UPPS 02.02.03 - Protection of Human Research Subjects

POLICY STATEMENT

Texas State University is committed to upholding the highest ethical standards in research involving human subjects.

1. SCOPE

   1. All human research conducted by members of the Texas State University community, using university facilities or resources, or involving use or disclosure of identifiable private information created or maintained by the university, will be guided by the ethical principles found in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research’s report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”) and will be performed in compliance with applicable federal and state law.

2. ETHICAL PRINCIPLES

   1. Texas State is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the Belmont Report regardless of whether the research is subject to federal regulation, with whom it is conducted, or the source of support (i.e., sponsorship).

3. REGULATIONS AND PROCEDURES

   1. To fulfill this commitment, Texas State has developed and submitted to the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) a Federalwide Assurance (FWA) for the Protection of Human Subjects, following the terms of the FWA specified by HHS. In addition, Texas State has registered with OHRP an Institutional Review Board (IRB), established in accordance with and for the purposes expressed in 45 CFR 46. Researchers engaging in approved human subject research studies at Texas State are prohibited from disclosing to research participants any results from diagnostic tests related to their health.

   2. The FWA delineates the following concepts and procedures:

      1. institutional principles;

      2. applicability of the terms of the FWA;

      3. compliance with the federal policy for the protection of human subjects and other applicable federal, state, local, or institutional laws, regulations, and policies;

      4. use of written procedures;

      5. scope of the IRB’s responsibilities;

      6. informed consent requirements;

      7. requirement for assurances for collaborating institutions;

      8. written agreements with independent investigators who are not otherwise affiliated with the institution;

      9. the role of the institutional official;

      10. institutional support for the IRB;

      11. compliance with the terms of the assurance; and

      12. a program of training in the protection of human research subjects.

   3. At a minimum, all human subjects research performed at Texas State or using its resources will meet the following requirements:

      1. Respect for Persons

         1. Research protocols must say how subjects will be recruited.

         2. Subjects must freely agree to participate after receiving complete information about the research and its risks, potential benefits, and alternatives.

         3. Subjects must fully understand their rights, including the right to discontinue at any time without loss of otherwise available benefits.

         4. Vulnerable populations (fetuses, children, prisoners, those without decisional capacity, and those with economic or educational vulnerability) must receive special consideration and protection.

      2. Minimizing Risks and Avoiding Unreasonable Risks

         1. Research may not expose subjects to unreasonable risk of harm (whether physical, psychological, social, legal, or economic in nature).

         2. The probability and magnitude of possible harm must be reasonable in relation to the anticipated direct or indirect benefits of participation in any research project.

         3. Identifiable risks that practicably could be avoided without undermining legitimate research objectives must be eliminated.

         4. Sound research designs that minimize risks and maximize benefits of participation must be used.

      3. Equitable Recruitment and Selection of Subjects

         1. Research protocols must promote equitable recruitment and selection of subjects, as applicable, with the overall goal of ensuring fair distribution of the burdens and benefits of research. Subjects should be selected for participation for reasons directly related to the questions under study.

         2. Subjects must not be induced to participate in research projects by means or under circumstances that may overcome the voluntary nature of their participation. Enrollment into a study may never be the product of coercion or undue influence.

      4. Investigator Qualifications and Responsibilities

         1. Research must be performed or closely supervised by individuals qualified by training and/or experience to minimize risks and otherwise protect subjects. When research is performed by students, supervising faculty members will be responsible for ensuring that the students are qualified to conduct the research and to safeguard subject rights and welfare.

         2. Primary responsibility for research with human subjects is vested in the principal investigator (PI) conducting a study. This includes responsibility to comply with the laws, regulations, and institutional policies that regulate research. Others engaged in the conduct of the research such as co-investigators and research staff share this responsibility. The PI must assure that all study team members are appropriately trained to the protocol or study procedures.

         3. Investigators must follow institutional policy for initial submission and approval of proposals, continuing review, amendment to the study, and reporting of unanticipated problems and adverse events. Investigators are responsible for informing IRBs of existing knowledge of any risks involved in participating in a study at the time of initial review and for apprising IRBs of any new risks identified during the course of the study.

         4. Investigators must explain to subjects, prior to their participation in research projects, the objectives of the research, the procedures to be followed, the risks and potential benefits of participation, and alternatives to participation, as well as funding sources and conflicts of interest, where applicable. Individuals may participate as a subject only after voluntarily consenting to participation and must be made aware of their right to withdraw without risking benefits or services to which they otherwise would be entitled. In addition, in most cases, investigators will obtain the assent of subjects, such as minors or mentally incapacitated individuals, before participation. Investigators are responsible for ascertaining that subjects consenting or assenting to research actually comprehend the information provided to them before enrolling them in studies and that subjects are aware of their right to ask questions about the research before, during and after participation. IRBs may waive some of these consent requirements only in limited circumstances.

