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Change in Leadership of the NIH Office of Behavioral and Social Sciences Research
April 11, 2014


The Health Consequences of Smoking - 50 Years of Progress. A Report of the Surgeon General
January, 2014


Dr. Patricia Mabry Co-Authors SOPHE Special Journal Suplement Showcasing New Applcations of Systems Science to Health Promotion and Public Health
November, 2013

  More News >>

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May 16, 2014
2 pm - 3 pm EST.
BSSR Lecture Series:

Demographic, Social, Behavioral, and Emotional Determinants of Cardiovascular Risk
Rockville, MD 


May 23, 2014
2 pm - 4 pm EST.
BSSR Lecture Series:

Culture, Research, and Health Outcomes Panel
Bethesda, MD 

More Events >>

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Home > About OBSSRActivities > Adherence Research Network


Policy

Policy Issues in Adherence Research

Table of Contents
  • Protecting Privacy of Patients and Research Subjects (HIPPA)
  • NIH Data Sharing Policy
  • Human Research Protection (IRBs)
  • Certificate of Confidentiality
  • Bioethics Resources
Protecting the Privacy of Patients and Research Subjects (HIPPA)

The Department of Health and Human Services (HHS) issued the Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to provide the first comprehensive Federal protection for the privacy of personal health information. Many of those who must comply with the Privacy Rule must do so by April 14, 2003.

While certain provisions of the Rule specifically concern research and may affect research activities, the Privacy Rule recognizes that the research community has legitimate needs to use, access, and disclose Protected Health Information (PHI) to carry out a wide range of health research protocols and projects. The Privacy Rule protects the privacy of such information while providing ways in which researchers can access and use PHI when necessary to conduct research.

Various summaries are available offering guidance on the application of HIPPA

Information for Researchers

http://privacyruleandresearch.nih.gov/

Centers for Medicare & Medicaid Services:

http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/std_alp.php

DHHS Office of Civil Rights:

http://www.hhs.gov/ocr/hipaa/

NIH Data Sharing Policy
http://grants1.nih.gov/grants/policy/data_sharing/
All investigator-initiated applications with direct costs greater than $500,000 in any single year must address data sharing in their application. Applicants are encouraged to discuss their data sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. Applicants are reminded that agreement to accept assignment of applications over $500,000 must be obtained at least six weeks in advance of the anticipated submission date. Instructions related to the data sharing policy as it is applied to applications and proposals responding to a specific Request for Application (RFA) or Request for Proposals (RFP) will be described in the specific solicitation. In some cases, Program Announcements (PA) may request data sharing plans for applications that are less than $500,000 direct costs in any single year.

Human Research Protection
Office of Human Research Protections http://ohrp.osophs.dhhs.gov/

This site includes links to a wide variety of regulations and policy statements as well as ethical guidelines (e.g., Belmont Report). Also posted is information about Institutional Review Boards (IRB).

NIH Brochure on Protecting Human Subjects in Behavioral and Social Research
http://obssr.od.nih.gov/IRB/protect.htm

This document addresses many issues including:
  • The definition of human subjects.
  • What you need to do to comply with Federal requirements if your research involves human subjects.
  • The role of your Institutional Review Board (IRB) and the types of review it conducts.
  • How to decide if your research falls into an exemption category and does not require IRB approval.
  • Informed consent requirements.
  • Privacy and confidentiality including applying for a certificate of confidentiality.
  • Key points when applying for federal funding.
  • Additional resources.
Certificate of Confidentiality
http://grants1.nih.gov/grants/policy/coc/index.htm

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.

Bioethics Resources on the Web
http://www.nih.gov/sigs/bioethics/

The Internet is replete with resources available to those with an interest in bioethics including education, research involving human participants and animals, medical and health care ethics, and the implications of applied genetics and biotechnology. This website contains a broad collage of annotated web links, and while this list is comprehensive, it is not totally inclusive. The listed resources provide background information and various positions on issues in bioethics. (This a NIH website.)

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                  Office of Behavioral and Social Sciences Research, Office of the Director
National Institutes of Health, 31 Center Drive, Building 31 Room B1C19, Bethesda, MD 20892
Phone: 301 402 1146 | Fax: 301 402 1150

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