Human Subjects Policy & Procedures Introduction :: IRB Functions and Responsibilities :: General Procedures for Submitting an IRB Application :: Levels of IRB Review :: Actions & Time Limits Pertaining to IRB Review :: Grievance Procedure :: Appendices (in Word)
NEW MEXICO STATE UNIVERSITY
POLICY AND PROCEDURES FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS
12/12/01
RESEARCH INVOLVING HUMAN SUBJECTS: PRINCIPLES AND PROCEDURES
New Mexico State University (NMSU), through the Office of the Vice President for Research, has established these policies and procedures for the conduct of research involving human subjects in order to protect the rights, well being, and personal privacy of individuals; to assure a favorable climate for the conduct of scientific inquiry; and to protect the interests of NMSU and its faculty, students, and staff. NMSU has established the Institutional Review Board (IRB) to administer NMSU policies and procedures regarding research involving human subjects. A list of the current NMSU IRB members and Chairperson is available from the Office of the Vice President for Research.
The following general principles apply equally to all research involving human subjects or data related to human subjects, whether carried out solely within NMSU resources or with the assistance of extramural funds. NMSU assumes responsibility for providing procedural guidelines; however, all faculty members, staff, and students who anticipate conducting development, demonstration, or research projects involving human subjects are responsible for familiarizing themselves with the policies.
1. NMSU and the individual members of its faculty, staff, and student body recognize their responsibility for protection of the rights and welfare of human subjects.
2. Appropriate professional attention and facilities shall be provided to insure the safety and well being of human subjects. No subject in a research activity shall be exposed to unreasonable risk to health or well-being.
3. No subject will be coerced in any way to participate in a research project but will do so on a strictly voluntary basis.
4. The confidentiality of information received from subjects in experiments or respondents to questionnaires shall be fully protected, both during and after the conduct of a research activity, within the limits of the law.
5. In research which involves more than minimal risk or which involves substantial stress or discomfort, such risk, stress, or discomfort shall be carefully explained to the subject before his or her participation; the investigator shall be satisfied that the explanation has been understood by the subject; and the written consent of the subject, such consent containing the substance of the explanation, shall be obtained and kept as a matter of record. The elements of informed consent are established by the federal government and by NMSU (see Appendix A).
6. Research involving special subject populations (e.g., pregnant women, persons under the legal age of consent*, other legal incompetents, subjects of reduced competence, prisoners) may be conducted as long as a qualified guardian signs the consent form (see Appendix A).
7. A request by any subject to withdraw from a research activity shall be honored promptly without penalty or loss of benefits to which the subject is otherwise entitled, within the limits of the research.
*Eighteen years of age in New Mexico; for the legal age elsewhere, contact the individual state.
I. IRB FUNCTIONS AND RESPONSIBILITIES
1. The IRB shall recommend to the Vice President for Research, and review on a continuing basis, NMSU policies and procedures regarding the use of human subjects in research.
2. The IRB shall review and have authority to approve, require modifications to secure approval, or disapprove all research activities involving human subjects or data related to human subjects.
3. Research activities shall be reviewed by the IRB for compliance with established federal regulations related to the protection of human subjects, as issued by the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), and contained in the Code of Federal Regulations (CFR) 45, part 46.
4. Research covered by these regulations that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by officials of NMSU. However, those NMSU officials may not approve the research if it has not been approved by the IRB.
5. The IRB shall provide advice and guidance to investigators regarding the protection of the rights and welfare of human subjects.
6. The IRB shall ensure that investigators have been certified in the ethical principles of using human subjects in research.
7. Where necessary, the IRB shall serve as a referral board for complaints from subjects of research.
8. The IRB shall require that information given to subjects as part of informed consent is in accordance with federal regulations as indicated in 45 CFR 46. The IRB may require that information in addition to that specifically mentioned in 45 CFR 46 be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of the subjects. Documentation of that process shall also be required. The CFR outlining requirements for the protection of human subjects is available by contacting the NMSU Office of the Vice President for Research.
9. The IRB shall notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
10. The IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
11. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator and appropriate NMSU officials.
12. If a research subject registers a complaint, the investigator shall attempt to relieve the complaint by explanation or by a change of procedure. Written IRB approval is required for procedural changes.
13. It is the responsibility of the IRB to determine whether applications that involve more than minimal risk to human subjects are of sufficient scientific merit to answer the proposed research questions or hypotheses.
14. It is recommended that all investigators review the "NMSU IRB Policy Definitions" (see Appendix B), and "Answers to Frequently Asked Questions About IRB Regulations" (see Appendix C).
II. GENERAL PROCEDURES FOR SUBMITTING AN IRB APPLICATION
It is the obligation of each investigator (faculty, staff, or student) to bring any proposed research activity involving the use of human subjects or data related to human subjects to the attention of the NMSU IRB or IRB Chairperson for review and approval. All IRB applications (regardless of level of review described below) must contain certain documents and information, as described below.
1. Completed Application for Permission to Use Human Subjects in Research
Applications (see Appendix D) must be completed in full, and must be typed for processing.
a. Protocol of Research Project
This section of the application should briefly state the study's procedures, and describe all aspects of interaction with human subjects. This section should address:
· subject recruitment procedures
· exclusion/inclusion criteria
· procedures to be used to gather data
· who will have access to the data collected
· whether and how data will be made available to future researchers, funding organizations, or the public
· the research framework
· rationale for the study grounded in previous literature
· the research questions or hypotheses
b. Safety Measures
This is the most critical section of the application. This section should describe fully:
· potential risks to subjects (including emotional or physical discomfort or harm, social or financial consequences, etc.)
· justification for the use of deception and description of debriefing techniques, if applicable
· potential benefits to subjects
· steps that will be taken to minimize risk
· how confidentiality or anonymity will be maintained
· procedures for obtaining informed consent
c. Certification of Education in the Use of Human Subjects in Research.
Every applicant must become certified in the care and use of human subjects. The certification form must be attached to the application upon submission (see Appendix E).
2. Application for Exemption from Full IRB Review or Application for an Expedited IRB Review
These forms are only necessary for applications believed to qualify for either an expedited review (see Appendix F), or exemption from full IRB review (Appendix G). A description is contained in Section III. Levels of IRB Review.
3. Consent/Assent Forms
IRB applications must include a copy of consent forms (for adults) and assent forms (for minors). Applications requesting an exemption from full IRB review may not require a consent form (contact the IRB Chair with questions).
4. Measures/Data Collection Instruments
Researchers must include a copy of all data collection instruments. If measures are copyrighted, please include a description of the instrument, with sample questions. For qualitative research, areas of inquiry must be specified.
The IRB authorizes four levels of review based on the type of research activity. These levels are 1) review by the IRB Chairperson, (2) review by a course instructor, (3) review by the IRB Chairperson and one IRB member, and (4) review by the full IRB. The following are general procedures to be followed by researchers when preparing IRB applications.
1. Review by the IRB Chairperson (for research projects exempt from full IRB review)
Research activities in which the only involvement of human subjects will be in one or more qualifying categories are exempt from full IRB review, but need to be submitted to the IRB Chairperson for approval prior to collection of data. The categories of research qualifying for an exemption from full IRB review are described on the Application for Exemption from Full IRB Review (see Appendix G) . The investigator should submit an Application To Use Human Subjects in Research and an Application for Exemption from Full IRB Review with appropriate supporting materials to the IRB Chairperson for review. The applications should follow the guidelines outlined above. If the IRB Chairperson determines that the research does not meet the criteria for exemption, the investigator will be notified that the proposal must be reviewed by the full IRB. It is then the investigator's responsibility to initiate the procedures for a full IRB review, as described below.
2. Review by Course Instructor
Student research activities (below the master's thesis level) that are undertaken as partial fulfillment of course requirements need only be submitted to the course instructor for approval prior to collection of data, provided the instructor has an approved Certification Form for Course Instructors (see Appendix H ) for that course on file with the IRB. An instructor must complete a Certification Form for Course Instructors for each course he/she teaches in which students collect data from human subjects for research projects. Once filed with the Office of the Vice President for Research, the certification will remain in effect for three academic years. No research within this category shall be initiated until written approval has been obtained from the faculty member. Approval by the faculty member indicates that the research involves no more than minimal risk to the human research subjects. If the research activity involves more than minimal risk to the subject(s) (see Appendix B) , the faculty member must refer the project to the IRB for the appropriate level of review. All students (below the master's thesis level) wishing to conduct research activity as a project within a course, for which the faculty member does not have an approved Certification on file with the IRB, must submit their project to the IRB for review and approval following the procedures described in this section. This requirement applies to all investigators who are conducting research as students of NMSU even if the activity is not taken for academic credit.
3. Review by IRB Chairperson and One other IRB Member (for research projects qualifying for an expedited review)
Research activities in which the only involvement of human subjects will be in one or more of eight qualifying categories are eligible for an expedited review by the IRB Chairperson and one other IRB member. The categories of research qualifying for an expedited review appear on the Application for Expedited IRB Review (see Appendix F). The investigator should submit an Application To Use Human Subjects in Research (Appendix D) and an Application for an Expedited IRB Review (Appendix F) with appropriate supporting materials to the IRB Chairperson for review. The IRB application should follow the guidelines outlined above. If the IRB Chairperson determines that the research does not meet the criteria for an expedited review, the investigator will be notified that the proposal must be reviewed by the full IRB. It is then the investigator's responsibility to initiate the procedures for a full IRB review, as described below.
