Faculty Handbook
The University has adopted the following policy on the supplementation of faculty salaries from research contract funds. This policy is based on a statement of the committee on Sponsored Research of the American Council on Education which reads in part as follows:
"...universities should avoid extra compensation (compensation above the full-time base salary) for work on special projects during the academic year. The base university salary should include compensation for all university duties (for example teaching, research, administration, intrauniversity consulting). Exceptions to this rule should be made only for very compelling reasons and in unusual cases. Whenever it is not feasible for the salaries of faculty members to be converted to a 12-month basis, the percent of effort devoted to sponsored projects should be determined for the academic year and the university should request reimbursement for the corresponding portion of each salary."
Very few cases exist in which salaries are continuously augmented during the academic year by research funds. In some of these cases, severe hardship has resulted to the faculty members whose income was contingent on the continuation of a research contract. The policy is intended to govern the concept of continuous supplementation and does not preclude occasional supplementation, where such compensation falls within the policy of the granting agency. This policy is generally that of government granting agencies, with but a few exceptions. It is and has been the policy of the University to request reimbursement for salary cost as a part of research grant proposals.
According to UH Board of Regents Policy 49.02 (October, 1987), faculty research may be subsidized by and performed with University research agencies or private organizations; however, such research, consulting, concertizing or other work must not interfere with primary University duties. (See also Dual Employment 49.04 and Consulting Policy SAM 02.A.08).
Employees of the University of Houston System shall adhere to and be furnished a copy of the Statutory Standards of Conduct (Section 572.051, Texas Government Code) and avoid conflicts of interest, generally described as the use of one's university employment to obtain unauthorized privileges, benefits or things of value for oneself or others, including the following:
1. No employee shall solicit, accept or agree to accept any privilege, benefit or thing of value for the exercise of his/her discretion, influence or powers as an employee, except as is allowed by law.
2. No employee shall accept any privilege, benefit or thing of value that might influence him/her in the discharge of his/her duties as an employee.
3. No employee shall use his/her position to secure special privileges or exemptions for himself/herself or for others, except as is allowed by law.
4. Any employee who is an officer, agent, employee or member of, or owns a significant interest in any entity doing business with any component of the UH System must disclose such relationship in writing to his/her immediate superior.
5. No employee shall accept employment or engage in any business or professional activity which foreseeably might require or induce him/her to disclose confidential information acquired by reason of his/her University position.
6. No employee shall disclose confidential information gained by reason of his/her University position nor shall he/she otherwise use such information for his/her personal gain or benefit.
7. No employee shall transact any business for the University with any entity of which he/she is an officer, agent, employee or member or in which he/she owns a significant interest.
8. No employee shall make personal investments in any enterprise which foreseeably might create a substantial conflict between his/her private interests and the University's interests.
9. No employee shall accept other employment which might impair his/her independence or judgment in the performance of his/her University duties.
10. No employee shall receive any compensation for his/her services from any source other than the State of Texas except as is allowed by law.
11. No employee who exercises discretion in connection with contracts, purchases, payments, claims or other pecuniary transactions shall solicit, accept, or agree to accept any benefit from a person or entity the employee knows or should know is or is likely to become financially interested in such transactions.
Failure of an employee to comply with the foregoing shall constitute grounds for discharge or other disciplinary action.
The integrity of the research process is an essential aspect of a university's intellectual and social structure. Research is defined as all research, scholarly, and creative activities that support the intellectual endeavors of the University. Although incidents of misconduct in research may be rare, those that do occur threaten the entire research enterprise. Ethical codes govern the protection of human subjects and the welfare of animals and ensure compliance with specific terms or conditions of an award.
The integrity of the research process must depend largely upon self-regulation. Formalization of the rights and responsibilities underlying the methods used is imperative in the research process. The following policy on ethical responsibilities in conducting research is directed toward preserving the integrity of the research process at the University of Houston-Clear Lake.
It is the responsibility of UH-Clear Lake to foster a research environment that encourages ethical conduct in all research and that deals forthrightly with possible misconduct associated with research, especially when funds have been provided or requested for the research. Any failure to comply with our assurance to funding agencies and the requirements of Federal regulations may result in enforcement action against UH-Clear Lake including loss of Federal funding, and may lead to the Federal agency conducting its own investigation.
