Section 2: The Institutional Review Board

2.0 General IRB Policies
2.0.1 Functions and Responsibilities
2.0.2 Confidentiality of the Review Process
2.0.3 Research Determinations
2.0.4 Undue Influence of IRB Members or HRPP Staff
2.0.5 Suspension & Termination Policy
2.0.6 Reporting Policy
2.0.7 IRB Resources
2.1 Meetings
2.2 IRB Minutes
2.3 Approval Timeframes
2.3.1 Expiration and Inactive Notices
2.4 Protocol Files
2.5 Consultants
2.6 IRB Advisory Committee
2.7 HRPP Complaints, Feedback, Concerns, and Issues

2.0 General IRB Policies

The governing regulations for University of Texas at Austin’s IRB are 45 CFR Part 46, 21 CFR Parts 50, 56, 312, and 812, and HIPAA.  University of Texas at Austin’s Federal Wide Assurance (# 2030) with OHRP specifies that the institution will follow 45 CFR 46 and 21 CFR 50 and 56 for all funded and non-funded research.

2.0.1 Functions and Responsibilities

1. 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 research activity involving human subjects may be undertaken by any faculty, staff, employee or student at The University of Texas at Austin unless our IRB has reviewed and approved the research prior to commencing the research activity.  
2. The review will determine whether the subjects will be placed at risk and, if risk is involved, that:
   1. Risks to participants are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose participants to risk.
   2. Risks to participants are minimized whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
   3. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
   4. Selection of participants is equitable.
   5. Informed consent will be sought from each prospective participant or the participant’s legally authorized representative, in accordance with, and to the extent required by the regulations.
   6. Informed consent will be appropriately documented, in accordance with, and to the extent required by the regulations.
   7. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
   8. When appropriate, there are adequate provisions to protect the privacy of participants.
   9. When appropriate, there are adequate provisions to maintain the confidentiality of data.
   10. When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.
   11. The conduct of the activity will be reviewed at intervals determined by the IRB, but not less than annually.
3. The determination of when an individual is at risk is a matter of the application of common sense and sound professional judgment as relates to the circumstances of the research activity in question.
   1. The IRB will carefully weigh the relative risks and benefits of the research procedures to be applied to the subject.
   2. Research activities designed to yield fruitful results for the benefit of individual subjects or society in general may incur risks to the subjects provided such risks are outweighed by the benefit to be derived from activities.
   3. The degree of risk involved in any activity should never exceed the humanitarian importance of the problems to be solved by that activity. Likewise, compensation to volunteers should never be such as to constitute an undue inducement to the subject.
   4. There is a wide range of medical, social and behavioral research projects and activities in which no immediate physical risk to the subject is involved; e.g., those utilizing personality inventories, interviews, questionnaires, or the use of observation, photographs, taped records, or stored data. However, some of these procedures may involve varying degrees of discomfort, harassment, or invasion of privacy.
   5. There may also be projects that involve tissues, body fluids, and other materials obtained from human subjects. The use of these materials obviously involves no element of physical risk to the subject. However, their use for research, training, and service purposes may present psychological, sociological, or legal risks to the subjects. In these instances, application of the policy requires IRB review to determine that the circumstances under which the materials are to be procured are appropriate and, if the subject is deemed to be at risk, that adequate and appropriate consent will or can be obtained for the use of these materials for research purposes.
   6. Similarly, some studies depend upon stored data or information that was often obtained for quite different purposes. Here, the IRB will determine whether the use of these materials is within the scope of the original consent, or whether consent should be obtained or waived.
4. Investigators from other institutions who wish to conduct research on The University of Texas at Austin campus must similarly obtain UT IRB approval prior to the start of their research.  IRBaccess requires the PI have a high-assurance UTEID.
5. Any activity involving the use of radiation, lasers, biohazards, or otherwise prohibited or restricted material, device, or process must have approval from the appropriate oversight office.  Specifically, as indicated in the IRB application (step 4, questions 1-14) the IRB requires documentation (email, letter, fax) from the Office of Environmental Health and Safety before it can issue approval.
6. 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 Rules and Regulations of the Board of Regents of The University of Texas System.

