Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues, 57469-57470 [2010-23517]

Download as PDF Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 14, 2010. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. GLAASS Financial, LLC; to become a bank holding company through the acquisition of 36.4 percent of the voting shares of EMSWATER Financial, LLC, both in Exeter, Nebraska. In connection with this application, Applicant also has applied to acquire EMSWATER Financial, LLC and First National Insurance Agency, Inc., both of Exeter, Nebraska pursuant to section 225.28(b)(11)(A) of Regulation Y. Board of Governors of the Federal Reserve System, September 16, 2010. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2010–23522 Filed 9–20–10; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM Government in the Sunshine Act Meeting Notice Board of Governors of the Federal Reserve System. srobinson on DSKHWCL6B1PROD with NOTICES AGENCY HOLDING THE MEETING: 12 p.m., Monday, September 20, 2010. The business of the Board requires that this meeting be held with less than one week’s advance notice to the public, and no earlier announcement of the meeting was practicable. TIME AND DATE: VerDate Mar<15>2010 19:02 Sep 20, 2010 Jkt 220001 Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, NW., Washington, DC 20551. STATUS: Closed. PLACE: Matters To Be Considered 1. Implications of Dodd-Frank Reform Act for Board Organization and Staffing. FOR MORE INFORMATION PLEASE CONTACT: Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202–452–2955. SUPPLEMENTARY INFORMATION: You may call 202–452–3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board’s Web site at https:// www.federalreserve.gov for an electronic announcement that not only lists applications, but also indicates procedural and other information about the meeting. Dated: September 17, 2010. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2010–23669 Filed 9–17–10; 4:15 pm] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues Office for Human Research Protections, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The Office for Human Research Protections (OHRP), within the Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, ‘‘Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.’’ The guidance document provides OHRP’s first formal guidance on this topic. The document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/policy/ subjectwithdrawal.html or https:// www.hhs.gov/ohrp/policy/ subjectwithdrawal.pdf, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). The guidance document SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 57469 announced in this notice finalizes the draft guidance entitled, ‘‘Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,’’ that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized. Comments on OHRP guidance documents are welcome at any time. ADDRESSES: Submit written requests for a single copy of the guidance document entitled, ‘‘Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues,’’ to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–402–2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document. Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to ohrp@hhs.gov or via facsimile at 240–402–2071. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240–453–6900; e-mail Irene.StithColeman@hhs.gov. DATES: SUPPLEMENTARY INFORMATION: I. Background OHRP, Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled, ‘‘Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues.’’ The guidance document provides OHRP’s first formal guidance on this topic. The document is intended primarily for IRBs, investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. The guidance document applies to non-exempt human subjects research conducted or supported by HHS. The guidance addresses the following six topics: (1) What does it mean when a subject withdraws from a research study? E:\FR\FM\21SEN1.SGM 21SEN1 srobinson on DSKHWCL6B1PROD with NOTICES 57470 Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices (2) May an investigator retain and analyze already collected data about a subject who withdraws from the research or whose participation is terminated by the investigator? (3) Can investigators honor subjects’ requests to have their data destroyed or excluded from any analysis? (4) Should the withdrawal of a subject from a research study be documented? (5) What is the relationship of this guidance to FDA’s guidance on this issue and to the HIPAA Privacy Rule? (6) When seeking the informed consent of subjects, what should investigators tell subjects about data retention in the event the subjects withdraw? Of particular importance, the guidance document clarifies that when a subject chooses to withdraw from (i.e., discontinue his or her participation in) an ongoing research study, or when an investigator terminates a subject’s participation in such a research study without regard to the subject’s consent, the investigator may retain