Section 3: General Policies and Procedures
3.1 Applicable Regulations and Laws
The purpose and responsibility of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects. The IRB reviews and oversees research activities involving human subjects and requires that the research complies, as applicable, with Federal regulations at 45 CFR 46, Subparts A, B, C, and D, (or equivalent policies and procedures), the FDA 21 CFR Parts 50, 56, 312, and 812, Texas law and all other pertinent regulations and guidelines. Compliance with this policy or the procedures set forth herein will in no way render inapplicable pertinent laws of the State of Texas, any local law which may bear upon the proposed activity, or The University of Texas System Rules or Regulations of the Board of Regents.
In addition, the Office of the Vice President for Legal Affairs provides the IRB, ORS, and other components on the HRPP with counsel on an as needed basis, primarily on matters related to state laws, cooperative agreements, conflicts of interest, and contractual issues in human subjects research.
3.2 Institutional Review Board
Safeguarding the rights and welfare of subjects at risk in any research activity, whether financially supported or not, and irrespective of the source of any supporting funds, is primarily the responsibility of the institution. In order to provide for the adequate discharge of the institutional responsibility, no non-exempt research activity involving human subjects may be undertaken by any faculty, staff, employee or student at The University of Texas at Austin (University) unless an IRB has reviewed and approved the research prior to commencing the research activity.
3.2.2 Designation and Authority
The University has designated one IRB responsible for conducting initial and continuing reviews and providing oversight for all research activities involving the use of human subjects performed by agents or employees of the University. The scope of research reviewed by the IRB is not limited and the IRB reviews all types of research submitted.
The Institutional Officer (IO) formally grants the IRB the following authority relative to the protection of human subjects:
- To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the agents of the organization and involving human subjects, based on its consideration of the risks and potential benefits of the research and whether the rights and welfare of the subjects are adequately protected;
- To require reports for protocol continuing review;
- To continuously monitor the conduct of research with human subjects;
- To suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious risk to subjects;
- To place restrictions on a study, if necessary to protect human research subjects;
- To observe, or have a third party observe, the consent process;
- To observe, or have a third party observe, the conduct of the research.
No official within the organization may approve a protocol or human subjects research activity that has not been approved by the IRB. However, the IO or any other University executive administrative official may disapprove a protocol or research activity that has been approved by the IRB.
3.2.3 Composition and Appointment of the IRB
The IRB is a committee formally appointed by the IO, with input and membership nominations coming from the IRB Chair and IRB members, the ORS Director, University department chairs, and self-nominations, and is composed of a sufficient number of members to assure complete and adequate review of activities commonly conducted at the University. The composition of the IRB exceeds the minimum regulatory requirements and is sufficiently qualified through the maturity, experience, and expertise of their members and diversity (experience, expertise, racial, cultural, and gender) of membership to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the IRB is able to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes and are constituted to meet those requirements.
Scientific members of the IRB generally will have had experience in research involving human subjects, and will be recruited from among active research members of the University. Nonscientific members will be recruited from the faculty at large and will reflect professional expertise in a non-scientific area, such as law, ethics, human or patient rights, etc. The appointment of non-affiliated (community) members and a prisoner representative will also be done by the IO but the Office of Research Support (ORS) Director is responsible for determining whether or not the nominees are truly unaffiliated and/or have appropriate expertise to serve as prisoner representative.
Alternates are appointed and function in the same manner as the primary IRB members. The alternate's expertise is comparable to those of the primary member. The role of the alternate member is to serve as a voting member of the IRB when the regular member is unable to attend a convened meeting. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the IRB meeting that the primary member received or would have received. The alternate member will not be counted as a voting member unless the primary member is absent. The IRB minutes will document when an alternate member replaces a primary member.
At times, the IRB may not have the necessary expertise to judge the scientific soundness of a research protocol and may be unable to make a fair and accurate determination of the risk-benefit ratio. For these protocols the IRB Chair, or the primary reviewer after consultation with the IRB Chair, may call upon an ad hoc consultant for assistance in review for scientific merit or to perform an in-depth review of the study. The ad hoc consultants are not considered to be members of the IRB, are utilized only for expert scientific review, have no voting rights and must disclose whether or not he/she has any conflicts of interest with the protocol. The consultants will submit a written report and copies of the report will be distributed to all IRB members. The report and recommendations will be documented in the IRB minutes for the meeting. It is expected that, because of the wide diversity of IRB members, the use of ad hoc consultants will be a rare occurrence.
The IO may appoint administrative staff and/or faculty (e.g., legal counsel) at the University to serve as non-voting members of the IRB should the IO, the IRB Chair, or the ORS Director decide that such persons would be of assistance to the IRB in conducting its duties. A non-voting member cannot be counted in the quorum and cannot vote, but can participate in discussions and deliberations. OSP staff/director is usually present but have no voting rights (so as to separate University related business functions from ethical review.)
