A624E35EC511A22EA96BE3E7265ABF72
NIH privacy rules and research
https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html
http://leaux.net/URLS/ConvertAPI Text Files/AAABE75AA57554B95238188E4F65DBAD.en.txt
Examining the file media/Synopses/AAABE75AA57554B95238188E4F65DBAD.html:
This file was generated: 2020-02-29 20:34:54
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Health
Searching for indicator health:
(return to top)
p.(None): menu
p.(None):
p.(None): Health Information Privacy
p.(None): U.S. Department of Health & Human Services
p.(None):
p.(None):
p.(None):
p.(None): I'm looking for...
p.(None):
p.(None):
p.(None): HHS A-Z Index
p.(None):
p.(None):
p.(None): HHS > HIPAA Home > For Professionals > Special Topics > Research
p.(None):
p.(None):
p.(None): More Topics In This Section
p.(None):
p.(None):
p.(None):
p.(None): Research
p.(None): 45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532) ( Download a copy in PDF - PDF)
p.(None):
p.(None): Background
p.(None):
p.(None): The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research
p.(None): purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to
p.(None): develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health
p.(None): information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule) without regard to the provisions below.
p.(None):
p.(None): The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes,
p.(None): and their rights to access information about them held by covered entities. Where research is concerned, the Privacy Rule protects the privacy of individually
p.(None): identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital
p.(None): research. Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug
p.(None): Administration’s (FDA) human subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are similar to, but separate from,
p.(None): the Privacy Rule’s provisions for research. These human subject protection regulations, which apply to most Federally-funded and to some privately funded
p.(None): research, include protections to help ensure the privacy of subjects and the confidentiality of information. The Privacy Rule builds upon these existing Federal
p.(None): protections. More importantly, the Privacy Rule creates equal standards of privacy protection for research governed by the existing Federal human subject
p.(None): regulations and research that is not.
p.(None):
p.(None): How the Rule Works
p.(None):
p.(None): In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy
p.(None): Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual
p.(None): authorization under limited circumstances set forth in the Privacy Rule. Research Use/Disclosure Without Authorization. To use or disclose protected health
p.(None): information without authorization by the research participant, a covered entity must obtain one of the following:
p.(None):
p.(None): Documented Institutional Review Board (IRB) or Privacy Board Approval. Documentation that an alteration or waiver of research participants’
p.(None): authorization for use/disclosure of information about them for research purposes has been approved by an IRB or a Privacy Board. See 45 CFR
p.(None): 164.512(i)(1)(i). This provision of the Privacy Rule might be used, for example, to conduct records research, when researchers are unable to use de-
p.(None): identified information, and the research could not practicably be conducted if research participants’ authorization were required. A covered entity may use
p.(None): or disclose protected health information for research purposes pursuant to a waiver of authorization by an IRB or Privacy Board, provided it has obtained
p.(None): documentation of all of the following:
p.(None):
p.(None): - Identification of the IRB or Privacy Board and the date on which the alteration or waiver of authorization was approved;
p.(None):
p.(None): - A statement that the IRB or Privacy Board has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in
p.(None): the Rule;
p.(None):
p.(None): - A brief description of the protected health information for which use or access has been determined to be necessary by the IRB or Privacy Board;
p.(None):
p.(None): - A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and
p.(None):
p.(None): - The signature of the chair or other member, as designated by the chair, of the IRB or the Privacy Board, as applicable.
p.(None):
p.(None): The following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule:
p.(None):
p.(None): 1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of
p.(None): the following elements:
p.(None):
p.(None): an adequate plan to protect the identifiers from improper use and disclosure;
p.(None): an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research
p.(None): justification for retaining the identifiers or such retention is otherwise required by law; and
p.(None):
p.(None): adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by
p.(None): law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be
p.(None): permitted by this subpart;
p.(None):
p.(None): 2. The research could not practicably be conducted without the waiver or alteration; and
p.(None):
p.(None): 3. The research could not practicably be conducted without access to and use of the protected health information.
p.(None):
p.(None): Preparatory to Research. Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is
p.(None): solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information
p.(None): from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose. See 45
p.(None): CFR 164.512(i)(1)(ii). This provision might be used, for example, to design a research study or to assess the feasibility of conducting a study. The
p.(None): Privacy Rule does not prohibit a covered entity’s granting remote access to PHI to a researcher for activities that qualify as reviews preparatory to
p.(None): research, provided reasonable and appropriate safeguards are in place, as described in OCR’s guidance, Remote Access to PHI for Activities
p.(None): Preparatory to Research - PDF.
