Human Research Subjects Protection (A-62)

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Human Research Subjects Protection (A-62)

Original Implementation: April 30, 2002
Last Revision: October 30, 2007

I. Introduction

Stephen F. Austin State University (SFASU) is a dynamic, learning-centered university dedicated to student success, vital community outreach programs, and the advancement of knowledge and creativity. While fulfilling this mission, the university seeks to protect the welfare of every person who may be involved in research and training projects.
The university bears the responsibility for complying with federal, state, and local laws and gives assurance that it will comply with the Department of Health and Human Services (DHHS) regulations for the Protection of Human Subjects in Research (45 CFR 46, as amended), which include additional protections for specific groups involved in research, such as pregnant women, children, prisoners, and persons confined to facilities where the individual's freedom of movement might be restricted.
Therefore, the university has set forth the following policy and principles, which should be interpreted in the context of the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"), and in the Code of Federal Regulations (CFR).

II. Institutional Policy

It is the policy of the university that all research and research-related activities, in which humans are used as subjects, shall be subject to review under current DHHS regulations by an Institutional Review Board (IRB).
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
This policy does not apply to program assessment or evaluation, journalistic inquiries, and activities designed to gather information about specific topics which are not generalizable beyond the scope of the investigation. (See also Section VI. Exempted Research)
Except for research in which the only involvement of human subjects is in one or more of the categories exempted by this policy, all research projects involving human subjects, and all other activities which even in part involve such research must be approved by the IRB acting in whole or in part if:

the research is sponsored by this institution; or
the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities (this includes student research under the direction of a faculty sponsor); or
the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution; or
the research involves the use of this institution's non-public information to identify or contact human research subjects or prospective subjects; or
the research is conducted by or under the direction of any employee or agent of another institution but who is using research subjects associated with this institution or using facilities or property belonging to the university under written agreement with appropriate university officials.

III. Guiding Principles to the Ethical Use of Human Research Subjects

Since the participation of humans in research projects may raise fundamental ethical and civil rights questions, SFASU makes no distinctions between funded and unfunded projects, sponsored and unsponsored projects, or between projects carried out by students, faculty, or other university employees, on-campus or off-campus.
All activities involving humans as subjects must provide for the safety, health and welfare of every individual. Rights, including the right to privacy, must not be infringed.
The direct or potential benefits to the subject or the importance of the knowledge to be gained must outweigh the inherent risks to the individual.
Participation in projects must be voluntary, and informed consent must be obtained from all subjects, unless this requirement is specifically waived by the Institutional Review Board (IRB) as provided in 45 CFR 46.116(c). To obtain the subject's informed consent, the researcher must use methods that are in accordance with the requirements of 45 CFR 46.116 and 45 CFR 46.117 and adequate and appropriate to the risks of the project.
Whenever possible, consent should be obtained from the participants themselves. If a subject is not legally or physically capable of giving informed consent, a legally authorized representative may do so.
An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to withdraw from a research project at any time or can refuse to participate; in either case, the subject must not experience loss of benefits to which he or she would otherwise be entitled. Further, a subject has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information, and to be free from undue embarrassment, discomfort, anxiety, and harassment.
Safeguarding information about an individual that has been obtained in the course of an investigation is a primary obligation of the investigator. When the investigator is a student, responsibility for the conduct of the research and the supervision of human subjects lies with the faculty sponsor.
Projects are reviewed by the IRB as set forth in this policy. All members of the university community involved in investigation are responsible for continual monitoring to assure compliance of their research with these principles.
No individual involved in the conduct and/or supervision of a specific project can participate in IRB review, except to provide information.
A second review may be required if: a) a long interval has elapsed between the initial IRB review and the beginning of the project; b) the proposed effort is in a rapidly changing scientific area; or c) the principle investigator wishes to change procedures after the proposed project has been reviewed by the IRB.
All approved research is subject to continuing review at intervals appropriate to the degree of risk, but not less than once per year.
In all cases, the investigator should show practical regard for the SFASU community, recognizing that violations of the ethical and legal standards incorporated in this statement of principles (for example, concerning confidentiality, informed consent, debriefing, and regard for the health, safety and welfare of all human subjects) could impugn the investigator's own name and reputation and the reputation of the university. The investigator does not abdicate ethical and legal responsibility merely by complying with this protocol. It is always the responsibility of the investigator to obtain clearance from the IRB prior to the initiation of any research activity involving the use of human subjects. Failure to do so may result in personal restrictions on the research activities of such individuals, as well as potentially endanger all federal funding to the university.
Involving human subjects in research will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained.

