1. What is the Belmont Report?
On September 30, 1978, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research submitted its report entitled, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research.” The basic ethical principles are:
The report also describes how these principles apply to the conduct of research. Specifically, the principle of respect for persons underlies the need to obtain informed consent; the principle of beneficence obliges researcher to weigh the risk/benefit factor and minimize risks, and principal requires that subjects be fairly selected.
2. What is the federal legal basis for the protection of human research subjects?
The Federal Policy for the Protection of Humans Subjects was published in the Federal Register on June 18, 1991, as a common final rule (56FR28004). It applies to 16 federal agencies conducting or supporting research involving human subjects and seeks to protect assessment of risks and benefits of research to human subjects; and an informed consent process.
3. What is the University’s policy for the use of human subjects in research?
The University’s policy, affirmed in a formal assurance to the federal government, is that all research involving human subjects, conducted by Texas A&M International University (or any other agency of The Texas A&M International University) faculty, employees, or postdoctoral, graduate, and undergraduate students or using members of The Texas A&M International University community as subjects and regardless of the source of funding, will be reviewed and approved by The Texas A&M International University’s Institutional Review Board-Human Subjects in Research (IRB) (in accordance with federal policy and the Belmont Report), except for categories specifically exempt. The IRB will not permit involvement of human subjects in research until it has reviewed and approved the protocol and the appropriate informed consent documents. The IRB is the final authority on determining exempt protocols.
1. What is the Institutional Review Board (IRB)?
The IRB is the Texas A&M International University committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB have at least five members representing a variety of backgrounds, training and experience, at least one member must have no formal or family connection with the University and be invited to serves as a representative of the community to the Board. The Provost appoints the University’s Board members.
2. What are the IRB’s responsibilities?
The IRB reviews research protocols to ensure that the rights and welfare of subjects are protected and that the proposed use of human subjects is in compliance with federal, state and University regulations.
3. How does the IRB work?
4. What criteria does the Board use for reviewing research protocols?
Before granting approval, the IRB must be satisfied that the following criteria are met:
(1) The 1st ethical principle of Beneficence is based on the maxim, “Do no harm.” Risks and benefits must be stated, therefore, subjects must be protected from discomfort and harm;
(2) The 2nd ethical principle is based on Human Dignity, which is based on two components: the right to self-determination and the right to full disclosure. The right to self-determination means that subjects must be able to make their decision about participating in a study without fear or risk of incurring a penalty or prejudicial treatment. This decision must NOT be made under coercion. The right to full disclosure means that the subjects have the right to be informed about the purpose and nature of a study, what will participation involve, the researcher’s role in the study, and the risks and benefits that are likely to be incurred as a result of participation;
(3) The 3rd ethical principle is Justice. The principle encompasses subjects’ rights to fair treatment and privacy. The two strategies used to protect privacy are anonymity and confidentiality.
5. Can the Board stop me from conducting my experiment?
Yes. The IRB has the authority to suspend or terminate research that is not carried out according to its requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the IRB’s reasons for its action and will be reported promptly to the principal investigator, the department head, and the funding agency, if there is one.
6. Does the IRB serve as a scientific review panel?
No, but the purpose of an IRB is for the protection of the participants in the research by reviewing a study’s informed consent and adherence to the ethical principles for conducting research.
7. Does the IRB continue to review projects once they have been approved?
Yes. The Board is required to conduct continuing review of research covered by federal regulations at intervals appropriate to the degree of risk, but not less than once each year. The Board also has the authority to observe or have a third party observe the consent process and the research.
8. If I make any changes in my protocol does the IRB have to review and approve it again?
Yes. Any changes to your protocol must be reviewed and approved by the Board prior to use. In most cases, however, this can be done quickly by the IRB chair and/or selected members of the Board.
9. Is IRB Approval needed if research is conducted as a course requirement?
Some classroom projects may not require IRB approval. We suggest contacting the IRB.
10. Is the IRB approval required for the graduate research involving human subjects?
Yes. If the Dean of the College or the Office of Graduate Studies has no record of an IRB approval, and thesis is part of the degree requirement, the University will deny awarding the degree.