"Research Misconduct" may include the fabrication of falsification of data, plagiarism, or other fraudulent practices in proposing, executing, or reporting results from research. It might also involve a material failure to comply with Federal requirements for protecting researchers, human/animal subjects, or the public. In general, gross negligence of research standards and any action taken with the intent to defraud are considered forms of research misconduct. This definition does not include the results of honest error or honest differences in interpretation or judgments of data. (Definition based on statement 42 CFR Part 50, Federal Register August 8 1989)
The primary way to prevent misconduct in research at the University is for faculty to promote and maintain a climate consistent with high ethical standards. To reduce the likelihood of misconduct in research, the faculty and administration should facilitate the following:
A. Encouragement of intellectual honesty. Because of the primary role played by a climate of intellectual honesty in an academic community, a commitment to the ethical responsibilities of research by all of its practitioners is essential. We must emphasize the importance of such common practices as submission of work to peer review, avoidance of conflict of interest, scholarly exchange of ideas and data, and self-regulation. Mentor relationships between research leaders and new practitioners serve to guarantee the transmission of ethical standards in research.
B. Assurance that quality rather than quantity of research is emphasized in promotion and tenure review and merit pay consideration for faculty.
C. Acceptance of responsibility by research supervisor. University policies must define a focus of responsibility for the conduct of research and must ensure that the individual(s) charged with the supervision of researchers can realistically execute the responsibility. These supervisors of research should be experienced researchers who serve as mentors in transmitting the ethics and responsibilities underlying the research approaches used. The larger the research team, the more critical the role of the supervisor in promoting open communication and scholarly exchange of ideas, data, and results. It is also the responsibility of the supervisor to encourage publication of as much primary data as possible.
D. Establishment of well-defined research procedures. Well-designed and strictly-adhered-to methods are a deterrent to fraud.
E. Appropriate assignment of credit and responsibility. Publications should recognize the contributions of others through adequate citation. Publications should also name as authors only those who have had a genuine role in the research and who accept responsibility for the quality of the work being reported. Ordering all authorship should accurately reflect the contributions of the major participants in the research and writing process, including students.
The University of Houston-Clear Lake will conduct inquiries and investigations into reported allegations of misconduct in conducting research by faculty, staff or students. These inquiries and investigations will be pursued in compliance with the rights to privacy, due process and academic freedom of those being accused. Proof of misconduct will result in appropriate disciplinary action by the University.
These procedures assume the University will act to protect the rights and reputations of all individuals, including any person who is alleged to have engaged in misconduct, as well as the person(s) who made the allegations. Also assumed is the University's prompt, careful, and objective review of such allegations. Confidentiality shall be maintained throughout the proceeding by all parties involved.
A. In each school, the Dean or an individual designated by the Dean shall have principal responsibility for assessing a proper response to allegations of misconduct in conducting research. To assist the Dean's office in meeting this obligation, all allegations of misconduct, whether discovered by a faculty member or other member of the academic community, shall be brought to the attention of the appropriate Office of the Dean unless the allegations are clearly frivolous or otherwise lacking in substance.
B. The Dean or the Dean's designee shall decide whether it is appropriate to resolve the matter through informal processes and discussions. Such processes shall begin immediately upon receipt of the allegation and shall be completed within 30 days of initiation unless an extension of no more than 30 days is requested by the Dean and granted by the Provost. A written report of the inquiry shall be prepared by the Office of the Dean and submitted to the Senior Vice President and Provost and the individual who is the subject of the allegation, as well as any co-investigators on the research project(s) involved. Final resolution through informal means shall require approval by the Provost or his/her designee.
C. If the matter is not resolved through informal efforts and if, in the view of the Office of the Dean or the Provost, further proceedings are required, the allegation shall be referred to the University Research Committee.
D. The Chair of the University Research Committee shall appoint from its membership an ad hoc committee of five members to hear the allegation of misconduct in research. Any individual who has been involved in the school level inquiry may not serve on the ad hoc committee. The Chair of the committee may supplement by not more than two members (who shall be voting members) the subcommittee's membership when special expertise is necessary to understand the research in question and/or when allegations concern other universities or agencies. The subcommittee shall investigate the facts and submit the results to the University Research Committee. The committee, with the benefit of the report from the subcommittee and after such proceedings and deliberations as it deems appropriate, shall submit its report including recommendations to the Senior Vice President and Provost. The investigation shall be completed within 60 days of initiation unless an extension of no more than 30 days is requested by the committee and granted by the Senior Vice President and Provost.
E. The Senior Vice President and Provost shall take action or make such recommendations as may be required.
F. Special procedures must be followed when the alleged misconduct occurs in a research program funded by Federal or State agencies. It becomes necessary to notify the appropriate Federal or State agency, if at any stage of the inquiry or investigation, it is ascertained that one of the following conditions exists:
1. There is an immediate health hazard involved;
2. There is an immediate need to protect Federal funds or equipment;
3. There is an immediate need to protect the interests of the person(s) making the allegations or of any individual who is a subject of the allegations as well as his/her co-investigators and associates, if any;
4. It is probable that the alleged incident is going to be reported publicly.
5. There is a reasonable indication of possible criminal violation. In that instance, the institution must inform the appropriate Federal or State agency within 24 hours of obtaining that information.
