Committee for Care and Use of Animals
Policies and Procedures: Human Subjects in Research
The University of Illinois at Springfield Institutional Review Board (IRB) operates under policies and procedures mandated by the U.S. Department of Health and Human Services and the Office for Human Research Protections. These policies are available for review at www.hhs.gov/ohrp/. This document is meant to serve both as a policy statement for the IRB at UIS, and as a handbook for investigators involving human subjects in their research.
Questions regarding this document or submission of materials should be directed to:
Dr. Lynn Pardie
Associate Vice Chancellor for Graduate Education and Research
Public Affairs Center Room 525
University of Illinois Springfield
One University Plaza
Springfield, IL 62703-5407
217-206-7230 (phone)
217-206-7623 (fax)
pardie.lynn@uis.edu
Deborah Koua, staff to the IRB, can also provide assistance. She can be reached at 217-206-7409, koua.deb@uis.edu.
The following statement of policy applies to all research conducted at or sponsored by the University of Illinois at Springfield.
1) Anyone conducting research or responsible for research involving human subjects must:
2) The decision of human subjects to participate in research governed by this policy must meet the standards of informed consent. An individual’s decision to participate must be:
If persons are involved as subjects who cannot legally give consent but are capable of assent, normally their assent to participate must be solicited in addition to the permission of a parent or guardian.
3) The selection of research subjects must be fair. Subjects should not be selected for potentially beneficial research on the basis of favoritism, nor should risky research be targeted to subjects who are less powerful.
4) The procedures for recruiting subjects must protect their privacy and be reasonable in terms of their condition or circumstances. No coercion, explicit or implicit, should be used to obtain or maintain cooperation.
5) Risks to subjects must be minimized and should be justified by the anticipated benefits to the subject or society.
6) Adequate provision must be made to protect the privacy of subjects and to maintain the confidentiality of identifiable information.
7) Approval for conducting research with human subjects must be obtained prior to any involvement of the subjects. All such research protocols must be reviewed by the UIS Human Subjects Research Officer; the IRB; or in cases of signed, written agreements between a department and the IRB, by a designated departmental review officer.
8) This policy does not apply to routine course, workshops, or curriculum development using accepted educational practices sponsored by the University of Illinois; or to aid or services provided by professionals to their clients.
This policy applies to any research activity conducted at or sponsored by the University of Illinois at Springfield that involves human subjects. The policy is relevant to research in which an investigator 1) obtains data through intervention or interaction with an individual or 2) obtains private information by which an individual could be identified. The policy is therefore applicable to research involving human beings whose physical, emotional, or behavioral conditions, responses, tissues, or fluids are investigated for research purposes (that is, for any reason other than the sole purpose of benefiting the subject as an individual). It applies to the use of interviews, tests, observations, and inquiries designed to elicit or obtain nonpublic information about individuals or groups, as well as the study of existing public or privately held records where the identity of individuals is known.
The policy is applicable whether the research is undertaken on a large or small scale and whether or not it is externally funded. Pilot projects, student dissertation and thesis projects, independent study projects, and course projects must follow this policy if they involve research with human subjects.
UIS will waive human subjects review for studies aimed at improving institutional effectiveness that are carried out by administrative units. The responsible administrator should contact the Human Subjects Review Officer prior to conducting the study in order to confirm eligibility for the human subjects review waiver.
The IRB shall consist of a minimum of five persons with varying backgrounds. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. It must also 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.
A quorum shall be met if more than one half of the members are present and voting at any meeting. Members shall be appointed by the Chancellor upon recommendation from the Vice Chancellor for Academic Affairs, and shall serve for terms of three years. There is no limit on the number of terms an individual can serve.
The Human Subjects Review Officer (HSRO) is appointed by the Chancellor. Duties of the HSRO include, but are not limited to:
The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals are not considered voting members of the IRB.
The IRB meets several times each semester, and posts its meeting schedule on its website (www.uis.edu/grants/irb/index.html). Protocols and supporting materials are due to the Grants and Contracts Office, MS PAC 525, at least two weeks before each meeting date. Materials not received in a timely fashion will be discussed at the next regularly scheduled IRB meeting. Researchers submitting protocols during semester breaks, or any time when faculty are not normally on campus, may need to allow additional time for the approval process. Researchers (and their faculty adviser, when applicable) are required to attend the IRB meeting at which their protocol is discussed.
In 1978, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research developed broad ethical principles to provide a basis on which specific rules could be developed. These principles, discussed in The Belmont Report, are: respect for persons, beneficence, and justice.
Respect for persons – this principle specifies that individuals should be treated as autonomous agents, and that persons with diminished autonomy are entitled to protection. In most cases of research involving human subjects, respect for persons demands that subjects enter the research voluntarily and on the basis of adequate information about the research situation and possible consequences.
Beneficence – this principle requires investigators to maximize possible benefits and minimize possible harm. Learning what will, in fact, benefit may require exposing persons to risk. Careful consideration must be given to determine when it is justifiable to seek certain benefits, despite the risks involved, and when the possible benefits should be foregone because of the risks.