11. Do principal investigators and department chairs have any role in reviewing proposals involving human subjects?
Yes. Both the principal investigator (PI) and the department chair are responsible to ensure that all research involving human subjects is submitted to the IRB for appropriate review. The IRB makes the final decision whether a protocol receives exempt status. If there is a question, you are encouraged to call the IRB chair. PIs and department chairs are also responsible for reporting promptly to the IRB any serious or continuing noncompliance with federal or University policies.
12. Can I begin my research before I receive IRB approval?
No. Research must be approved by the IRB before research can be conducted.
13. If I do begin my research before IRB approval, what action may be taken against me?
Your research study will be terminated by the IRB, which could lead to loss of research funding. Graduate students who begin human subject research before IRB approval may be denied permission to graduate.
1. What are the forms and procedures I must follow to have my research approved?
The forms and procedures are available from the Texas A&M International University IRB website. All forms are to be typewritten, the consent form (s), and instrument (s) are also to be submitted at the same time.
2. What is the difference between “practice” and “research” or between “program evaluation” and “research”?
“Practice” consists of interventions designed to enhance the well-being of a patient or client. “Program Evaluation” consists of standard questionnaires or procedures designed to evaluate the effectiveness of standard, non-experimental programs. The purpose of program evaluations is for administrative review, not to answer a research question. “Research” is designed to test research questions, hypothesis, and permit conclusions to be drawn; thereby, develop or contribute to generalize knowledge.
Research and practice can be carried out together, as can a program evaluation and research. However, as a general rule, if there is any element of human-subject research in an activity, then that activity should be described in a protocol and submitted to the IRB.
3. Do I need IRB approval if my work will be conducted outside of the Texas A&M International University campus? Do I need IRB approval if my study is already approved by another IRB?
Yes. To ensure that Texas A&M International University’s investigators comply with federal and University regulations, it is important that the University, through the IRB, be aware of where and by whom such research is being done, even if it is done in a foreign country. In cases where the research is not funded through Texas A&M International University, or conducted outside the Campus, formal approval still must come from a human subjects review panel in the host institution or country. This approval must then be received and approved by the Texas A&M International University IRB.
4. What procedures are recommended for conducting international research?
Review the laws, regulations, and guidelines for the country where you are proposing to do your research project, which may be found in the International Compilation of Human Research Standards (http://www.hhs.gov/ohrp/international/index.html), then write up and submit your TAMIU IRB protocol.
5. Will the IRB accept approval for research by a foreign or host country review panel?
Yes, but only if the IRB and/or the funding agency determines that procedures prescribed by a foreign institution give protection at least equal to U.S. regulations. In such cases the funding agency head may approve the substitution of foreign procedures in lieu of the procedural requirements for U.S. regulations. The IRB must be notified when such substitutions are sought and granted.
6. Do I need IRB approval if my study is already approved by another IRB?
Yes, Members of the Texas A&M International University family who will be collaborating in a study already approved by another IRB may be required to submit the required forms to the Texas A&M IRB for approval. If the investigation is being completed on the Texas A&M International University campus, then the Texas A&M IRB consent forms must be used. If the investigation is not being completed on the Texas A&M campus, then the investigator will have to follow the requirements of the other IRB.
7. Who do I contact about projects involving UISD or LISD schools?
LISD - Gerardo G. Cruz, Assistant Superintendent for Human Resources, 273-1001, gcruz@Laredoisd.org LISD Research Request
UISD - Liz Raymond, Coordinator of Family Services, 473-8772, email@example.com UISD Research Agreement
8. What is the correct address and phone number for the TAMIU Community Counseling Center?
Services are provided in two different locations: 915 Zaragoza St. (Casa Ortiz) and 5201 University Blvd. (Canseco Hall 205A). To obtain an appointment please call and leave your information at: (956) 326-3120
9. How do I administer an electronic survey?
Documentation of consent for electronic surveys is difficult. Therefore in most cases, investigators need to request a waiver of documentation of informed consent.
After the survey and protocol have been approved, if you need help with dissemination, the TAMIU IRB will forward firstname.lastname@example.org a copy of your approved survey. If necessary, then you contact the Information Security Officer (email@example.com to discuss how to disseminate your survey. You need to include the standard IRB sentences (see below) in the text of the mass email when you send it out to request participants fill out the survey.
