GUIDELINES FOR RESEARCH, DEMONSTRATION AND RELATED ACTIVITIES INVOLVING HUMAN SUBJECTS
UNIVERSITY POLICY STATEMENT
TABLE OF CONTENTS
- Determination of the Need for Review
- Determination of "Subject at Risk"
- Safeguarding Information
- Informed Consent
- Basic Elements of Informed Consent
- Procedures for Obtaining Informed Consent
- Procedures for Reviewing and Monitoring Projects
- Types of Review
- Modifications to Research Protocol
- The Institutional Review Board
- IRB Training Module
- Instructions for taking Human Subjects Training Quiz
- APPENDIX A: University Policy Statement
- Application Form for Approval to Use Human Subjects
- Request for Time Extension, Annual Update, or Modification to Research Protocol
- Sample Informed Consent Document
Since 1965, agencies of the federal government have been establishing policies and regulations concerning the use of human subjects in research, development, or demonstration projects. Though these regulations initially dealt with medical research, they have been expanded to include all biomedical and behavioral research and "related activities." (Related activities are those labeled as other than research or development; for instance, training, demonstration, improvement, or support, but which nevertheless contain an R & D component.) The applicable regulations are Code of Federal Regulations, Title 45, Subtitle A, Part 46, published in the Federal Register on May 30, 1974, revised November 13, 2001, effective December 13, 2001.
Essentially, these regulations require that any institution receiving funds from the federal government must have an institutional review board for determining if projects involving human subjects meet federal guidelines for the protection of those subjects.
At Emporia State University, the mandated board is the Institutional Review Board for Treatment of Human Subjects, which is responsible to the President through the Provost/Vice President for Academic Affairs. This board is also responsible for assuring that the University policy relative to human subjects research is appropriately implemented. All faculty, staff, or students wanting approval to use human subjects must first review the IRB Training Module and take the Human Subjects Training Quiz. A score of 80% is required before approval can be given to proceed with the research. Both the IRB Training Module and the Quiz are available on Blackboard. The instructions for locating the module and quiz are included at the end of this document.
In fulfilling the basic requirements of the Federal Regulations and the University policy, the following procedures must be followed:
The Principal Investigator (or cognizant faculty member) must determine if the human subjects used in the research project or related activity (or research or related activity being conducted under their supervision) will be placed at risk. If so, then even if the risks are minimal, the researcher must demonstrate that the potential benefits of the research will outweigh any risks involved. When such can be shown and is approved by the Institutional Review Board, the principal investigator can conduct the research activity so long as appropriate consideration is given to the following three items:
- subjects must be adequately informed concerning the nature of their participation and must freely give their consent;
- appropriate procedures must be developed to care for possible emergencies that might arise; and,
- provisions must be made for assuring the participants' rights to privacy.
The Institutional Review Board, then, is charged with the responsibility of reviewing all experimentation involving humans as subjects and thus to insure that the rights and welfare of the subjects are protected. However, a second purpose is to facilitate research within the University. Therefore, the Institutional Review Board seeks not only to protect the interests of human subjects and of the University, but also to safeguard the interests of the investigators or the individuals responsible for the research.
The Review Board's responsibilities do not cover evaluation of the quality of research, but only evaluation of the adequacy of the protection of the rights and welfare of human subjects in research.
Finally, the jurisdiction of the Review Board includes all experimental activities involving the rights and welfare of human subjects both at the University and elsewhere, when carried out by staff or students of the University acting in any capacity related to the institution. Faculty and staff under whose direction students may conduct experiments with human beings are reminded of their responsibility to insure compliance with these policies and procedures.
The determination of when an individual is "at risk" is largely a matter of being familiar with, or having access to, the definitions of subjects at risk in the federal regulations, and the application of common sense and professional judgment to the circumstances of the proposed activity. The major responsibility for making that decision resides with the principal investigator or cognizant faculty member. A second level of responsibility rests with the department chairperson, who is responsible for coordinating departmental research with the Institutional Review Board. When doubt exists as to the need for review by the review board, the Chair of the Institutional Review Board for Treatment of Human Subjects should be consulted.
(In an attempt to clarify the need for review, the federal government has stated that, "In considering the scope of institutionally supported R&D activities, educational institutions should be careful to distinguish classroom, laboratory, or field exercises from actual research.")