Justice – this principle requires researchers to carefully consider the selection of research subjects. An injustice occurs when some benefit to which a person is entitled is denied without good reason, or when some burden is imposed unduly. The selection of research subjects needs to be scrutinized in order to determine whether some groups are being systematically selected simply because of their easy availability, their compromised position, or their ability to be manipulated, rather than for reasons directly related to the problem being studied.
This section is intended to provide definitions of terms and provide guidance to investigators.
Human Subjects Research – research is defined as any systematic gathering and analysis of information that aims to test a hypothesis, to discover some unknown principle, or to re-examine some known or suggested principle. The term research includes:
The term “research” is not intended to apply to:
Human Subject – the term human subject means an individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information.
Intervention includes both physical procedures and manipulations of the subject or the subjects’ environment that are performed for research purposes. Interaction includes communication or interpersonal contact between the investigator and the subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual with the reasonable expectation that it will not be made public (for example, a medical record). Information is individually identifiable if the identity of the subject is associated with the information or can be readily ascertained by the investigator.
The definition of subject excludes all accepted and established service relationships, such as normal relationship of patients to physicians, students to instructors, and other clients to professionals in which the patient, student, or client is receiving aid or services consistent with accepted and established practice, that is intended only to meet her or his own personal needs.
Responsible Project Investigator – a qualified staff or faculty member must serve as the responsible investigator and oversee the conduct of research involving human subjects. In cases of student theses or dissertations, this person is normally the student’s project adviser.
Informed Consent – participation in research must be voluntary and be based upon adequate knowledge and understanding of relevant information. The informed consent process ensures that both of these principles are followed in all research involving the participation of human subjects.
The methods used to obtain consent may vary. They should be designed to fit the nature of the research; the nature and magnitude of the risks involved; the research setting; the nature of the subjects who will participate; and the requirements of applicable policies, laws, and regulations.
Minimal Risk – research is defined as having minimal risk if the risks of anticipated harm are not greater, considering probability and magnitude, than those ordinarily encountered in the subject’s daily life or during the performance of routine physical or psychological examinations or tests.
Children – children are persons who have not attained the legal age for consent to treatment or procedures involved in research. In Illinois, this age is 18 years.
All research involving human subjects that is conducted at or sponsored by the University of Illinois at Springfield must comply with federal policy for the protection of human subjects. This policy applies whether the research is funded or unfunded, and whether it is conducted by faculty, staff or students. It applies to pilot projects, student thesis and dissertation projects, independent study projects, and course projects if they involve human subjects. The Institutional Review Board and authorized departmental review bodies share responsibility for ensuring that all UIS research activities meet both federal and campus policy.
How to Obtain Approval for Human Subject Research
Any research involving human subjects must be submitted to either the Human Subjects Review Officer, or the designated departmental review officer authorized to approve exempt research. (Note: As of January, 2008, departmental authorization to approve exempt research has been granted to the UIS Psychology and Communications programs.)
A research project may be exempted from full review if the only involvement of human subjects will be in one or more of the six categories listed in Section B below. Regardless of the researcher’s view of the project’s fit one of these six categories, a protocol for research involving human subjects must be submitted to either an authorized academic department or the UIS Human Subjects Review Officer (HSRO). Upon completion of review by the department, HSRO, or IRB, a letter will be sent to the researcher (and faculty adviser in the case of student research) authorizing initiation of the project or noting stipulations that must be met before approval is granted. The portion of the research project involving human subjects cannot be undertaken until formal approval to proceed is granted.
Research in any of the following six categories may be exempt from full IRB review. The following categories are defined in the Federal Policy for the Protection of Human Subjects.
Research conducted in established or commonly accepted educational settings, involving normal education practices such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. |
LimitationsSubjects must be placed at no more than minimal risk.The consent of authorized school officials can serve in lieu of consent of the individual subjects, but consent must be obtained in an appropriate way. Children with the capacity to give assent are normally asked to do so.Confidentiality of identifiable information must be maintained without the expressed permission of the subjects to do otherwise. |
Research involving the use of educational tests (diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
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LimitationsSubjects must be placed at no more than minimal risk.If the research is undertaken in a commonly accepted educational setting, the consent of authorized school officials can serve in lieu of consent of the individual subjects. Otherwise, consent of the subjects or their authorized representatives must be obtained. Children with the capacity to give assent are normally asked to do so.Confidentiality of identifiable information must be maintained without the expressed permission of the subjects to do otherwise. |
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
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LimitationsSubjects must be placed at no more than minimal risk.Confidentiality of identifiable information must be maintained without the expressed permission of the subjects to do otherwise. |
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. |
LimitationsSubjects must be placed at no more than minimal risk.The requirement for consent of the subjects is waived if the data, documents, records, or specimens, etc. are publicly available. The authorization of the custodian of the data can serve in lieu of specific subject consent for access to data, which are not publicly available. In such cases, the investigator must be satisfied that the custodian is authorized to release the data for research purposes. |
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:
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LimitationsSuch work cannot be exempted if prior review is specifically required by statute, or if the Secretary of HHS determines that a research or demonstration project presents a danger to the physical, mental, or emotional wellbeing of a participant or subject of the research or demonstration project. |
Taste and food quality evaluation and consumer acceptance studies if
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Different standards apply is the research is governed by HHS |
The IRB review process hinges on the following, each of which is described in detail below:
As noted earlier, the participation of human subjects in research must be voluntary. Each subject must give informed consent or, if a subject lacks the capacity to consent, an authorized representative must consent. The principle of voluntary participation of subjects applies whether or not the research is federally funded and whether or not the research requires full IRB review. Federal regulations regarding informed consent are listed here:
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.
