Frequently Asked Questions

The Institutional Review Board (IRB) is a standing University committee established under the Federal Regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the auspices of the University of Texas Medical Branch. It oversees Institutional Compliance with Federal, State, and University guidelines relating to research with human subjects.

The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.

The committees are composed of persons who are sufficiently qualified, through experience and expertise, to review the research presented to them. In addition, they should be able to ascertain the acceptability of proposed research in terms of institutional policy, applicable law and standards of professional conduct and practice. Each committee includes at least one member whose primary concerns are in nonscientific areas and one member who is not affiliated with the institution, or part of the immediate family of a person who is affiliated with the institution. The members are appointed by the Institutional Official. Most members are UTMB faculty or staff. Nominations are received from the Chairs of University Departments.

No. The roster of our Institutional Review Boards change too frequently to provide you with a list of the members. The IRB will supply a letter for your sponsor in lieu of the membership list that includes a description of the composition of the IRB.

Please visit the UTMB IRB home page. There are several resources available including the IRB quarterly newsletter called the Navigator at http://research.utmb.edu/IRB/default.shtm. For the most complete information, the UTMB IRB Policy and Procedure manual is posted on line at http://research.utmb.edu/IRB/files/PPManual.pdf.

At UTMB the Institutional Official (IO) is a member of the senior leadership who is appointed by the UTMB President. The Institutional Official is responsible for overseeing that animal and human research complies with governmental regulatory requirements. In the case of human subject research, the IO makes the commitment on behalf of UTMB to comply with 45 CFR Part 46. The Institutional Official is responsible for reporting investigator noncompliance to regulatory authorities and sponsors as specified in Federal Regulations.

The Federalwide Assurance (FWA) is the agreement which UTMB has signed with the Office for Human Research Protections (OHRP), allowing research involving human subjects to take place.

Authority for the IRB is granted through the federal regulations that require any institution that receives federal money for research to establish Institutional Review Boards.

For activities involving human subjects in research, the Institutional Review Board has the authority to:

• Approve, require modifications to, defer action on, or disapprove research protocols involving human subjects;
• Require progress reports from the investigators;
• Oversee the conduct of human subject research ;
• Suspend or terminate IRB approval of protocols that are found to be noncompliant with institutional policies and procedures, state laws, and/or federal laws or regulations, taking into consideration the welfare of currently enrolled subjects;
• Place restrictions on serving as an investigator on human subject protocols;
• Conduct reviews and inquiries regarding research activities as needed to obtain information necessary for the fulfillment of their responsibilities under the institutional assurances;
• Place a “partial clinical hold” on the research, requiring the cessation of some aspect of the research (e.g., a particularly risky arm of a study, or stopping additional enrollments) until the non-compliance issues have been resolved and an adequate corrective action plan implemented;
• Order compliance audits;
• Issue letters of reprimand;
• Order notification of enrolled subjects (past or present) of issues regarding their participation in a study;
• Require modification to research protocols;
• Determine frequency of continuing review or monitoring;
• Monitor the consent process;
• Stipulate changes in consent process or documents;
• Require that currently enrolled subjects re-consent to participation;
• Request more information prior to making a final decision;
• Refer issues to other organizational entities such as UTMB legal counsel, risk management, or the research integrity officer; and
• Other actions as appropriate.

IRB approval is required prior to conducting human subject research. Two basic questions should be asked about an activity. The first is whether human subjects are involved and the second is whether it is research. The Office for Human Research Protections (OHRP) provides a useful decision chart at http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1

A “human subject” is a living individual about whom an investigator obtains either data through intervention or interaction with the individual or identifiable private information. Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize including interviews with persons, observation of behavior, and medical chart review.

The collection of information from medical records involves human subjects. Use of human subjects in research also includes the use of bodily materials, such as cells, blood or urine, tissues, organs, placenta, hair or nail clippings. Even if specimens are collected for medical reasons and then discarded, their use may constitute human subject research. The use of cell lines or DNA samples that can be associated with an individual is considered to involve human subjects. The NIH provides a useful brochure on the subject at: http://www.cancerdiagnosis.nci.nih.gov/humanSpecimens/ethical_collection/brochure.pdf

Research is defined as a systematic investigation when human beings or their environment is manipulated; when information is sought from them directly (as through interview, examination, or questionnaire) or indirectly (as through observation), and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, or other depositories--or through direct inquiry.