In addition, funding agencies may have additional IRB membership requirements. For example, the National Institute on Disability and Rehabilitation Research (NIDRR) specifies that when an IRB reviews an NIDRR-funded research project that purposefully includes children with disabilities as research subjects, the IRB must include at least one person whose primary interest is the welfare of children with disabilities. When reviewing these types of research projects, the IRB may use ad hoc reviewers with specific expertise in treating children with disabilities.
ORS will report changes in IRB membership to OHRP as required.
3.3 Term of Appointment
IRB members are appointed to one-year, renewable terms. The IRB Chair and Vice Chair are expected to hold the positions for several years. Upon appointment and again at time of annual reappointment, each IRB member is queried to determine roster information such as affiliation status, relationship of the member to the University, indications of experience and other relevant information. IRB member's performance will be reviewed annually by the IRB Chair and Vice Chair. IRB members who are not performing in accordance with the IRB's mission or policies and procedures or who have an undue number of absences will not be reappointed. Feedback will be provided to the members by the IRB Chair and IO.
3.4 Committee Officers
The IRB will have a Chair and a Vice Chair chosen from IRB members and will typically be members of the faculty of the University knowledgeable in human subjects research, including the federal and state regulations, University policies, and ethics relevant to such research. The IRB Chair shall preside over and be authorized to speak for the IRB. Whenever the Chair is not available, the Vice Chair will assume the responsibilities of the IRB Chair during the period of their absence.
In order to conduct IRB business, there must be a quorum of members present at a convened meeting. If quorum is lost, votes are not taken until it is restored. To be approved, a protocol must receive a majority of votes of members present at the meeting. The IRB shall hold regular meetings at a time and place to be determined by the IRB and posted electronically. Researchers are welcome to attend to address specific concerns regarding research protocols but will be asked to leave the meeting during all deliberations and votes. Other members of the University community are permitted to attend meetings but, due to limited seating space, must request attendance through the IRB Director. Guests may be asked to sign a confidentially agreement.
Prior to each full board meeting the IRB Program Coordinators or the IRB Chair will review the agenda of protocols and will assign primary reviewer(s) knowledgeable about or experienced in working with these types of studies. The IRB Program Coordinator ensures that either the Primary or Secondary Reviewer is present at the meeting or available by teleconference during the convened meeting.
3.6 IRB Meeting Minutes
IRB meeting minutes are recorded in writing in sufficient detail to allow an outside observer to reconstruct protocol specific discussions and determinations. IRB Program Coordinator(s) monitor quorum at each meeting, records and IRB discussion points for the minutes. Meeting minutes are distributed each month to those IRB members who were in attendance at the given meeting, the ORS Director and Assistant Director, and the IRB Program Coordinators via secure website with a request for comments and/or suggested changes regarding the document's accuracy. After all comments are reviewed and addressed if appropriate, a pending version of the minutes are available for review prior to and discussion at the next IRB meeting. A vote for approval of the final version of the minutes occurs at the next convened meeting. Once approved, the IO is notified and provided access to the secure location of the approved minutes in order to review all actions taken by the IRB.
Minutes shall include:
- A protocol summary and the deliberations for each protocol and the resulting IRB action.
- The approval period for each initial review, continuing review and amendment.
- A record of attendance for each protocol including the names of members who left the meeting due to a conflict of interest and a notation of such.
- The voting record for each protocol and the previous meeting's minutes reflecting the number of members for, against or abstaining from the vote and when alternate members replaced a primary member.
- The basis for requiring changes to a protocol, tabling or disapproving research.
- A written summary of the discussion and resolution of controverted issues.
- Justification of deletions or substantive modifications of information concerning risks or alternative procedures contained in a HHS approved consent form.
- If applicable, summaries of deliberations of protocols for inclusion of vulnerable populations.
- If applicable, the rationale for significant risk/non-significant risk device determinations.
- If applicable, protocol specific justifications for waivers of consent and research involving vulnerable populations.
- A list of all actions that were taken administratively during the previous month.
3.7 Confidentiality of the Review Process
During the process of initial, continuing review, or amendment of an activity, material provided to the IRB and ORS shall be considered privileged information and the IRB shall assure the confidentiality of the data contained therein.
3.8 Conflict of Interest
3.8.1 IRB Members – Convened Meeting
The IRB is charged with protecting research subjects from risks in experimental studies. Principles codified in the Nuremberg Code, the Declaration of Helsinki, Belmont Report, and existing federal regulations are employed to provide a framework for ethical considerations and assessment of risk and benefit in individual studies. The decisions made by the IRB are guided by these principles, but the IRB can only be successful if members are free of conflict of interest (COI).