The IRB may waive the requirement for the investigator to obtain a signed consent for some or all subjects if it finds 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. Also, if the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context the consent form may be waived. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
The basic elements of informed consent are presented below. Not all items will be applicable to every project, but the language used in every consent form should be understandable to the subject or representative (the UIS IRB recommends an 8th grade reading level or below for information given to the general population).
There are different risks inherent in different research procedures. For purposes of safeguarding human subjects, risks are classified as either minimal risk or more than minimal risk. Under minimal risk, the risks of harm in the proposed research are no greater, considering probability and magnitude, than those ordinarily encountered in the subject’s daily life or during the performance of routine physical or psychological examinations or tests.
The potential for physical risk is most obvious in procedures requiring medical intervention or involving strenuous exertion. There is a wide range of medical, social and behavioral research that may pose no immediate physical risk to the subject, buy may involve varying degrees of emotional stress, deceit, invasion of privacy, etc. It is the investigator’s responsibility to minimize the risks associated with any research and to make clear to the research subjects any benefits that may result to them directly or more generally to society. Direct payments or other forms of remuneration to the research subject are not considered to be benefits of participation. Evaluation of the risk/benefit ratio is a primary consideration in the IRB review of research proposals.
The selection of subjects must be carefully considered. Subjects should not be selected for potentially beneficial research on the basis of favoritism, nor should risky research be directed to subjects who have limited power. Certain groups, such as the economically disadvantaged, the very sick, and the institutionalized, may have compromised capacity for free consent, and should be protected against the danger of being involved in research solely for administrative convenience or because they can be relatively easily manipulated.
No coercion, explicit or implicit, should be used to obtain or maintain cooperation. When the investigator has a specific relationship—faculty-student, professional-client, employer-employee—with a potential subject, special care must be taken to ensure that the subject feels completely free to decline to participate. Where access to subjects is gained through cooperating institutions or individuals, care should be taken not to abridge prior commitments made to the subjects about the confidentially or other terms of the primary relationship.
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the expressed permission of the subject to do otherwise. The more sensitive the material, the greater the care that must be exercised. Ordinarily, the following requirements must be met:
Some research projects utilize audio and video taping of research subjects. Subjects should always be told in the informed consent that taping will occur, how tapes will be disposed of, and when disposal will occur. Explicit consent must be obtained for any public use of the tapes such as use in the classroom or as part of a public presentation of the research results, since this constitutes a waiver of the normal confidentiality of research data.
Some studies involve collection of data on sensitive matters such as sexual behavior or criminal activities. There have been instances in which the identities of subjects or research data have been sought by law enforcement agencies. Researchers can obtain an advance grant of confidentiality that will provide some protection even against a subpoena for research data. Please contact the HSRO if you have questions on this matter.
The IRB and IRB-approved departmental review bodies conduct continuing reviews of research at intervals appropriate to the degree of risk, but at least once per year.
Federal regulations and University of Illinois policy require that all records relating to the IRB and to human subjects activities be retained for at least three years after completion of the research. Records, including signed consent forms and collected data, must be accessible for inspection at any time.
The following special requirements are imposed on all research involving children. In Illinois, individuals under the age of eighteen are usually considered children.
Permission of Parents or Guardians
When children are subjects in research, the permission of the child’s parent(s) or guardian(s) must usually be obtained prior to the child’s participation. The requirements for obtaining parental permission are essentially the same as those for obtaining consent. The permission of one parent is usually sufficient, especially if the research does not involve greater than minimal risk. Special provisions must be met for children who are wards of the state.
Assent of Children
In addition to parental permission, the investigator must obtain the assent of the children who are to be subjects in the research, as long as those children are capable of providing assent. A child’s desire not to participate in a given research project should be respected by the investigator, even if parental permission has been granted. The level of information provided to the children will vary depending on age and sophistication of the children involved. It can vary from a simple description of what the children will experience to the equivalent of the information that would be presented to an adult subject. All children capable of assent must be informed that they are free to withdraw from participation at any time.
Waiver of permission and assent
Under some circumstances the IRB may waive some or all of the parental permission and child assent requirements. Some examples of instances when waivers may occur include:
- The research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children) and
- An appropriate mechanism is devised for protecting the children who participate in the research and
- The waiver is not inconsistent with federal, state or local laws.
In addition to the requirements listed elsewhere in this policy, the following requirements apply to all research involving prisoners.
In addition to the requirements listed elsewhere in this policy, the following requirements apply to all research involving fetuses, pregnant women, and human in vitro fertilization.
All research conducted by UIS students must be supervised by a UIS faculty member. That faculty member is responsible for:
