Sentences with phrase «protecting research subjects»

For research that relies on the use or disclosure of protected health information by covered entities without authorization, the final rule applies the Common Rule's principles for protecting research subjects by, in most instances, requiring documentation of independent board review, and a finding that specified criteria designed to protect the privacy of prospective research subjects have been met.

The new network is also taking steps to standardize the prioritization of new studies and to put in place a unified system — including a central institutional review board that will cover studies conducted by the entire system — to protect research subjects at more than 3,000 clinical trial sites.

The Common Rule's waiver criteria were designed to protect research subjects from all harms associated with research, not specifically to protect individuals» privacy interests.

Not exact matches

The regulation is there to protect patients and research subjects against risks of the research but also to ensure integrity of the data that may be used for the marketing approval for these new drugs.

The Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services (DHHS), develops policies to protect human subjects and monitors clinical trials at research instiResearch Protections (OHRP), an office within the Department of Health and Human Services (DHHS), develops policies to protect human subjects and monitors clinical trials at research instiresearch institutions.

A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects.

A training manual — Protecting Study Volunteers in Research — co-written by Rochester's Cynthia Dunn, director of the Clinical Research Institute, and Gary Chadwick, executive director of the Research Subjects Review Board, was released last September.

Both committees were charged with exploring stem cells and protecting human subjects in research.

► «A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects,» Jennifer Couzin - Frankel wrote Monday at ScienceInsider.

If interest in space colonization continues apace, research into methods of enhancing radioresistance to protect against the various forms of space radiation that spacefarers would be subjected to needs to be accelerated accordingly.

The Institute of Medicine, at the behest of DHHS, has convened a committee on «Assessing the System for Protecting Human Research Subjects.»

The U.S. Department of Health & Human Services (HHS) has issued a Notice of Proposed Rulemaking (NPRM) seeking comment on «proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.»

The purpose of the IRB is to protect the rights and welfare of human research subjects and to ensure that all human subject research be conducted in accordance with federal, state, institutional, and ethical guidelines.

Data that is anonymised / pseudonymised better protects research participants» privacy and is not subject to the same restrictions as Personal Data.

Internet pet sales are not regulated by any government agency, and are not subject to the Animal Welfare Act, legislation meant to protect a class of animals from cruelty, set «standards of care and treatment for certain animals bred and sold as pets, used in biomedical research, transported commercially or exhibited to the public.»

Under the NPRM, if a covered entity used or disclosed protected health information for research, but the researcher did not record the protected health information in a manner that persons could be identified, such an activity would have constituted a research use or disclosure that would have been subject to either the individual authorization requirements of proposed § 164.508 or the documentation of the waiver of authorization requirements of proposed § 164.510 (j).

The current scope of the federal regulatory protections for protecting human subjects in research is just one of the issues that will be addressed in the by the Commission's report, and the Department looks forward to receiving the Commission's recommendations.

We disagree with the comment that suggests that existing provisions under the Common Rule are sufficient to protect the privacy interests of individuals who are subjects in research that involves the delivery of treatment.

We believe that the our proposed requirements for the use or disclosure of protected health information for research are consistent with the ethical principles of «respect for persons,» «beneficence,» and «justice,» which were established by the Belmont Report in 1978, and are now accepted as the quintessential requirements for the ethical conduct of research involving human subjects, including research using individually identifiable health information.

While it is true that the first provision of the Nuremberg Code states that «the voluntary consent of the human subject is absolutely essential,» it is important to understand the context of this important document in the history of protecting human subjects research from harm.

Response: Although we share the concern raised by commenters that the option for the documentation of privacy board approval for an alteration or waiver of authorization may perpetuate the unequal mechanisms of protecting the privacy of human research subjects for federally - funded versus publically - funded research, the final rule is limited by HIPAA to addressing only the use and disclosure of protected health information by covered entities, not the protection of human research subjects more generally.

We would note that nothing in the final rule overrides Certificates of Confidentiality, which protect against the compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research as provided by the Public Health Service Act section 301 (d), 42 U.S.C. 241 (d).

Moreover, a covered entity doing research, or another entity requesting disclosure of Start Printed Page 82771protected health information for research that is not currently subject to IRB review (research that is 100 percent privately funded and which takes place in institutions which do not have «multiple project assurances») may need to seek IRB or privacy board approval if they want to avoid the requirement to obtain authorization for use or disclosure of protected health information for research, thereby creating the need for additional IRBs and privacy boards that do not currently exist.

We reviewed the important purposes identified in the comments for government access to protected health information, and believe that the disclosures of protected health information that should appropriately be made without individuals» authorization can be achieved through the other disclosures provided for in the final rule, including provisions permitting covered entities to disclose information (subject to certain limitations) to government agencies for public health, research, health oversight, law enforcement, and otherwise as required by law.

One contract specifies that the issuer may use and disclose protected health information about the participants in the group health plan for research purposes without authorization (subject to the requirements of this rule) and one contract specifies that the issuer must always obtain authorizations for these uses and disclosures.

Therefore, in the final rule, we modeled the criterion on the relevant Common Rule requirement for the approval of human subjects research, and revised the proposed criterion to state: «the privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to the anticipated benefits if any to the individuals, and the importance of the knowledge that may reasonably be expected to result from the research.»

If a covered entity obtained a consent, authorization, or other express legal permission from the individual who is the subject of the research, it would be able to rely upon that consent, authorization, or permission, consistent with any limitations it expressed, to use or disclose the protected health information it created or received prior to or after the compliance date of this regulation.

We believe this provision in the final rule provides covered entities that participate in research necessary flexibility to enhance privacy protections for research information and provides prospective research subjects with needed information to determine whether their privacy interests would be adequately protected before agreeing to participate in a research study that involves the delivery of health care.

Response: We disagree with the comments asserting that the proposed requirements for authorization for the use or disclosure of protected health information would have offered research subjects no additional privacy protection.

(C) A privacy board may use an expedited review procedure if the research involves no more than minimal risk to the privacy of the individuals who are the subject of the protected health information for which use or disclosure is being sought.

We proposed to permit covered entities, subject to limited exceptions for psychotherapy notes and research information unrelated to treatment, to use and disclose protected health information to carry out treatment, payment, and health care operations without authorization.

One state does not allow automatic release of protected health information for research purposes without notifying the subjects that their health information may be used in research and allowing them an opportunity to object to the use of their information.

As mentioned above, HHS looks forward to receiving the recommendations of the National Bioethics Advisory Commission, which is currently examining the current scope of federal regulatory protections for protecting human subjects in research as part of its overarching report on the federal oversight of human subjects protections.

Thus, a covered entity's research records are subject to this regulation to the extent they contain protected health information.

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