Policy Regarding Protection of Human Subjects
The Florida Institute of Technology, hereinafter known as the "institution", hereby gives assurance that it will comply with the Department of Health and Human Services (HHS) Regulations for the Protection of Human Research Subjects (45 CFR 46, as amended) as specified below.
Principles, Policies, and Applicability
I. Ethical Principles
A. This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the Belmont Report), regardless of whether the research is subject to Federal regulation or with whom conducted or the source of support (i.e., sponsorship).
B. This institution also accepts the ethical principles in the following documents:
1. Ethical Standards of Psychologists (1973).
2. Ethical Principles in the Conduct of Research with Human Participants (American Psychological Association, 1982)
II. Institutional Policy
A. All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable human subject research, regardless of sponsorship, except as otherwise noted in this Assurance.
B. Except for those categories specifically exempted or waived under Section 101 (b)(1-6) or 101(i), all research covered by this Assurance will be reviewed and approved by an Institutional Review Board (IRB). The involvement of human subjects covered by this Assurance will not be permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject's legal representative.
C. This institution assures that before human subjects are involved in research covered by this policy, proper consideration will be given to:
A. The risks to the subjects;
B. The anticipated benefits to the subjects and others;
C. The importance of the knowledge that may reasonably be expected to result, and
D. The informed consent process to be employed.
D. This institution encourages and promotes constructive communication among the research administrators, department heads, research investigators, human subjects and institutional officials as a means of maintaining a high level of awareness regardin g the safeguarding of the rights and welfare of the subject.
E. This institution will exercise appropriate administrative overview, carried out at least, annually to ensure that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied in compliance with this Assurance.
A. Except for research in which the only involvement of human subjects is in one or more of the categories exempted or waived under 45 CFR 46.101 (b) (1-6) or 46.101 (i) of the HHS regulations, this policy is applicable to all research involving human subjects, and all other activities which even in part involve such research, if either:
1. the research is sponsored by this institution, or,
2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or,
3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
4. the research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects.
B. All human subject research which is exempt under Section 101(b)(1-6) or 101(i) will be conducted in accordance with: (1) the Belmont report, (2) this institution's administrative procedures to ensure valid claims of exemption and (3) orderly accoun ting for such activities.
A. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects, covered by this policy, including responsibility for complying with Federal, state, or local las as they may relate to suc h research.
B. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects covered by this Assurance.
C. This institution will require additional safeguards in research when that research involves (1) prisoners, (2) fetuses, pregnant women, and human in vitro fertilization, (3) children, (4) individuals institutionalized as mentally disabled, a nd (5) other potentially vulnerable groups.
D. This institution has established an IRB in accordance with the composition requirements of 45 CFR 46.107. The institution will provide meeting space and staff to support the IRB's review and record keeping duties.
E. This institution is responsible for ensuring that it complies fully with all applicable Federal policies and guidelines, including those concerning notification of seropositivity, counseling and safeguarding confidentiality where research activitie s directly or indirectly involve the study of human immunodeficiency virus (HIV).
F. This institution shall provide each individual at the institution conducting or reviewing human subject research with a copy of this statement of ethical principles and policy.
II. Vice President for Research (VPR)
A. The VPR will review all research involving human subjects (whether exempt or not) and decide whether the institution will permit the research. However, neither the VPR nor any other office of the institution may approve a research activity that has been disapproved by the IRB.
B. The VPR will forward certification of IRB approval of proposed research to the appropriate Federal or state department or agency only after all IRB-required modifications have been incorporated to the satisfaction of the IRB.
C. The VPR will designate procedures for the retention of signed consent documents for at least three years past completion of the research activity.
D. The VPR will maintain and arrange access for inspection of IRB records as provided for in Section 115.
E. The VPR is responsible for ensuring constructive communication among the research administrators, department heads, research investigators, clinical care staff, human subjects and institutional officials as a means of maintaining a high level of aw areness regarding the safeguarding of the rights and welfare of the subjects.
