Protecting Human Subjects of Research at Chipola College
This document is supplementary to applicable Chipola College policies and procedures. Research activities involving or pertaining to individuals in their capacity as Chipola College students or employees must obtain IRB approval. Individuals proposing human subjects research projects should read and be familiar with contents of this document.
The National Research Act (PL 93-348, July 12, 1974) created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify ethical principles in the conducting of research involving humans and to develop guidelines that ensure research is conducted in accordance with those principles. In 1978, the Commission submitted its report entitled "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (commonly referred to as simply The Belmont Report). For more information about The Belmont Report, please visit the U.S Department of Health & Human Services website.
The Belmont Report established three ethical principles that now underlie research on human subjects.
- Respect for persons obligates researchers to recognize and protect the personal dignity and autonomy of individuals.
- Beneficence obligates researchers to protect individuals from harm and to maximize possible benefits to those individuals.
- Justice obligates researchers to ensuring that the benefits and burdens of their research are distributed fairly among participants.
The Belmont Report further identified three requirements of research practices when following the ethical principles.
- Informed consent ensures that human subjects of research receive information on the research procedures, its purpose, and the risks and benefits of participation. The subjects have opportunities to ask questions and to withdraw from the research at any time. The researcher is responsible for ensuring that the subjects comprehend the information and understand their role in the research project.
- Assessment of risks and benefits enables the researcher to identify potential alternative ways of obtaining the information sought through the proposed research. The researcher must ensure that risks to individuals are minimized and that benefits are maximized.
- Selection of subjects requires that research project participants be selected fairly and without undue benefits or risks being assigned to individuals in a discriminatory manner.
Research that includes as subjects individuals in their capacity as students or employees of Chipola College shall be guided by the three ethical principles and subsequent practices stated in The Belmont Report.
The Chipola College Institutional Review Board
In 34 CFR 97, the U.S. Department of Education sets forth policy on protecting human subjects of research. Included in 34 CFR 97 are the membership, functions, and operations of an institutional review board (IRB) as it pertains to the protection of human subjects. Research is defined in 34 CFR 97.102(d) as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” For more information about 34 CFR 97, please visit the U.S. Department of Education website.
The Chipola College IRB membership shall comply with requirements set forth in the applicable Code of Federal Regulations. Per 34 CFR 97.107(a):
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 it the members, including consideration of race, gender, and cultural background 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 standards of professional conduct and practice.
Additionally, 34 CFR 97.107(d) states that the IRB “shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.”
IRB Functions and Operations
The Chipola College IRB is charged with assessing the ethical aspects of proposed research in which the College’s students or employees are subjects or participants. The IRB shall approve, require modifications prior to approval, or disapprove proposed research activities involving individuals as Chipola College students or employees based on its assessment. No research activities may take place involving individuals as Chipola College students or employees without prior approval of the IRB.
The IRB shall require that the researcher (also referred to the investigator) provide to subjects information in accordance with 34 CFR 97.116.
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject 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 or appear 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.
(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of the purposes of the research 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 benefits to the subject or to others which may reasonably be expected from the research;
(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, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and 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 the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) A statement that the particular 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.
(c) 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 waive the requirement to obtain informed consent provided the IRB finds and documents that:
(1) 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:
(i) Public benefit of service programs;
(ii) Procedures for obtaining benefits or services under those programs;
(iii) Possible changes in or alternatives to those programs or procedures; or (iv) Possible changes in methods or levels of payment for benefits or services under those programs; and
(2) The research could not practicably be carried out without the waiver or alteration.
(d) 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 in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(e) The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
The IRB shall require that the researcher provide to subjects information in accordance with 34 CFR 97.117.
(a) Except as provided in paragraph (c) of this section, 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.
(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:
(1) A written consent document that embodies the elements of informed consent required by 34 CFR 97.116. 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; or
(2) A short form written consent document stating that the elements of informed consent required by 34 CFR 97.116 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 IRB 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 shall be given to the subject or the representative, in addition to a copy of the short form.
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(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.
Exemptions from IRB Approval
The IRB may determine that proposed research is exempt from IRB review if the researcher requests an exemption based on criteria stated in 34 CFR 97.101(b):
(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2)of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The IRB shall maintain records in accordance with 34 CFR 97.115:
(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in 34 CFR 97.103(b)(3)
(6) Written procedures for the IRB in the same detail as described in 34 CFR 97.103(b)(4) and 34 CFR 97.103(b)(5).
(7) Statements of significant new findings provided to subjects, as required by 34 CFR 97.116(b)(5).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.
For additional information, contact Dr. Matthew Hughes, IRB chair, at email@example.com.