G. The following actions are recommended when alleged misconduct is substantiated by a thorough investigation:
1. The sponsoring agency should be notified of the findings of the investigation, and appropriate restitution should be made.
2. All pending abstracts and papers emanating from any research found to be fraudulent should be withdrawn, and editors of journals in which previous abstracts and papers appeared should be notified.
3. Institutions and sponsoring agencies with which the individual has been affiliated should be notified if there is reason to believe that the validity of previous research might be questionable.
4. A faculty member whose misconduct is substantiated may be barred from submission of proposals to internal and/or external funding sources for a period of time.
5. Appropriate action should be taken to terminate or alter the status of faculty members whose misconduct is substantiated.
6. Institutional administrators should consider, in consultation with legal counsel, the release of information about the incident to the public press, particularly when public funds were used in supporting any research found to be fraudulent (recommendation from the Association of American Medical Colleges, June 24, 1984, pp. 5-6)
H. The Office of the Dean and the University Research Committee shall maintain records of all proceedings in which they were involved. To the extent allowed by law, such records shall be made available to the accused.
I. The researcher(s) involved in the alleged misconduct shall be informed in a timely fashion of the nature of the allegation and the preliminary evidence upon which it is based. Throughout the investigation he or she shall be advised of the progress of the investigation and be afforded the opportunity to respond and provide additional information. He or she shall be able to continue his or her activities unless legal, ethical, or contractual guidelines prohibit such continuation. Throughout the investigation, all parties involved shall maintain confidentiality.
J. When a thorough investigation fails to substantiate an allegation of misconduct, formal measures will be instituted to ensure restoration of the reputation of the researcher(s) involved in the alleged misconduct. Appropriate actions will be taken against those who leveled the allegation if their unfounded charges are demonstrated to have been malicious or intentionally dishonest.
The following definitions comply with those given in the Federal Policy for the Protection of Human Subjects, June 18, 1991.
1. Research means systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The systematic investigation may include data collected from written, oral, or video-taped formats.
If classroom activities or class-related activities involve any of the following: sensitive issues, issues of a personal nature, confidential information; then the activity will be treated as research and an application for approval must be submitted to the committee. (Note categories for exemptions-Section Vlll.)
2. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or through identifiable, private information.
3. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
4. Interaction includes communication or interpersonal contact between investigator and subject.
5. 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, (i.e. a medical record). To be considered private, information must be individually identifiable (i. e., the identity of the subject is or may be ascertained readily by the investigator or associated with the information).
6. At Risk means that an individual is considered to be at risk if that individual may be exposed to the possibility of injury, including physical, psychological, or social injury as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet the subject's needs (i.e., standard and recognized procedures that have diagnostic, therapeutic, or prognostic value) or which increases the ordinary risks of daily life including the recognized risks inherent in a chosen occupation or field of service. The determination of when an individual is at risk is a matter of the application of common sense and sound professional judgment to the circumstances of the activity in question.
7. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
8. Informed Consent means the knowing, legally effective consent of any individual or the individual's 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. Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. Informed consent shall be documented by the use of an approved written consent form which is signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
9. 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).
10. Expedited Review is a procedure set forth in federal regulations which is allowed for research involving no more than minimal risk to the subjects.
11. School-based Subcommittee is a legally recognized component of the Committee for the Protection of Human Subjects (CPHS) and is comprised of at least one experienced reviewer designated from among members of the CPHS. The purpose of a subcommittee is to review applications that are designated at minimal risk or qualify for expedited review as per federal regulations. Subcommittees may approve protocols. Subcommittees may not disapprove a protocol, but must forward problematic or questionable protocols for full committee review.
A. RESPONSIBILITY OF THE UNIVERSITY The University of Houston-Clear Lake seeks to protect the health, welfare, and rights of every person who may be involved in research and training projects. The conduct of research involving human subjects requires a balancing of freedom of inquiry for the advancement of knowledge on the one hand with the protection of the rights of the human subjects on the other hand. An individual, by consenting to take part in a project, abdicates no rights. The human subject has the right to receive appropriate professional care, to be free from embarrassment, discomfort, and anxiety. The subject has the right to privacy and confidentiality in the use of personal information. To assure these rights, the following basic principles are affirmed.
1. Types of projects The requirements for the protection of human subjects are the same for funded or non-funded projects, faculty or student projects, and on-campus as well as off campus projects.
2. Rights of human subjects All activities involving human subjects must provide for the safety, health, and welfare of every subject. Rights, including the right of privacy, must not be usurped in any way.
3. Benefits The actual or potential benefits to the subject, or the importance of the knowledge to be gained, must significantly outweigh the inherent risks to the individual, and such risk should not be excessive in any case.
