Human Subjects Institutional Review Board (HSIRB) Policy

Purpose

McNeese State University established a Human Subjects Institutional Review Board (HSIRB) in compliance with the Protection of Human Subjects Code of Federal Regulations (45 CFR 46). The HSIRB ensures that all human subjects used in research, training, experimentation, or instruction at McNeese State University are afforded the rights and protection from risk guaranteed by 45 CFR 46.

Human Subjects Institutional Review Board

McNeese State University’s HSIRB assures that research involving human subjects is done ethically. To this end, the principles and applications discussed in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979) are applied to guide researchers in formulating informed consent, assessing risks and benefits, and selecting subjects. The principles of respect for persons, beneficence, and justice will prevail in HSIRB reviews of research involving human subjects.

All individuals conducting research involving human subjects must have their proposed research studies reviewed. Any McNeese State University faculty member, unclassified staff person, or other personnel performing, advising, or supervising research involving human subjects must comply with all McNeese State University HSIRB requirements and ensure that the students involved comply with the same requirements.

The HSIRB is appointed by the provost and consists of:

• The chairperson;
• A faculty member from each of the following areas: agriculture, biology, business, education, graduate studies, liberal arts, nursing, and psychology; and
• One member not affiliated with McNeese State University and not an immediate family member of a person affiliated with the University.

The responsibilities of the HSIRB are:

• To advise the University administration on all matters regarding human subjects’ rights and welfare during research; and
• To ensure University compliance with all applicable federal, state, and University policies and regulations regarding the use of human subjects.

The functions of the HSIRB are:

• To authorize the use of human subjects for research, teaching, training, and experimentation when required after reviewing the human subjects use protocol application;
• To prepare and submit all appropriate evaluation forms to the Office of Research and Sponsored Programs;
• To make recommendations to the administration regarding any aspect of the University’s human subjects use program; and
• To review any concerns involving the use of human subjects at the University.

Required Training for Researchers

All researchers involved in research with human subjects must complete a CITI Program training module about human subjects protection, either “Biomedical Comprehensive” or “Social/Behavior/Educational Comprehensive” depending on the discipline of the research. After completing the module, researchers can download a certificate of completion to submit with an HSIRB application. This certificate constitutes adequate documentation of training in the protection of human research.

General Guidelines

Exempt/Expedited/Full Review

In keeping with a proportionate approach to research ethics review, the level of HSIRB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (exempt/expedited review); the higher the level of risk, the higher the level of scrutiny (full review).

When reviewing applications, the HSIRB assesses whether there is risk to human subjects and whether the research protocol is eligible for exempt or expedited status (see this flowchart). Special attention is given to protecting 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.

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 laws may prohibit some types of projects, and others may be approved only after the intent has been published in the Federal Register. Specific information on these restrictions is available in 45 CFR 46, Subpart C.

Students: While the HSIRB has not identified McNeese students as a vulnerable population, the HSIRB expects researchers to maintain the anonymity or confidentiality of student data and to protect the voluntary nature of student participation.

Exempt Review

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

1. The research is conducted in established or commonly accepted educational settings, involving normal educational 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.
2. The research involves educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior. The information taken from these sources will be recorded in such a way that subjects cannot be identified, either directly or through identifiers linked to the subjects. Any disclosure of the subjects’ responses outside the research cannot create a risk of criminal or civil liability or be damaging to subjects’ financial standing, employability, or reputation.
3. The research involves 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:
   • The subjects are elected or appointed public officials or candidates for public office; or
   • 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. The research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources should be publicly available, or the investigator should record information in such a way that subjects cannot be identified, either directly or through identifiers linked to the subjects.
5. The research and demonstration projects are conducted by or subject to the approval of department or agency heads and are designed to study, evaluate, or otherwise examine:
   • Procedures for obtaining benefits or services under those programs;
   • Possible changes in or alternatives to those programs or procedures; or
   • Possible changes in methods or levels of payment for benefits or services under those programs.
6. The research involves 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 deemed safe by the Food and Drug Administration, the Environmental Protection Agency, or the Food Safety and Health Inspection Service of the U.S. Department of Agriculture.
7. Research that involves observing the 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.

Expedited Review

The HSIRB may use 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 their 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 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 skin 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);
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 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 teeth scaling and the process adheres to 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, 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; and/or
10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

Advertising

The advertisement should be limited to:

1. The name and address (or phone number) of the investigator;
2. The purpose of the research and a summary of 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; and
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 at 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 HSIRB approval of their research protocol.

Anonymity and Confidentiality

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

• Anonymity means that no one, including the principal investigator, can 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, their identities will be kept confidential and reports of research findings will not permit associating subjects with specific responses or findings. Investigators must provide procedures that guarantee confidentiality, including security for data that contains subject identifiers.