Prior to discussion of protocols at a convened meeting, the IRB Chair will ask if any member has a COI with any protocol being discussed at that meeting. Should an IRB member declare involvement in any way in a research protocol under review by the IRB, or state a COI with the research protocol the following is required:
- IRB member is excluded from discussion and voting except to provide information requested by the IRB.
- IRB member leaves the meeting room during discussion and voting.
- IRB member is not counted towards quorum.
3.8.2 Designated Reviewers for Expedited Review
IRB members who are IRB Chair designated reviewers for initial or continuing review of research protocols, reports of noncompliance, protocol deviations, unanticipated problems, and amendment requests that qualify for expedited review will self-identify any COI that they may have with the research or PI. In such cases, the review responsibility will be reassigned to another experienced IRB member.
3.8.3 Examples of IRB Member COI
IRB members are considered to have a conflict of interest if they:
- Are involved in the design, conduct, or reporting of the research study.
- Have direct administrative powers over the investigators or the study.
- Have a financial and/or ownership interest of any amount in or related to the research and the value can be readily determined.
- Have a financial and/or ownership interest in or related to the research but the value cannot be readily determined.
- Received or will receive compensation and/or have ownership interest of any amount with value that may be affected by the outcome of the study.
- Have received in the past year, currently are receiving, or will receive from the sponsor of the study, honoraria, payments, or compensation of any amount.
- Have a proprietary interest in the research, including but not limited to a patent, trademark, copyright, or licensing agreement.
- Serve as directors, board members, scientific advisors or hold other decision making positions in the entity sponsoring the research.
- Are not an investigator, co-investigator, or consultant on a study, but are closely associated with the investigators on the study being reviewed, or other studies.
- Have personal, familial, or intimate relationships with the principal investigator.
- For any reason, believe they cannot be objective concerning a study.
3.8.4 Principal Investigator
All PIs and their research staff are required to disclose any financial COI according to the University COI policy found in the Handbook of Operating Procedures and Policy Memoranda. Disclosed COIs that might affect the protection of subjects must have a management plan in place. Management plans may include: partial or complete divestment, limiting involvement of the conflicted individual, additional oversight, or disclosure. Disclosure alone cannot be used to manage conflicts of interests that might affect the protection of subjects.
When made aware of a possible researcher conflict, the IRB formally refers cases to the Committee on Objectivity in Research (COIR), which in turn determines if formal COI management strategies are required. If required, the COIR Chair will request the PI/researcher prepare a draft COI Management Plan for submission to the COIR for review. The COIR Chair will work with the PI/researcher to develop and finalize a COI Management Plan. When finalized, the COI Management Plan will be submitted to the IRB for review and final approval. Under no circumstances will research be approved until the IRB has reviewed and approved the COI Management Plan.
In cases in which the COIR identifies a situation involving possible institutional COI, such cases will be sent to the Institutional Compliance Officer for review and disposition. Institutional COIs are handled according to the University Institutional Conflict of Interest in Human Subjects Research policy found in the Handbook of Operating Procedures and Policy Memoranda.
3.9 Interaction with Other University of Texas Components and Commencement of Research Activities
The University is comprised of multiple types of research review and some reviews are accomplished by standing committees, e.g., Objectivity in Research Committee, Scientific Integrity Committee, Biological Safety Committee, and the Office of Sponsored Projects. The successful fulfillment of the University’s intent to protect human research subjects is dependent upon open communication among these various institutional components. These committees and offices exchange information, when necessary, to assure that, in addition to IRB review, human subjects research receives all appropriate review prior to implementation of the research activities. Human subjects research is not allowed to commence until all applicable reviews are complete and notification of approval is received by the IRB.
3.10 Types of Research Conducted at the University
The majority of research at the University is social-behavioral in nature. The University does not participate in planned emergency research described in and covered under 21 CFR 50.54 and OHRP Guidance 97-01.
3.11 Categories of Research Subjects
Human subjects research at the University generally includes normal healthy individuals; adults and/or children. The IRB reviews and approves research proposing inclusion of vulnerable populations. The vulnerable populations most commonly included in research activities are children, prisoners, pregnant women, and decisionally impaired adults.