4. Review by Full IRB (for research projects that do not qualify for exempt or expedited reviews)
For all research which does not fall within the exempt or expedited categories or which is not part of a class project below the master's thesis level, the investigator shall submit 12 copies of a full Application To Use Human Subjects in Research to the Office of the Vice President for Research. The IRB application must follow the guidelines described above. Applications that are incomplete (e.g., missing or not fully addressing one of the sections) will be returned due to insufficient information. The 12 copies of the IRB application should be submitted to the Office of the Vice President for Research two weeks prior to the regularly scheduled IRB meetings. The schedule of IRB meetings will be on file in the Office of the Vice President for Research and will be distributed to faculty and unit administrators at the beginning of each academic year. Meetings are generally scheduled four times per fall and per spring semester. The IRB does not schedule regular meetings during the summer months; however, an investigator may contact the IRB Chairperson with an application that needs to be reviewed during the summer months. The chairperson will arrange a review by the full IRB, if necessary. Attendance by the investigator or a designated representative at the IRB review meeting in which his or her research activity is scheduled for discussion is welcome. No research within the purview of the IRB shall be initiated until approval has been given.
IV. ACTIONS AND TIME LIMITS PERTAINING TO IRB REVIEW
1. The formal actions taken by the IRB will be communicated to investigators in writing following the review, and will take one of the following forms:
a. "Approved" indicates the researcher may begin data collection and that the project meets the IRB standards for protection of human subjects in research.
b. "Approval Withheld Pending Resubmission to the Full IRB" indicates approval by the IRB has been withheld pending revision of specific points. Research may not be undertaken until the outlined revisions are submitted to and approved by the IRB.
c. "Approval Withheld Pending Resubmission to the IRB Chairperson" indicates approval by the IRB has been withheld pending revision of specific points, to be approved upon resubmission directly to the IRB Chairperson.
d. "Disapproved" indicates the proposed research does not meet NMSU and/or federal guidelines for the protection of human subjects. The research activity may not be undertaken and will not be afforded NMSU endorsement. The investigator shall have the opportunity to respond in person or in writing to the IRB.
2. Approval of proposed research is usually granted for a period of twelve months commencing with the date approval is granted by the IRB. Based on the degree of risk to human subjects, the IRB may grant special conditions whereby the investigator has a shorter approval period or must report research progress at specific intervals. Continuation of projects past the approval period requires resubmission to the IRB. It is the responsibility of the investigator to reapply and obtain the approval of the IRB prior to expiration of the approved period. At least one month prior to the expiration of the approved period of continuing projects, a Progress Report (see Appendix I) should be submitted to the IRB. When a student is conducting the approved research, the faculty member identified on the original proposal as directing the research is responsible for ensuring that the progress report is submitted on schedule or, failing that, for suspending the research activity by the student.
3. The IRB will formally notify the investigator of IRB action in writing.
4. When the research activity involves an outside agency (e.g., hospital, public school, clinic), the investigator must secure written approval from the appropriate official within the agency prior to receipt of final approval from the IRB.
5. If the IRB gives the research proposal an Approval Withheld Pending status, the investigator must contact the IRB chair regarding the required action within 60 days or the proposal will be withdrawn from further IRB action.
If a research subject registers a complaint, the investigator shall attempt to relieve the complaint by explanation or by a change of procedure.
1. If the research was originally approved by a student's instructor (other than master's thesis research), documentation of the procedural change should be submitted to the faculty member for review. If the faculty member determines that the procedural change remains within the purview of his or her certification, he or she has the authority to approve the change. However, if the faculty member determines the procedural change would place the subjects above "minimal risk," referral to the IRB is required. In such cases, a description of the original project and the procedural changes are required.
2. If the research activity was originally approved by the IRB, the IRB Chairperson or the IRB Chairperson and one other IRB member, documentation of the procedural change must be submitted to the IRB for action.
Complete Appendices
A: Instructions for Informed Consent Document for the IRB
B: Policy Definitions
C: FAQ about IRB Regulations
D: Application to Use Human Subjects in Research
E: Certification of Education in the Use of Human Subjects in Research
F: Application for Expedited IRB Review
G: Application for Exemption from Full IRB Review
H: Certification For Course Instructors
I: Progress Report