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2.0.2 Confidentiality of the Review Process

During the process of initial or continuing review of an activity, material provided to the Institutional Review Board and ORS shall be considered privileged information and the Board shall assure the confidentiality of the data contained therein.

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2.0.3 Research Determinations

Investigators seeking guidance regarding whether an activity is human subjects research should consult http://www.utexas.edu/research/rsc/humansubjects/
special_topics/policy_updates.html#oral or http://www.utexas.edu/research/ rsc/humansubjects/whatis.html.  If questions still remain, please contact ORS.  Investigators seeking a determination about whether an activity is human research should submit a formal request (topics to address in your research proposal) to the ORS with a detailed description of the activity.  The Program Coordinator, ORS director, and IRB Chair will meet and reach consensus regarding whether the activity represents human subjects research and then the IRB chair formally approves this action.  Determinations are based upon the definition of “human research” as defined in the glossary.  IRB staff will document determinations using the Human Research Determinations Checklist.

If research involves the use of a food, biologic, nutritional, or food supplement that might fit the FDA definition of a “drug,” IRB staff will review this definition in the Federal Food, Drug, and Cosmetic Act Section 201(g)(1) to determine whether the research involves the use of a drug.  If the research involves a drug, IRB staff will consult the FDA regulations 21 CFR 312.2(b) to determine whether the drug is exempt from the requirement for an IND.  If an IND is required, the IRB will not review the research and IRB staff will return the protocol to the investigator with a written explanation.

If research involves the use of a device that might fit the FDA definition of a “device,” IRB staff will review this definition in the Federal Food, Drug, and Cosmetic Act Section 201(h) to determine whether the research involves the use of a device.  If the research involves the use of a device, IRB staff will consult the FDA regulations 21 CFR 812.2(c) to determine whether the device is exempt from the requirement for an IDE.  If an IDE is not required, the protocol may be reviewed by the IRB.  IF an IDE is required, IRB staff will evaluate whether the sponsor or investigator has claimed that the device is not significant risk, not banned, and the research meets the requirements of 21 CFR 812.2(b).  If not, the IRB will not review the research and the IRB staff will return the protocol to the investigator with a written explanation.  Otherwise, the IRB will review the protocol and consider whether the device is not significant risk.

If an investigator or sponsor claims a device is not significant risk, then the IRB will review research involving the investigational device at a convened meeting.  The IRB will determine whether the device is not significant risk by reviewing the criteria in 21 CFR 812.3(m) (see Appendix N).  If the IRB determines that the device is not significant risk, it will document that determination in the primary and secondary reviewer checklist and the minutes along with the IRB’s rationale for that decision.  Otherwise, the IRB will disapprove the research, and notify the investigator, and sponsor, if any.

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2.0.4 Undue Influence of IRB Members or HRPP Staff

In cases in which an IRB member or an HRPP staff person experiences either direct or indirect undue influence or coercion to make a ruling for a specific research study or investigator, the following process should be used.  The IRB member or HRPP staff person is asked to document the issues related to the case in writing to both the Director of the ORS 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 Director of ORS will then subsequently inform the IRB of the findings. The IO has the authority to take corrective action in consultation with the IRB.

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2.0.5 Suspension & Termination Policy

Suspension means a temporary withdrawal of approval of some or all research, or a permanent withdrawal of approval of some research activities.  A suspended protocol requires continuing review.  Termination means a permanent withdrawal of approval of all research activities.  A terminated protocol does not require continuing review.  The IRB has the authority to suspend or terminate approval of a research protocol that has been determined to not be conducted according to The University’s human subjects research policies and procedures, or in cases in which there has been unexpected serious harm to participants.

