs; improve mental health outcomes; reduce risk of HIV infection; improve treatment adherence and/or health-care systems adopting standards of care to improve overall quality of life.

Modified to read (in italics)

The purpose of this funding opportunity announcement (FOA) is to develop, adapt, and test the effectiveness of (prevention and/or treatment) interventions to improve health outcomes in Native American (NA) populations. For the purposes of this FOA, the term ‘Native Americans’ includes the following populations: Alaska Native, American Indian, and Native Hawaiian. The term ‘Native Hawaiian’ means any individual whose ancestors were natives, prior to 1778, belonging to the area that now comprises the State of Hawaii.

Intervention submitted to this FOA should: be culturally appropriate and promote the adoption of healthy lifestyles; improve behaviors and social conditions and/or improve environmental conditions related to chronic disease; prevent or reduce the consumption of tobacco, alcohol, and other drugs; improve mental health outcomes; reduce risk of HIV infection; develop, implement, and disseminate treatment interventions; improve treatment adherence and/or health-care systems adopting standards of care to improve overall quality of life. The intervention should be designed so that it can be sustained within the entire community with existing resources, and, if successful, disseminated in other NA communities. The long-term goal of this FOA is to reduce morbidity and mortality in NA communities.

This FOA recognizes that many NA communities are small and many members are dispersed across the United States, so it is not a requirement to provide pilot data from the community under study. However, investigator(s) are encouraged to provide such data if they are available.

Part 2. Full Text of Announcement

Section IV. Application and Submission Information

 

Currently reads:

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Protection of Human Subjects: A Data and Safety Monitoring Plan (DSMP) may be required or projects that are proposing to pilot test interventions. If a DSMP is needed, the PD(s)/PI(s) of each study will establish a DSMP to monitor data and oversee participant safety in each study supported by this initiative.
Applicants should not appoint DSMP members in advance of the peer review, or even inquire about the interest of possible DSMP members, to facilitate peer review. 

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed

Should correctly read (in italics):

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan: A Data and Safety Monitoring Plan (DSMP) may be required or projects that are proposing to pilot test interventions. If a DSMP is needed, the PD(s)/PI(s) of each study will establish a DSMP to monitor data and oversee participant safety in each study supported by this initiative.

Applicants should not appoint DSMP members in advance of the peer review, or even inquire about the interest of possible DSMP members, to facilitate peer review. 

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Shobha Srinivasan, Ph.D. 
National Cancer Institute (NCI)
Telephone: 240-276-6938
Email: ss688k@nih.gov

Martha L. Hare, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-451-8504
Email: harem@mail.nih.gov