3.12 Determining if IRB Review is Required
3.12.1 Determination of Human Subjects Research
Most of the time, it will be obvious whether or not the University and a PI are engaged in human subjects research. However, at times, the IRB Program Coordinators (consulting with the ORS Director, Chair, or Vice Chair, if needed) will need to determine if the proposed activity constitutes engagement in human subjects research. The first determination is whether or not the activity proposed is research (for HHS supported studies) or a clinical investigation (for FDA regulated studies). The second determination to be made is whether or not human subjects are involved. The determination is made by using the appropriate definitions found in Section 2 of this manual. The ORS office will accept requests for determinations by telephone, e-mail or by letter. Information required to make the determination includes a description of the activity, data collection methods and the research setting. Further information may be requested. Determinations of whether or not activities constitute human subjects research will generally be relayed to investigators immediately for telephone requests, and within five work days from the date of receipt of the e-mail or the letter for written requests. IRB Program Coordinators will also determine of the proposed research must be reviewed by the IRB.
According to HHS regulations, the University becomes engaged in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes, or (ii) obtain individually identifiable private information about those individuals for research purposes. Under FDA regulations, the institution becomes engaged in human subjects research when it undertakes a clinical investigation on individuals who are or become subjects in the investigation, either as recipients of a test article or as controls and may be either patients or healthy non-patients.
PIs are automatically considered to be “engaged” in human subjects research whenever they apply for or receive a direct award to support research that includes human subjects, even if all the activities involving human subjects will be carried out by a subcontractor or collaborator. In all cases the institution to which the grant has been awarded bears the responsibility for protecting human subjects under the award.
3.12.2 Class Projects
Class projects typically do not meet the definition of human subjects research. As such, IRB review may not be required. For guidance regarding institutional policy regarding the review of class projects, visit the ORS website at http://www.utexas.edu/research/rsc/humansubjects/class_project.html.
3.12.3 Oral History Projects
The following is based on guidance received from OHRP:
A decision whether oral history or other activities solely consisting of open ended qualitative type interviews are subject to the policies and regulations outlined in an institution’s Federalwide Assurance (FWA) and HHS regulations for the protection of human research subjects (45 CFR 46) is based on the prospective intent of the PI and the definition of “research” under HHS regulations at 45 CFR 46.102(d): “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Specifically, for the purposes of this policy in order to be subject to the University’s human research protections policies, the activity must meet the following standards and general principles for evaluating Oral History type activities:
- The activity involves a prospective research plan which incorporates data collection, including qualitative data, and data analysis to answer a research question; and
- The activity is designed to draw general conclusions (i.e., knowledge gained from a study maybe applied to populations outside of the specific study population), inform policy, or generalize findings.
- Oral history activities, such as open ended interviews, that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute “research” as defined by 45 CFR 46. For example, an oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the video take does not intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their story.
- Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute “research” as defined by 45 CFR 46. For example, an open ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings would require IRB review and approval.
- Oral historians and qualitative investigators may want to create archives for the purpose of providing a resource for others to do research. Since the intent of the archive is to create a repository of information for other investigators to conduct research as define by 45 CFR 46, the creation of such an archive would constitute research under 45 CFR 46. For example, open ended interviews are conducted with surviving Negro League Baseball players in order to create an archive for future research. The creation of such an archive would constitute research under 45 CFR 46 since the intent is to collect data for future research.
PI’s are advised to consult with their IRB Program Coordinator regarding whether their oral history project requires IRB review and approval.
3.13 Coded Private Information as Relates to Human Subjects Research
The OHRP does not consider an institution or PI to be engaged in human subjects research if the PI consults or collaborates on human subjects research by obtaining coded private information or human biological specimens from another institution, engaged in the research, which retains the code. However, one of the following four conditions must be met:
- The key to decipher the code is destroyed before the investigator receives the coded information.
- The consulting or collaborating PI and the holder of the key enter into an agreement prohibiting release of the key under any circumstances.
- The releasing institution has IRB-approved written policies and procedures applicable to the research project that prohibit release of the key to consultants or collaborators under any circumstances.
- There are other legal requirements prohibiting release of the key to consultants or collaborators.
OHRP also does not necessarily consider authorship as a factor in determining whether or not an institution is engaged in human subjects research. It is possible that the authors of a paper or presentation were not involved in obtaining “data about subjects of the research through intervention or interaction with them” or “identifiable private information about the subjects of the research.” If a PI simply receives unidentifiable or coded information about human subjects, OHRP has determined that analysis of the information and/or publication of conclusions based on analysis of the information does not constitute being engaged in human subjects research.
3.14 Cooperative Activities
The IRB shall have special responsibilities in the review and approval of proposals involving cooperative activities. Cooperative activities are those in which the University faculty, students or staff, obtain access to human subjects involved through one or more cooperating institutions, or when PIs from cooperating institutions obtain access to human subjects at the University. When a PI plans to conduct research at a site external to the University (not owned or operated by the University), the PI must respond to questions in the application that informs the IRB of:
- The contact information of the site(s);
- Whether the site(s) has an IRB;
- Whether the site(s) has granted permission for the research to be conducted and;
- If the site has an IRB, has the IRB approved the research or does the site plan to defer to the University IRB.