A subject or individual is considered to be "at risk" if that individual may be exposed to the possibility of injury, including physical, psychological, or social injury as a consequence of participation as a subject in any research, development, or related activity which departs from those established and accepted methods necessary to meet the student's needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. Risk may be a consequence of participation as a subject in a research, development or demonstration project or in other activities such as attitude surveys of students in classes, organizations, dormitories, etc.
Risk does not include accepted and established service functions such as the normal relationship of patients to physicians; students to teachers; and other clients to professionals in which the patient, student, or client (or authorized representative) is receiving aid or services intended only to meet his/her own personal needs. The requirement of strenuous physical exertion, subjection to deceit, public embarrassment and humiliation are all examples of procedures which require thorough scrutiny by the principal investigator and the Institutional Review Board for Treatment of Human Subjects.
Many medical, social and behavioral projects and activities involve no immediate physical risk to the subject; however, they may involve different degrees of discomfort, harassment, invasion of privacy, or may constitute a threat to the subject's dignity through the imposition of demeaning or dehumanizing conditions; e.g., those utilizing personality inventories, interviews, questionnaires, or the use of observation, photographs, taped records, or stored data. Projects posing these types of risks are subject to the review and approval of the Institutional Review Board for Treatment of Human Subjects.
If a project or activity places individuals at risk, the proposal must carefully describe the procedures for safeguarding information that could be traced to or identified with the human subjects.
- Questionnaires, inventories, interview schedules and other data gathering instruments and procedures must be designed so as to limit the personal information to be acquired to that which is absolutely essential to the project or activity.
- Names, addresses, serial numbers, and data transferred to tapes, disks, and printouts must be encoded or enciphered.
- Codes and ciphers must be kept in secure places distinctly separate from encoded and enciphered data.
- All edited, obsolete, or depleted data on punched cards, tapes, disks, and other records must be destroyed after completion of a project or activity.
- Security of the transfer, storage and handling of data must be maintained.
Informed consent is the agreement obtained from a subject (or authorized representative) to the subject's participation in a project or activity. Every human being has a legal right to determine what should and should not be done to his/her body and/or mind, and every director of a project or activity which involves the use of human subjects must respect such rights regardless of the potential benefits or value of any proposed procedure. If the subject is a minor (under 18 years), is incompetent, or is under some other legal disability, consent must be obtained from the legal guardian of such person and from the subject unless that subject is very young (under 8 years old) or a court has declared the subject legally incompetent.
A consent is valid only if it is an "informed" consent. The consent must be made after the proposed procedure, treatment, or activity and the risks, dangers and possible complications have been carefully described to the subject and/or authorized representative.
Informed consent given for a particular procedure or treatment does not extend to a different procedure, treatment, or activity, or to a procedure or treatment involving different or greater risks or hazards. Different or more dangerous procedures or treatments require separate and specific consent.
If, under certain circumstances, a consent document is deemed unnecessary or undesirable, the circumstances must be carefully explained and justified to the Institutional Review Board for Treatment of Human Subjects before the project can be approved.
All informed consent documents must include the following basic elements:
1. A statement that the study involves research, an explanation of the purposes of the research, a description of the procedures to be followed, including an identification of those which are experimental, and the expected duration of the subject’s participation;
2. A description of any reasonably foreseeable discomforts or risks;
3. A description of the benefits to the subjects or others which may be reasonably expected from the research;
4. A disclosure of appropriate alternative procedures, if any, that would be advantageous for the subject;
5. A statement describing the extent, if any, to which confidentiality of data identifying the subjects 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 offer to answer any inquiries concerning the procedures and an explanation of whom to contact in the event the subject has questions later or sustains a research related injury;
8. An instruction that participation is voluntary and the subject is free to withdraw consent and to discontinue participation in the project or activity at any time without any penalty or loss of benefits to which the subject is otherwise entitled, and refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled;
9. The agreement, whether written or oral, entered into by the subject should include no exculpatory language (that which would free the faculty member or institution from guilt) through which the subject is made to waive, or seem to waive, any legal rights, or to release the institution or its agents from liability or negligence.
The actual procedure for obtaining informed consent is to be fully documented in one of the following two ways:
- A written consent document embodying all basic elements of informed consent that will be signed by the subject or authorized representative. A sample form is contained in this document.
- A "short" form written consent document indicating that the basic elements of informed consent have been presented orally to the subject. Written summaries of what is given orally to the subject must be approved by the Institutional Review Board. The "short" form is signed by the subject or authorized representative and an auditor/witness to the oral presentation.
