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t:\irb\irb policy\2013\irb-1000 10.4.13.docx Institutional Review Board Policy Memorandum -

ADMINISTRATION

POLICY MEMORANDUM

POLICY SUBJECT: INSTITUTIONAL REVIEW BOARD

POLICY NUMBER: IRB-1000

JCAHO FUNCTION AREA: Leadership

POLICY APPLICABLE TO: Anyone Doing Patient Research

POLICY EFFECTIVE DATE: December 17, 1996

POLICY REVIEWED: 12/17/1996, 3/9/1999, 3/22/1999, 2/3/2000, 2/10/2000, 12/1/2002, 1/4/2008, 01/09/2009, 04/03/2009, 06/05/09,08/07/09, 08/13/09, 11/1/11, 10/04/13

POLICY REVISED: 12/10/2002; 10/01/2004; 10/05/07; 01/04/08; 04/03/09; 08/13/09; 12/2/11

ALTERNATE WORD SEARCH: Institutional Review Board, Research, Investigational New Drug,

HUD, Humanitarian Use Device, Device(s)

Page No.

POLICY STATEMENT ...........................................................................................3

1. MEMBERSHIP OF BOARD ..............................................................................3

2. WHEN IRB APPROVAL REQUIRED ................................................................5

3. CRITERIA FOR APPROVAL OF RESEARCH.......……………………………...5

4. CATEGORIES OF RESEARCH REVIEW ........................................................7

5. APPLICATION FOR APPROVAL OF INVESTIGATION ...................................8

6. SUBMISSION OF APPLICATIONS...................................................................9

7. SCIENTIFIC REVIEW COMMITTEE………………………………………… ... …9

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Institutional Review Board Policy Memorandum -

8. IRB OPERATIONS TEAM ..................................................... …………………11

9. EXPEDITED REVIEW COMMITTEE……………………………….……………13 10. REVIEW OF APPLICATIONS ...................................................................... 14 Index Cont’d.

11. APPROVAL OF INVESTIGATIONS & AGREEMENT OF INVESTIGATORS .......................................................... 15

12. DISAPPROVAL ............................................................................................ 17

13. STUDY CLOSURE, SUSPENSION OR TERMINATION OF APPROVAL .. 18 14. PROTOCOL DEVIATIONS……………………………………...………………20

15. ADVERSE OR UNANTICIPATED EVENTS ................................................ 21

16. EXEMPT STUDIES ...................................................................................... 22

17. EXPEDITED STUDIES…………………………………………………………..24

18. FULL BOARD…………………………………………………………………..…26

19. EMERGENCY USE ...................................................................................... 28

20. INFORMED CONSENT ................................................................................ 29

21. EXCEPTIONS FROM INFORMED CONSENT ............................................ 32

22. AUTHORIZATIONS AND WAIVER .............................................................. 34

23. SAFEGUARDS FOR CHILDREN................................................................. 37

24. RESEARCH INVOLVING PREGNANT WOMEN OR FETUSES ................ 40

25. RESEARCH INVOLVING NEONATES ........................................................ 42

26. TRAINING .................................................................................................... 44 27. RECORDS ................................................................................................... 44

28. RELATIONS WITH OTHER ENTITIES OR INSTITUTIONS ....................... 45


29. PAYMENTS .................................................................................................. 45

30. NATURE OF IRB AND LIABILITY................................................................. 46

31. REVIEW OF POLICY .................................................................................. 46 POLICY STATEMENT: The Institutional Review Board (IRB) shall (1) approve or disapprove biomedical research, investigational studies and clinical trials involving human subjects; (2) conduct periodic reviews of such research, studies and trials; and (3) provide this policy for the protection of the rights and welfare of such human subjects. Concern for the interests of the subjects must prevail over the interests of science and society. 1. MEMBERSHIP OF BOARD

a) The IRB shall have not less than five (5) members and not more than twelve (12) members. Members shall be appointed by the Administrator/CEO of the Ector County Hospital District and shall serve a term of four (4) years. Members may be reappointed to successive terms. Vacancies may be filled by the Administrator/CEO. Each member shall have one vote. Terms will overlap 2 years to maintain continuity.

b) The members shall elect a Chairperson at the first meeting of the

IRB in alternate calendar years. The Chairperson shall serve a term of two (2) years and may be elected to successive terms. A vacancy in the office shall be filled by the members for the remainder of the term at the next meeting following such vacancy. The Chairperson may also vote.