4. Informed Consent Requirements Informed consent must be obtained when the safety, health, or welfare of participants are determined by the CPHS to be at risk. Participation in projects where subjects are at risk must be voluntary and so documented. Methods that are adequate and appropriate must be used to obtain the subject's informed consent. The basic elements of information to be provided to prospective subjects which are necessary for such consent include
a. Explanation of the research A fair explanation of the purpose of the study, the expected duration of the subjects' participation, the procedures to be followed, and the identification of any procedures which are experimental. In those circumstances where the nature of the work prevents full prior explanation of procedures, adequate debriefing procedures must be followed as soon as possible during or after the experiment. All terms should be defined upon first appearance in the consent form.
b. Explanation of the risks A description of the attendant discomforts and risks, if any, which may be reasonably expected.
c. Explanation of the benefits A description of any benefits to the subject or to others which may reasonably be expected.
d. Explanation of the alternative procedures Disclosure of any appropriate alternative procedures, if any, that might be advantageous for the participant.
e. Explanation of confidentiality A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
f. Explanation of the procedures An offer to answer any inquiries concerning the procedures.
g. Explanation of the withdrawal of consent An assurance that the participant is free to withdraw his/her consent and to discontinue participation in the project or activity at any time without penalty or loss of benefits.
5. Obtaining consent Consent should be obtained from the participants themselves. If a subject is not legally or physically capable of giving informed consent, consideration may be given the validity of consent by any next of kin, legal guardians, or by other responsible third parties to represent the participant's interests. In the latter instance, the person consenting for the participant who is unable to give informed consent must be the participant's legally authorized representative. Careful consideration shall also be given to the third party's depth of interest and concern with the participant's rights and welfare. A parent, for example, may have no authority to expose his child to risk, except for the child's benefit. Great care should also be taken to determine that the consent is adequate in the light of risks to the participant and the circumstances of the project.
6. Written consent Consent will be obtained in writing unless prior arrangements are made through the CPHS. The consent document must embody all of the basic elements of informed consent in paragraph 4 above and be retained by the university under the authority of the committee for a period of three years following the completion of the research.
7. Waiver of written consent In cases where the documentation requirement is waived, the CPHS may require the investigator to provide subjects with a written statement regarding the research. The CPHS may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either
a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality and no alternative method of record keeping (i. e., one that does not use the consent form as a link between the subject and the research) is available. In such a case, each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern
b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally requested outside of the research context.
8. Rights An individual does not abdicate any rights by consenting to take part in a project. The individual may withdraw consent at any time or can refuse to participate, in either case, without loss of benefits to which the subject would otherwise be entitled.
9. Responsibility for security of information 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 ultimately lies with the faculty advisor. Such information shall not be communicated to others unless the following conditions are met.
a. Release of subject identity Only after obtaining explicit, written or recorded permission from the individual may that individual's identity be released. When data are released without permission for identification, the investigator assumes responsibility for adequately disguising individual sources.
b. Use of data Information about individuals may be discussed only for professional purposes and only with persons clearly concerned with the project and clearly not in a position to personally benefit from the acquisition of personal information concerning individual subjects. Written and oral reports should present only data germane to the purposes of the project, and every effort should be made to avoid invasion of privacy.
c. Security and disposition of records Provisions must also be made for the maintenance of confidentiality in the preservation and ultimate disposition of any data collected. Maximum practical security measures must be described to a review committee and carried out during the program. Records which contain private information shall be destroyed as soon as possible.
10. Continuation of monitoring Projects will be given initial and continuing review by the CPHS. All members of the university community involved in investigation and training are responsible for continual monitoring to assure compliance of their research with these principles.
11. Involvement of research personnel with review committee No individual involved in the conduct of a specific project shall participate in its review, except to provide information to the committee.
12. Additional reviews
a. A second review may be required if
* an interval of one year has elapsed between committee review and initiation of the research
* the committee decides that a more frequent review is necessary for the particular research (e.g., if the proposed effort is in a rapidly changing scientific area)
* the principal investigator wishes to make substantive changes after the proposed project has been reviewed by the committee.
b. In no case will work take place without at least an annual review.
B. RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR In all cases the investigator should show practical regard for the University of Houston System 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) may involve research participants, students, or colleagues in damaging personal conflicts, and impugn the investigator's own name and the reputation of the university. Even so, 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 CPHS 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 endangering all federal funding to the university.
C. TYPES OF COMMITTEES
1. School based subcommittee (expedited review.)
2. University wide (non expedited review.)
A. JURISDICTION OF THE COMMITTEE The CPHS shall only have direct jurisdiction over the UHCL campus. Each campus of the University of Houston System is independently responsible for compliance with federal human subjects research guidelines. (Each campus must apply for separate federal assurances as desired or necessitated.)
