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Why does Morningside College have an Institutional Research Review Board (IRRB)?
This board ensures that Federal guidelines regarding research are followed. The IRRB also answers to the college's mission statement, providing ethical leadership for campus research and encouraging civic responsibility in regard to research practices.
Who should complete an IRRB Approval Request Form?
Faculty, staff, and/or students at Morningside College who are engaging in research activities with human and/or animal subjects should complete an approval request form.
A. ACTIVITIES WITH HUMAN AND/OR ANIMAL SUBJECTS THAT DO NOT REQUIRE COMMITTEE NOTIFICATION: Classroom activities or projects in which students practice procedures such as routine classroom practice at administering tests, replication experiments, role playing, collection of observations in which subjects are anonymous, and routine activities in field experiences or internships in which there is not even minimal risk to subjects are not considered research that requires notification to the committee.
B. ACTIVITIES WITH HUMAN AND/OR ANIMAL SUBJECTS REQUIRING COMMITTEE NOTIFICATION: These may include classroom projects and assignments that require faculty and/or students to gain informed consent of subjects or their guardians. Such projects that fall under the guidelines for exempt research (see below) do not require research protocols but should be directed to the attention of the committee, which will review informed consent procedures. Researchers are required to submit three copies of the request including completion of items 1 through 10 on the request form.
C. ACTIVITIES WITH HUMAN AND/OR ANIMAL SUBJECTS REQUIRING FULL COMMITTEE REVIEW: Activities in which there may be at least minimal risk to human or animal subjects and which do not fall under the guidelines for exempt research (see below) should be reported to the committee. In order to adequately review the research, faculty should notify the committee by completing all items on the request form, including a complete research protocol. Researchers are required to submit seven copies of the request for a Full Review. Again, researchers should plan on submitting their request for approval, at least two weeks prior to the beginning of the study.
When should the form be completed?
The form must be completed at least two weeks prior to the beginning of your study for the committee to read and review the proposal, and research should not begin until approval has been gained by the committee. Faculty and/or students will be informed when the proposal will be reviewed and may attend the committee meeting. At times, principal investigators (and/or their faculty sponsors where appropriate) may be asked to attend and respond to questions about the proposal.
Where should the form be sent?
Copies of the completed form and accompanying documents should be sent to Susan Burns, Chair, Institutional Research Review Board Committee.
To whom should questions about the review process be addressed?
All questions about completing the request form, about informed consent, or about the approval process should be addressed to Susan Burns, Chair of the Institutional Research Review Board Committee.
How should the form be completed?
Complete each line of the form following these guidelines:
1. TYPES OF SUBJECTS: “Normal adults” are individuals 18 years of age or older who have the capacity to render legally informed consent for their own participation in the study. The participation of minors requires the signature of at least one parent or guardian as well as the assent of the minor. Special care must be taken to exclude minors from projects involving college students when parental permission has not been obtained. When using animals, a description must be provided concerning number and species of animals, with additional explanation of how and where the animals will be obtained and how they will be used.
2. DRUGS: Indicate whether any drugs, chemicals, or biological agents will be used in the treatment or testing of subjects.
3. SPECIMENS: Indicate whether the study will require the collection of tissue, body fluids, or other specimens from subjects.
4. VOLUNTARY INFORMED CONSENT. Informed consent means the knowing consent of an individual or his/her legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The basic elements of information necessary to such consent include:
a) a fair explanation of the procedures to be followed, and their purposes, including identification of any procedures that are experimental.
b) a description of any reasonably foreseeable discomforts or risks.
c) a description of any benefits reasonably to be expected.
d) a disclosure of any appropriate alternative procedures that might be advantageous for the subject.
e) an offer to answer any inquiries concerning the procedures.
f) an instruction that the person is free to withdraw her/his consent and to discontinue participation in the study at any time without prejudice to the subject.
g) information of efforts to keep confidential any individual’s data provided.
h) amount of time required.
The committee will review Voluntary Informed Consent Forms with this list in mind, and thus researchers should take care to include all of the above information. Signed voluntary informed consent means the subject or her/his legally authorized representative will sign a form consenting to act as a subject. For some surveys involving interviews or mailed questionnaires, voluntary informed consent may be implied by the subject's completion of the survey instrument. An information sheet covering the eight points listed above must be submitted to the subject. So the subjects truly can provide voluntary informed consent, this information will be read by or to the subject and/or parent and/or legally authorized representative. If signed consent will be obtained, include a copy of the form to be used for this purpose.
5. EXEMPTION FROM COMMITTEE REVIEW: In conformity with US Department of Health and Human Services regulations, certain low risk human subject research may be excluded from the requirements of full Human Subjects Research Committee review. The research may be exempted if it includes activities that fall entirely within one or more of the following categories:
COMMON EDUCATIONAL RESEARCH: research conducted under the close supervision of faculty and required to meet course requirements. Exempt research would include research involving procedures that involve no physical, mental, or psychological risk and/or hazard. For example, exempt research would include educational research conducted in established or commonly accepted educational settings involving normal educational practices such as research involving regular or special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management schedules. Other examples would include research on individuals’ or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, in which the investigator does not manipulate the subjects' behavior, and research will not involve even minimal risk to subjects.
EDUCATIONAL TESTS: research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. If more than one educational test is administered per course or research study, only one request form listing each assessment needs to be completed.
SURVEY/INTERVIEW RESEARCH: research involving survey or interview procedures, except where responses are recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and (1) the subjects’ responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing or employability; and (2) the research deals with sensitive aspects of the subjects’ own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
OBSERVATIONAL RESEARCH: research involving the observation (including observation by participants) of public behavior, except where observations are recorded in such a manner that the subjects can be identified, directly or through identifiers linked to the subjects; and (1) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; or (2) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
STUDY OF EXISTING DATA: research involving the collection or study of existing data, documents, or records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information was recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
COMMON PHYSIOLOGICAL AND MEDICAL RESEARCH: research in any one of the following categories involving not even minimal risk:
a. collection of hair and nail clippings in a non-disfiguring manner; deciduous teeth and permanent teeth if patient care indicates a need for extraction.
b. 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.
c. recording of data from human subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice, including 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 (e.g., x rays, microwaves).
d. 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.
e. voice recordings made for research purposes such as investigations of speech defects.
f. moderate exercise by healthy volunteers.
g. study of existing data, documents, records, pathological specimens, or diagnostic specimens.
6. RESEARCH PROTOCOL: A concise but complete narrative description must be included. This narrative should include the following:
a) a concise statement of objectives (including therapeutic intent, if any) of the study.
b) the specific selection procedures which will be used to select subjects, including an enumeration of criteria for eligibility.
c) the total duration of participation for each subject.
d) a description of compensation, remuneration, or other rewards provided subjects for their participation.
e) a description of the expected benefits, if any, which may reasonably be expected to accrue to individual participants (apart from (d) above).
f) explicit description of the methods, procedures, and design of the study, including a review of all treatments, tests, or other procedures involving the human and/or subjects.
g) identification of any potential risks and hazards to subjects associated with participation in the study, including both physical and mental or psychological risk and hazard.
h) a description of procedures which will be followed to minimize or reduce the potential risks and hazards associated with the study and identification of the provisions which will be made to provide care, treatment, or remedy for injury resulting from participation in the study.
i) a description of the procedures which will be followed to secure the legally effective voluntary informed consent of human participants and/or their legal representatives.
Which types of research may be exempt from review by the IRRB? (Please note that the IRRB should be notified about the research even if the research is exempt from review.)
Please see no. 5 above.
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