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IRB Application Guidelines

IRB Application Guidelines

IRB Application Guidelines

The guidelines below are keyed to each item in the application form. Those items that are self explanatory are not discussed.

A. Directions for Item #6: "EXEMPT/EXPEDITED REVIEW"

When reviewing applications submitted for either exempt or expedited review procedures, the IRB first assesses whether there is risk to human subjects and whether the research protocol is eligible for exempt or expedited status under the federal guidelines listed below. Special attention is given to protecting adequately the rights and welfare of certain vulnerable populations: children, prisoners or other institutionalized populations, pregnant women, physically and/or mentally handicapped/disabled persons, economically or educationally disadvantaged persons, fetuses, and subjects in studies of human in vitro fertilization.

In responding to this item, you first determine under what criterion your study qualifies for exempt or expedited review, and then check the appropriate place on the application. Then you provide a rationale, citing the paragraph(s) that apply to your study. For example, "Subjects will not be exposed to stress or risk greater than those normally experienced in a typical educational setting. According to the guidelines, this research may be expedited according to item (i) on page 3 of the guidelines (research on individuals...such as studies of...cognition... where the investigator does not manipulate the subjects' behavior and the research will not involve stress to the subjects)."

EXEMPT:Unless the subjects are members of a vulnerable population, a researcher may request exemption from full IRB review if the project involves no more than minimal risk and only involves subjects in one or more of the following categories:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if the information taken from these sources is recorded in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects and if any disclosure of the human subjects' responses outside the research cannot place subjects at risk of criminal or civil liability or be damaging to subjects' financial standing, employability, or reputation.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that does not meet exemptions (1) and/or (2) above is exempt if:
    1. the subjects are elected or appointed public officials or candidates for public office or
    2. federal statutes require, without exception, that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter (pending implementation by the U.S. Office of Science and Technology).
  4. 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.
  5. 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:
    1. procedures for obtaining benefits or services under those programs,
    2. possible changes in or alternatives to those programs or procedures; or
    3. possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without chemical additives are consumed or if food is consumed that contains a food additive, agricultural, chemical, or environmental contaminant at or below a level and for a use found to be safe by the Food and Drug Administration, the Environmental Protection Agency, or the Food Safety and Health Inspection Service of the U.S. Dept. of Agriculture.
  7. Research involving observation of public behavior of children is exempt when the investigator(s) do not participate in the behavior being observed. Specific information on restrictions on research with children is available in 45 CFR 46, Subpart D.

NOTE: PRISONERS:The Federal Guidelines are specific and restrictive about the type of research projects that may use prison populations as subjects. Investigators should be aware that some types of projects may be forbidden by law and others may be approved only after intent has been published in the Federal Register. Specific information on these restrictions is available in 45 CFR 46, Subpart C.

NOTE: MSU STUDENTS:While the MSU IRB has not identified MSU students as a vulnerable population, the IRB is especially concerned that the anonymity or confidentiality of MSU student data is maintained and that the voluntary nature of student participation is protected.

EXPEDITED:The IRB may also use the expedited review procedures to review minor changes in a previously McNeese State University approved proposal during the period for which approval is authorized. A researcher may request an expedited review of his/her project if it involves no more than minimal risk and only involves human subjects in one or more of the following categories:

  1. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.

  2. 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.

  3. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the 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 visible range (for example, x-rays, microwaves).

  4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

  5. 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.

  6. Voice recordings made for research purposes such as investigations of speech defects.

  7. Moderate exercise by healthy volunteers.

  8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

  9. Research on individuals or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

  10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

B. Directions for Item #8f: SUBJECT POPULATION: Advertising

The advertisement should be limited to:

  1. The name and address (or phone) of the investigator

  2. The purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study

  3. A straightforward and truthful description of the benefits (e.g. payments or free treatment) to the subject from participation in the study

  4. The location of the research and the person to contact for further information

Although all advertisements are limited to the above four items, all must contain items 1 and 2 as a minimum. No claims should be made, either explicitly or implicitly, that any drug, device, treatment, or procedure is safe or effective for the purposes under investigation, or that it is in any way equivalent or superior to any other.

Researchers may not advertise that they have IRB approval of their research protocol.

C. Directions for Item #8g: SUBJECT POPULATION: Anonymity and Confidentiality

Investigators should be careful to distinguish between anonymity and confidentiality. IRB defines these terms as follows:

Anonymity means that no one, including the principal investigator, is able to associate responses or other data with individual subjects. Investigators may promise anonymity only under this condition.

Confidentiality means that although subjects' identities may be known to the principal investigator and a limited research staff, subjects' identities will be kept confidential and that reports of research findings will not permit associating subjects with specific responses or findings. For confidentiality, investigators must provide adequate procedures to guarantee confidentiality, including security for data which contains subject identifiers.

In addition, Louisiana law (H 1055) specifies that "confidential data" pertaining to public health epidemiological information may be used only in the aggregate and only for statistical, scientific and medical research purposes relating to the cause or condition of health. The law provides civil penalties for violations of this confidentiality. This confidential data is protected from subpoena.

The Department of Justice and the Department of Education's National Center for Educational Statistics also protect certain data by statute (see 42 U.S.C. 3789g(a) and 20 U.S.C. 1221e-1).