1. Make-up of the committee
a. Five full-time, tenure track faculty members
b. One graduate student
c. One community representative
d. One representative from the Office of Research Initiatives
2. Appointments and terms Appointments to the committee shall be made by the senior vice president and provost from lists submitted by the deans in schools that participate in research involving human subjects. The provost shall ensure that appropriate diversity exists on the CPHS. All faculty representatives shall serve for two-year terms, with one-half rotation each year. Non-faculty representatives shall serve for one-year terms. A chair and vice-chair shall be selected by the committee from among the five faculty members.
3. Selection of committee members Faculty members will be selected according to the university's research needs but shall include at least one member from each of the four UHCL Schools that participate in human subject research. The overall membership of the committee will be selected with the following guidelines:
a. Concerns At least one committee member shall have concerns which are primarily scientific and at least one committee member shall have concerns which are primarily non-scientific, serving as the subjects' advocate. ] b. Diversity The committee members must be selected so as to ensure diversity with respect to gender, ethnicity, religion or creed, handicap, and social or economic status. Further, the committee shall not be comprised entirely of members of the a same profession.
c. Legal consultation The UH System Legal Counsel may serve as consultants to the committee.
d. Conflict of interest In the event that conflicting interests arise for any committee member(s), then that/those committee member(s) will not be allowed to participate in a review or reevaluation of the research project which precipitates the conflict.
e. Identification of committee members A list of the committee members identified by name, earned degrees, representative capacity, indications of relevant experience, and employment relationship to the university will be made available to investigators from the Office of Research Initiatives.
f. Special competence The committee 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 within the committee. These invited individuals shall have no voting rights.
B. COMPLIANCE A dean or his/her designee will be responsible for ensuring that research by individuals (faculty, students or employees) is conducted according to human subjects guidelines. Upon request by the CPHS, the dean may be asked to supply additional expertise or information to aid the committee in its review process. The Director of Research Initiatives will be responsible for non-school personnel.
A. JURISDICTION OF SCHOOL-BASED SUBCOMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS (SSPHS). Subcommittees for the CPHS may be established to conduct an expedited review of proposals within each school.
B. SCHOOL-BASED SUBCOMMITTEE ORGANIZATION
1. Authorized Subcommittees
Natural and Applied Sciences NAS - SSPHS Human Sciences & Humanities: HSH - SSPHS Business & Public Administration BPA - SSPHS Education EDU - SSPHS
2. Make-up of each Subcommittee
a. One faculty member from the school who is a member of the CPHS.
b. One faculty member from the school-at-large who does not have a conflict of interest.
c. Other members as designated in each school's subcommittee procedures.
C. PROCEDURES Each school-based subcommittee will establish procedures that comply with all facets of expedited review including appointments of members, tenure of term, submission, review, and other related factors contained in Section V of this policy. Procedures must ensure that the application, approval recommendation, and other pertinent supporting documentation are forwarded to the permanent CPHS files in the Office of Research Initiatives.
1. Subcommittee Response The response of the SSPHS to the application may come in one of three forms.
a. Approval of investigator's claim for exemption (See Section Vlil for specific information on exemptions.)
b. Approval of applications for projects meeting all established guidelines for the protection of human subjects
c. Approval with modifications for projects that meet most of the guidelines for the protection of human subjects and which, if modified as stipulated in writing by the SSPHS, would fully meet the established guidelines. Documentation of modification must be reported to the Office of Research Initiatives before data are collected from the human subjects.
d. Forwarding of proposal to the full CPHS for projects
* being submitted for external funding
* that may place the subjects at risk of criminal or civil liability or may be damaging to their financial standing or employability
* that deal with subjects' behavior in such areas as illegal conduct, drug abuse, sexual behavior, or use of alcohol
* about which the SSPHS is uncertain or that significantly deviate from established guidelines for the protection of human subjects. The SSPHS cannot reject, only forward to the full CPHS.
2. Notification to applicant The SSPHS chair shall notify each applicant of the SSPHS decision.
3. Notification of Committee for the Protection of Human Subjects The Office of Research Initiatives and CPHS will establish procedures for informing CPHS and the Office of Research Initiatives of SSPHS activities. All files will be forwarded to and reside in the Office of Research Initiatives.
A. APPLICATION AND REVIEW
1. Submission of research for approval All research projects involving the use of human subjects must be submitted to the CPHS for approval; however, studies which are not externally funded and meet federal regulation guidelines as minimal risk to subjects may qualify for expedited review by school-based subcommittees. If it is unclear whether the proposed research involves human subjects or whether it should be submitted to the full committee or a subcommittee, the investigator should seek assistance from the Office of Research Initiatives in making a determination. Application forms may be obtained from the Office of Research Initiatives.