In addition, Louisiana Revised Statute § 40:3.1 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 protects confidential data from subpoenas and provides civil penalties for violations of confidentiality.

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)).

Voluntary Participation and Informed Consent

Participants should receive a copy of each consent form they sign to keep for their records.

The following documentation about informed consent should be included on (or with) the HSIRB 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); and
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 HSIRB approval.

The methods used to obtain consent may vary and 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. A signed consent is necessary in most proposals that 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 study’s procedures and their purposes, including any experimental procedures, presented in simple, non-technical language that potential human subjects can easily understand;
2. A description of any physical or emotional discomforts and risks to be expected, if any;
3. A description of any benefits 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. A statement that (a) participation is voluntary and (b) the individual is free to withdraw their consent and to discontinue participation in the project or activity at any time without prejudice to the subject; and
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. The 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; and
3. A written explanation of procedures to be given to subjects if this explanation does not appear on the consent form.

If the subject is a minor, researchers should make provisions to obtain a parent or guardian’s informed consent (signature). Researchers will also obtain the minor’s verbal assent when feasible (see below).

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

1. Who will provide emergency medical treatment in the event of injury; and
2. Who will pay for this treatment.

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

As a rule, the HSIRB 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 assent, the HSIRB will consider the ages, maturity levels, and psychological states of the subjects.

Investigators have several options for obtaining consent for the participation of children, including:

1. Representative consent only (that is, consent by the subject’s representative in an institutional setting (e.g., nursery school, school, hospital);
2. Representative consent plus information to parents; and/or
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. To make projects less cumbersome for the researcher, parents, and institutional representatives, the HSIRB supports simplifying consent procedures when justified.

The more unusual the research procedures are compared to the child’s usual and expected activities, 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 (e.g., school, hospital, park district), the more likely the HSIRB will accept a less elaborate consent procedure.

Risk/Benefit

The risk/benefit concept is discussed on the application form, but the following information regarding risk should be noted.

Researchers should not assume that a survey that 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 HSIRB will review the questionnaire and other data-gathering tools to determine potential types of harm, including:

1. Physical harm: Harm resulting from intervention to an individual’s body such as contact, the administration of any substance, or the requirement to accomplish specific movements or exercises.
2. Psychological harm: Harm resulting from the expression of negative feelings such as anxiety, stress, anger, fear, embarrassment, sadness, and hatred.
3. Social harm: Harm resulting from an individual’s loss of status such as employment, income, or reputation, or a breach of an individual’s rights such as privacy or confidentiality.

Review Procedures

The HSIRB looks at four principal issues when reviewing a proposal:

1. Are the rights of human subjects safeguarded?
2. Does the proposal ensure that the University meets relevant federal guidelines?
3. Do the procedures cause the least amount of risk necessary?
4. Are the procedures and design sufficiently effective to justify involving human subjects?

Each proposal must detail the measures taken to protect the confidentiality and privacy of the subjects. The depth to which the HSIRB examines proposals depends on the research question, subjects, and/or methods. Working with individuals at special risk or using unusually invasive procedures requires more extensive justification.

The federal government recognizes three categories of research proposal review: full reviews, expedited reviews, and exempt reviews (in this case, exempt means “exempt from full review”). Exempt reviews are conducted by the HSIRB chair or an appointed HSIRB member rather than by the full board. Expedited reviews are conducted by a two-person subcommittee instead of the entire HSIRB.

Researchers applying for exempt or expedited review must submit the completed HSIRB application, including informed consent forms, questionnaires, tests, other data collection tools to be used, and the full research proposal. If the research is not eligible for exempt or expedited review, the investigator must submit the completed HSIRB application form, including all informed consent forms, questionnaires, tests, other data collection tools to be used, and an abstract of the research proposal.

HSIRB approval is for one year only, unless the risk level, subject population, or research protocol has changed. Any change in the risk level, subject population, or research protocol requires immediate HSIRB review. For any project in which the use of human subjects extends beyond one year, the investigator must apply for renewal one month before the expiration date. Applications for renewal must include the last two signed consent forms from subjects and stipulate the following:

1. The human subject protocol is the same as in previous studies;
2. There have been no ill effects suffered by the subjects due to their participation in the study;
3. There have been no complaints by the subjects or their representatives related to their participation in the study; and
4. There has been neither a change in the research environment nor new information that would indicate greater risk to human subjects than that assumed when the protocol was initially reviewed and approved.

Complaints or ill effects that result from the research must be reported and sufficiently described for HSIRB review as soon as possible after occurring.

Outside Requests for Research

If an individual or group from another institution requests to conduct research on McNeese State University faculty, staff, and/or students, they must submit their request and the institutional research board approval documentation from their institution to the director of institutional research at ir@mcneese.edu. The director will coordinate communication between the researcher(s) and relevant individuals at McNeese.

Communication

This policy is distributed via the University Policies webpage.