Identifiable Data Procedures - IRB
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The Institutional Review Board (IRB) of the Virginia Department of Health:

Standard Operating Procedures and Guidelines for Obtaining Review

December 2010

I.  Guidelines for obtaining review by the institutional review board (IRB) of the Virginia department of health (VDH)

a.  Introduction

One of the many ways the Virginia Department of Health (VDH) serves the public and fulfills its mission is through research.  Research is defined in federal regulations as a systematic investigation designed to develop or contribute to generalizable knowledge. Periodically VDH conducts research that involves human subjects.  VDH considers the protection of human subjects as important as the methodology, research findings, or any other component of the research project.

VDH has developed policies and procedures to ensure that the rights and welfare of human subjects involved in research are protected and consistent with both State (12 VAC 5-20-10) and Federal (45 CFR Part 46). The Office for Human Research Protections (OHRP), under the U.S. Department of Health and Human Services Assistant (HHS) Secretary for Health, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research. Policies, guidelines and regulations from OHRP, provided the framework for the development of the State regulations, and provide the structure for VDH review and approval of human subjects research.

A major component of the process for ensuring the protection of the rights and welfare of human subjects involved in VDH research is the Institutional Review Board (IRB), also known as the research review committee.  Research protocols must be either approved or granted an exemption by the IRB before human subjects can begin participation.  The IRB also conducts continuing review of each approved protocol at least annually.  The IRB may modify, suspend or terminate approval of research that has been associated with serious harm to subjects or is not being conducted in accord with the IRB's decisions, stipulations, and requirements.

The purpose of this document is to assist researchers and managers with determining whether a particular project requires review by the IRB, and if so, which of the various types of review is required.  Additionally, this document outlines the actual processes and procedures needed for obtaining review by the IRB.  Finally, this document also contains the text of the state regulations concerning the conduct of human research for VDH and a reproducible copy of all forms needed for obtaining review by the IRB.

i.  Key Decisions about Human Subjects Review Requirements

a.  In general, any human subjects research that is conducted by VDH, by outside investigators in collaboration with VDH, or by outside investigators using VDH data, is subject to review and approval by the VDH Institutional Review Board. However, not all studies require IRB review. In brief, the decision-making process is divided into five key decision steps:

b.  Is the project considered research?

c.  Does the project involve human subjects?

d.  Does the project qualify for exemption review?

e.  Does the project qualify for expedited review?

May informed consent and/or its documentation be waived or altered?

In making the determination regarding Step 1, The Council of State and Territorial Epidemiologists have developed a document entitled “Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Distinctions”.  The purpose of this report is to provide a practical guide principally for state and local public health officials, their staff, and their partners on the distinctions between public health practice and research for activities carried out by, or under the authority of, state or local health departments. The report can be found at:  http://www.vdh.state.va.us/healthpolicy/policyanalysis/documents/PublicHealthPracticeversusResearch.pdf and may also be helpful to federal government public health officials and public and private sector institutional review board (IRB) members and their staff considering similar issues in reviewing or approving research proposals.

In addition, the following are the Office for Human Research Protections (OHRP) decision charts developed to provide guidance for institutional review boards (IRBs), investigators and others on whether an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.   The charts should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.

These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.

 

Chart 1

 

Chart 2

 

Chart 3

 

Chart 4

 

Chart 5

 

Chart 6

 

Chart 7

 

Chart 8

 

Chart 9

 

Chart 10

 

Chart 11

 

II.  Procedures for obtaining review by the Institutional review board (IRB) of the Virginia Department of Health (VDH).

a.  Introduction

Researchers and managers who have reviewed the guidelines and have made the determination that a project does indeed involve human subjects and is considered research will need to make a request for IRB review.  Requests for IRB review will fall into one of three categories:

i.  Request for Full Board Review;

ii.  Request for Expedited Review; or

iii.  Request for Exemption from IRB Review.  

All requests for review are to be submitted to the Office of Minority Health and Health Equity/Institutional Review Board, VDH. Criteria and procedures for obtaining clearance for each of the specific categories are described in Sections B, C, and D.

iv.  General Criteria for IRB Approval of Research:  In order to approve non-exempt research, the IRB will consider the following elements of the proposal:

1.  The adequacy of the description of the potential benefits and risks involved and the adequacy of the methodology of the research.  Risks to subjects are to be minimized and benefits to subjects maximized by using procedures which are consistent with sound research design.

2.  The degree of risk, and, if the research is nontherapeutic*, whether it presents greater than minimal risk**.  Risks to subjects are to be minimized by using procedures which do not unnecessarily expose the subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

3.  The necessity and utility of the research and whether the risks to the subjects are outweighed by the potential benefits of the research and the importance of the knowledge that may reasonably be expected to result.  In evaluating risks and benefits, the IRB will consider only risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).  The IRB will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks or potential benefits that fall within the purview of its responsibilities.