Completed forms must be retained in the department office or other appropriate administrative unit of the principal investigator for a minimum of three years after termination of the project.
Submission to the Institutional Review Board - At least one month before beginning research or related activities involving human subjects (or before submitting a funding proposal involving human subjects to an external agency) the principal investigator forwards one copy of the "Application for Approval to Use Human Subjects" to the Chair of the Institutional Review Board, along with a definitive statement of the proposed research or related activity and how human subjects are to be used in the study. The Chair scans the application and the statement of activity to insure that the following procedures are carefully described:
- provisions for safeguarding privileged or confidential data;
- precautions for dealing with emergencies;
- informed consent includes the seven basic elements;
- procedures for obtaining and documenting informed consent.
If these conditions are not satisfied, the proposal is returned to the originator with statements of what provisions must be added.
FULL REVIEW - Full committee review is required for all research involving greater than minimal risk to subjects, as well for all research activities involving vulnerable subject populations, including but not limited to children, elderly, and psychiatric patients.
When the application satisfies the four requirements mentioned above, the Chair will forward the application to the Review Board for their perusal. Committee members have three options in casting their vote regarding each request.
1. Approval without comments, suggestions and/or restrictions 2. Approval with comments, suggestions and/or restrictions 3. Disapproval with comments
The Chair informs the principal investigator of the Review Board's decision by letter. If any comments, suggestions and/or restrictions are made, these are included with a statement that the principal investigator must assure the Review Board in writing that any stipulations specified in the approval letter will be satisfied. Furthermore, any anticipated procedural changes in carrying out the project must be approved by the Review Board before such changes are implemented.
EXPEDITED REVIEW - Expedited review is provided for research which involves no more than minimal risk or for review of minor changes in previously approved research protocols. This review requires approval of the Chair only. In order for the application to be eligible for expedited review, all of the following requirements must be satisfied.
- Risks to subjects are minimal;
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result;
- Selection of subjects is equitable;
- Informed consent will be sought from each subject or the subject's legally authorized representative;
- Informed consent will be adequately documented;
- When appropriate, the research plan makes adequate provision for monitoring data collected to ensure safety of subjects; and
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
EXEMPTED REVIEW - The following cases may exempt your research project from full IRB review, as determined by the Chair.
1. Research involving normal educational practices;
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior, unless the obtained information is recorded in such a manner that human subjects can be identified;
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior that is not exempt under (2) if the subjects are elected or appointed public officials or candidates for public office, or federal statutes require without exception the confidentiality of the personally identifiable information be maintained throughout the research and thereafter;
4. Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens if these sources are publicly available, or if the information is recorded in such a manner that subjects cannot be identified;
5. Research and demonstration projects that are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs; and
6. Taste and food quality evaluation and consumer acceptance studies.
Typically, approval is given for research protocols for a period of one year from the approval date. If it is necessary to conduct research with subjects past this expiration date, it will be necessary to submit a request for a time extension. If the original protocol was approved for longer than one year, the principal investigator must submit an annual update. Likewise, if there have been any modifications to the original approved protocol, such as changes in survey instruments, changes in procedures, or changes to possible risks to subjects, the principal investigator must submit a request for approval for modifications. The above requests should be submitted on the appropriate form, REQUEST FOR TIME EXTENSION, ANNUAL UPDATE, or MODIFICATION TO RESEARCH PROTOCOL, included at the end of this document.
Requests for time extensions should be submitted at least 30 days before the expiration date. Annual updates should be submitted within 30 days after each 12-month period. Modifications should be submitted as soon as it becomes evident that changes have occurred or will need to be made.
The Institutional Review Board for Treatment of Human Subjects was established in 1975. The Board is composed of six regular members, with one member being non university personnel, which is consistent with federal requirements.
A quorum of the Board is four. Although only a favorable majority vote is necessary for approval, the Board strives for a unanimous decision by suggesting changes or additions in procedure that satisfy objections raised by Board members. Following is a list of the current members of the Board.
