Sentences with phrase «waiver criteria»

Response: We disagree with the comments recommending that the waiver criteria of the Common Rule should be permitted to be used in lieu of the waiver criteria identified in the proposed rule.

The NPRM proposed to prohibit the use or disclosure of protected health information for research without individual authorization as stipulated in proposed § 164.508 unless the covered entity had documentation indicating that an IRB or privacy board had determined that the following waiver criteria had been met:

Comment: In addition to the proposed waiver criteria, several commenters recommended that the final rule also instruct IRBs and privacy boards to consider the type of protected health information and the sensitivity of the information to be disclosed in determining whether to grant a waiver, in whole or in part, of the authorization requirements.

Response: In the final rule, we have added an additional waiver criteria to require that there are adequate written assurances from the researcher that protected health information will not be re-used or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart.

In the final rule, we also have clarified our intent not to interfere with existing requirements for IRBs by amending the language in the waiver criteria to make clear that these criteria relate to the privacy interests of the individual and are separate from the criteria that would be applied by an IRB to any evaluation of the underlying research.

Response: We do not agree with the comment that there is a conflict between either the FDA or the ISO regulations and the proposed waiver criteria in the rule.

Response: We agree with these comments, but believe that the requirement to consider the type and sensitivity of protected health information was already encompassed by the proposed waiver criteria.

We understand that the waiver criteria in the final rule may initially cause confusion for IRBs and researchers that must attend to both the final rule and the Common Rule, but we believe that the additional waiver criteria adopted in the final rule are essential to ensure that individuals» privacy rights and welfare are adequately safeguarded when protected health information about themselves is used for research without their authorization.

For these reasons, many commenters recommended that the final rule should permit the waiver criteria of the Common Rule, to be used in lieu of the waiver criteria identified in the proposed rule.

In addition, before covered health care providers or health plans may use or disclose protected health information for research without authorization, they must obtain documentation that an IRB or privacy board has found that specified waiver criteria have been met, unless the research will include protected health information about deceased individuals only, or is solely for reviews that are preparatory to research.

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.

We encourage and expect that IRBs and privacy boards will take into consideration the type and sensitivity of protected health information, as appropriate, in considering the waiver criteria included in the final rule.

In the final rule, we have amended the language in the waiver criteria to make clear that these criteria relate only to the privacy interests of the individual.

In addition, some commenters argued that the proposed waiver criteria were redundant with the Common Rule and were confusing because they mix elements of the Common Rule's waiver criteria — some of which they argued were relevant only to interventional research.

Use of the expedited review mechanism permits review by a single member of the IRB or privacy board, but continues to require that the covered entity obtain documentation that all of the specified waiver criteria have been met.

We were not persuaded by the comments received that contractual requirements would provide necessary additional protections, that would not also be provided by the less burdensome waiver criteria for adequate written assurance that the researcher will not re-use or disclose protected health information, with few exceptions.

We believe that this additional waiver criteria provides additional assurance that protected health information will not be misused by researchers, while not imposing the additional burdens of a contractual requirement on covered health care providers and health plans.

The department's waiver criteria also clearly outlines that teacher evaluations must include the state test where it's available, he said.

Here, once again, AB 5 is not aligned with the ESEA waiver criteria.

Response: We disagree with the comments recommending that the term «practicability» be deleted from this waiver criterion.

In the final rule, we include a waiver criterion requiring «there are adequate written assurances that the protected health information will not be re-used or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart.»

Comment: A few comments recommended that there be a additional waiver criterion to safeguard or limit subsequent use or disclosure of protected health information by the researcher.

This waiver criterion in the final rule states, «the research could not practicably be conducted without the alteration or waiver.»

Proposed waiver criterion iii (waiver criterion § 164.512 (i)(2)(ii)(C) in the final rule) is revised as follows to clarify that it also pertains to alterations of individual authorization: «the research could not practicably be conducted without the alteration or waiver.»

This criterion is unlike waiver criterion § 164.512 (i)(2)(ii)(B) in that it focuses on the privacy risks and benefits of the research project more broadly, not on the waiver of individual authorization.

Proposed waiver criterion viii (waiver criterion § 164.512 (i)(2)(ii)(G) in the final rule) is revised as follows: «there is an adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law.»

