Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults With Cardiovascular Risk Factors)
Education and Health: New Frontiers (Meeting Summary)
August 25, 2014
Wireless Health 2014 - Call for Submissions
Deadline: September 15, 2014
Emotional Stress a Stronger Risk Factor for Heart Disease in Women Compared To Men
July 31, 2014
NHLBI Request for Information(RFI): Collaborative Translational Research Consortium to Develop T4 Translation of Evidence-based Interventions (NOT-HL-14-028)
Released July 2, 2014
More News >>
October 23, 2014
3 pm - 4 pm EST.
Intervention science: Using social psychology to reduce achievement gaps and health disparities - NHGRI SBRB
October 29, 2014
2 pm - 4 pm EST.
BSSR Lecture Series and Videocast : mHealth Measurement
October 29 - 31, 2014
Wireless Health 2014
November 3, 2014
8 am - 5 pm ET.
mHealth Training: Developing Mobile Health Interventions to Treat Pediatric Obesity
Boston Convention and Exhibition Center
More Events >>
Home > About OBSSR > Activities > Adherence Research Network
Policy Issues in Adherence Research
Table of Contents
Protecting the Privacy of Patients and Research Subjects (HIPPA)
- Protecting Privacy of Patients and Research Subjects (HIPPA)
- NIH Data Sharing Policy
- Human Research Protection (IRBs)
- Certificate of Confidentiality
- Bioethics Resources
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
Centers for Medicare & Medicaid Services:
DHHS Office of Civil Rights:
NIH Data Sharing Policy
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
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
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
This document addresses many issues including:
Certificate of Confidentiality
- 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.
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
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.)