2. Method of review
a. Full Committee Review The Office of Research Initiatives will log in the application material and distribute it to the CPHS Committee. Full CPHS review will take place with due regard for a thorough but speedy assessment of applications. In instances where there are concerns or questions, a meeting of the full committee is required. To assure consideration of an application by the CPHS, the investigator must initially submit a completed application and eight (8) copies to the Office of Research Initiatives no later than thirty days prior to the desired starting date for the research or the proposal submission deadline for a funded research project.
b. Expedited review Expedited review procedure is done by school subcommittees as described in Section IV, and each school shall establish its own submission, voting, and notification process.
3 Considered factors The CPHS and SSPHS will weigh the following primary factors.
a. The rights and welfare of the subjects must be adequately protected, and risks to subjects must be minimized. 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. The CPHS is concerned with the protection of anonymity and the confidentiality of all data collected, as well as the minimization of personal embarrassment, mental anguish, and questions of conscience resulting from participation in a study. The CPHS shall ensure that both the mental and physical well-being of the subjects are adequately protected. The CPHS expects that human subjects will not be used in projects which are poorly designed. However, the responsibility for monitoring research design quality lies primarily with the appropriate school administrator or faculty sponsor. Rights may be ensured and risks may be minimized by
* using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk
* whenever appropriate, using procedures already being performed on the subjects for diagnostic or treatment purposes.
b. The risks to the subjects must be reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge which may reasonably be expected to result. The committee shall focus on risks and benefits that may result from the research as opposed to any risks or benefits associated with therapies which subjects would receive even if not participating in the research. Possible long term effects of the research on public policy are not within the domain of the committee.
c. The informed consent of subjects must be obtained by adequate and appropriate methods described in Section Vl. All subjects will be fully informed by the investigator of the procedures to be followed, including discomforts, risks, and possible benefits. Risks must be well defined in terms understandable to the subjects. Informed consent must be obtained from all subjects, unless specifically waived by the CPHS in accordance with 45 CFR 46.117 (c) (1) or (2).
4. Voting of committee Final approval by the CPHS shall then require a majority vote of the voting members. If the CPHS is agreed that the proposed research protects human subjects in accordance with established standards, its conclusion shall constitute certification of approval. A letter of approval will be sent to the investigator.
B. NO DATA INVOLVING HUMAN SUBJECTS SHALL BE COLLECTED UNTIL CPHS APPROVAL IS GRANTED. Any data collected before approval cannot be used in the study.
C. EXTERNAL INVOLVEMENT
1. External agency In the case of a proposal being submitted to an external funding agency, certification of approval of the research protocol by the CPHS, if required, will be made by the Office of Research Initiatives at the time the proposal is submitted in the form required by the agency.
2. Cooperative projects Cooperative research projects are those projects, normally supported through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor. When a HCL employee is involved in a cooperative research project for which HCL is the primary recipient of funds, the CPHS of HCL remains responsible for certifying that human subject safeguards have been met. When HCL is not the primary recipient of funds, the CPHS of HCL may certify that the specific activities of the HCL employee meet established guidelines for human subject protection or it may rely upon the review of the CPHS from the institution which is the primary grant recipient.
A. PROCESS OF INFORMED CONSENT Informed consent is a process, not just a piece of paper. Informed consent, in writing, documents this process, but cannot serve as a substitute for it. 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 shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether to participate. Particular attention should be paid towards the minimization of the possibility of coercion or undue influence. This is particularly crucial when the participants are enrolled in a course for credit which is directed by the researcher or when some of the subjects are likely to be vulnerable to coercion or undue influence as in the case of children, pregnant women, prisoners, or mentally disabled persons, or economically or educationally disadvantaged persons.
1. Language of informed consent The information given to the subject, or the subject's legally authorized representative, must be in simple, easily understood language. If the subject is not English speaking, the informed consent must be presented in an appropriate language. Committee or subcommittee members shall seek verification that the translation is accurate and clear.
2. Documentation of informed consent Written documentation of the consent process (i.e. a cover letter or cover sheet) is always required unless specifically waived by the CPHS. The consent document should be signed by the subject or the subject's legally authorized representative unless this requirement is waived by the CPHS. If the subject is a minor (under the age of 18), written parental consent is required unless this requirement is waived by the CPHS. A waiver of the written informed consent requirement in accordance with 45 CFR 46.116 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 CPHS has waived the requirement.