p.(None):
p.(None): Research on Protected Health Information of Decedents . Representations from the researcher, either in writing or orally, that the use or disclosure
p.(None): being sought is solely for research on the protected health information of decedents, that the protected health information being sought is necessary for
p.(None): the research, and, at the request of the covered entity, documentation of the death of the individuals about whom information is being sought. See 45
p.(None): CFR 164.512(i)(1)(iii).
p.(None):
p.(None): Limited Data Sets with a Data Use Agreement. A data use agreement entered into by both the covered entity and the researcher, pursuant to which the
p.(None): covered entity may disclose a limited data set to the researcher for research, public health, or health care operations. See 45 CFR 164.514(e). A limited
p.(None): data set excludes specified direct identifiers of the individual or of relatives, employers, or household members of the individual. The data use agreement
p.(None): must:
p.(None):
p.(None): - Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research, and which may not
p.(None): include any use or disclosure that would violate the Rule if done by the covered entity;
p.(None):
p.(None): - Limit who can use or receive the data; and
p.(None):
p.(None): - Require the recipient to agree to the following:
p.(None):
p.(None): - Not to use or disclose the information other than as permitted by the data use agreement or as otherwise required by law;
p.(None):
p.(None): - Use appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement;
p.(None):
p.(None): - Report to the covered entity any use or disclosure of the information not provided for by the data use agreement of which the recipient becomes
p.(None): aware;
p.(None):
p.(None): - Ensure that any agents, including a subcontractor, to whom the recipient provides the limited data set agrees to the same restrictions and
p.(None): conditions that apply to the recipient with respect to the limited data set; and
p.(None):
p.(None): - Not to identify the information or contact the individual.
p.(None):
p.(None): Research Use/Disclosure With Individual Authorization. The Privacy Rule also permits covered entities to use or disclose protected health information
p.(None): for research purposes when a research participant authorizes the use or disclosure of information about him or herself. Today, for example, a research
p.(None): participant’s authorization will typically be sought for most clinical trials and some records research. In this case, documentation of IRB or Privacy Board
p.(None): approval of a waiver of authorization is not required for the use or disclosure of protected health information. To use or disclose protected health
p.(None): information with authorization by the research participant, the covered entity must obtain an authorization that satisfies the requirements of 45 CFR
p.(None): 164.508. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes.
p.(None): However, several special provisions apply to research authorizations:
p.(None):
p.(None): - Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or
p.(None): event, or that the authorization continues until the “end of the research study”.
p.(None):
p.(None): - An authorization for the use or disclosure of protected health information for a research study may be combined with a consent to participate in the
p.(None): research, or with any other legal permission related to the research study.
p.(None):
p.(None): - An authorization for the use or disclosure of protected health information for a research study may be combined with an authorization for a different
p.(None): research activity, provided that, if research-related treatment is conditioned on the provision of one of the authorizations, such as in the context of a
p.(None): clinical trial, then the compound authorization must clearly differentiate between the conditioned and unconditioned components and provide the
p.(None): individual with an opportunity to opt in to the unconditioned research activity.
p.(None):
p.(None): - An authorization may be obtained from an individual for uses and disclosures of protected health information for future research purposes, so long as
p.(None): the authorization adequately describes the future research such that it would be reasonable for the individual to expect that his or her protected health
p.(None): information could be used or disclosed for the future research purposes.
p.(None): - New Guidance on HIPAA and individual authorization of uses and disclosures of protected health information for research. - PDF This guidance
p.(None): explains certain requirements for an authorization to use or disclose PHI for future research. The guidance also clarifies aspects of the individual’s
p.(None): right to revoke an authorization for research uses and disclosures of PHI.