F. The VPR will arrange for and document in its records that each individual who conducts or reviews human subject research has first been provided with a copy of this Assurance, as well as ready access to copies of 45 CFR 46, regulations of other Fed eral departments or agencies as may apply, the Belmont Report and all other pertinent Federal policies and guidelines related to the involvement of human subjects in research.
G. On reports from the IRBs, VPR will report promptly to appropriate institutional officials, the Office of Protection from Research Risks (OPRR) for DHHS-supported research, and any other sponsoring department or agency head:
1. any injuries to human subjects or other unanticipated problems involving risks to subjects or others;
2. any serious or continuing non-compliance with the regulations or requirements of the IRB; and,
3. any suspension or termination of IRB approval for research.
H. The VPR will ensure (a) solicitation, receipt and management of all assurances of compliance (whatever the appropriate format) and (b) subsequent submission of these documents to the proper authorities as a condition for involvement in human subject research activities sponsored by DHHS or any other Federal department or agency or any other sponsor for which this Assurance applies.
I. The VPR will be responsible for procedural and record keeping audits not less than once each calendar year for the purpose of detecting, correcting, and reporting (as required) administrative and/or material breaches in uniformly protecting the rig hts and welfare of human subjects as required by the regulations and as may otherwise be additionally required by this institution.
III. Institutional Review Board (IRB)
A. The IRB will receive from investigators, through their supervisors, all research protocols which involve human subjects; keep them informed of decisions and administrative processing; and, return all disapproved protocols to them.
B. The IRB is responsible for reviewing the preliminary determinations of exemption by investigators and supervisors and for making the final determination based on Section 101 of the regulations. Notice of concurrence for all exempt research will be promptly conveyed in writing to the investigator. All non-exempt research will be reviewed by the IRB.
C. The IRB will make the preliminary determination of eligibility for expedited review procedures (permitted under Section 110, see Appendix B). Expedited review of research activities will not be permitted where full board review is required.
D. The IRB will review, and have the authority to approve, require modification of, or disapprove all research activities involving human subjects, including proposed changes in previously approved human subject research. For approved research, the IR B will determine which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was previous IRB review and approval.
E. IRB decisions and requirements for modifications will be promptly conveyed to investigators and the VPR, in writing. Written notification of decisions to disapprove will be accompanied by reasons for the decision with provision of an opportunity fo r reply by the investigator, in person or in writing.
F. Initial and continuing convened IRB reviews and approvals will occur in compliance with 45 CFR 46 and provisions of this Assurance for each project unless properly found to be exempt (Sections 101(b) and (i)) by the VPR. Continuing reviews will be preceded by IRB receipt of appropriate progress reports from the investigator, including available study findings.
G. The IRB will observe the quorum requirements of Section 108(b). This institution's IRB has effective knowledge of subject populations, institutional constraints, differing legal requirements and other factors which can be foreseen to contribute to a determination of risks and benefits to subjects and subjects' informed consent and can properly judge the adequacy of information to be presented to subjects in accordance with requirements of Sections 103 (d), 107(a), 111, and 116.
H. The IRB will ensure that legally effective informed consent will be obtained and documented in a manner that meets the requirements of Sections 116 and 117. The IRB will have the authority to observe or have a third party observe the consent proces s.
I. Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners and children as required by Subparts B, C, and D of 45 CFR 46.
J. Scheduled meetings of the IRB for review of each research activity will occur not less than every 12 months and may be more frequent, if required by the IRB on the basis of degree of risk to subjects. The IRB may be called into an interim review se ssion by the Chairperson at the request of any IRB member or any institutional official to consider any matter concerned with the rights and welfare of any subject.
K. The IRB will prepare and maintain adequate documentation of its activities in accordance with Section 46.115 and in conformance with VPR requirements.
L. The IRB will forward to the VPR any significant or material finding or action at least to ensure the following:
1. injuries or any other unanticipated problems involving risks to subjects.