D. Directions for Item #9: VOLUNTARY PARTICIPATION/INFORMED CONSENT

Where consent is required a copy of each consent form that the participants have signed should be given to them to keep for their records. Example consent forms are attached as appendices to this document. Click here for PDF or MS Word forms 

The following documentation about informed consent should be included on (or with) the IRB Application for Review form:

  1. Explanation of how subjects are told about the project and how they are invited to participate;

  2. Written statement of the oral information or a copy of the written information given to the subjects and/or their representatives to enlist their voluntary participation in the study (especially important in securing the assent of minors);

  3. Copies of the written consent form and/or parental consent form (parental consent forms are required if research subjects are minors).

Researchers may not state in informed consent documents that they have IRB approval.

The methods used to obtain consent may vary. They should be designed to fit the research setting -- the nature of the research, the magnitude of the risks involved, the nature of the subjects who will participate, and the requirements of applicable policies, laws, and regulations. In most cases a written consent form is used. A signed consent is necessary in most proposals which require expedited and full review. In some types of research where the participant's identity must be protected a letter of information alone should be given to the participants. In many exempt-from-full-review proposals, the consent to participate is understood when the participant accepts and completes the instrument but a letter of information about the study should be made available to the participant. In all cases, written or oral, the basic elements necessary for legally effective consent include:

  1. A fair explanation of the procedures to be followed and their purposes, including identification of any procedures which are experimental, presented in non-technical and simple language understandable by those anticipated to serve as subjects;

  2. A description of any attendant physical or emotional discomforts and risks reasonably to be expected, if any;

  3. A description of any benefits reasonably to be expected, either for the subject or for society;

  4. A disclosure of any appropriate alternative procedures that might be advantageous for the subject (normally applicable only in therapeutic research);

  5. An offer to answer any inquiries concerning the procedures;

  6. An instruction that (a) participation is voluntary and (b) the individual is free to withdraw his or her consent and to discontinue participation in the project or activity at any time without prejudice to the subject.

  7. A statement indicating how the subjects' privacy and/or confidentiality will be protected. If the researcher promises anonymity, protections for anonymity must be addressed.

If a written informed consent document is used, the following should be included as well:

  1. A phone number of an individual who will be available to answer inquiries from subjects;

  2. A statement that subjects may have a copy of the consent form;

  3. A written version of the explanation given to subjects of procedures to be followed if this explanation does not appear on the consent form.

If the subject is a minor, provisions should be made for obtaining parent's or guardian's informed consent (signature), and the minor's verbal assent will also be obtained when feasible (see below).

If there is more than minimal risk of injury to the subject(s) a statement must appear in the consent form that indicates:

  1. Who will be responsible for providing emergency medical treatment in the event of injury and

  2. Who will be responsible to pay for this treatment

The consent form should not include any exculpatory language whereby the subject waives, or appears to waive, any of his/her legal rights, including any release of the institution or its agents from liability for negligence.

As a general rule, the IRB does not approve research that makes use of minors or those with diminished capacity if the research and its objectives can be met by using adults and/or those without diminished capacity. When the research can only appropriately be conducted using minors or those with diminished capacity, special considerations are given to risk and to consent procedures. In determining whether children or those with diminished capacity are capable of assenting, MSU IRB will take into account the ages, maturity, and psychological state of the subjects.

Investigators should be aware that there are several options for obtaining consent for the participation of children. Among these options are:

  1. Representative consent only (that is, consent by the subject's representative in an institutional setting, e.g. nursery school, school, hospital, park district);

  2. Representative consent plus information to parents;

  3. Information to parents plus consent of parents (oral or signed).

Researchers should not assume that it is best to "go the full route" toward parent information/consent in all cases. With the intention of making projects less cumbersome for the researcher, the parents, and the institutional representatives, the IRB supports the simplification of consent procedure whenever justified.

The more unusual the research procedures for a given setting in comparison to the usual and expected activity in which the child engages, the more information needs to be conveyed to parents and the greater the formality needed in the consent process. The more similar the research procedures are to experiences usually encountered by subjects in designated settings (school, hospital, park district) the more likely the IRB will accept a less elaborate consent procedure.

E. Directions for Item #10: "RISK/BENEFIT RATIO"

The RISK/BENEFIT concept is discussed on the application form, but the following information should be noted:

RISK:Researchers should not assume that a survey which involves no physical activity for the subject is risk free. At the least, the subject is inconvenienced, commits time to the project, and may reveal private information to the investigator. Violation of confidentiality is a risk.

As part of its overall risk assessment, the IRB will review the questionnaire and other data-gathering tools to determine whether answering or contemplating answers to the questions could cause psychological discomfort to the subject (renewal of painful memories, admission of socially unacceptable feelings or behavior, etc.). These psychological effects are considered a risk to the subject.

BENEFITS:The investigator should consider benefits of the research project both to the individual subject and to society as a whole.

F. Directions for completing Item #11:" Checklist"

The checklist is fairly self-evident; it specifies the items that must be included in a complete application. Typically, researchers most commonly forget to include copies of their data collection tools. These are needed so that the IRB may make a fair and complete evaluation of the research project. Another item commonly overlooked is the letter from the supervising faculty member for student proposals. It is not sufficient that the supervising professor merely sign the form. Researchers often fail to justify their requests for exempt or expedited status in item 5. Finally, researchers do not always provide a full and complete proposal. Often, the purpose of measures or the design of the study is not clear from the information on the form. The Board members will review the proposal in order to understand the project more clearly. The Board members will also read over the proposal to be sure that all measures are included.

Adapted from UL Lafayette 04/02/01