p.(None):
p.(None): Accounting for Research Disclosures. In general, the Privacy Rule gives individuals the right to receive an accounting of certain disclosures of
p.(None): protected health information made by a covered entity. See 45 CFR 164.528. This accounting must include disclosures of protected health information
p.(None): that occurred during the six years prior to the individual’s request for an accounting, or since the applicable compliance date (whichever is sooner), and
p.(None): must include specified information regarding each disclosure. A more general accounting is permitted for subsequent multiple disclosures to the same
p.(None): person or entity for a single purpose. See 45 CFR 164.528(b)(3). Among the types of disclosures that are exempt from this accounting requirement are:
p.(None):
p.(None): - Research disclosures made pursuant to an individual’s authorization;
p.(None):
p.(None): - Disclosures of the limited data set to researchers with a data use agreement under 45 CFR 164.514(e).
p.(None):
p.(None): In addition, for disclosures of protected health information for research purposes without the individual’s authorization pursuant to 45 CFR164.512(i), and that
p.(None): involve at least 50 records, the Privacy Rule allows for a simplified accounting of such disclosures by covered entities. Under this simplified accounting
p.(None): provision, covered entities may provide individuals with a list of all protocols for which the patient’s protected health information may have been disclosed
p.(None): under 45 CFR 164.512(i), as well as the researcher’s name and contact information. Other requirements related to this simplified accounting provision are
p.(None): found in 45 CFR 164.528(b)(4).
p.(None):
p.(None): Transition Provisions. Under the Privacy Rule, a covered entity may use and disclose protected health information that was created or received for
p.(None): research, either before or after the applicable compliance date, if the covered entity obtained any one of the following prior to the compliance date
p.(None):
p.(None): An authorization or other express legal permission from an individual to use or disclose protected health information for the research;
p.(None):
p.(None): The informed consent of the individual to participate in the research;
p.(None):
p.(None): A waiver of authorization approved by either an IRB or a privacy board (in accordance with 45 CFR 164.512(i)(1)(i)); or
p.(None):
p.(None): A waiver of informed consent by an IRB in accordance with the Common Rule or an exception under FDA’s human subject protection regulations at 21
p.(None): CFR 50.24. However, if a waiver of informed consent was obtained prior to the compliance date, but informed consent is subsequently sought after the
p.(None): compliance date, the covered entity must obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a temporary
p.(None): waiver of informed consent for emergency research under the FDA’s human subject protection regulations, and informed consent was later sought after
p.(None): the compliance date, individual authorization would be required before the covered entity could use or disclose protected health information for the
p.(None): research after the waiver of informed consent was no longer valid. The Privacy Rule allows covered entities to rely on such express legal permission,
p.(None): informed consent, or waiver of authorization of informed consent, which they create or receive before the applicable compliance date, to use and disclose
p.(None): protected health information for specific research studies, as well as for future unspecified research that may be included in such permission.
p.(None):
p.(None): OCR HIPAA Privacy
p.(None): December 3, 2002 Revised December 18, 2017
p.(None):
p.(None): Back to Top
p.(None):
p.(None):
p.(None): Other HIPAA and Research Resources
p.(None): HIPAA Privacy Rule Booklet for Research
p.(None):
p.(None): Clinical Research Fact Sheet
p.(None):
p.(None): Institutional Review Boards Fact Sheet
p.(None):
p.(None): HIPAA Authorization Fact Sheet and Sample Language
p.(None):
p.(None): Health Services Research Fact Sheet
p.(None):
p.(None): Information for Patients
p.(None):
p.(None): Research Repositories and Databases Fact Sheet
p.(None):
p.(None): View our Frequently Asked Questions
p.(None):
p.(None):
p.(None):
p.(None): Print Share
p.(None):
p.(None):
p.(None): Content created by Office for Civil Rights (OCR)
p.(None): Content last reviewed on June 13, 2018
p.(None): Connect With OCR
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Sign Up for OCR Updates
p.(None): To sign up for updates or to access your subscriber preferences, please enter your contact information below.
p.(None):
p.(None): Sign Up
p.(None):
p.(None):
p.(None):
p.(None): Office for Civil Rights Headquarters
p.(None): U.S. Department of Health & Human Services
p.(None): 200 Independence Avenue, S.W.
p.(None): Washington, D.C. 20201
p.(None): Toll Free Call Center: 1-800-368-1019
p.(None): TTD Number: 1-800-537-7697
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact HHS HHS Archive Budget/Performance FOIA
p.(None): Careers Accessibility Inspector General The White House
p.(None): HHS FAQs Privacy Policy EEO/No Fear Act USA.gov
p.(None): Nondiscrimination Notice Viewers & Players
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to
p.(None): develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health
p.(None): information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule) without regard to the provisions below.
