Common Questions and Answers
about the Institutional Review Board
- Ethical and Regulatory Background
- Institutional Review Board
- Procedures for Review of Research Involving Human Subjects
- Exempt Protocols
- Informed Consent
I. Ethical and Regulatory Background
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:
- Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.
- Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
- Justice requires that the benefits and burdens of research be distributed fairly.
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.
II. Institutional Review Board
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 President/ Provost appoint 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?
One copy of the necessary information (See Procedures and Forms for Requesting Approval to Conduct Research Involving Human Subjects) are submitted to one of the IRB members at least five (5 ) working days prior to the monthly meeting. The Board typically meets on the third Wednesday of each month. All of the Board members who are present at the meeting will evaluate and discuss the protocol. The Board approval requires a majority vote, providing a quorum is present. In addition, the Board may require additional information or modification of the research protocol. The Board may also table or not approve a protocol if the research is unclear or the procedures poorly defined and/or if the proposal does not significantly comply with the IRB’s requirements and regulations. You will be notified in writing of the Board’s decision.
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:
- The basic ethical principles are stated:
(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.
- Informed Consent: each subject must be given this document that contains the three ethical principles as stated above. Therefore, informed consent consists of three components: adequate information, comprehension of the information, and free choice regarding participation. See checklist of informational components for informed consent.
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. Most reviews are conducted through a questionnaire reporting the status of the project, completed by the principal investigator and returned to the Chair.
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. In most cases, however, this can be done quickly through an expedited review by the IRB chair and 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 principle 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 PI may request an exemption from full board review, but 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. However, a member of the IRB can give permission to a person to start the research after the member has reviewed the protocol, with the knowledge that the research can be stopped after all members of the IRB committee have reviewed the protocol and requests more information..
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.
III. Procedures for Review of Research Involving Human Subjects.
1. What are the forms and procedures I must follow to have my research approved?
The forms I & II and procedures are available from any member of the IRB. They also can be downloaded from the IRB web site posted on Texas A&M International University website. All forms are to be typewritten, the consent form (s), check-list, 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. 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.
5. 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 will still 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.
6. Who do I contact about projects involving UISD or LISD schools?
LISD - David Garza, Executive Director of Human Resources, 795-3201, email@example.com
UISD - Liz Raymond, Coordinator of Family Services, 473-8772, firstname.lastname@example.org UISD Research Agreement
7. How do I administer an electronic survey?
If you are requesting demographic information that is specific enough that it is possible to identify person filling out the survey, it needs to either make it explicitly clear that the demographic section is not required or you need to state that the survey is “confidential” not “anonymous” and clearly define what that means, so respondents know exactly what will be done with their data. Before any study involving mass emails for survey subject recruitment can be approved, the principal investigator needs to submit their protocol and get the survey approved by the IRB.
After the survey and protocol have been approved, the TAMIU IRB will forward email@example.com a copy of your approval letter and approved survey. Next you pick up your approval letter from KL326 and then you contact the Information Security Officer (firstname.lastname@example.org and Cc email@example.com) and discuss how to disseminate your survey. Basically this is to give OIT a heads up that this type of survey is coming and for them to review your proposed electronic survey administration plan with an eye on the potential security issues or problems. 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, 956-326-2673, firstname.lastname@example.org, or Dr. Roberto Heredia (English/Spanish), 956-326-2637, email@example.com.
IV. Exempt Protocols
1. Do all research require full review and approval by the IRB?
No. Some protocols, because of the nature of the research involved, are exempted by the federal regulations for 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 in the TAMIU IRB Policy and Procedure Manual under the heading “Categories Exempt From Full IRB Review.” However all exempt protocols must still be submitted to the IRB.
3. How are exempt protocols administered?
All exempt protocols, along with the cover sheets and an informed consent document must be submitted to the IRB Representative of your College, where it will be sent for review and approval by the IRB Committee. All exempt protocols are, however, subject to review by the full IRB at its discretion.
4. Are consent forms required for exempt research?
Yes. Informed consent documents must be provided unless the research involves telephone, mail out or person-on-the-street surveys.
V. Informed Consent
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:
- Informed consent has been specifically waived by the IRB,
- Informed consent is not required as part of an exempt protocol, or
- The researcher has obtained the legally effective informed consent from the subject’s legally authorized representative, guardian, etc.
2. What kind of consent form must I use?
You may use a consent from that is either:
- A written consent document that includes the information outlined in the packet, “Procedures and Forms for Requesting Approval to Conduct Research Involving Human Subjects.” 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 or;
- A short form written consent document stating that the required information has been presented orally to the subject or the subject’s legally authorized representative. When the short form is used, you must ensure that:
(a) a witness is present at the oral presentation;
(b) the short form is signed by the subject or the representative;
(c) the witness signs both the short form and copy of the written summary of the oral presentation;
(d) the person obtaining consent signs a copy of the summary;
(e) a copy of both the short form and summary is given to the subject or the representative; and
(f) the written summary of what is to be said to the subject or the subject’s representative receives the prior approval of the IRB.
- In a sensitive tape recorded interview which might be compromised by the presentation of official forms to be signed, the interviewer will ask the subject, on tape, to state his/her understanding of and willingness to participate in the research project. This taped statement may be used in lieu of a signed consent form, but all elements of consent must be included in the taped discussion. Additionally, the subject must be given a copy of the script if they so desire. In such cases, this tape recording must be kept for three years after completion of the project.
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. Assent means permission from children under the age of eighteen (18) and must be obtained from the child and the parent or legal guardian; children under seven (7) may have their part in the research explained to them verbally. Special care should be taken to draft an informed assent document easily understood by the age group selected for the research.
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.