While Chair of the IRB, Director of ORS, and Program Coordinator have the right to suspend a study that poses an immediate risk to participants, generally suspensions will be determined by a vote of the full IRB.  Suspensions or terminations ordered by the Chair of the IRB, Director of ORS, and Program Coordinator must be placed on the agenda of the next IRB meeting for consideration of continuation or reversal of the suspension.  Should a study be suspended or terminated so that interventions or interactions with current participants will stop or change, the IRB will communicate to the PI in its letter that the PI must inform current participants that the study has been suspended or terminated along with the reasons for such suspension or termination.  Typically, such a letter will be submitted to the full IRB for formal approval prior to use.  Before suspending or terminating research, the person or committee ordering the suspension or termination will consider whether the action might adversely affect the rights or welfare of current participants.  In such cases, the IRB will require explicit conditions for participant withdrawal.  The IRB will consider whether follow-up of participants for safety reasons is necessary and if so, the IRB will require that the PI notify participants of this and require the PI to continue to report unanticipated problems.  Such information must be formally submitted to the IRB for their review and approval.

The written report of the IRB’s suspension or termination of approval will be written by the Program Coordinator for Compliance for review and approval by the full IRB, unless the suspension or termination was enacted by the Chair or Director as described above.  The Chair and the Director will sign the written report.

Information to be included in the written report include level of study risk, category of review, a summary of the events, previous non-compliance history for PI, co-PI and faculty sponsor, how event was reported to the IRB, steps (if any) that PI has taken to rectify situation, reasons for IRB suspension or termination, findings of organization and/or IRB, actions taken by the IRB, future plans.  This report will be distributed according to the Reporting Policy detailed in section 2.0.6 below.

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2.0.6 Reporting Policy

The IRB enacts the following reporting policy when one or more of the following occurs:

1. The IRB determines an unanticipated problem report represents an unanticipated problem involving risks to participants or others; or
2. The IRB makes a determination of serious or continuing non-compliance with the federal regulations, UT-Austin policies and procedures, or IRB determinations; or
3. The IRB, the IRB Chair, Director of ORS, or Program Coordinator suspends or terminates a previously approved research protocol.

A Program Coordinator in the ORS will prepare a report (see Non-Compliance/Unanticipated Problem Report Form). Reports will be reviewed and approved by the UT-Austin IRB Chair, who will also sign the report.   A Program Coordinator will ensure that the previous reporting steps are completed within 21 days.

The report is promptly delivered to the PI and copied to:

1. Vice President for Research
2. Associate Vice President for Research (IO)
3. Associate Vice President for Legal Affairs (ex-officio member of IRB)
4. Dean of PI’s School
5. Chairman of PI’s Department
6. Chair of the IRB
7. Project File
8. Faculty Advisor (if applicable);
9. OSP (when the study is externally funded); and
10. Any federal department that has oversight due to funding, conduct, or assurance, including but not limited to, OHRP, NIH, FDA, Department of Education, etc.  Note, that if OHRP is likely to learn of the event before completion of a decision as to whether the event is reportable, the Director of the ORS and IRB Chair will provide OHRP with a preliminary report that describes the situation, indicates the current review of the event by the Board and a time frame for a final, follow-up report.
11. The complainant (when necessary)

Unanticipated problems are appropriately reported to the IRB, and are reflected in the monthly IRB minutes.

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2.0.7 IRB Resources

The ORS provides primary administrative support for the HRPP and maintains an annual budget containing funding for operating expenses, staff salaries, community IRB member reimbursements, and travel and educational materials for IRB members.  In addition, the Vice President for Research provides funding to support the positions of the Chair and Vice-Chair of the IRB.  Each year the ORS Director and Associate Vice President for Research meet to review the current resources and to consider time, space, and staffing needs to determine if a formal budget request should be submitted to the University’s Budget Council through the Vice President for Research.  The Vice President for Research submits appropriation requests (for additional resources) to the University Budget Council.

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2.1 MEETINGS

The IRB shall hold one regularly scheduled meeting per month, at a time and place to be pre-determined and posted on the web site http://www.utexas.edu/research/rsc/humansubjects/meeting_dates.html. All members of the research community are welcome to attend and address specific concerns regarding research protocols.  Visitors are asked to leave the meeting during all votes.  The ORS mails all agenda items for review to IRB members at least 5 business days prior to each scheduled meeting date (See Section 6 and 7 for specific review details).