Yes. A few examples are as follows:

• Activity: the use of specimens or information obtained at autopsy. Reasoning: A living human subject is not involved.
• Activity: utilization of Medicare diagnoses and billing data where no personally identifiable information is available. Reasoning: there is no living human subject that can be affected by the researcher’s interaction with the data.
• Activity: A hospital Quality Improvement project. Reasoning: The information collected is not generalizable to other clinics or institutions. The intent is to improve care in that location. Note: Some Quality Improvement projects may also include aspects that are considered human subject research and therefore would require IRB review.
• Activity: A case report on an unusual medical case. Reasoning: The information in the case report is not a systematic investigation.

Some journals and organizations require IRB approval of studies prior to publication or presentation. If you plan to publish/present or you have any question about whether a study needs IRB approval, please contact the IRB staff. http://research.utmb.edu/IRB/contacts.shtm

Engaging in human subject research without IRB approval has serious ethical implications and violates UTMB and federal policies. Students, faculty, and staff are required to have IRB approval before embarking human subject research. Even pilot studies must be approved by the IRB. If you have any question about whether your project needs IRB approval, please contact the IRB staff.

http://research.utmb.edu/IRB/contacts.shtm

Any instances of non-compliance will be reported to the appropriate governing agencies. The University's policy states that non-compliance may result in, among other things, suspension or termination of the study; and/or suspension of research privileges at the University.

Ramifications for Faculty and Staff

• Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete or pending at the time of proposal submission.
• Many sponsors will not release funds to the University for the investigator’s use without IRB approval. The Sponsored Programs Pre-Award and Development office may establish an account for billing the IRB fee but the account cannot be used by the investigator until IRB approval is in place.
• Articles may not be published: most professional journals require evidence of IRB approval when considering articles for publication.
• UTMB will not support unapproved research: liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the University. The University will not, therefore, provide an investigator of an unapproved project, the resources to answer a liability complaint.
• Suspension of research: UTMB can suspend all research activities for a specified time frame as a disciplinary measure.

No. The IRB cannot provide approval for human subject research that occurred “after the fact.” The IRB can only approve activities before they occur.

Yes. The first class of research places subjects at no more than minimal risk. It is called “exempt” because IRB approval is not required. Studies in this class must be in one of several categories. The investigator must submit an Exempt application via INFOED to obtain IRB agreement that the activities are indeed exempt from IRB review.

The second class also places subjects at no more than minimal risk and the activities must all fall under the allowable categories for expedited review. This class is termed expedited because the protocol is not required to be reviewed at a convened meeting of the IRB.

The final class are those studies that may place subjects at more than minimal risk or do not fit the categories for exempt or expedited research. Such studies must be approved at a convened meeting of the IRB.

According to Federal Guidelines (45 CFR 46), research that presents little or no risk to human subjects (non-vulnerable subjects) does not require review at a convened meeting of the Institutional Review Board. Please see the decision chart http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c2

Although the project does not require full board review, the investigator must apply for the exemption before the research study may commence. A Chairman, Vice-Chairman or designated IRB member will administratively review the application for exemption. If the risks to human subjects appear more than minimal or the project does not fit into the allowable categories for exemption, the investigator will be notified that he/she must submit the study as a new project, for either full or expedited review. If you have doubts about the type of review, discuss your study with the IRB staff prior to submission.

• An observational study of the public behavior of persons at a tennis club, as long as you are not videotaping or photographing the people you are observing.
• An anonymous survey or interview (e.g., no names are collected or can be linked to the participants), as long as the survey does not cover sensitive or psychologically distressing topics.
• A study analyzing secondary data sets (e.g., Census Data or Medicare Data).
• Any study using archival documents that are publicly available, such as library archives or legal cases.

The categories for exemption can be viewed in the decision charts at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

• Use of personal/individual identifiers;
• Use of minors where interaction with researchers is involved (e.g., school settings that go beyond observations or where the researcher has contact with the children);
• The subject of research relates to sensitive information where the identities of the subjects may be capable of being recognized;
• Audiotaping or videotaping the subjects because then the subjects are not anonymous;
• Use of vulnerable populations including minors, pregnant women, prisoners, and cognitively impaired persons. Other groups may be considered vulnerable populations based on the study design.

A research project eligible for an expedited review is any research project in which the involvement of human subjects is considered low risk and it meets one or more of several categories. Please see

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c8 and http://www.hhs.gov/ohrp/policy/expedited98.html.

An expedited review is performed by an experienced IRB committee member (usually a Chairman or Vice-Chairman). The reviewer can approve, approve with stipulations, defer or refer to full board. The reviewer cannot disapprove a protocol. If the reviewer does not believe a protocol is approvable, he or she must forward it to the full board. Typically, expedited reviews occur within a few days of submission because they do not usually need to go to a scheduled full board meeting.