This research study has been reviewed by the Institutional Review Board (IRB) at Texas A&M International University. For questions regarding your rights as a research participant, or if you have complaints, concerns, or questions about the research, you can contact Dr. Jennifer Coronado (English), IRB Chair, 956-326-3060, firstname.lastname@example.org, or Dr. Roberto Heredia (English/Spanish), 956-326-2637, email@example.com.
1. Do all research require full review and approval by the IRB?
No. Some protocols, because of the nature of the research involved, are exempt by the federal regulations from full IRB approval. Exempt does not mean the protocols will not be reviewed by the IRB, only that these protocols will not be reviewed by the full committee. The IRB makes the final decision on whether a proposal falls under the exempt category. In addition, there are expedited reviews for certain kinds of low-risk research.
2. What is the basis for exemption?
There are number of clearly specified exempt categories for human-subject research. These are listed on the Office of Human Research Protections website: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html. However all exempt protocols must still be submitted to the IRB.
1. Is it always necessary to furnish an informed consent document to participants in a study?
Consent is required from any human being who is a subject in research unless:
2. What kind of consent form must I use?
A written consent document based on the consent form template. This form may be read to the subject or the subject’s legally authorized representative. In any event, you shall give either the subject or the representative adequate opportunity to read the form before signing it.
3. How long must I keep signed consent forms?
Signed forms must be kept on file for a least three (3) years after the completion of the study. Some areas of research require that the forms and data be kept longer (e.g., American Psychological association requires forms and data be kept for six years).
4. Do I need to obtain consent from children?
Yes. Title 45 CFR Part 46, Subpart D provides for “Additional Protections for Children Involved as Subjects of Research.”
If your research involves children you need to obtain consent in the form of an ASSENT FORM (contact firstname.lastname@example.org for age appropriate assent template). Assent means permission from children under the age of eighteen (18) and must be obtained from the child and consent obtained from the parent or legal guardian; children under seven (7) may have their part in the research explained to them verbally.
The laws defining the minor status of a child are statutory and vary from state to state. Often a child’s competency to consent is governed by age, with incompetence being nonrefutable up to age 7 years. A child younger than 7 years is not believed to be mature enough to give assent or consent to research. By age 7, a child is capable of concrete operations of thought and can give meaningful assent to participate as a subject in studies.
5. Do projects involving students in the Departmental Subject Pools or in class require any additional information in the consent form?
Yes. For students required to participate in the subject pool you must make clear the terms under which they will receive credit for full or partial participation, their freedom to not take part in all or any part of an experiment, and the alternative ways in which they might fulfill their course requirements.
If students in a class (not a subject pool) are potential participants, they must be told what, if any, benefit or credit they will receive. Alternative ways to obtain credit that is value equivalent and requires equivalent time and effort must be provided.
An instructor should not approach his/her class to be research participants. Someone other than the instructor should carry out the consent process, research endeavors, and care should be taken to set up conditions to prevent a student from being coerced to participate in a research endeavor.
In all human-subject research where sensitive issues of personal behavior (e.g. depression, addiction, substance abuse, dietary disorders, suicidal tendencies, sexual disorders) might be revealed in the course of research, you must include on the consent form sources of professional consultation and care. In addition, efforts must be made to insure that all participants are legally adults.
Because much research, particularly in Psychology, is conducted in the context of both teaching and research, you are encouraged to provide the subjects with an oral or written explanation (debriefing) of the nature, design, and implications of the project even if deception is not a part of the experiment.
6. Is it necessary to explain to the subjects ahead of time how data from the study will be used?
Yes. If data obtained will be made available to any person or organization other than the subject, the investigator, and the investigator staff, the informed consent must disclose: the person or agencies to whom the information will be furnished; the purpose of the disclosure; and the nature of the information to be furnished.
7. How can I protect the anonymity/confidentiality of research subjects if they are paid research subjects?
If research subjects are paid from University funds, there is no guarantee that the fact that the subjects participated in the investigation can be kept anonymous or confidential. Paying research subjects with money or gift certificates purchased with University funds requires that a record of their participation be kept. This is a Texas A&M Fiscal Office rule, not an IRB rule. Consequently, if research subjects are to be paid for participating, a statement must be placed in the consent form stating that while the information provided by the subject is anonymous or confidential, the fact that the subject participated has been paid with University funds, the research study is subject to the Open Records Act.