Full board research protocols (all protocols other than exempt or expedited) will be reviewed only at convened meetings of the IRB at which quorum has been established and includes at least one non-scientific member.  Thus, for example, if the IRB roster has 15 members, at least eight members must be present, one of whom is a nonscientific member.  To be approved, a protocol must receive a majority of votes of members present at the meeting.  If quorum fails during a meeting, such as due to a lack of a majority of IRB members being present or an absence of a nonscientific member, the IRB will not take further actions or votes until the quorum is restored.  Should an IRB member declare involvement in any way in a research protocol under review by the IRB, or state a conflict of interest with the research protocol, the IRB member may neither participate in the deliberations (other than to provide information as requested), nor vote on the outcome of the study. Further, this member is not counted towards quorum.  In these circumstances, the IRB Chair requires all conflicted members to leave the room during the discussions and voting. 

Prior to each full board meeting the IRB staff or the IRB chair will review the agenda of protocols (full board) involving vulnerable populations and will assign primary reviewer(s) knowledgeable about or experienced in working with these participants.  The ORS ensures that either the Primary or Secondary Reviewer is either present at the meeting or available by teleconference during the convened meeting. Should such experience within the IRB membership not be available, relevant consultation will be obtained.

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2.2 IRB MINUTES

Minutes of each IRB are recorded in writing 45 CFR 46.115(a)(2).  The IRB approves the previous months minutes at the subsequent IRB meeting.  Approval of the minutes by the committee members is indicated by their absence of response within five days of the University of Texas at Austin IRB request for comments on or before packet. The IRB Chair will review, monthly, each set of minutes to evaluate the veracity of correct determinations and subsequent justifications. This is done in consultation with a Program Coordinator to provide training on documentation of committee discussion. The IRB Chair documents his/her approval of the minutes by signing the official copy of the document.  Minutes are distributed monthly to all IRB members (chair, members, and alternates), ORS director, and the Institutional Official by email.  Minutes include:

1. attendance at the meeting for each action (designating any advocates for vulnerable populations that are present, and alternate members replacing primary members);
   1. “Members present” documents the names of IRB members present at any time during the meeting
   2. “Members absent” documents the names of IRB members who never attended the meeting at any time.
2. a list of all full board studies with the respective information:
   1. Actions taken and decisions made by the Committee, including disapprovals.
   2. Votes will record the number of members voting for, against, and abstaining, and the names of IRB members listed under “Members Present” who were absent from the vote.  If a member was absent due to a conflicting interest, the notation “absent due to a conflicting interest,” will appear next to the name.
   3. Basis for requiring modifications to the research proposal or consent documents or for disapproving the research proposals;
   4. A summary of the discussion of controversial issues and their resolution;
   5. A summary of discussion of issues pertinent to the protocol;
   6. Minutes will also document, by referencing the primary and secondary reviewer form, determinations required by the regulations along with project specific findings that justify each determination. These determinations include those for waiver or alteration of consent, waiver of consent documentation, research involving children, prisoners, pregnant women, fetuses, and neonates.
   7. Justification for any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample informed consent document.
   8. For initial and continuing review, the approval period.
   9. The names of IRB members who absented themselves from the meeting due to conflict of interest.
   10. The rationale for significant risk/non-significant risk device determinations.
3. a list of all actions that were taken administratively during the previous month.

Minutes include separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB. The minutes will document the total number of members attending the meeting.  In order to document the continued existence of a quorum, vote totals for each action will be recorded in the minutes by listing the number of members originally present, that were absent for this vote only, along with the breakdown of members voting for, against, and abstaining.  In order for a protocol to be approved, it must receive the approval of a majority of members present at the meeting.  The minutes include the documentation of any potential conflict of interest that an IRB member may have with a particular protocol and indicate that the IRB member was absent from the room for the discussion and vote. IRB minutes reflect decisions and justifications regarding human subjects research involving vulnerable populations.  IRB minutes list all suspended and terminated protocols that occurred during the previous month. The program coordinator of ORS is assigned to monitor quorum at each meeting and determine vote counts and recording IRB discussion points for the minutes.