A list of procedures in certain categories helps to guide what type of review should be chosen and therefore what type of submission should be prepared. The activities listed on the expedited review form should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The expedited review form has the categories as described by federal regulations.

This list includes the following types of studies and methodologies:

1. Clinical studies of drugs or devices in which an IND or IDE application is not required.
2. Collection of blood samples by venipuncture in amounts not exceeding 450 mls.
3. Noninvasive collection of biological specimens such as hair and nail clippings, deciduous teeth, sweat, saliva, placenta removal at delivery, dental plaque and calculus, etc.
4. Collection of data through noninvasive, routinely employed clinical procedures (not x-rays).
5. Research involving materials that have been/will be collected for non-research purposes.
6. Voice recordings for research purposes, (i.e. to investigate speech defects).
7. Research on individual or group behavior via surveys, interviews or observations.

Yes. That is very common. For example, a study involving a simple blood draw, a medical chart review and a brief survey can be approved under categories 2, 5 and 7.

All research activities involving greater than minimal risk (physical, social, psychological, or financial risks) to the subjects must be considered through Full Board Review. This means the IRB must meet and review the application, protocol and associated documents at a convened meeting.

New Protocol Submissions:

Each protocol requiring full board review is assigned a Primary Reviewer. The Primary Reviewer examines all of the materials in the submission and presents it at a convened meeting of the IRB. All IRB members attending the meeting review the materials as well. The IRB assess that subjects are not exposed to undue risks by the research; that the nature of procedures of the research are ethical; and that the prospective subject can participate voluntarily as evidenced by the consent form.

The type of review is determined by federal guidelines that include evaluating the risks of the research project, what is involved, whether information is collected anonymously or confidentially, and other factors. Depending on the type of review, some can only be carried out at scheduled meetings of the IRB.  Investigators need to plan ahead when doing research and submit to the IRB so there is adequate time for review and approval before data collection is planned. 

If your protocol is scheduled for full board review, you will be notified by letter of who is assigned as the Primary Reviewer. All board members are expected to review the protocol but it is the responsibility of the Primary Reviewer to closely review the application, protocol and related documents and to present this information at the board meeting. The Primary Reviewer should attempt to identify issues that may potentially hold up approval and to try to resolve the issues if possible before the meeting. In doing this, the Primary Reviewer may contact the principal investigator or the research team to discuss the issue(s). Sometimes, other board members may have issues with a protocol that the Primary Reviewer did not foresee. Therefore, the Primary Reviewer should not be blamed if a protocol is not approved.

If an investigator would like to discuss concerns about an expedited or exempt protocol (a protocol that does not go before a full board) with the IRB reviewer, the request should be directed to IRB staff and they will contact the reviewer. The reviewer will contact the Principal Investigator.

After the IRB meeting, the IRB staff prepares the minutes. Memorandums are generated from the minutes advising investigators about the status of their projects. (It usually takes about 10 days for the memorandum to get to the investigator.) Investigators with projects receiving full approval at the meeting receive approval memorandums. Investigators with projects requiring additional work receive letters outlining what needs to be done to prepare an approvable submission. Sometimes projects are tabled or deferred because there is insufficient/inappropriate information in order for the IRB to make an appropriate decision. When a project is tabled or deferred, it must be re-considered by the IRB committee that tabled or deferred it. That is, the earliest it can be reconsidered is at the very next meeting of the same IRB. Both IRB’s meet once per month.

You can contact the IRB staff. Contact information can be found at http://research.utmb.edu/IRB/contacts.shtm

The forms are part of the INFOED system. Once you have the appropriate access in INFOED, the forms are available to you.

Exempt and expedited protocols usually take about 2 weeks. Approvals for protocols requiring full board review take on average 55 days although it can be done much more quickly. Much of it depends on the quality and care put in to the application and how quickly the investigator responds to the questions and stipulations of the IRB.

Though this may seem like a long time, the materials must be processed by the IRB staff, distributed to the IRB committees 10-14 days before the meeting for review, and then considered at the IRB meeting. The minutes from the meeting must be transcribed and the memorandums to the investigators prepared.

In keeping with the ethical obligation to respect patients’ privacy, the IRB encourages health care providers to inform their patients, and where appropriate, the patients’ families, that a case report is being prepared and how it may be used (lectures, publications, teaching rounds). This is particularly true when the case is rare enough that a patient, or someone close to the patients, could identify the patient given the condition being reported and the clinician's institutional affiliation.

In the event that a journal requests documentation of IRB approval for a single case report, the IRB has prepared a letter explaining its policy which can be sent to the editor.

All changes to an approved study must be submitted through INFOED for review and receive IRB approval before the changes can be implemented.