- John Barnett, Social Sciences
- Mike Butler, IRB Chair, Health, Physical Education and Recreation
- Kathy Ermler, Dean, Graduate School and Distance Education
- Susan Hernandez, Educational Consultant
- Pamelyn MacDonald, Psychology
- Gary Wyatt, Sociology, Anthropology, and Crime & Delinquency Studies
All faculty, staff, or students wanting approval to use human subjects must first review the IRB Training Module and take the Human Subjects Training Quiz. A score of 80% is required before approval can be given to proceed with the research. Both the IRB Training Module and the Quiz are available on Blackboard. Instructions
EMPORIA STATE UNIVERSITY POLICY FOR THE UTILIZATION OF HUMAN SUBJECTS IN RESEARCH AND RELATED ACTIVITIES
I. Members of an academic community engaged in research and related activities involving the use of human subjects have obligations to their subjects and to the University. This Policy is intended to give broad guidelines for conducting such research.
II. Commitment to the Risk/Benefit concept. In brief, there are no absolutes. Each investigator must make a judgment of the benefits likely to result from the research in the light of the possible risks to the subject.
III. Specific Principles:
A. Protection of Subjects
- 1. Only when a problem is significant and can be investigated in no other way is the investigator justified in exposing research subjects to emotional or physical stress. The investigator must seriously consider the possibility of potential harmful aftereffects and should be prepared to remove them as soon as possible. Where danger of harmful aftereffects exists, the research should be pursued only when the subjects or their responsible agents are fully informed of this possibility and volunteer nevertheless. 2. The identity of research subjects must not be revealed without explicit permission, and safeguards must be developed to prevent information being traced to, or identified with, subjects. If data are published without permission for identification, the investigator is responsible for adequately disguising their source. 3. Investigators who assume obligations to research subjects in return for the subjects' cooperation in research studies are obliged to fulfill these obligations. 4. The informed consent of subjects must be obtained by methods that are adequate and appropriate. Subjects must be instructed that they are free to withdraw their consent and to discontinue participation in the project or activity at any time. 5. In cases where student participation in research as a class requirement (or for bonus credit) occurs, the following must be considered:
Because research participation usually has pedagogical value and also provides benefits to the investigator, alternative participation opportunities should be provided. These should be equally demanding of the students' time and effort and they should be designed for pedagogical purposes. Equal bonus credit should be obtainable through either form of voluntary participation.
When bonus credit is utilized, the instructor must first assign grades on the basis of his routine appraisal of student achievement. The grades of volunteers may then be adjusted upward.
The adjustment upward of grades should be commensurate with the value of the activity and the effort required. Care should be exercised to fully inform students of the potential for increasing their grade through volunteer participation.
1. 6. Instructors should exercise extreme care in recruiting subjects for their own research from their own classes. Students must not feel pressured to participate at the request of their instructor. 7. Instructors should not require students in their own class to collect data for scientific investigations of their own or others. However, 1) they may recruit paid assistants from class while being mindful of no. 6 above; 2) they may assign students to data collection tasks when this assignment is appropriate to keep the time and effort involved commensurate with the importance of the objective. 8. Surveys and questionnaires of student behavior, beliefs, etc. must be utilized with due regard to the student's right to privacy. Therefore, all previous principles apply equally here. Particularly salient are subjects' rights to privacy and the necessity to obtain informed consent (see no. 4 above).
B. Responsibility to the University
1. 1. As a matter of common courtesy, surveys or other investigations of special groups for which a responsible sponsor or authority can be identified (e.g. members of a religious congregation, a residence hall, an academic department, etc.) should not be undertaken without prior consultation with the responsible individual. 2. Investigators are expected to respect the nonpartisan role of the University. Without impairing freedom of intellectual inquiry, the University requires that reports of research studies which relate to specific political philosophies or practices must include a disclaimer noting that the University does not take an official position on political questions. When in doubt whether such questions of political practices or philosophies involved might compromise the neutrality of ESU, the investigator should consult the Vice President for Academic Affairs.
C. Responsibilities of the Investigator
1. 1. Whenever an investigator is uncertain as to whether the proposed research violates the rights of human subjects, guidance should be sought from the Institutional Review Board for Treatment of Human Subjects. This review is required for all federal proposals. 2. The investigator should recognize that in the final analysis, collegial review should not be regarded as relieving him/her of personal responsibility or diffusing it.
IV. It is possible that the preceding ethical guidelines may seem, under certain circumstances, to come into conflict with cherished principles such as academic freedom or freedom of intellectual inquiry. To serve the latter while violating human rights is a difficult position to defend. Put in stark terms, there can be a conflict between the values of science to benefit all and the values that emphasize concern for the individual subject. Such conflicts cannot be resolved through recourse to absolutes, but they can perhaps be reduced through attention to the preceding principles.