p.(None):
p.(None): The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes,
p.(None): and their rights to access information about them held by covered entities. Where research is concerned, the Privacy Rule protects the privacy of individually
p.(None): identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital
p.(None): research. Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug
p.(None): Administration’s (FDA) human subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are similar to, but separate from,
p.(None): the Privacy Rule’s provisions for research. These human subject protection regulations, which apply to most Federally-funded and to some privately funded
p.(None): research, include protections to help ensure the privacy of subjects and the confidentiality of information. The Privacy Rule builds upon these existing Federal
...
p.(None): or disclose protected health information for research purposes pursuant to a waiver of authorization by an IRB or Privacy Board, provided it has obtained
p.(None): documentation of all of the following:
p.(None):
p.(None): - Identification of the IRB or Privacy Board and the date on which the alteration or waiver of authorization was approved;
p.(None):
p.(None): - A statement that the IRB or Privacy Board has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in
p.(None): the Rule;
p.(None):
p.(None): - A brief description of the protected health information for which use or access has been determined to be necessary by the IRB or Privacy Board;
p.(None):
p.(None): - A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and
p.(None):
p.(None): - The signature of the chair or other member, as designated by the chair, of the IRB or the Privacy Board, as applicable.
p.(None):
p.(None): The following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule:
p.(None):
p.(None): 1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of
p.(None): the following elements:
p.(None):
...
p.(None): justification for retaining the identifiers or such retention is otherwise required by law; and
p.(None):
p.(None): adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by
p.(None): law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be
p.(None): permitted by this subpart;
p.(None):
p.(None): 2. The research could not practicably be conducted without the waiver or alteration; and
p.(None):
p.(None): 3. The research could not practicably be conducted without access to and use of the protected health information.
p.(None):
p.(None): Preparatory to Research. Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is
p.(None): solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information
p.(None): from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose. See 45
p.(None): CFR 164.512(i)(1)(ii). This provision might be used, for example, to design a research study or to assess the feasibility of conducting a study. The
p.(None): Privacy Rule does not prohibit a covered entity’s granting remote access to PHI to a researcher for activities that qualify as reviews preparatory to
p.(None): research, provided reasonable and appropriate safeguards are in place, as described in OCR’s guidance, Remote Access to PHI for Activities
p.(None): Preparatory to Research - PDF.
p.(None):
p.(None): Research on Protected Health Information of Decedents . Representations from the researcher, either in writing or orally, that the use or disclosure
p.(None): being sought is solely for research on the protected health information of decedents, that the protected health information being sought is necessary for
p.(None): the research, and, at the request of the covered entity, documentation of the death of the individuals about whom information is being sought. See 45
p.(None): CFR 164.512(i)(1)(iii).
p.(None):
p.(None): Limited Data Sets with a Data Use Agreement. A data use agreement entered into by both the covered entity and the researcher, pursuant to which the
...
p.(None):
p.(None): Clinical Research Fact Sheet
p.(None):
p.(None): Institutional Review Boards Fact Sheet
p.(None):
p.(None): HIPAA Authorization Fact Sheet and Sample Language
p.(None):
p.(None): Health Services Research Fact Sheet
p.(None):
p.(None): Information for Patients
p.(None):
p.(None): Research Repositories and Databases Fact Sheet
p.(None):
p.(None): View our Frequently Asked Questions
p.(None):
p.(None):
p.(None):
p.(None): Print Share
p.(None):
p.(None):
p.(None): Content created by Office for Civil Rights (OCR)
p.(None): Content last reviewed on June 13, 2018
p.(None): Connect With OCR
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Sign Up for OCR Updates
p.(None): To sign up for updates or to access your subscriber preferences, please enter your contact information below.
p.(None):
p.(None): Sign Up
p.(None):
p.(None):
p.(None):
p.(None): Office for Civil Rights Headquarters
p.(None): U.S. Department of Health & Human Services
p.(None): 200 Independence Avenue, S.W.
p.(None): Washington, D.C. 20201
p.(None): Toll Free Call Center: 1-800-368-1019
p.(None): TTD Number: 1-800-537-7697
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact HHS HHS Archive Budget/Performance FOIA
p.(None): Careers Accessibility Inspector General The White House
p.(None): HHS FAQs Privacy Policy EEO/No Fear Act USA.gov
p.(None): Nondiscrimination Notice Viewers & Players
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): protected health information for specific research studies, as well as for future unspecified research that may be included in such permission.