If the site defers to the IRB, the site must submit a FWA that designates the institution’s IRB as an IRB that the site relies upon for review of human subjects research. Communication between the University IRB Office and the site will occur as needed. Generally, an Inter-Institutional Agreement or Memorandum of Understanding (MOU) that delineates the specific roles and responsibilities of each participating institution must be established and executed. Activities involving investigators from one or more institutions who may exchange or pool similar data obtained from human subjects who participate in independently sponsored projects are not cooperative activities as defined above.
For PIs performing research in which the University is the lead or coordinating institution, the PI should note in the initial IRB application that the University is the lead or coordinating institution of a multi-site study. The PI should also provide the following information:
- The name(s) of each participating institution that will be engaged in human subjects research.
- Confirmation that each participating institution has an FWA.
- The contact name and information for the PI at each institution.
- The contact name and information for the IRB of record at each institution.
- The method of multilateral communication between institutions/IRBs of any unanticipated problems involving risks to subjects or others and other study related information.
The researcher should also upload copies of IRB approved documents and relevant correspondence between participating sites.
3.15 Undue Influence of the IRB or ORS Staff
It is the policy of the University that the human subjects research review process and implementation of IRB policies and procedures are conducted objectively and without undue influence over deliberations or processes. Individual members of the IRB whether employed by the institution or community members, as well as HRPP staff, have the right and obligation to report any undue pressure upon them to make decisions that would favor an individual PI over subject protections, during the initial and continuing review processes or when conducting or participating in other IRB related business. The IRB member or HRPP staff person is asked to document the issues related to the case in writing to both the ORS Director and the IO in order to open a formal report. The IO will formally review the information and may convene a meeting and/or otherwise obtain additional information as necessary. The ORS Director will then subsequently inform the IRB of the findings. The IO has the authority to take corrective action in consultation with the IRB.
Upon resolution, the IRB will determine if the attempted, inappropriate influence represents an unanticipated problem involving risks to subjects or others and will determine if reporting to OHRP is appropriate.
3.16 Training Requirements
The University HRPP policy requires training for all faculty, faculty mentors, researchers, and students, including researchers from other institutions who wish to conduct human subjects research at the University. All key personnel (PI, Co-PI, Faculty Sponsor), originally listed or later added to a study through an amendment, must complete the required human subjects training. In order to comply with the policy, researchers are required to complete the University’s training affiliated with Collaborative Institutional Training Initiative (CITI). Completion of this training must be accomplished every three years. Webinars and local conferences are made available to the University community for additional training.
3.16.2 IRB Members
IRB members and their alternates must complete the required human subjects training. ORS will provide orientation information and copies of the following information:
- CD-ROM of the PRIM&R Investigator 101 Tutorial
- Institutional Review Board: Member Handbook, by Robert Amdur, 2003.
Continuing educational material(s) are distributed at each IRB meeting in the form of relevant periodicals or articles. Webinars and local conferences are made available to the members to attend.
3.16.3 Department Review Committee (DRC) Members
DRCs should review IRB the Policies and Procedures Manual and must complete CITI Training. DRCs may be invited to attend IRB meetings as necessary. Webinars and conference are made available for additional training. Also, upon request a member of the IRB staff will meet one-on-one with a DRC.
3.16.4 ORS Staff
ORS staff must document that they have completed the CITI training. Attendance at regional and national meetings, (e.g., PRIM&R) is encouraged and supported for ORS staff. ORS staff are encouraged to attend any additional training, such as webinars, that are offered by ORS. IRB Program Coordinators and the Senior Program Coordinator are highly encouraged to obtain IRB Certification (Certified IRB Professional (CIP)).
3.17 Roles and Responsibilities
3.17.1 Principal Investigators
The following are the PI responsibilities and are not all inclusive:
- Assure that all personnel listed on the research protocol have completed the human subjects research training and submitted a Financial Interest Disclosure.
- Submit protocols for IRB review and approval of proposed research activities prior to commencing the research activities.
- Employ sound study design in accordance with standards of the PI’s discipline.
- Assure that adequate time and resources are present before conducting a research study to assure participant protections.
- Maintain appropriate oversight of each research study, as well as research staff, and appropriately delegate research responsibilities and functions.
- Insure that the research is conducted according to the protocol, any signed agreements, in compliance with all applicable laws and regulations and organizational policies and procedures with the highest of ethical standards.
- Submit for review and approval all proposed protocol and consent form changes prior to implementing the changes in the protocol except where necessary to eliminate apparent immediate hazards to human subjects.
- Obtain legally effective informed consent from subjects prior to commencement of research activities, unless the requirement is waived by the IRB.