3. Waiver of written informed consent Under certain circumstances, the use of a signed informed consent may be waived by the CPHS. However, the CPHS may require that a statement describing the procedures and objectives of the research be supplied to the subjects in a written format. An example of such a project would be the analysis of a questionnaire which is distributed and returned anonymously through the mail. A cover letter accompanying the questionnaire should include all the elements of informed consent listed in this section. If informed consent is to be obtained orally (i.e. prior to a telephone interview) a written summary of what the subject will be told must be provided to the CPHS for review and approval.
4. Legal rights of the subjects No informed consent, whether oral or written, may waive or limit in appearance or in fact, the subject's legal rights; nor may it include any release of the investigator, the sponsor, the institution or its agents from liability for negligence.
5. Contents of written informed consent Unless waived by the CPHS, the following information shall be supplied in all written informed consents.
a. About the research A statement that the study involves research, an explanation of the purpose(s) of the research, a description of the procedures to be followed, including the expected duration of the subject's participation, and the identification of any procedures which are experimental. This statement should include a description of any anticipated benefits the subject or others might reasonably expect.
b. About the risks A description of any reasonably foreseeable risks or discomforts to the subject (including likely results if an experimental treatment should prove ineffective). If the risk potential is currently unknown or unmeasurable, a statement to that effect will be required.
c. About the statement The following statement will be included in all written informed consents (including cover letters). It is suggested that this statement be inserted at the bottom margin of the form, letter, or portion of the form that is to be retained by the subject.
THIS PROJECT HAS BEEN REVIEWED BY THE UNIVERSITY OF HOUSTON-CLEAR LAKE COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS (PHONE: 281/283-3015).
d. About the alternative procedures A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
e. About the confidentiality of records A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
f. About the availability of compensation A statement regarding the availability of compensation, medical treatments or both, if injury occurs, will be required for research which involves more than minimal risk. If compensation or medical treatment will be provided, information about how it may be obtained or where further information may be secured will be required.
g. About the investigator A statement that any new information developed during the course of the research which may relate to the subject's willingness to continue participation will be provided. Related to this, an offer to answer any questions the subject (or the subject's representative) might have regarding the subject's rights shall be included. This statement should include the name, address and/or telephone number of the principal investigator as the contact point if questions or problems should occur as well as the name of any sponsoring or funding source supporting the research. The University of Houston-Clear Lake shall be identified as the, or one of the, responsible institution(s).
h. About the voluntary nature of participation A statement that participation is voluntary and that refusal to participate or a subsequent decision to discontinue participation will not result in penalty or loss of benefits to which the subject is otherwise entitled. This statement should include a description of the consequences, if any, that would accompany such a decision to withdraw.
6. Copies of the informed consent A copy of the informed consent shall be supplied to the subject or the subject's legally authorized representative. Additionally, a copy will be retained by the investigator or the sponsor.
7. Retainment of informed consents Federal law mandates that copies of all informed consents be retained for a minimum of three years after the completion of the research. The principal investigator is responsible for the maintenance and retention of such records. If the principal investigator is a student, the faculty sponsor is responsible for the maintenance of these records. If the investigator leaves the institution within this 3-year period, all records must be forwarded to the Office of Research Initiatives for retention.
Examples of various types of informed consents are available from the Office of Research Initiatives. These are only to be used as examples/guides for formulation of individual informed consents and not as standard forms.
B. COMPLIANCE WITH NON-DISCRIMINATION LEGISLATION FOR CASES INVOLVING PAYMENT OR COURSE CREDIT
1. Payment In cases where payment for subject participation in the form of money of other tangible benefit is provided to subjects, the investigator must ensure that subjects will not experience discrimination in selection or treatment on the basis of ethnicity, creed or religion, gender, age, social or economic status, or disability. Further, physically challenged or developmentally disabled subjects must be provided with reasonable accommodations in accordance with the Americans with Disabilities Act. If the experiment requires discrimination, then the subjects cannot be paid. They may, however, be reimbursed for expenses incurred such as travel to the experiment site or the purchase of special attire which is required for the experiment but cannot be provided by the investigator (i. e., for health code reasons).
2. Course credit In cases where credit or extra credit is provided to student participants, the investigator must ensure that subjects will not experience discrimination in selection or treatment on the basis of ethnicity, creed or religion, gender, age, social or economic status, or disability. If any students are excluded from participation because of any of these factors, then those students must be provided with an equally viable alternative means of earning the same amount of credit or extra credit which accompanies participation in the investigator's experiment. (For example, if a student finds the experiment morally objectionable because of his personal or religious creed, or if a student feels that the experiment would be difficult or painful because of a physical disability, then the investigator is obligated to provide the student with another means of earning the same credit or extra credit which is offered to participants. This other means should not require more time nor be more difficult than participation in the experiment.) Further, before any credit or extra credit is offered, the students being recruited as participants must be informed of this nondiscrimination policy.