IV. IRB Membership and Institutional Responsibilities

SFASU has established an Institutional Review Board for the Protection of Human Subjects in Research (IRB) which has the responsibility and authority to review, approve, disapprove, or require changes in appropriate research activities involving human subjects.

The IRB shall have direct jurisdiction over all human subject research activities of SFASU faculty, staff, and students. The IRB shall have at least six members: one community representative not associated with the university, four faculty members knowledgeable about applicable laws and standards of professional conduct and practice in the use of human subjects in research, and one faculty member from a non-scientific department. All members are appointed by the president of the university for indefinite terms. The IRB chair is selected and appointed by the president of the university from among the faculty members on the IRB.

The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals shall have no voting rights.
Whenever possible, the chair of the IRB will be granted a one course release each semester in order to assure sufficient staff to support the committee’s review and recordkeeping duties.
The IRB will meet once each month or as needed with due regard for a thorough but speedy assessment of applications.
An expedited review procedure is possible for those applications which involve no more than minimal risk to subjects and also fall under one of the research categories eligible for expedited review or fall under the categories exempted by federal regulations. Final determination as to whether a specific project is eligible for expedited review can only be made by the IRB.
The department chair or director (or a designated faculty member responsible for preliminary IRB review) will be responsible for insuring that research by individuals (faculty, students, or employees) is conducted according to human subjects guidelines.
The IRB will weigh the following primary factors in making its determination:
1. That the rights and welfare of the subjects will be adequately protected. Each project will be scrutinized with the interests of the subjects foremost in consideration. No procedures shall be followed that would result in unnecessary or unacceptable risks to the subjects. Appropriate safeguards and emergency measures must be provided.
2. That the risks to the subjects are reasonable in relation to anticipated benefits. The project protocol will be evaluated to determine if the risks to subjects are reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. The IRB expects that human subjects will not be utilized in projects which are poorly designed. However, the responsibility for monitoring research design lies primarily with the appropriate department chair, division director, or faculty sponsor.
3. That the informed consent of subjects will be obtained by adequate and appropriate methods.
It is the responsibility of a faculty/staff member to monitor classroom projects of their students that involve human subjects, and to consult with the IRB on projects that involve human subjects.

V. Informed Consent

No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent must be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether or not to participate. Particular attention should be paid toward minimizing the possibility of coercion or undue influence.
The information given to the subject or to the subject's legally authorized representative must be in simple, easily understood language. If the subject population is not English speaking, the informed consent must be presented in whatever language is appropriate.
If the subject is a minor, written parental consent is required unless this requirement is waived by the IRB. A waiver of the written informed consent requirement in accordance with 45 CFR 46.116(c) will be granted only if the investigator can provide adequate justification for the request. In addition to obtaining parental consent, the investigator must obtain the assent of the child unless the child is incapable of giving assent and the IRB has waived the requirement.

NOTE: As defined by the General Counsel of SFASU, the legal age of consent (for research purposes) in the State of Texas is 18 years old.
No informed consent, whether written or oral, may waive or limit in appearance or in fact, the subject's legal rights, including any release of the institution or its agents from liability or negligence.
Specific requirements for informed consent and guidelines can be found on the Office of Research and Sponsored Programs (ORSP) web site at www.sfasu.edu/orsp.