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2.3 APPROVAL TIMEFRAMES

Exempt and Expedited studies are approved for a period of one year from the approval date.  For a protocol reviewed by a convened IRB the approval period starts on the date the IRB approved the research or the date that the IRB chair determined that explicit conditions required by the IRB were satisfied.  The expiration date is defined as the first day that the protocol is no longer approved without continuing review and approval by the IRB. The expiration date is calculated as the date the IRB approved the protocol or approved the protocol with explicit conditions, plus the interval of approval (maximum one year). The approval period ends on the day before the expiration date, unless earlier closed pursuant to notice from the Investigator. For example, if the protocol was approved by the convened IRB for one year with explicit conditions on 4/15/2004 and the IRB chair confirmed that the conditions were met on 4/20/2004, then the approval period is 4/20/2004 to 4/14/2005 and the expiration date is 4/15/2005.

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2.3.1 Expiration and Inactive Notices

IRBaccess sends investigators email notices 90, 60, and 30 days prior to the study expiration date.  Notices list the study title, IRB protocol number, expiration date, and continuing review and closure instructions.  The University of Texas at Austin IRB encourages PIs to submit a closure report if the PI does not intend on continuing research for another year (https://utdirect.utexas.edu/vr/IRBClose.WBX).  PIs do not need to file continuing reviews for data analysis only, provided there is no risk of a breech of confidentiality to participants.  PIs desiring to continue research beyond the study approval period must submit a continuing review (see Section 7).  IRBaccess sends investigators an expiration notice early the morning of the expiration date.  The expiration notice states that all research and research related activities must immediately cease, including enrollment, recruitment, interventions and interactions on current participants, and data analysis.  It lists the study title, IRB protocol number, expiration date, and continuing review and closure instructions.  The PI has a 30-day grace period from the expiration date to submit a continuing review or closure report.  However, this is an administrative grace period only and the expiration notice clearly states that all research must immediately cease.  If the PI does not request a continuation or closure within the 30-day grace period, then IRBaccess emails the PI a formal notice stating the protocol is now inactive, and the failure to submit a continuation or closure is handled according to 6.7 Non-Compliance with IRB Policies, Procedures, or Decisions.  The University of Texas at Austin IRB lists the study as inactive and stores it accordingly. IRB minutes list all suspended and terminated protocols that occurred during the previous month.

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2.4 PROTOCOL FILES

Protocol files are maintained in locked file cabinets in the Office of Research Support, which encompasses the IRB. Files are assigned protocol numbers that are parallel to those in the online database, IRBaccess.  IRBaccess maintains a corresponding electronic copy of each file.  Each file contains the following:

1. A copy of the IRB Application (Appendix B and at http://www.utexas.edu/research/rsc/humansubjects/forms.html.)
2. A copy of the complete research proposal (Topics to Address in a Research Proposal, Appendix C and at http://www.utexas.edu/research/rsc/humansubjects/forms.html.)
3. Any supplementary forms, for example: Applications for funding from outside agencies, Certificate of Consistency, Request for Waiver of Informed Consent, Request for Waiver of Documentation of Informed Consent, research questionnaires or scripts, etc.
4. Any correspondence with the IRB, both formal and informal (including all emails), related to the research protocol.
5. Completed Primary and Secondary Reviewer Checklists including determinations, justifications, and findings of the IRB. For initial and continuing review of expedited studies, Reviewer Checklists include the specific permissible category. For initial review of exempt studies, the specific category of exemption is documented.
6. Official notification of IRB action.
7. Any changes made to the original research proposal, as requested by the IRB.
8. A stamped copy of the approved consent form.
9. Applications for continuing review and all correspondence and records related to that review (Application for Continuing Review, Appendix D and at https://utdirect.utexas.edu/vr/IRBContRev.WBX.)
10. Applications to amend a protocol and all correspondence and records related to that review (Application to Amend a Research Protocol, Appendix E and at https://utdirect.utexas.edu/vr/IRBAmendment.WBX.)
11. Reports of unanticipated problems and related IRB review and action (Unanticipated Problem Form, Appendix F and at https://utdirect.utexas.edu/vr/IRBAdverse.WBX.)
12. Any IRB action regarding non-compliance and related correspondence.
13. Copies of scientific evaluations, if any.
14. Copies of DHHS-approved sample consent documents.
15. Reports of injuries to participants.
16. Statements of significant new findings provided to participants.