and analyze already collected data relating to that subject, even if that data includes identifiable private information about the subject. The guidance document announced in this notice finalizes the draft guidance entitled, ‘‘Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,’’ that was made available for public comment through a notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and organizations, and those comments were considered as the guidance was finalized. In addition to the change in the title, the final guidance document differs from the draft guidance document that was made available for public comment in the following three key ways: (1) All content regarding biospecimens that was included in the draft guidance document has been removed from the final guidance document. This change makes the final guidance document more harmonious with the Food and Drug Administration’s (FDA’s) corresponding guidance entitled, ‘‘Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,’’ which also focuses on data retention when subjects withdraw from research and is silent on issues related to biospecimens. Furthermore, research involving the banking and use of biospecimens for research purposes is a complex, evolving area of research. VerDate Mar<15>2010 19:02 Sep 20, 2010 Jkt 220001 OHRP believes that guidance on the use of biospecimens obtained from subjects who subsequently withdraw from research should be addressed in the future by a more comprehensive guidance document that addresses more broadly research involving biospecimens. In the meantime, individuals with questions regarding how to handle biospecimens obtained from subjects who subsequently withdraw from a research study should contact OHRP by telephone at 240–453– 6900 or 866–447–4777 or by e-mail at ohrp@hhs.gov. (2) The final guidance document includes more examples of social and behavioral research activities in order to emphasize that the guidance applies to such research, in addition to its applicability to biomedical research. (3) The final guidance includes a recommendation that investigators plan for the possibility that subjects will withdraw from research and that they include a discussion of what withdrawal will mean and how it will be handled in their research protocols and informed consent documents. Furthermore, the final guidance addresses the question of what investigators, when seeking the informed consent of subjects, should tell the subjects about data retention in the event the subjects withdraw. For HHS-conducted or supported research that is regulated by FDA, FDA’s guidance on this issue also should be consulted. FDA’s guidance entitled, ‘‘Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDARegulated Clinical Trials’’ can be found at https://www.fda.gov/OHRMS/ DOCKETS/98fr/FDA–2008–D–0576-gdl. pdf. II. Electronic Access Persons with access to the Internet may obtain the guidance document on OHRP’s Web site at https://www.hhs.gov/ ohrp/policy/subjectwithdrawal.html or https://www.hhs.gov/ohrp/policy/subject withdrawal.pdf. III. Comments Interested persons may submit comments regarding this guidance document to OHRP at any time. Please see the ADDRESSES section for information on where to submit written comments. Dated: September 15, 2010. Jerry Menikoff, Director, Office for Human Research Protections. [FR Doc. 2010–23517 Filed 9–20–10; 8:45 am] BILLING CODE 4150–36–P PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Proposed Collection; Comment Request; Customer and Other Partners Satisfaction Surveys In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the opportunity for public comment on the proposed data collection projects, the National Institutes of Health Clinical Center (CC) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Customer and Other Partners Satisfaction Surveys. Type of Information Collection Request: Extension request. Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; and (4) to evaluate the satisfaction of various Clinical Center customers and other partners with implemented service modifications. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center’s operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer’s needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. Frequency of Response: The participants will respond yearly. Affected public: Individuals and households; businesses and other for profit, small businesses and organizations. Types of respondents: These surveys are designed to assess the satisfaction of the Clinical Center’s major internal and external customers with the services provided. These customers include, but are not limited to, the following groups of individuals: SUMMARY: E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 182 (Tuesday, September 21, 2010)]
[Notices]
[Pages 57469-57470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23517]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Guidance on Withdrawal of Subjects From Research: Data Retention 
and Other Related Issues

