Sections

You are at: Home Boards & Committees Institutional Review Board Policy No: 9.03 Protections of Human Subjects & Establishment of Institutional Review Board

Document Actions

Policy No: 9.03 Protections of Human Subjects & Establishment of Institutional Review Board

This policy has been established to provide guidance to all Agency employees, contractors, affiliated researchers and other interested parties, concerning the protection of human subjects and their protected health information in research. It establishes an institutional review board (IRB) to examine proposed research and ensure that the research procedures will respect and protect subjects, maximize benefits and minimize harm and risk. This board will also provide the required assurances to the Department of Health and Human Services that any research, funded in whole or in part by that Department, is in compliance with 45 ­CFR 46.

I. Purpose

This policy has been established to provide guidance to all Agency employees, contractors, affiliated researchers and other interested parties, concerning the protection of human subjects and their protected health information in research. It establishes an institutional review board (IRB) to examine proposed research and ensure that the research procedures will respect and protect subjects, maximize benefits and minimize harm and risk. This board will also provide the required assurances to the Department of Health and Human Services that any research, funded in whole or in part by that Department, is in compliance with 45 ­CFR 46.

Definitions:

Institutional Review Board (IRB) : A committee, established for the primary purpose of protecting the rights and safety of human subjects by reviewing and approving research protocols involving human subjects.

Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. 45 CFR 46, paragraph 46.102(e).

Generalizable: Knowledge that can be applied to populations outside of those persons served by Agency of Human Services

Protected Health Information: Information, including demographic information, that relates to the past, present, or future physical or mental health or condition of a patient, or the provision of health care to a patient that identifies the patient or, with respect to which there is a reasonable basis to believe, the information can be used to identify the patient.

Informed Consent : An ongoing process of communication between the researcher and participant by which the participant understands the implications of participation. Consent is reflected in an agreement to participate in the research project following an explanation about the research and its risks with an opportunity to ask questions throughout the study. Such consent is normally documented by the participant’s signing a written consent form.

Quality Assurance Practice: Those activities that a department undertakes to assure that policies, practices, regulations and best practice are adhered to within a given service, program or organizations. This may involve discussions with staff, providers and recipients of services and/or their families to elicit opinion, feedback, satisfaction and/other input related to how we deliver our services.

II. Context

  1. Human rights and protections from exploitation must be guaranteed in all research and experimental settings, including the examination of protected health information. When any members of any vulnerable population, (e.g. children, pregnant women, fetuses, prisoners, persons who are in institutions) serve as subjects, additional protection is required.
  2. The Federal Department of Health and Human Services Code of Federal Regulations at 45 CFR 46 requires that all research involving human subjects, funded in whole or in part by HHS with certain specific exceptions, be approved by an Institutional Review Board.

III. Scope

Research conducted by a component of the Agency of Human Services involving a participant who is a client of the agency, or a recipient of public services or benefits furnished by the agency, or which may involve their protected health information, must be approved before the research begins. The Agency Institutional Review Board (IRB) reviews applications concerning research on human subjects or their protected health information when the subjects are Agency clients or recipients of public services or benefits furnished by the Agency AND when the research is proposed by, affiliated with, conducted at the request of, or involves an Agency department, division, program or office.

When research is conducted and reviewed by the IRB at one of the cooperating institutions, listed below, the research does not need to be reviewed by the Agency of Human Services IRB. This includes research reviewed by the IRBs at

  • University of Vermont
  • Dartmouth College

This policy does not apply to

  • Routine record keeping, data collection, or actuarial counts that are used to facilitate day-to-day functioning of the Agency of Human Services, its departments, divisions or offices.
  • The use of aggregate data in which no individual can be identified directly or indirectly.
  • The use of existing data, documents, records, or specimens if these sources are publicly available.
  • Research conducted in established or commonly accepted educational settings involving normal educational practices such as research on instructional strategies or comparison of instructional techniques, curricula, or classroom management methods.
  • Research involving the use of educational tests, if information taken from these sources is recorded in such a manner that subjects cannot be identified.
  • Research involving survey or interview procedures if the research does not investigate sensitive aspects of the subjects' own behavior such as illegal conduct, drug or alcohol use, illness, sexual behavior. However, research involving survey or interview procedures is not exempt if responses are recorded in such a way that the subject can be identified or, if the responses were to become known outside the research, the responses could place the subjects at risk of criminal or civil liability or be damaging to the subjects' physical, psychological, emotional or financial well being or to their reputation or employability.
  • Research involving the observation of public behavior if observations are recorded in such a manner that the subjects cannot be identified, or, if the observations are such that should they become known outside the research, the subjects would not be placed in any form of risk, e.g., the observations do not deal with sensitive aspects of the subjects' behavior.
  • Research which studies, evaluates, or otherwise examines the following: certain public benefit or service programs, procedures for obtaining benefits or services under these programs, possible changes to these programs or procedures or possible changes in methods or levels of payment for benefits and services relating to the programs may be exempt when the research is conducted by or subject to the approval of the agency or a department, division or office head.