p.(None):
p.(None): OCR HIPAA Privacy
p.(None): December 3, 2002 Revised December 18, 2017
p.(None):
p.(None): Back to Top
p.(None):
p.(None):
p.(None): Other HIPAA and Research Resources
p.(None): HIPAA Privacy Rule Booklet for Research
p.(None):
p.(None): Clinical Research Fact Sheet
p.(None):
p.(None): Institutional Review Boards Fact Sheet
p.(None):
p.(None): HIPAA Authorization Fact Sheet and Sample Language
p.(None):
p.(None): Health Services Research Fact Sheet
p.(None):
p.(None): Information for Patients
p.(None):
p.(None): Research Repositories and Databases Fact Sheet
p.(None):
p.(None): View our Frequently Asked Questions
p.(None):
p.(None):
p.(None):
p.(None): Print Share
p.(None):
p.(None):
p.(None): Content created by Office for Civil Rights (OCR)
p.(None): Content last reviewed on June 13, 2018
p.(None): Connect With OCR
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Sign Up for OCR Updates
p.(None): To sign up for updates or to access your subscriber preferences, please enter your contact information below.
p.(None):
p.(None): Sign Up
p.(None):
p.(None):
p.(None):
p.(None): Office for Civil Rights Headquarters
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): right to revoke an authorization for research uses and disclosures of PHI.
p.(None):
p.(None): Accounting for Research Disclosures. In general, the Privacy Rule gives individuals the right to receive an accounting of certain disclosures of
p.(None): protected health information made by a covered entity. See 45 CFR 164.528. This accounting must include disclosures of protected health information
p.(None): that occurred during the six years prior to the individual’s request for an accounting, or since the applicable compliance date (whichever is sooner), and
p.(None): must include specified information regarding each disclosure. A more general accounting is permitted for subsequent multiple disclosures to the same
p.(None): person or entity for a single purpose. See 45 CFR 164.528(b)(3). Among the types of disclosures that are exempt from this accounting requirement are:
p.(None):
p.(None): - Research disclosures made pursuant to an individual’s authorization;
p.(None):
p.(None): - Disclosures of the limited data set to researchers with a data use agreement under 45 CFR 164.514(e).
p.(None):
p.(None): In addition, for disclosures of protected health information for research purposes without the individual’s authorization pursuant to 45 CFR164.512(i), and that
p.(None): involve at least 50 records, the Privacy Rule allows for a simplified accounting of such disclosures by covered entities. Under this simplified accounting
...
Social / home
Searching for indicator home:
(return to top)
p.(None): menu
p.(None):
p.(None): Health Information Privacy
p.(None): U.S. Department of Health & Human Services
p.(None):
p.(None):
p.(None):
p.(None): I'm looking for...
p.(None):
p.(None):
p.(None): HHS A-Z Index
p.(None):
p.(None):
p.(None): HHS > HIPAA Home > For Professionals > Special Topics > Research
p.(None):
p.(None):
p.(None): More Topics In This Section
p.(None):
p.(None):
p.(None):
p.(None): Research
p.(None): 45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532) ( Download a copy in PDF - PDF)
p.(None):
p.(None): Background
p.(None):
p.(None): The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research
p.(None): purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to
p.(None): develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None):
p.(None): A waiver of informed consent by an IRB in accordance with the Common Rule or an exception under FDA’s human subject protection regulations at 21
p.(None): CFR 50.24. However, if a waiver of informed consent was obtained prior to the compliance date, but informed consent is subsequently sought after the
p.(None): compliance date, the covered entity must obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a temporary
p.(None): waiver of informed consent for emergency research under the FDA’s human subject protection regulations, and informed consent was later sought after
p.(None): the compliance date, individual authorization would be required before the covered entity could use or disclose protected health information for the
p.(None): research after the waiver of informed consent was no longer valid. The Privacy Rule allows covered entities to rely on such express legal permission,
p.(None): informed consent, or waiver of authorization of informed consent, which they create or receive before the applicable compliance date, to use and disclose
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| emergency | Public Emergency |
| health | Health |
| home | home |
| language | Linguistic Proficiency |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input