- Ensure the rights, safety and welfare of the research subjects are upheld and protected.
- Follow reporting requirements for problems that require prompt reporting (see Section 24).
- Submit requested data at specified times for continuing review of ongoing research activities.
- Upon completion of a study, honor all commitments that were agreed to as part of the approved research, e.g., providing information about the study results to research subjects or honoring commitments for reimbursements to subjects.
- Upon completion of a study, submit a Closure Report to the IRB.
- Disclose all conflicts of interest.
- Retain records as required by the regulations, the sponsoring entity and local policy for the appropriate time period (See Section 3.21 Record Retention).
- When PI is the lead researcher for a multi-site study, include in your application packet information about the management of information that is relevant to the protection of research participants, e.g., how unanticipated problems involving risks to partipants or other unanticipated problems will be managed.; how communication of unanticipated problems to all sites will occur; how protocol modifications will be managed; is there a formal agreement in place delineating each site’s roles and responsibilities.
- If you hold an IND/IDE, adhere to sponsor responsibilities in addition to investigator responsibilities as per 21 CFR Parts 312/812.
- If appropriate, assure that applicable clinical trials (includes some of the NIH funded trials) are registered on the governmental database at http://www.ClinicalTrials.gov. Applicable clinical trials are defined by Federal Statute (Public Law 110-85). Generally, these trials include:
- Trials of Drugs and Biologics: Controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation; and
- Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
- Address research participant’s concerns, complaints, or requests for information.
Members of the International Committee of Medical Journal Editors (ICMJE) will consider the results of clinical research for publication only if the trial has been registered prior to enrollment of the first subject. ICMJE defines a clinical trial as: “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and health outcome.” …This definition includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes and the like.” ICMJE further defines “medical intervention” as “any intervention used to modify a health outcome.”
3.17.2 Faculty Mentors/Sponsors
Mentorship is a serious responsibility. It is time-consuming and requires an enthusiastic commitment to the students and to the program. In addition to tangible evidence of willingness to make a commitment to the students, mentors must have a demonstrated commitment to scholarship. In all likelihood, it may be the student's first experience with formal research. The success of the student's experience will be measured not only in the outcome of their projects, but also in what they learn from the faculty sponsor as a role model. These experiences will help form their perception of scientific research, and in some cases, determine whether a career in academic research is right for them. The following are the faculty mentor/sponsors responsibilities and are not all inclusive:
- Advise the student on the selection of a topic, the content and preparation of their research proposal.
- Assist student with the preparation of the IRB application. Complete and sign forms as required.
- Serve as the IRB protocol Principal Investigator of record for the student when the research meets the criteria for exemption from the regulations.
- Obtain all necessary approvals (i.e., IRB) before initiating the project.
- Ensure on-going compliance with federal regulations and institutional policies and procedures relating to human subjects research.
- Guide and interact with the student throughout the research period. Remember, students should not be treated as if they were just another pair of hands to put to work. Teach them to think about their projects.
- Assist the student to monitor and evaluate the progress of the study and appropriately report any unanticipated problems to you and the IRB.
- Ensure that any continuing reviews are submitted in a timely manner.
- Encourage students to present their results at other meetings or to co-publish them, if appropriate.
- Advise and assist students with the preparation of poster presentations and papers, as applicable.
- Be available to the student during the active research period.
3.17.3 Departmental Review Committees
In its review of human subjects research, the IRB expects the DRC to review protocols for scientific/scholarly validity. More specifically, the DRC should consider the following:
- The rationale for the study is clearly stated and the rationale is scientifically sound.
- The aims and corresponding hypothesizes are being clearly stated and the primary outcome (and secondary outcomes, as appropriate) is clearly defined.
- The questions or hypothesizes that are being tested are providing important knowledge to the field and the design of the study is appropriate for the questions that are posed.
- Statistical considerations, including sample size and justification, estimated accrual and duration, and statistical analysis are clearly being described and is adequate to meet the study objectives.
3.17.4 Institutional Official
The IO is designated by the University President to have responsibility for the Human Research Protection Program with the authority to delegate activities as may be necessary to fulfill the following responsibilities:
- Assure compliance with institutional policies and all applicable regulations for the protection of human research subjects.
- Is legally authorized to represent the institution in matters regarding human subjects research and is the signatory authority for all the Federal-Wide Assurance to the Office for Human Research Protections.
- Responsible for review and evaluation of reports on HRPP performance and QI activities.
- Responsible for further institutional review and approval or disapproval of research approved by the University IRB (neither the IO nor any other University official can approve research that was disapproved by the IRB).
- Reviews copies of all IRB meeting minutes, containing reports of IRB deliberations on human subjects protocols, the results of QI audits, and noncompliance findings.