         5. Investigators must respect the privacy of subjects participating in their protocols and implement safeguards to protect the confidentiality of data gathered for the research.

   4. All federally funded research (excluding the Department of Justice) covered by this policy will be reviewed and approved by the IRB, except for those categories specifically exempted or waived by federal regulation, as outlined in 45 CFR, Section 46.104 (d)(1-8) and Section 46.101 (i). The involvement of human subjects in federally funded research covered by this policy will not be permitted until the IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject’s legal representative, as required by federal regulations (45 CFR, Sections 46.111, 46.116 and 46.117). All research sponsored by the Department of Justice will be subject to the regulations set forth by 28 CFR 46.

   5. IRB approval for all federally sponsored research involving human subjects will be submitted to the OHRP or the appropriate federal department or agency. Compliance will occur within the time and in the manner prescribed for forwarding certifications of the IRB review to HHS or other federal departments or agencies for which this policy applies. As required by 45 CFR, Section 46.119, in the event research is undertaken without the intention of involving human subjects but it is later proposed to involve human subjects in the research, the research shall just be reviewed by the IRB. Human research involvement will not be permitted until IRB approval is received by the appropriate federal department or agency.

   6. As the institutional official named in the FWA, the Chief Operating Officer, Division of Research is responsible for monitoring amendments to these regulations and procedures and for proposing revisions to the FWA. Proposed amendments to the FWA are subject to approval of the vice president for Research.

   7. These regulations, procedures, concepts, and other relevant communications will be published on the IRB website. Maintenance, revisions, and updates of this material will be the responsibility of the Division of Research.

   8. Research Testing and Clinical Laboratory Improvement Amendment (CLIA) requirements serve to ensure the accuracy and reliability of patient results. CLIA applies to all laboratories that examine “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” CLIA regulatory requirements vary according to the kind of tests each laboratory conducts and whether the results are made available in such a way as to make that testing facility a “laboratory” under the CLIA regulations. Tests are categorized as waived, moderate complexity, or high complexity. Texas State allows research testing on human specimens that do not report patient-specific results in accordance with CLIA regulations. An example of a non-patient specific result would be “10 out of 30 participants were positive for gene X.” The result in this example is a summary of the group data and is not indicative of an individual’s health.

      IRBs do not generally assess whether CLIA would apply to a given testing situation, and they do not have authority to determine CLIA applicability on behalf of the CLIA program. The federal regulations that govern human research subject protection are unrelated to the CLIA requirements, and the IRBs that consider human research subject protection considerations would not be expected to consider the applicability of the CLIA regulations. The state agency maintains the certificate information for new and existing laboratory providers within their state and is responsible for lab inspections. The CLIA State Agency Contacts list can be used to access CLIA state contacts. Questions about the CLIA program should be submitted to LabExcellence@cms.hhs.gov.

   9. Texas State IRB reviews all non-Food and Drug Administration-regulated and Food and Drug Administration-regulated protocols within its current committee’s expertise. An external IRB may be utilized and serve as IRB of record if Research Integrity and Compliance determines one of the following is applicable:

      1. Regulations 45 CFR 46.114 for cooperative research are applicable.

      2. Complexity of project requires a level of expertise that the current board lacks or Research Integrity and Compliance is unable to secure a consultant to ensure protection of participants.

      3. High risk project determined by the IRB chair in consultation with Research Integrity and Compliance places the institution at risk.

      4. Quality improvement monitoring reviews may occur to assure that the rights and welfare of human subjects are being protected in accordance with applicable regulations, policies, and guidelines.

      5. Noncompliance issues that are determined by the IRB to be serious or ongoing may result in actions to include suspension or termination.

4. APPLICABILITY

   1. This policy applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:

      1. the research is sponsored by the university;

      2. the research is conducted by or under the direction of any employee or agent of the university in connection with their institutional responsibilities;

      3. the research is conducted using any property or facility of the university;

      4. the research involves the use of the university’s non-public information to identify or contact human research subjects or prospective subjects; or

      5. the research is conducted to support a student thesis or dissertation.

   2. All human subject research that is exempt under 45 CFR, Section 46.104 (d) (1-8) or 46.101 (i) will be conducted in accordance with:

      1. the Belmont Report;

      2. the university’s administrative procedures to ensure valid claims of exemption; and

      3. Research Compliance and Integrity documentation of such activities.

5. REVIEWERS OF THIS UPPS

   1. Reviewers of this UPPS include the following:

      Position	Date
      Associate Vice President of Operations	October 1 E5Y
      Director, Research Integrity and Compliance	October 1 E5Y
      Chair or Co-Chairs, Institutional Review Board	October 1 E5Y

6. CERTIFICATION STATEMENT

   This UPPS has been approved by the following individuals in their official capacities and represents Texas State policy and procedure from the date of this document until superseded.

   Associate Vice President of Operations; senior reviewer of this UPPS

   Vice President for Research

   President