If you are revising your consent form(s) questionnaires, or recruiting material, attach the new form(s). Please provide a hi-lighted version indicating where the changes were made.

The protocol may be changed without prior IRB approval only when there is an apparent immediate hazard to a subject, however, the IRB must be notified by letter as soon as possible of such a change and review is required immediately. The submission of a revision does not change the expiration date of a project. The expiration date is always one year from the time of the initial review or periodic review.

Changes in study personnel must be submitted via INFOED using the “Request for Change in Study Personnel” e-Form. This requested change must be reviewed and approved by the IRB before new personnel begin their participation in the study.

Submit the flyers, advertisements, radio scripts, brochures, etc. via INFOED using the “Miscellaneous Request e-Form”. Do not utilize such materials until they are reviewed and approved by the IRB.

A Continuing Review is a reevaluation of an approved project conducted at least once a year, as mandated by federal regulations. This review allows the IRB to monitor the progress of the project. For protocols requiring annual review, a “Report for Continuing Review” e-Form must be submitted via INFOED approximately 10 months after the date of last year's approval. Although the IRB will send courtesy memorandums stating the Continuing Review is due, it is the investigator’s responsibility to know when his/her project expires (occasionally, for one reason or another, the investigator may not receive a memorandum). The failure to submit a Report for Continuing Review e-Form on time will likely result in the suspension of some, if not all research activities on the protocol.

If the study is in the stage of data analysis, it should remain open. Research protocols must have continuing approval until all data analysis have been completed and termination reports are submitted. After the project has expired, no further research can be done. It is very important if you don't want your project closed that you remain in compliance by submitting your application for renewal in adequate time for review. If your project is not reviewed and approved prior to the expiration date, no further research can be done. All research must stop.

If you are uncertain about the expiration date of your project, consult the initial approval letter. The expiration date does not change despite other submissions about the project during the year.

IRB staff sends an electronic communication, “Notice of Continuing Review” reminder to the principal investigator eight weeks prior to the deadline for submission. Investigators should also track their periodic review due dates themselves. The periodic review should be submitted about 60 days before it is scheduled to expire.

Federal regulations allow IRBs to review the progress of a study as often as necessary to ensure the rights and safety of the research participants. The IRB usually decides the frequency of review based on the level of risk associated with participation although other factors such as the experience and expertise of the investigator may be a consideration as well. The IRB may require review after the enrollment of a number of patients or after a certain period (e.g., 6 months).

Yes, the “Application for Inclusion of Prisoners as Research Subjects” e-form needs to be completed in INFOED. Additionally, there is paperwork that you must file with the Texas Department of Criminal Justice (TDCJ). The inclusion of prisoners requires special considerations and alternate procedures. For example, the consent form needs to contain information appropriate for prisoners (see template http://research.utmb.edu/IRB/infoedforms.shtm).

• The research under review represents one of the categories of research permissible under 45 CFR 46.306(a)(2).
• Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
• The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
• Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
• The information is presented in language which is understandable to the subject population.
• Adequate assurance exists that parole boards will not take into account a prisoner's. participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.
• Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.

The research must fit one of the following categories:

• Incarceration and criminal behavior- Research that involves the study of the possible causes, effects, and processes of incarceration, and of criminal behavior. The research must not involve more than minimal risk, and no more than inconvenience to subjects.
• Prisons as institutions, or prisoners as incarcerated persons- Research that involves the study of prisons as institutional structures, or prisoners as incarcerated persons. The research must not involve more than minimal risk, and no more than inconvenience to subjects.
• Conditions affecting prisoners as a class- Research that involves the study of conditions that particularly affect prisoners as a class (i.e., research on hepatitis which is more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction and sexual assaults).
• Practices to improve the health or well-being of subjects- Research that involves the study of practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of subjects are applicable to this category. When the research requires assignment of prisoners to control groups which may not benefit, federally funded projects may require a process of federal consultation and review prior to initiation of the study.
• Epidemiological Research - defined as ‘public health research’ that focuses on a particular condition or disease in order to (i) describe its prevalence or incidence by identifying all cases, including prisoner cases, or (ii) study potential risk factor associations, where the human subjects may include prisoners in the study population but not exclusively as a target group, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.

For research that is funded by the Department of Health and Human Services (DHHS) (or otherwise federally funded, with required reporting to the DHHS) approval to start enrolling prisoners requires a receipt by the IRB of the certification letter from the DHHS. The DHHS must also agree that the research fits an allowable category.

“Minimal risk” is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

No. You are not targeting the population nor are you directly interacting with prisoners. Their status as a prisoner should not be recorded in the research data.