- Signs all correspondence and reports sent to federal regulatory agencies regarding PI or institutional noncompliance.
3.17.5 Institutional Review Board
IRB main responsibilities in safeguarding the rights and welfare of subjects are as follows and are not all inclusive:
- Conduct review of initial protocol submissions, continuing reviews, and all revisions to protocols of human subjects research conducted by the University researchers.
- Approve, require modifications to secure approval, defer (table), or disapprove research activities overseen and conducted under the auspices of the University, regardless of location of the research activities.
- Systematically analyze protocols for benefits to subjects and importance of knowledge to be expected and assess the potential benefits in relation to the potential risks involved in the research.
- Report in writing the findings and actions of the IRB to the PIs, IO, and, when applicable, to federal regulatory agencies or departments, as necessary.
- Determine the interval at which ongoing studies need to be reviewed by the IRB (must be at least annually).
- Determine which studies need verification from sources other than the researchers that no material changes have occurred since the previous IRB review.
- Observe, or have a third party observe, consent processes and/or the conduct of research.
- Ensure prompt reporting of any changes in research activities to the IRB by researchers.
- Ensure prompt reporting, by PIs, to the IRB and/or federal agencies or departments (where applicable) of:
- Unanticipated problems involving risks to subjects or others.
- Serious or continuing noncompliance with regulations.
- Suspension or termination of IRB approval.
- Determine if studies involving drugs need an investigational new drug (IND) number designated by the FDA.
- Determine if studies involving investigational devices pose significant or non-significant risk and whether an IDE is required.
- Suspend or terminates approval of research not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.
- If applicable, act as the Privacy Board for research involving use of PHI.
3.17.6 IRB Chair and Vice Chair
IRB Chair and Vice Chair main responsibilities are as follows and are not all inclusive:
- Serve as public spokesperson for the IRB.
- Chair convened meetings of the IRB.
- Ensure adequate expertise for review and determinations.
- Review protocols, continuing review reports, unanticipated problem and deviation reports, and other documentation submitted to the IRB.
- Delegate review responsibilities as necessary and applicable.
- Maintain up-to-date knowledge of human subjects regulations and pertinent events.
- Consult with investigators as necessary.
- Suspend the conduct of research when individuals are placed at an unacceptable level of risk.
- Collaborate with the ORS Director to provide continuing education for IRB members.
- Collaborate with the ORS Director to resolve IRB-related issues with faculty or subjects.
- Recognize and support partnership with ORS to assure IRB efficiency and effectiveness.
3.17.7 IRB Members
IRB members responsibilities are as follows and are not all inclusive:
- Be familiar with IRB policies and procedures and federal, state, and local regulations policies or guidelines relating to human subjects research.
- Review submitted proposals as assigned by the Chair of Chair’s designee.
- Review meeting packets in advance of IRB meetings and be prepared for discussion of submitted protocols.
- Act as a primary or secondary reviewer of protocols when assigned.
- Maintain confidentiality of IRB proceedings.
- Disclose conflicts of interest, if applicable.
3.18 Monitoring/Verification of Compliance from Sources Other than the PI
In accordance with 21 CFR 56.108(a)(2) (FDA) and 45 CFR 46.103(b)(4)(ii) (OHRP), it is incumbent upon the IRB to assure itself, by whatever method it deems appropriate, that the rights and welfare of human subjects are being protected. This applies to transnational research and research taking place in other states and in Texas. In doing so, the IRB may determine that it is appropriate to use sources other than reports from the investigator to verify that no material changes in the protocols have occurred since their most recent review, and that investigators are conducting the research in compliance with all regulations, laws (domestic and international), policies, and guidelines. Also, the IRB may determine that the consent process for some higher risk protocols should be observed.
To assess whether there have been no material changes in the protocols as stated above, the IRB may request that members of the IRB and/or ORS staff conduct an observational visit for a specific protocol. This review will help ensure that investigators are not implementing protocol changes prior to IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects.
As a part of an ongoing Quality Improvement (QI) program, monitoring reviews may be initiated in other ways:
- The QI staff may randomly select protocols from a list of currently approved protocols;
- The PI or the PI’s department may wish to have research protocols reviewed proactively for compliance;
- The IRB may determine that verification of compliance is required because the protocol is very complex and involves unusual levels or types of risk to subjects;
- A relatively high risk protocol is being conducted by a PI who is inexperienced in human subjects research;
- A protocol is being conducted by an investigator who previously failed to comply with regulations, the protocol, local policy, or IRB determination; or
- Other reasons primarily related to subjects’ risk and safety.