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2.5 CONSULTANTS

Any time the IRB, primary reviewer, or ORS staff determine they do not have the necessary scholarly or scientific expertise for sound review, they may request ad hoc consultants.  Furthermore, the IRB Chair evaluates each protocol to determine whether the IRB has the required expertise.  If the IRB chair determines that the IRB does not have the required expertise, additional expertise will be obtained from a consultant.  Consultants are independent of the IRB and are selected according to scholarly and scientific expertise.  Prior to counsel, consultants must disclose any conflicts of interest according to the conflict of interest policy (see 3.7).  Consultants with conflicts of interest will be replaced and will not be used in those instances.  The person requesting consultation must confirm the consultant does not have any conflict of interest and document in protocol file.

Consultants may be called upon to judge the scientific soundness of a research protocol, make a fair and accurate determination of the risk-benefit ratio, review the cultural appropriateness of the informed consent process, and offer additional and unique expert advice.  However, consultants cannot make any review determinations and may not vote with the IRB; they may only provide counsel.  When requesting additional consultation, the IRB, primary reviewer, or ORS should contact the director of the ORS, IRB Chair, or appropriate department review chair for a consultant referral.  The ORS maintains on its website two lists of outside expert consultants from which the IRB can seek a consultant referral through the appropriate Institutional procedures:

• A protocol specific consultant list (in domestic violence, prisoner researcher, privacy / confidentiality, special education, adolescent depression, deception, and sexual assault) and
• international consultants with cross cultural and international research expertise. 

The IRB, primary reviewer, or ORS will document in the protocol file and distribute to all IRB members, all counsel received prior to formal IRB protocol review (see 6.4 and 6.5).  Consultants are required to either attend meetings to present their comments or to provide their comments to the IRB in a written report.  If consultants attend a meeting a summary of their findings will be described in the minutes.  If consultants provide a written report, a copy of the report will become part of the protocol file.

Furthermore, the IRB has several non-voting members providing expert counsel: representatives from Legal Counsel and Environmental Health and Safety.  Legal counsel and advice may be sought at any time, either formally in writing from the IRB to the expert counsel or informally by IRB members or ORS staff during the review of new, ongoing and/or non-compliance cases.  Additionally, legal counsel is regularly sought to provide detail on Texas State Law as it pertains to interpretation of 45 CFR 46.

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2.6 IRB ADVISORY COMMITTEE

The Vice-President for Research (IO) annually appoints the IRB Advisory Committee.  Membership includes the IRB Chair, Director of the Office of Research Support and three to four faculty members. The determination of Chair of the IRB Advisory Committee is made annually by the IO.  The charge given to this committee includes review of current University policies and procedures and necessary revisions thereof.  This committee is also charged with review of national regulatory and institutional advances that may require consideration of, and possible enhancement of the current policies and procedures. Finally, the Advisory Committee for the IRB meets on an as needed basis to review concerns and suggestions made by investigators, participants and others.

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2.7 HRPP COMPLAINTS, FEEDBACK, CONCERNS, AND ISSUES

All complaints, feedback, concerns, or related issues should be directed to the IRB Chair or ORS as noted in the consent form. Please consult section 1.5 for contact information or email orsc@uts.cc.utexas.edu. Any allegations of noncompliance will be directed to the Program Coordinator according to section 6.6 and adjudicated accordingly. All other complaints will be directed to the IRB Chair. The Chair can direct the IRB to review the complaint or meet with the involved parties and ORS director to reach a satisfactory resolution. Complaints will be formally documented with resolutions noted as formal actions in the protocol files. PIs may bring forward to the Advisory Committee concerns or recommendations regarding the human research protection program, including the IRB review process.  Unanticipated problems will be reported to the IRB using the unanticipated problem procedure (see section 7.3).

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