Research Policies - Information to be Furnished by the Research Investigator (OSP)

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Describe the requirements for a subject population and explain the rationale for using, in this population, special groups such as prisoners, children, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question. Include information such as:
- the purpose of research and the setting in which it will be conducted;
- the approximate number of subjects;
- their likely age range;
- their occupational characteristics (e.g., students, policemen, bankers, etc.);
- any special racial, ethnic, socioeconomic, or gender characteristics;
- the relationship of subjects to the research investigator (e.g., students, advisees, etc.);
- the method of contacting potential subjects (e.g., students in classes, newspaper ads, etc.);
- the method of selecting subjects;
- division of subjects into experimental/control groups, etc.
Describe and assess any and all potential risks -- physical, psychological, social, legal, or other -- and assess the likelihood and seriousness of such risks. If methods of research create potential risks, describe other methods, if any, that were considered and why they will not be used. Include both the subtle and the more obvious facets of any procedures such as: physiological stimuli (mechanical, electrical, chemical, biological, etc.); psychological stimuli (contrived social situation, manipulation of subject's self-esteem, etc.); pain, stress; deception/debriefing and associated risks; disclosure by subjects of information regarding finances, religion, sexual activities, etc; disclosure by subjects of illegal activities, etc.
Describe procedures (including confidentiality safeguards) for protecting against or minimizing potential risks and an assessment of their likely effectiveness. Consider items such as:

personal identifying indicators (e.g., names, social security numbers);
security of transmittal and storage of data;
access to data (numbers of people; need-to-know, etc.);
method of eliciting data (interview, questionnaire, standardized testing instrument, etc.);
proper operation and maintenance of means used to administer stimuli;
recognition of a reaction to non-expected behavior on part of subject(s);
competence of the investigator, by training and experience, to control the procedures;
using procedures which are consistent with sound research design;
using procedures already being performed on the subjects for diagnostic or treatment purposes.

Assess the potential benefits to be gained by the individual subject, as well as the importance of the knowledge that might reasonably be expected to result and any other benefits which may accrue to society in general as a result of planned work. Include:
- explanations of the connection between specific benefits and portions of the procedure (e.g., specific areas of questioning which may not be readily apparent);
- discussions of alternate ways of obtaining such benefits and why they were rejected.
Analyze the risk-benefit ratio.
Describe consent procedures to be followed, including how and where informed consent will be obtained.

Preparing the Informed Consent Document

Attach a written consent document that embodies the elements of informed consent which must include, as a minimum, the elements of informed consent stated in 1-10 below.

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;
A description of any reasonable foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others which may reasonably be expected from the research;
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
For research involving more than minimal risk, an explanation as to whether any compensation will be made 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;
An explanation of who to contact for answers to pertinent questions about the research and research subjects' rights, and who to contact in the event of a research-related injury to the subject (Note: please include the chair of the IRB among your list of contact persons);
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;
No exculpatory language through which the subject or the representative of the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the research investigator, the sponsor, the institution, or its agents from liability for negligence; and
When appropriate, one or more additional elements of informed consent listed in Section 46.116 (b) (1) through (6) of the DHHS regulations for the protection of human research subjects:
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.

The consent form should have a signature line (with the name typed below) for both the subject and the Research Investigator. If the subject is under the age of 18, parents (guardians) must sign in addition to the minor subjects.

Return required information to John Smith , Compliance Specialist, (phone: (309) 298-1191), Office of Sponsored Projects, 320 Sherman Hall.