VI. Expedited Review

DHHS regulations recognize that there are certain categories of research which involve procedures which pose no more than minimal risks to subjects and for which clear standards can be set. Accordingly, research projects which fall under one of the categories listed below will be eligible for expedited review. The research protocol will be reviewed by the IRB chair and/or one or more experienced IRB members selected by the chair. This group will exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.
`Listed below are six categories subject to expedited review. In addition, there are five categories subject to expedited review which involve medical, dental, and pharmacological research. Information on these five categories is available from ORSP. Expedited review will be given only for research protocols that fall under one of the following categories.
1. Minor modifications or additions to existing approved studies.
2. Research on individual or group behavior or characteristics of individuals (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior, game theory, and test development) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies, when the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
3. The study of existing data, documents, records, pathological specimens or diagnostic specimens.
4. Collection of data from voice, video, digital, or image recordings made for research purposes (e.g., investigations of speech defects).
5. Moderate exercise by healthy volunteers.
6. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice.

VII. Exempted Research

The university has adopted six categories of research as exempt from ongoing IRB review based upon DHHS regulations published in the Federal Register on January 26, 1981 and March 4, 1983.

It is the department chair's responsibility, in consultation with an IRB contact person as needed, to determine whether research projects fall within the following categories of exemption:

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on:
1. regular and special education instructional strategies; or
2. the effectiveness of or the comparison among instructional techniques, or curricula
Research involving the use of educational tests (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.
Research involving survey or interviewing procedures, EXCEPT where any of the following conditions exist:
1. responses are recorded in such a manner that the subjects can be identified, directly or through identifiers linked to the subject;
2. the subject's 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 subject's financial standing or employability;
3. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol; or
4. the research involves the use of children, minor age students, or other vulnerable groups as subjects.
All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.
Research involving the observation (including observation by participants) of public behavior, EXCEPT where any of the following conditions exist:
1. observations are recorded in such a manner that the subjects can be identified, directly or through identifiers linked to the subjects;
2. the observations recorded about the individual, if they become 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;
3. the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol; or
4. the research involves the use of children, minor age students, or other protected or vulnerable groups as subjects and the investigator is a participant in the activities being observed.
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 principle investigator(s) in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine:
1. programs under the Social Security Act, or other public benefit or service programs;
2. procedures for obtaining benefits or services under those programs;
3. possible changes in or alternatives to those programs or procedures; or
4. possible changes in methods or levels of payment for benefits or services under those programs.

VIII. Definition of Terms

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.
Human Subject means a living person about whom an investigator conducting research obtains a) data through intervention or interaction with the individual (e.g., surveys, interviews) or b) identifiable, private information (e.g., existing records).
Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided for specific purposes by an individual and which that individual can reasonably expect will not be made public (e.g., a medical record).
Minimal Risk means that the risks of harm anticipated in the proposed research are not greater in either probability or magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Informed Consent means the knowing, legally-effective consent of any individual or the individual's legally authorized representative. Such consent can be obtained only under circumstances that a) provide the prospective subject or representative sufficient opportunity to consider whether or not to participate, b) minimize the possibility of coercion or undue influence, and c) provide information about the research to the participants.
Legally Authorized Representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the research procedure(s) (e.g., the parent of a minor child).

Application procedures, explanation of IRB procedures and requirements for approval, and IRB forms are located on the ORSP web site at www.sfasu.edu/orsp.

Cross Reference: Ethical Principles and Guidelines for the Protection of Human Subjects in Research: The Belmont Report; Title 45, Part 46 of the Code of Federal Regulations, as amended.

Responsible for Implementation: President; Provost and Vice President for Academic Affairs

Contact for Revision: Associate Vice President for Graduate Studies and Research

Forms: None

Stephen F. Austin State University

Human Research Subjects Protection (A-62)