2. any serious or continuing non-compliance, with the regulations or requirements of the IRB, and
3. any suspension or termination of IRB approval.
M. In accordance with Section 109, the IRB will have the authority to suspend or terminate previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
N. Certifications of IRB review and approval will be forwarded through the VPR to the appropriate Federal department or agency for research sponsored by such departments or agency.
4. Research Investigators
A. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance.
B. Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance.
c. Research investigators are responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are t o be retained in a manner approved by the VPR.
D. Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate appare nt immediate hazards to the subjects.
E. Research investigators are responsible for reporting progress of approved research to the VPR, as often as and in the manner prescribed by the approving IRB on the basis of risks to subjects, but no less than once per year.
F. Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects and others.
G. Research investigators shall not obtain research credit for, or use data from, patient interventions that constitute emergency medical care.
Research Exempt From Institutional Review Board
These exemptions shall not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization.
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
1. research on regular and special education instructional strategies, or
2. 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:
1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
2. any disclosure of the human subjects' responses outside the research could reasonable 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 (2) of this section, if:
1. the human subjects are elected or appointed public officials or candidates for public office; or
2. 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 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:
1. public benefit or service programs;
2. procedures for obtaining benefits or services under those programs;
3. possible changes in or altematives to those programs of procedures; or
4. 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
1. if wholesome foods without additives are consumed; or
2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be same, or agricultural chemical of 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.
Research Activities Which May Be Reviewed Through Expedited Review Procedures
Research activities involving no more than minimal risk and in which the only involvement of human will be in one or more of the following categories (carried out through standard methods) may be reviewed by the Institutional Review Board through the expedited review procedure authorized in Section 46.110 of 45 CFR Part 46.
1. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
3. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
5. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
6. Voice recordings made for research purposes such as investigations of speech defects.
7. Moderate exercise by healthy volunteers.
8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does non manipulate subjects' behavior and the research will not involve stress to subjects.
10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
Composition of the Institutional Review Board
The Institutional Review Board (IRB) for Florida Institute of Technology will be appointed by the President upon the recommendation by the Vice President for Research. The VPR will serve as a non-voting ex officio member of the IRB.
The IRB must have at least five (5) members. The members must be drawn from varying backgrounds of race, gender, profession, and cultural backgrounds in order to promote complete and adequate review of research involving human subjects. In the event th at the IRB were to regularly review research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, the IRB will consider whether to include one or more individuals who ar e knowledgeable and experienced with regard to such subjects.
The IRB membership may not be all of one gender nor of one profession. The IRB membership will include at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in non-scientific areas. The IRB members hip must include at least one member who is not affiliated in any way with Florida Tech and who is also not part of the immediate family of a person who is affiliated with Florida Tech.
The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of specific issues that are judged by the IRB to be beyond or in addition to its expertise. These individuals may not vote on IRB determinations. No member of the IRB may be a participant in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