Upon completion of the QI visit, the results will be reported to the ORS Director. The PI will be queried for a response to the findings of the visit, if applicable. The report and if appropriate, the PI’s responses will be brought to the IRB at a convened meeting for discussion and action. If the report indicates suspected or observed incidents of noncompliance, procedures outlined in Section 22 of this manual will be followed for investigation of possible noncompliance.
3.19 Contacts for Questions, Concerns, Complaints or Input
Faculty, research staff, students, and research subjects or any other person who has a question, concern, complaint, suggestion, or input regarding the HRPP or feels that they have been subjected to coercion or undue influence regarding aspects of human subjects research, or feels that they have observed issues of concern regarding human subjects research, may contact the ORS:
Any and all concerns, complaints, input or suggestions regarding the Human Research Protection Program and all allegations of coercion, undue influence or noncompliance are thoroughly investigated and, if applicable, corrective actions taken to rectify the situation. Ultimately, the ORS Director is responsible to assure that all concerns, complaints, and allegations have been addressed appropriately and that input and suggestions related to the HRPP are considered when reviewing the program. If it appears that the concern/complaint could be an incident of noncompliance, further inquiry will follow procedures delineated in Section 22. If the concern/complaint appears to involve an unanticipated problem involving risks to subjects or others, it will be reviewed according to Section 9 of this manual.
3.20 Periodic Review of the HRPP and Participant Outreach Programs
The ORS Director and Assistant Director, with input from the IRB Chairs will, at least annually, review the composition of the IRB and determine whether it is appropriate for the volume and types of research being reviewed to assure thorough and timely IRB review. Recommendations for the appointment of new members and removal of members will be forwarded to the IO. The ORS Director and Assistant Director will annually consider whether or not the resources and personnel being provided in support of the HRPP are adequate and advise the IO as necessary. The ORS Director and Assistant Director annually evaluates the performance of the IRB Chair and Vice Chair, with feedback from IRB members and the ORS Director and communicates the results of this evaluation to the IRB Chair and Vice Chair.
The ORS Director will, at least annually, review HRPP policies and procedures and make adjustments as necessary. Comments from research faculty and staff regarding the HRPP will be reviewed as they are received by the IRB Chair, Vice-Chair, ORS Director, and, if necessary, the IO. If applicable, modifications to the HRPP will be made and implemented and the effectiveness of the implemented changes monitored and discussed at least annually.
3.20.2 IRB Members and ORS Staff
The ORS Director and Assistant Director in consultation with the IRB Chair annually review the HRPP, including IRB Members, IRB member feedback, and any input from outside the IRB and provide recommendation(s) to the IO regarding the recruitment, retention, or dismissal of members. This review includes examination of attendance, specialty, expertise, education, affiliation, and diversity. A summary of the evaluations and member comments will be submitted through the ORS Director to the IO along with input for appointment for additional terms.
The ORS Director will be evaluated and provided feedback annually by the IO. IRB Program Coordinators will be evaluated and provided feedback annually by the IRB Senior Program Coordinator and/or ORS Assistant Director. Formal evaluation of the ORS Assistant Director’s performance is accomplished annually by the ORS Director at which time formal feedback is provided.
3.20.3 Participant Outreach
ORS dedicates a section of its website, entitled “Human Subjects Participant Page” to current and prospective research subjects. This section of the ORS website included resources such as “Frequently Asked Questions,” downloadable University brochures in English and Spanish regarding research participation, and links to relevant source documents and websites relating to volunteering as a subject in research. There are also links to the OHRP downloadable brochures intended to inform the general public about research participation. In addition, each person logging on to the website is asked to complete a brief survey of the website and the ease of navigation within the website.
To evaluate the effectiveness of the participant outreach program, ORS monitors the number of visits to the website and responses to the voluntary, anonymous survey. Comments, complaints, or input received regarding the website are evaluated, changes made if necessary, and the changes evaluated for effectiveness.
3.21 Record Retention Policy at The University of Texas at Austin
No official state records may be destroyed without permission from the Texas State Library as outlined in Texas Government Code, Section 441.187 (http://www.statutes.legis.state.tx.us/?link=GV) and 13 Texas Administrative Code, Title 13, Part 1, Chapter 6, Subchapter A, Rule 6.7 (http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_
dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=13&pt=1&ch=6&rl=7). The Texas State Library certifies Agency retention schedules as a means of granting permission to destroy official state records.
The University of Texas at Austin Records Retention Schedule (UTRRS; http://www.utexas.edu/business/accounting/retention/ret.html) is certified by the Texas State Library and Archives Commission. It has been adopted as an administrative rule of the University. All official state records (paper, microform, electronic, or any other media) listed on the UTRRS must be retained for the minimum period designated. Once official University records have met their retention periods, they must be disposed of in accordance with the policies and procedures of Office of Accounting’s Division of Records Management Services.