VII. Committee Response
A. COMMITTEE RESPONSE The response of the CPHS to the application may come in one of four forms.
1. Approval for projects meeting all established guidelines for the protection of human subjects.
2. Approval with modifications for projects which meet most of the guidelines for the protection of human subjects and which, if modified, would fully meet the established guidelines. Documentation of modification may be approved by the CPHS chair and reported to the full CPHS.
3. Rejection for projects significantly deviating from established guidelines for the protection of human subjects.
4. Action refused for violation of approval process for projects in which data has been collected from human subjects prior to CPHS approval. The study must cease immediately and notification of the committee's action will be forwarded to the senior vice president and provost.
B. PROVISIONS FOR COMMITTEE RESPONSES
1. In case of the need for modification The principal investigator may be asked to meet with the CPHS should it be apparent that clarification or modification of statements in the application are required. No individual involved in the conduct or supervision of the research project shall participate in its review, except to provide information to the CPHS. Even if the consensus of the CPHS is favorable, it may elect to impose some additional restrictions or recommendations under which the project shall be conducted.
2. In case of rejection If the CPHS action is to disapprove the application, reasons for this negative decision will be provided in writing to the principal investigator or project director. If the researcher decides to modify the proposed research in such a way as to meet the objections of the CPHS, the investigator may resubmit the application for consideration by the CPHS. If desired, the investigator may, in such cases, request a personal hearing at a meeting of the CPHS.
3. Reporting developments and changes Any substantial changes in the protocol, the emergence of problems (for example, evidence of risks or discomfort to participants) or the development of hazardous conditions for the subject(s) must be reported immediately to the CPHS by the responsible investigator. An amended protocol must then be approved by the CPHS before the research may continue.
4. Reevaluation Normally, reevaluation of the project so that continued acceptance of the protocol is assured will take place yearly. More complex and potentially dangerous projects will be reviewed at a frequency commensurate with the related risks. For projects requiring more frequent review, the CPHS will specify the minimum interval between reevaluations at the time the initial approval is awarded. Projects determined to be exempt may require additional review if so designated by the CPHS. Renewed projects should include a progress report as well as a description of any anticipated design changes. Projects may also be reevaluated if subjects involved in the research lodge a complaint with the CPHS, or the investigator reports problems with the research. In either case, the CPHS may elect to review the data accumulated by the investigator and may interview both the research staff and research participants.
5. Uncertainty about the involvement of human subjects Certain proposals may be submitted with the knowledge that human subjects may be involved with the project, even though definite plans for this involvement remain inconclusive at the time that the proposal is submitted. Such proposals shall be reviewed and certified in the same manner as more complete applications with the obligation that later review and approval will be required when more complete plans are made, but before the period during which human subjects would be used. In the case of an externally funded project, this later review and approval must precede the beginning of any grant budget period during which human subjects would be used.
6. Later inclusion of human subjects in research Ongoing projects modified to include humans as subjects also must be submitted to the CPHS for review and approval prior to the use of human subjects. In the case of an externally funded project, the granting agency would be notified of the CPHS action prior to the appropriation cycle for a budget period during which human subject involvement is proposed.
A. CATEGORIES OF EXEMPTION The following categories of exemption have been adopted by the University of Houston-Clear Lake based upon Department of Health and Human Services regulations published in the Federal Register on June 18, 1991. In order to establish an individual research project as exempt, an investigator must complete a CPHS form which clearly explains the project for the SSPHS (or Office of Research Initiatives if non-school personnel) and why an exemption is claimed. Final determination as to whether a research project is exempt rests with the CPHS. If an investigator has any doubt as to the status of the research regarding these categories of exemption, the investigator should contact the Office of Research Initiatives or CPHS for advice.
If a research project is certified as exempt by a SSPHS (or the Office of Research Initiatives if non-school personnel), the investigator need not resubmit the project for continuing CPHS review as long as there are no modifications in the exempted procedures.
1. Normal practice Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
a. Research on regular and special education instructional strategies
b. Research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods
c. Institutional research.
2. Tests. surveys observation Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. However, research in which any of the following conditions exists cannot be exempt.
a. Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subject,
b. 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, or
c. The research could reasonably be damaging to the subject's reputation as in the case of research which deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
3. Public persons All research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.
4. Existing data 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. Personal experiences Experiences of a personal education nature (i.e. stress reduction or guided imagery).
6. Research and demonstration projects Projects conducted by or subject to the approval of deans or the university's senior vice president and provost and designed to study, evaluate, or otherwise examine
a. Public benefit or service programs
b. Procedures for obtaining benefits or services under those programs
c. Possible changes in or alternatives to those programs or procedures
d. Possible changes in methods or levels of payment for benefits or services under those programs.
Approved by LRC August 31, 1994
Approved by Faculty Senate October 5, 1994
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