Epidemiology and Genomics Research
CANCER EPIDEMIOLOGY MATTERS E-NEWS
September 2015
Follow us on Twitter
Funding Opportunity AnnouncementsFundingOpps
PA-15-305
Supplements to Support Evaluation of the NCI Cancer Genomics Cloud Pilots (Admin Supp)
Application due date: October 18, 2015
Expiration date: October 19, 2015

PAR-15-340
NCI Exploratory/Developmental Research Grant Program (NCI Omnibus R21)
Application due date: November 10, 2015
Expiration date: November 11, 2015

PA-15-329
Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp)
Application due date: November 30, 2015
Expiration date: December 1, 2015

RFA-CA-15-007
Planning for Regional Centers of Research Excellence in Non-communicable Diseases in Low and Middle Income Countries (P20)
Application due dates: December 10, 2015; August 23, 2016
Expiration date: August 24, 2016

Small Business Innovation Research Technology Transfer (R43/44)
Application due dates: Standard dates apply
Expiration date: September 6, 2018 

NCI Prize Competition
Up For a Challenge? Stimulating Innovation in Breast Cancer Genetic Epidemiology
Submissions due January 2016
Grants Policy Announcementsgrantsmanship 
NOT-OD-15-152
Civil Rights Protections in NIH-Supported Research, Programs, Conferences and Other Activities

NOT-OD-15-154
Webinars for Grant Applicants and Grant Administrators: What You Need to Know about NIH Application Submission and Review

NOT-OD-15-160
Review of Grants Information for Fiscal Year 2015
Job OpportunitiesJob
Master's-Level Fellowship in Environmental Epidemiology

Master's-Level Fellowship in Clinical and Translational Epidemiology

Health Scientist for Health Assessment Research

International Agency for Research on Cancer Fellowships
Upcoming Webinars & WorkshopsEvents
2015 NIH Regional Seminar
October 14-16, 2015
San Diego, CA

October 16, 2015
Washington, DC

October 25-27, 2015
Rochester, MN

October 26-27, 2015

November 17-18, 2015
Bethesda, MD


Conference on the Science of Dissemination and Implementation in Health
December 14-15, 2015
Washington, DC
  

Global Cancer: Occurrence, Causes and Avenues to Prevention
June 7-10, 2016
Lyon, France
Bold Blueprint for Precision Medicine Initiative's Research Cohort
Dr. Francis Collins
NIH Director's Blog
Send Us Your IdeasSendUsIdeas

EGRP encourages readers to submit items of interest to Cancer Epidemiology Matters E-News. EGRP reserves the right to decide whether or not materials are appropriate for inclusion.

About EGRPAboutEGRP
The Epidemiology and Genomics Research Program (EGRP) in the Division of Cancer Control and Population Sciences (DCCPS) funds research in human populations to understand the causes of cancer and related outcomes.

The Program fosters interdisciplinary collaborations, as well as the development and use of resources and technologies to advance cancer research and translation of this research, which serve as the basis for clinical and public health interventions.
Contact UsContactUs
website: epi.grants.cancer.gov
blog: blog-epi.grants.cancer.gov
twitter: twitter.com/NCIEpi

Comments Sought by December 7, 2015
Image of doctor - patient conversation courtesy of the National Cancer Institute

The Federal Policy for the Protection of Human Subjects or the "Common Rule" was published in 1991. For all participating departments and agencies - such as the Department of Health and Human Services (HHS), which includes the National Institutes of Health (NIH) - the Common Rule outlines the basic provisions for Institutional Review Boards (IRBs), informed consent, and Assurances of Compliance. 

In July 2011, HHS announced that the federal government was contemplating ways to enhance the regulations that cover research on human subjects and invited public input on issues related to the ethics, safety, and oversight of human research in an Advanced Notice of Proposed Rulemaking (ANPRM). After consideration of responses to the ANPRM, on September 8, 2015, a notice was published in the Federal Register announcing a Notice of Proposed Rulemaking (NPRM) to the Common Rule, with proposed revisions to modernize, strengthen, and make more effective the federal policy for the protection of human subjects. HHS also published a summary of the proposed changes, which include:
  • Improving informed consent by increasing transparency and imposing stricter requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
  • Generally requiring informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. Such consent generally would be obtained by means of broad consent (i.e., consent for future, unspecified research studies) to the storage and eventual research use of biospecimens.
  • Changing the conditions and requirements for waiver or alteration of consent such that a waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances. 
  • Excluding from coverage under the Common Rule certain categories of activities that should not be deemed as research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
  • Adding categories of exempt research to accommodate changes in the scientific landscape and better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review.
  • Eliminating the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and merely are analyzing data or involve only observational follow-up in conjunction with standard clinical care.
  • Extending the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.
  • Mandating that U.S. institutions engaged in cooperative research rely on a single IRB for the portion of the research that takes place within the United States, with certain exceptions.
Investigators are encouraged to review and comment on the proposed changes no later than 5:00 p.m. on December 7, 2015. Comments should include the docket ID number "HHS-OPHS-2015-0008," and may be submitted by one of the following methods:
  • Federal eRulemaking Portal: Enter the above docket ID number in the "Enter Keyword or ID" field and click on "Search." On the next webpage, click on "Submit a Comment" and follow the instructions.  
  • Mail/Hand Delivery/Courier [for paper, disk, or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., Office of Human Research Protections (OHRP), U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
Comments received, including any personal information, will be posted without change to http://www.regulations.gov.

Cancer is the second leading cause of death in the United States. Cancer burden is differentially distributed across racial and ethnic minority groups, as well as across other sociodemographic, cultural, and geospatial factors. The United States currently is experiencing a demographic transition, and racial and ethnic minorities are expected to comprise 51% of the population by 2050. Other populations also are growing, including refugees, the elderly, marginalized rural and urban populations, and sexual orientation and gender identity minorities. A limited number of epidemiologic studies have examined cancer risks and burdens within these populations in the biomedical research portfolios of the National Cancer Institute (NCI) and the National Institutes of Health (NIH). 

Consequently, only limited epidemiologic data on health risks and outcomes are available to inform evidence-based cancer control, prevention, and intervention efforts for these diverse groups. In response to these gaps in scientific knowledge, the Epidemiology and Genomics Research Program (EGRP), within NCI's Division of Cancer Control and Population Sciences, initiated a discussion with stakeholders to facilitate research and improve scientific knowledge regarding cancer risks and outcomes within these understudied populations. 

  
On September 8 and 9, 2015, EGRP hosted a think tank to identify resources and opportunities that could expand ongoing efforts to bridge gaps and set research priorities in cancer epidemiology among understudied populations. The meeting, "Think Tank on Understudied Populations in Cancer Epidemiologic Research: Implications for Future Needs," convened experts in the fields of epidemiology, environmental health, clinical medicine, community health, behavioral science, global health, and health disparities. Participants discussed the resources needed to address relevant research challenges and the feasibility of proposed solutions.

The input gathered during the meeting will be used to inform future scientific initiatives and broaden the conversation within the larger scientific community. In the long term, this will help NCI promote studies to address cancer epidemiology in understudied populations to inform evidence-based cancer prevention and control guidelines and policies.

Additional information, including the agenda, is available on the meeting webpage. A white paper summarizing the meeting will be published in 2016.  

Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, 
National Cancer Institute | 9609 Medical Center Drive | 4 East, MSC 9763 | Bethesda | MD 20892