4.  The equity in criteria for selection of subjects, especially in research regarding the future development of mental or physical illness.  In making this assessment, the IRB will take into account the purposes of the research and the setting in which the research will be conducted and will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically/educationally disadvantaged persons.

5.  The adequacy of protection of rights and welfare of the participants.  These include the following:

6.  Voluntary informed consent is sought from each prospective subject or the subjects’ legally authorized representative and appropriately documented.

7.  Voluntary informed consent is obtained by methods that are adequate and appropriate to the subject’s educational level and language of greatest fluency.

8.  The written consent form is adequate and appropriate in both content and wording for the particular research and for the particular subjects of the research relative to their educational level and language of greatest fluency and reasonably reflects full explanation and adequate understanding.

9.  The person(s) proposed to supervise or conduct the particular research protocol are appropriately competent and qualified.

10.  When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

11.  When appropriate, there are adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of data.

12.  When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically/ educationally disadvantaged persons, additional safeguards are included in the study to protect the rights and welfare of these subjects.

v.  General Requirements for Informed Consent:  Informed consent means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice. For the purposes of human research, the basic elements of information necessary to such consent shall include:

1.  A reasonable and comprehensible explanation to the person of the proposed procedures or protocols to be followed, their purposes, including descriptions of any attendant discomforts, and risks and benefits reasonably to be expected;

2.  A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

3.  An instruction that the person may withdraw his consent and discontinue participation in the human research at any time without prejudice to him;

4.  An explanation of any costs or compensation that may accrue to the person and, if applicable, the availability of third party reimbursement for the proposed procedures or protocols;

5.  An offer to answer any inquiries by any individual concerning the procedures and protocols;

6.  A statement that the study involves research, and an explanation that includes identification of any procedures that are experimental; the expected duration of the individual's participation; a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained; and if any data from this study are published, the individual will not be identified without his written permission;

7.  A statement that there may be other risks not yet identified;

8.  A disclosure of any appropriate alternative procedures or therapies that might be advantageous for the individual;

9.  A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the individual is otherwise entitled, and the individual may discontinue participation at any time without penalty or loss of benefits to which he is otherwise entitled;

10.  An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury; and

11.  For research involving more than minimal risk, an explanation as to whether any compensation or medical care is available if injury occurs and, if so, what is included or where further information may be obtained. 

Information shall be provided in a manner that is understandable to the individual with regard to his educational level and language of greatest fluency.

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

a.  The research involves no more than minimal risk* to the subjects;

b.  The waiver or alteration will not adversely affect the rights and welfare of the subjects;

c.  The research could not practicably be carried out without the waiver or alteration; and

d.  Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

vi.  General Requirements for Documentation of Informed Consent:  Informed consent shall be documented by the use of a written consent form approved by the IRB  and signed by the subject or the subject’s legally authorized representative with the exception of the following situations:

1.  That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or

2.  That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Consent may take the form of either of the following:

a.  A written consent document that embodies the elements of informed consent required by this section. This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed and witnessed; or

b.  A short form written consent document stating that the elements of informed consent required by this section have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the committee shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary and a copy of the short form shall be given to the subject or the representative.

All forms and documents should be submitted to:

Office of Minority Health and Health Equity/Institutional Review Board

Virginia Department of Health

109 Governor Street, 10th Floor East

P.O. Box 2448

Richmond, VA  23218-2448

For questions or additional information, please contact:

Kathy H. Wibberly, Ph.D., Chair of the VDH IRB

Phone:  804-864-7426

Fax:  804-864-7440

E-mail:  Kathy.Wibberly@vdh.virginia.gov

 

b.  Requests for Full Board Review 

The following is a checklist of documents that must be submitted by the principal investigator in order to obtain full board review and clearance:

□ Request for Review and Clearance of a Project Involving Human Subjects (Appendix B); 

□ Study protocol (if the study is a part of a larger protocol, such as a cooperative agreement with CDC for public health surveillance/intervention, only submits relevant portions of the protocol) and informed consent form(s).  Study protocols should include sections on Hypotheses, Goals of Study, Background and Significance of Study, Preliminary Progress/Data Report (if available), Research Method and Design, and Statistical Analyses Planned (or in progress);

□ Letter(s) and other materials that will be supplied to study subjects;

□ Questionnaire(s) (when applicable);

□ CV or resume of Principle Investigator;

Full Board review requires the submission of 1 electronic OR 7 hard copies of the "Request for Review" application and supporting documents, and requires attendance of the principal investigator at a meeting of the IRB. The IRB is required by state regulations to review all requests within 45 days after submission.  The IRB is scheduled to meet quarterly (January, April, July, October) and will convene more often as needed.  In order for research to be approved, it must receive the approval of a majority of those members present at a meeting in which a quorum exists.  A quorum consists of a majority of the members, including at least one member whose primary concerns are in a nonscientific area.  All IRB decisions regarding approval, disapproval, or of required modifications will be communicated to the investigator in writing within 7 business days of the IRB meeting where the submission is reviewed.