In addition, the final rule (1) eliminates proposed waiver criterion iv, (2) modifies proposed waiver criteria ii, iii, vi, and viii, and (3) adds a waiver criterion.

Not exact matches

«The waiver is supposed to be a process for candidates who have some of the criteria but fall short on maybe one,» said Barron, who plans to hold a meeting with lawyers Monday to decide whether to file a temporary restraining order preventing Black from taking office as well as additional legal action.

For one thing, in getting a waiver from the federal No Child Left Behind Act, Indiana (like other states) promised the Obama administration it would adopt standards that met federal criteria; align curricula and teaching; select, pilot, and administer new tests aligned to the standards; and integrate the standards into both school - and teacher - accountability systems.

As it turns out, the College Board, worried about the rush to accommodation, tightened the criteria high - school counselors and other professionals were to apply when granting waivers.

We also randomly assigned three groups of 3,000 students who met the criteria for our target group to receive just one of the three ECO-C components (application guidance, information on net costs, or fee waivers) rather than all three.

It is being widely reported this morning that in September U.S. Secretary of Education Arne Duncan will publish criteria states will have to meet to be granted waivers from the No Child Left Behind Act.

All school divisions must certify annually that they meet one of the criteria above for a pre-Labor Day opening waiver or that they will not open prior to Labor Day.

Teachers on waivers are not fully certified under state criteria.

A postponement won't throw implementation off greatly, since the first year of the three - year waiver period will largely involve planning — including the accountability criteria and the designs of teacher evaluations.

President Obama outlined his criteria for states hoping to apply for waivers from some of No Child Left Behind's tougher provisions.

Much like LAUSD's new teacher evaluation system, the CORE waiver application wants school ratings to include dropout rates, graduation rates, truancy rates, school disciple and other criteria.

The letter criticizes selection criteria for the Race to the Top competition and NCLB waivers that include committing to college - and career - ready standards and the use of Race to the Top dollars to fund the two Common Core assessment consortia.

If these states are granted waivers, it is imperative that they have a plan in place so that all educators, parents, students and other stakeholders understand how schools will be monitored and what criteria will be used to determine school improvement.

The Elementary and Secondary Education Act of 1965 (ESEA) flexibility waiver provisions specify the identification and exit criteria for identification of schools as priority schools:

Based on his support for the initiative, and recent U.S. Department of Education criteria for granting NCLB waivers to states that pledge higher standards for student performance, greater accountability, and improved teacher effectiveness, Secretary Duncan clearly believes that it did.

O'Neal «is undeniably a military spouse eligible for admission» under the waiver program's objective criteria, the ABA brief says.

In considering waiver of authorization criterion § 164.512 (i)(2)(ii)(D), we expect the IRB or privacy board to consider the amount of information that is minimally needed for the study.

Under criterion § 164.512 (i)(2)(ii)(B), the question is whether the alteration or waiver of individual authorization would adversely affect the privacy rights and the welfare of individuals, not whether the research project itself would adversely affect the privacy rights or the welfare of individuals.

Also, for all of the proposed waiver of authorization criteria that used the term «subject,» we replace this term with the term «individual» in the final rule.

(B) A privacy board must review the proposed research at convened meetings at which a majority of the privacy board members are present, including at least one member who satisfies the criterion stated in paragraph (i)(1)(i)(B)(2) of this section, and the alteration or waiver of authorization must be approved by the majority of the privacy board members present at the meeting, unless the privacy board elects to use an expedited review procedure in accordance with paragraph (i)(2)(iv)(C) of this section;

Specifically, the comment recommended that the existing Common Rule structure be preserved for IRB - approved research, and that the waiver of authorization criteria for privacy purposes be kept separate from the other functions of the IRB.

A statement that the IRB or privacy board has determined that the alteration or waiver, in whole or in part, of authorization satisfies the following criteria:

Response: We agree with the comment supporting the proposed rule's provision to impose no requirements for the location or sponsorship of the IRB or privacy board that was convened to review a research proposal for the alteration or waiver of authorization criteria.

Therefore, in the final rule, we have retained the term «welfare» in this criterion for the alteration or waiver of authorization but modified the criterion as follows to focus more specifically on privacy concerns and to clarify that it pertains to alterations of authorization: «the alteration or waiver will not adversely affect the privacy rights and the welfare of the individual.»