C. This policy DOES apply to

  • Any systematic investigation in which individuals are exposed to risk greater than that encountered in daily life. This risk may involve the possibility of harm to the subjects' physical, psychological, emotional or financial well-being or to their reputation or employability.
  • Any systematic investigation of sensitive aspects of a subject’s behavior, including but not limited to, illegal conduct, drug and alcohol use, illness, sexual behavior, or any other private or protected health information.

If an investigator is unsure whether or not this policy applies to proposed research it is his or her responsibility to contact the IRB chairperson for clarification. There is no cost or penalty for submitting an AHS IRB Research Proposal Form describing any systematic investigation that is being considered.

IV. Institutional Review Board (IRB) Membership & Records

The Secretary's Office shall appoint one IRB member from each AHS department and office taking into consideration the recommendation of commissioners and directors. These appointees may be full or part time employees of AHS. It is the Secretary's responsibility to ensure that the membership is appropriate to both evaluate scientific and research issues and to protect the rights of subjects.

Membership & Composition

  • Pursuant to 45 CFR 46 (paragraph 46.107) "Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds including consideration of the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law and practice. The IRB shall therefore include persons knowledgeable in these areas."
  • When research proposals that involve any vulnerable group of subjects (including but not limited to prisoners, pregnant women, children, persons who are in institutions) are reviewed, the IRB is to include an ad hoc voting member who is either a member of that vulnerable population or an advocate or representative of a member of that population with appropriate background and expertise to serve in that capacity. The Secretary may reimburse any IRB member who is not an AHS employee, as resources allow, for time devoted to IRB activities according to a contractual agreement between AHS and the individual. The chairperson of the IRB is responsible for recruiting appropriate members and representatives of vulnerable populations to serve as IRB members.
  • The IRB may not consist entirely of men or entirely of women or entirely of members of one profession.
  • The IRB should include at least one member whose primary concerns are in nonscientific areas; for example: lawyers, ethicists, members of the clergy.
  • The IRB should include at least one member who is not otherwise affiliated with the Agency of Human Services and who is not part of the immediate family of a person who is affiliated with AHS.
  • The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
  • Should a vacancy occur on the IRB, the Secretary is responsible for appointing a replacement.

Records and Record Keeping

The clerical staff of the AHS Secretary’s Office shall be responsible for maintenance of IRB records including a list of members (including name, earned degrees, representative capacity, indications of experience such as board certification sufficient to describe each member's chief contribution to IRB deliberations and any employment or other relationship between each member and the Agency), copies of research proposals, minutes of meetings, records of continuing review activities, copies of correspondence, and statements of new findings developed in the course of research. Records shall be retained on site for at least three years and thereafter may be archived with the public records division of Vermont state government. On site records are open for inspection or review by any interested party during normal working hours. Archived records may be available through a Vt. Public records requests.

Chairperson and responsibilities

  • The Secretary shall designate one of the AHS employee members of the IRB as chairperson.
  • The IRB chairperson is responsible for insuring that the board in its makeup and activities is in compliance with 45 CFR 46 and any adjustments to that regulation published in the Federal Register.
  • The IRB chairperson with clerical staff will assure that all 3-year federal renewals, updates and annual reporting is complete and up to date

The Secretary’s Office will establish written procedures for:

  • Operations of the IRB
  • Researcher and Member Training
  • Continuing Review of Research
  • Reporting of Adverse Events
  • Review of Non-compliance Issues

V. Informed Consent

Unless the IRB waives the requirement, no investigator may involve a living human being as a subject in research covered by this policy without obtaining legally effective informed consent from the subject or the subject's legally authorized representative.

An investigator shall seek such consent using a process that provides the prospective participant (or their representative) sufficient opportunity to consider whether or not to participate and that minimizes the possibility of coercion or undue influence. The information that is given will be expressed in language understandable to the participant or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive any of the subject's legal rights or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Elements of informed consent include

  1. A statement that the study involves research, an explanation of the purposes and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
  2. A description of any reasonably foreseeable risks or discomforts to the subject.
  3. A description of any expected benefits to the subject or the others.
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
  5. A statement describing the extent to which confidentiality of records will be maintained.
  6. For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research related injury to the subject and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

When appropriate, one or more of the following elements of information shall also be provided:

  1. A statement that the treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
  3. Any additional costs to the subject that may result from participation in the research.
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.

An 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 waives the requirement to obtain informed consent provided the IRB finds and documents that:

a. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

  1. programs under the Social Security Act, or other public benefit or service programs;
  2. procedures for obtaining benefits or services under these those programs;
  3. possible changes in or alternatives to those programs or procedures; or
  4. possible changes in methods or levels of payment for benefits or services under those programs; and

b. The research could not practicably be carried out without the waiver or alteration.

An 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 waives the requirements 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.

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. A copy shall be given to the person signing the form. 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.

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

  • 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
  • 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 where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

VI. Violations

Any employee found to have intentionally violated these policies and/or acted in a manner that might place a subject at risk will be subject to appropriate discipline, up to and including dismissal.