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December 12, 2008
Retreat Refreshes Behavioral, Social Sciences
Dr. Christine Bachrach
Dr. Christine Bachrach, acting director of the Office of Behavioral and Social Sciences Research, wanted just one thing out of the first-ever day-long retreat for NIH’s widely dispersed community of behavioral and social scientists, held Nov. 12 at Natcher Bldg.
December 12, 2008
CBT4CBT
New Hope for Treatment of Addiction
Dr. Kathleen Carroll
Drug addiction is notoriously tough to treat, but now research is showing a fresh way to tackle the problem. It’s called computer-based training for cognitive-behavioral therapy (CBT4CBT)
OBSSR’s Mabry Wins with Systems Analysis Team
OBSSR’s Mabry Wins with Systems Analysis Team
More News >>
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January 28-29, 2009 Dissemination and Implementation Conference
February 9, 2009, 10:00 – 11:00 AM
Stigma: Lessons & New Directions from a Decade of Research on Mental Illness
July 12-24, 2009
OBSSR/NIH Summer Training Institute on Randomized Clinical Trials Involving Behavioral Interventions
May 3-8, 2009
Institute on Systems Science and Health
May 22-25, 2009
Gene-Environment Interplay in Stress and Health at the Association for Psychological Science 21st Annual Convention, San Francisco, CA
More Events >>
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Home > About OBSSR > Activities > Adherence Research Network
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Policy |
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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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