AGENCY: Office for Human Research Protections, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Office for Human Research Protections (OHRP), within the 
Office of the Assistant Secretary for Health, is announcing the 
availability of a guidance document entitled, ``Guidance on Withdrawal 
of Subjects From Research: Data Retention and Other Related Issues.'' 
The guidance document provides OHRP's first formal guidance on this 
topic. The document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or https://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf, is intended primarily for 
institutional review boards (IRBs), investigators, and funding agencies 
that may be responsible for the review or oversight of human subject 
research conducted or supported by the Department of Health and Human 
Services (HHS). The guidance document announced in this notice 
finalizes the draft guidance entitled, ``Guidance on Important 
Considerations for When Participation of Human Subjects in Research is 
Discontinued,'' that was made available for public comment through a 
notice in the Federal Register on December 1, 2008 (73 FR 72804). OHRP 
received comments on the draft guidance document from 30 individuals 
and organizations, and those comments were considered as the guidance 
was finalized.

DATES: Comments on OHRP guidance documents are welcome at any time.

ADDRESSES: Submit written requests for a single copy of the guidance 
document entitled, ``Guidance on Withdrawal of Subjects From Research: 
Data Retention and Other Related Issues,'' to the Division of Policy 
and Assurances, Office for Human Research Protections, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed 
adhesive label to assist that office in processing your request, or fax 
your request to 301-402-2071. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance document.
    Submit written comments to COMMENTS ON SUBJECT WITHDRAWAL GUIDANCE, 
Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, 
Rockville, MD 20852. Comments also may be sent via e-mail to 
ohrp@hhs.gov or via facsimile at 240-402-2071.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6900; e-mail Irene.StithColeman@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP, Office of the Assistant Secretary for Health, is announcing 
the availability of a guidance document entitled, ``Guidance on 
Withdrawal of Subjects From Research: Data Retention and Other Related 
Issues.'' The guidance document provides OHRP's first formal guidance 
on this topic. The document is intended primarily for IRBs, 
investigators, and funding agencies that may be responsible for the 
review or oversight of human subject research conducted or supported by 
HHS.
    The guidance document applies to non-exempt human subjects research 
conducted or supported by HHS. The guidance addresses the following six 
topics:
    (1) What does it mean when a subject withdraws from a research 
study?

[[Page 57470]]

    (2) May an investigator retain and analyze already collected data 
about a subject who withdraws from the research or whose participation 
is terminated by the investigator?
    (3) Can investigators honor subjects' requests to have their data 
destroyed or excluded from any analysis?
    (4) Should the withdrawal of a subject from a research study be 
documented?
    (5) What is the relationship of this guidance to FDA's guidance on 
this issue and to the HIPAA Privacy Rule?
    (6) When seeking the informed consent of subjects, what should 
investigators tell subjects about data retention in the event the 
subjects withdraw?
    Of particular importance, the guidance document clarifies that when 
a subject chooses to withdraw from (i.e., discontinue his or her 
participation in) an ongoing research study, or when an investigator 
terminates a subject's participation in such a research study without 
regard to the subject's consent, the investigator may retain and 
analyze already collected data relating to that subject, even if that 
data includes identifiable private information about the subject.
    The guidance document announced in this notice finalizes the draft 
guidance entitled, ``Guidance on Important Considerations for When 
Participation of Human Subjects in Research is Discontinued,'' that was 
made available for public comment through a notice in the Federal 
Register on December 1, 2008 (73 FR 72804). OHRP received comments on 
the draft guidance document from 30 individuals and organizations, and 
those comments were considered as the guidance was finalized.
    In addition to the change in the title, the final guidance document 
differs from the draft guidance document that was made available for 
public comment in the following three key ways:
    (1) All content regarding biospecimens that was included in the 
draft guidance document has been removed from the final guidance 
document. This change makes the final guidance document more harmonious 
with the Food and Drug Administration's (FDA's) corresponding guidance 
entitled, ``Guidance for Sponsors, Clinical Investigators, and IRBs: 
Data Retention When Subjects Withdraw from FDA-Regulated Clinical 
Trials,'' which also focuses on data retention when subjects withdraw 
from research and is silent on issues related to biospecimens. 
Furthermore, research involving the banking and use of biospecimens for 
research purposes is a complex, evolving area of research. OHRP 
believes that guidance on the use of biospecimens obtained from 
subjects who subsequently withdraw from research should be addressed in 
the future by a more comprehensive guidance document that addresses 
more broadly research involving biospecimens. In the meantime, 
individuals with questions regarding how to handle biospecimens 
obtained from subjects who subsequently withdraw from a research study 
should contact OHRP by telephone at 240-453-6900 or 866-447-4777 or by 
e-mail at ohrp@hhs.gov.
    (2) The final guidance document includes more examples of social 
and behavioral research activities in order to emphasize that the 
guidance applies to such research, in addition to its applicability to 
biomedical research.
    (3) The final guidance includes a recommendation that investigators 
plan for the possibility that subjects will withdraw from research and 
that they include a discussion of what withdrawal will mean and how it 
will be handled in their research protocols and informed consent 
documents. Furthermore, the final guidance addresses the question of 
what investigators, when seeking the informed consent of subjects, 
should tell the subjects about data retention in the event the subjects 
withdraw.
    For HHS-conducted or supported research that is regulated by FDA, 
FDA's guidance on this issue also should be consulted. FDA's guidance 
entitled, ``Guidance for Sponsors, Clinical Investigators, and IRBs: 
Data Retention When Subjects Withdraw from FDA-Regulated Clinical 
Trials'' can be found at https://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0576-gdl.pdf.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document on OHRP's Web site at https://www.hhs.gov/ohrp/policy/subjectwithdrawal.html or https://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf.

III. Comments

    Interested persons may submit comments regarding this guidance 
document to OHRP at any time. Please see the ADDRESSES section for 
information on where to submit written comments.

    Dated: September 15, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2010-23517 Filed 9-20-10; 8:45 am]
BILLING CODE 4150-36-P

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