1. one member of the Department of Psychology
2. a member of the Department of Biological Sciences
3. a member of one other College or School at Florida Tech
4. a member of the medical or nursing staff of Holmes Regional Medical Center
5. a representative from the greater Melbourne community
6. a member of the Department of Humanities
7. an undergraduate or graduate student at Florida Tech
Criteria For IRB Approval of Research
1. Risks to subjects are minimized.
2. Risks are reasonable in relation to anticipated benefits.
3. Selection of subjects is equitable.
4. Informed consent will be obtained and documented from each prospective subject Or representative (except as specifically exempted in 5. below) and the following information will be provided to each subject:
A. Explanation of the purpose(s) and duration of the study, and the procedures to be used
B. Description of any foreseeable risks or discomforts
C. Description of any benefits
D. Disclosure of alternative procedures or courses of treatment, if any exist that might be advantageous to the subject
E. Description of the measures taken to ensure confidentiality of records identifying the subjects
F. For research involving more than minimal risk, an explanation of any compensation or available medical treatments if injury occurs
G. Explanation of whom (or what entity) to contact for answers to pertinent questions, for further information, or for research-related injury
H. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits, that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled, and any consequences of withdrawing or refusing to participate
I. Description of circumstances under which a subject's participation may be terminated without regard to the subject's consent
J. Any additional costs to the subject that may result from participation
K. If related to a subject's willingness to participate, a statement that significant new findings developed during the course of the research will be provided
5. Informed consent will be documented, unless specifically excepted by meeting one or more of the following criteria:
A. the research is specifically exempted from IRB review;
B. the usefulness and integrity of the research would be jeopardized by the Informed Consent requirement, provided that the research involves only minimal risk and that appropriate full disclosure and debriefing will occur after participation, including the opportunity for a subject to withdraw his/her data;
C. the research involves only minimal risk, the principal risk would be due to breach of confidentiality, and the only document linking the subject and the research would be the Informed Consent document.
6. Data collection is monitored to ensure the safety of the subjects
7. Adequate provisions to protect the privacy of subjects and to maintain confidentiality of data are provided
8. Provisions have been included to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence
The main purpose of the informed consent process is to ensure that prospective research subjects are presented, in understandable language, the information that might influence the decision of giving or withholding consent to participate in a particular research project. Another requirement of the consent process is that the subject exercises free choice and is not subject to coercion or excessive inducement. The descriptions of informed consent and its documentation, including conditions under which the process may be waived are contained in 45 CFR 46 Sections 116 and 117. An appropriate informed consent process and consent form would include:
1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects' participation, and a description of the procedures to be followed.
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 that may reasonably be expected from the research.
4. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
5. an explanation of whom to contact for answers to pertinent questions about the research and about research subjects' rights.
6. a statement that participation is voluntary; that 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.
Other considerations in obtaining informed consent may be appropriate in certain cases, for example, when an experimental treatment is involved, when the true purpose of the research cannot be divulged to the participants, or when the research involves children or prisoners.
The consent form may not include any language that releases, or appears to release, the investigator or his/her institution from liability, or that waives, or appears to waive any of the subject's legal rights.
A copy of the consent form must be given to the person signing the form.
Sample Consent Form
We are seeking your participation in a research project involving a study of the burden born by persons providing home care to victims of Alzheimer's disease. It is our understanding that you have provided the primary home care to an Alzheimer's disease patient, either a spouse or a parent or parent-in-law, for at least one year. This study will involve about 50 persons who, like yourself, provide such care.
If you agree to participate you will be interviewed about the care you provide to the Alzheimer's patient and about your feelings toward him or her. The interview will take approximately one hour. Your participation will not subject you to any physical pain or risk, but, because some of the interview questions seek to solicit very personal information, you may be subject to some stress or embarrassment. Your name will not be recorded on the interview sheet. You will be assigned an anonymous code number and your replies will be known to, at most, two persons, the interviewer and ____________, the director of this study. We assure you that any reports about this research will contain only data of an anonymous or statistical nature. Your name and that of the AIzheimer's patient will not be used.
The goal of this research is to determine what physical and psychological burdens are borne by those who provide home care for Alzheimer's patients. It is hoped that this research can be used by Alzheimer's support groups and the medical community to ease these burdens. We cannot promise that your participation in this study will be of any direct benefit to you. You may find some therapeutic value in discussing the problems you encounter in caring for the Alzheimer's patient. You will receive no monetary compensation for participating in this study.
We are planning a follow-up study which would begin in about one year and you may be asked at that time to agree to another interview. However, participation in the present study in no way obligates you to participate in the follow-up study.
Any questions you have regarding this research may be directed to the interviewer or ____________ at ____________. Information involving the conduct and review of research involving humans may be obtained from the Chairman of the Institutional Review Board of the Florida Institute of Technology, ____________ at 768-8000 ext. ____________.
Your signature below indicates that you agree to participate in this research and that:
1. You have read and understand the information provided above.
2. You understand that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled; and,
3. You understand that you are free to discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled..
I have explained and defined in detail the research procedures in which the subject has consented to participate.