Continuation Review reports are to be submitted at least annually for all approved studies to ensure conformity with the proposal.   The frequency of such reports shall be consistent with the nature and degree of risk of each research project.   In addition, the IRB will require a study summary report from the investigator at the conclusion of the research project.   The Office of Minority Health and Health Equity/Institutional Review Board will automatically mail out the continuing review report form (Appendix C) to principal investigators just prior to the review due date.  The form must be completed and returned for ongoing projects.  

Finally, whenever an ongoing project acquires a new principal investigator, or whenever there are substantial changes (e.g., changes in consent procedures, addition of potentially sensitive items to research instruments, changes in treatment procedures) in the protocol or the subject population, another request for IRB review must be filed. 

c. Requests for Expedited Review 

The following is a checklist of documents that must be submitted by the principal investigator in order to obtain expedited IRB review and clearance:

□ Request for Review and Clearance of a Project Involving Human Subjects)   

□ Study protocol (if the study is a part of a larger protocol, such as a cooperative agreement with CDC for public health surveillance/intervention, only submit  relevant portions of the protocol) and informed consent form(s).  Study protocols should include sections on Hypotheses, Goals of Study, Background and Significance of Study, Preliminary Progress/Data Report (if available), Research Method and Design, and Statistical Analyses Planned (or in progress).

□ Letter(s) and other materials that will be supplied to study subjects

□ Questionnaire(s) (when applicable)

□ CV or resume of Principle Investigator

□ IRB approval document(s) (if requesting expedited review because the study has been approved via Full Board Review by the IRB at another institution or agency)  

Expedited review requires the submission of 1 electronic OR 2 hard copies of the "Request for Review" application and supporting documents. The decision to approve or disapprove a project submitted for expedited review will be made by the Chair of the IRB or his/her designee and one additional member of the review board. All IRB decisions regarding approval, disapproval, or of required modifications will be communicated to the principal investigator in writing within 15 business days following submission.

Continuation Review reports are to be submitted at least annually for all approved studies to ensure conformity with the proposal.   The frequency of such reports shall be consistent with the nature and degree of risk of each research project.   In addition, the IRB will require a study summary report from the investigator at the conclusion of the research project.   The Office of Minority Health and Health Equity/Institutional Review Board will automatically mail out the continuing review report form (Appendix C) to principal investigators just prior to the review due date.  The form must be completed and returned for ongoing projects.  

Finally, whenever an ongoing project acquires a new principal investigator, or whenever there are substantial changes (e.g., changes in consent procedures, addition of potentially sensitive items to research instruments, changes in treatment procedures) in the protocol or the subject population, another request for IRB review must be filed.

d.  Requests for Exemption from IRB Review

If an investigator believes that their research project qualifies for exemption review, the following is a checklist of documents that must be submitted in order to obtain IRB exemption status:

□ Request for Exemption from IRB Review Form (Appendix D);

□ Cover letter with a detailed written explanation of why the project should be regarded as exempt;

□ Study protocol (if the study is a part of a larger protocol, such as a cooperative agreement with CDC for public health surveillance/intervention, only submit relevant portions of the protocol). Study protocols should include sections on Hypotheses, Goals of Study, Background and Significance of Study, Preliminary Progress/Data Report (if available), Research Method and Design, and Statistical Analyses Planned (or in progress);

□ Letter(s) and other materials that will be supplied to study subjects;

□ Questionnaire(s) (when applicable);

□ CV or resume of Principal Investigator

Exemption review requires the submission of 1 electronic OR 2 hard copies of the "Request for Exemption" application and supporting documents. The decision to approve or disapprove a project submitted for exemption review will be made by the Chair of the IRB or his/her designee and one additional member of the review board. All IRB decisions regarding approval, disapproval, or of required modifications will be communicated to the principal investigator in writing within 15 business days following submission.

All forms and documents should be submitted to:

Office of Minority Health and Health Equity/Institutional Review Board

Virginia Department of Health

109 Governor Street, 10th Floor East

P.O. Box 2448

Richmond, VA  23218-2448

For questions or additional information, please contact:

Kathy H. Wibberly, Ph.D., Chair of the VDH IRB

Phone:  804-864-7426

Fax:  804-864-7440



Attachments 
 
 irb sops and guidelines appendix a 12-10.pdf (35.24 KB)
 irb sops and guidelines appendix b 12-10.pdf (48.48 KB)
 irb sops and guidelines appendix c 12-10.pdf (36.58 KB)
 irb sops and guidelines appendix d 12-10.pdf (23.79 KB)