Please follow this outline when preparing the Research Summary.
1. Briefly describe the proposed study including its purpose and the research question. Please use lay terms insofar as this is possible.
2. Describe the research design and procedures to be used. Describe how the design and procedures minimize risk to subjects.
Criteria for IRB approval: Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, AND, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
3. Describe all physical, psychological, and other risks to the subjects. If deception is to be used, describe what the deception will be and why it is necessary. Describe safeguards (e.g., medical consultation, counseling, etc.) that will be taken to reduce risks.
Describe all benefits to the subjects.
Describe how the risks are reasonable in relation to anticipated benefits.
Criteria for IRB approval: 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
4. Describe how subjects will be recruited, selected, and, if part of the design, placed into groups.
Criteria for IRB approval: Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons.
5. Describe how informed consent will be obtained from each subject or the subject's legally authorized representative.
Criteria for IRB approval: Informed consent will be sought from each prospective subject or the subject's legally authorized representative. 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.
6. Attach an informed consent document that contains the following items:
A. General elements of informed consent:
(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 that 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 that 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 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.
Criteria for IRB approval: Each required item is present. The IRB may waive or modify this requirement under certain circumstances . Justify any modification to informed consent procedures.
7. Describe how the data will be monitored to ensure the safety of the subjects.
Criteria for IRB approval: When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
8. Describe how the privacy of research subjects and the confidentiality of the data will be maintained. List all individuals who will have contact with the subjects. List all individuals who will have access to data individually linked to subjects.
Criteria for IRB approval: When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
9. If the research involves any subjects likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons, describe the additional safeguards that have been included in the study to protect the rights and welfare of these subjects.
Criteria for IRB approval: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.