c) The members shall have varying backgrounds to promote complete

and adequate review of research activities. Members shall be sufficiently qualified through experience, expertise and diversity, including considerations of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, so as to promote respect for the Board’s advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of


proposed research in terms of Hospital commitments and policies, applicable law, and standards of professional conduct and practice.

d) Membership shall include the following:

i) Community Representative(s) ii) Pharmacist iii) Hospital Administrator iv) Physician(s) v) Member of Clergy vi) Associate/Assistant Hospital Administrator vii) Registered Nurse

viii) A person who is not a physician but whose primary concerns are in the scientific area.

ix) Attorney (advisory & non-voting member)

At least two (2) members shall be unaffiliated with the Ector County Hospital District and Medical Center Hospital and shall not be part of the immediate family of a person who is affiliated with the District or the Hospital.

e) The IRB may, in its discretion, invite individuals with

competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote. Special areas include but are not limited to vulnerable categories of subjects, such as children, pregnant women, or handicapped persons.

f) No member may participate in the IRB’s initial review or

continuing review or monitoring of any study or investigation in which the member has a conflict of interest. The IRB shall determine whether a member has a conflict of interest from information submitted by the member.


g) A quorum of the IRB shall be necessary for the transaction of business. A quorum shall consist of a majority of the members, including at least one member whose primary concerns are in nonscientific areas. A concurrence of a majority of the members voting at any meeting shall be necessary in matters relating to the business of the IRB.

h) Regular meetings of the IRB shall be on the first Friday of

each month or such other fixed date or dates as the Members shall agree upon from time to time. Special meetings may be called by the chairperson, the Hospital Administrator/CEO or any two (2) members of the committee.

i) Following the last meeting of each calendar year the minutes

of the meetings of the IRB held that year shall be sent to the Office of the Board of Directors of the Ector County Hospital District as the report of the activities of the IRB for that year including an annual report of reviews of research projects. Names of subjects and other identifiers shall be deleted.

j) The Coordinator of the IRB shall act as secretary. The

Coordinator may not vote. 2. WHEN IRB APPROVAL REQUIRED

a) The use or clinical trial or investigation of any product or device which must be submitted to the FDA shall not be initiated unless the use or investigation has been reviewed and approved by the IRB.

b) The use or clinical trial or investigation of any product or device, the

results of which are intended to be submitted later to, or held for inspection by, the FDA shall not be initiated unless the investigation has been reviewed and approved by the IRB.

c) Clinically related projects or studies which involve observations of,

interviews with or obtaining information from patients or employees of the Ector County Hospital District or its facilities shall not be initiated unless the project or study has been reviewed and approved by the IRB.

d) Activities, projects or studies set out in Sections 18, 22, 23 and 24

shall not be initiated unless the activity, project or study has been


reviewed and approved by the IRB or, as appropriate, the expedited review subcommittee.

3. CRITERIA FOR APPROVAL OF RESEARCH

a) Before approving an investigation the IRB shall use its best efforts to determine that the following requirements are satisfied: i) Subjects will not be unnecessarily exposed to risks.

ii) The risks to the subjects are reasonable in relation to (a)

anticipated benefits, if any, to the subjects, and (b) the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB shall consider only those risks and benefits that may result from the investigation (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the investigation). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

iii) Risks to subjects are minimized: a) by using procedures which

are consistent with sound research design and which do not unnecessarily expose subjects to risk, and b) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

iv) The selection of subjects is equitable. In making this

assessment the IRB shall take into account the purposes of the investigation, the setting in which the investigation will be conducted and the special problems of investigations which involve vulnerable populations, such as children, pregnant women, handicapped, or economically or educationally disadvantaged persons.

v) Informed consent will be obtained from each subject or the

subject’s representative, in accordance with and to the extent required by Section 19.


vi) Where appropriate, the investigation plan makes adequate provision for monitoring the data collected to provide for the safety of the subjects.

vii) The investigation plan makes adequate provisions to protect

the privacy of the subjects and to maintain the confidentiality of data.

viii) When some or all of the subjects, such as children, pregnant

women, handicapped, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence, that safeguards have been included in the investigation to protect the rights and welfare of these subjects.

ix) Which investigations require review more often than annually and which investigations need verification from sources other than the investigator that no material changes have occurred since previous IRB review.

x) The investigation or study has been reviewed where

appropriate by the IRB Operations Team and/or the Scientific Review Committee.

xi) Each investigator and co-investigator will be a member of the

Medical Staff of MCH, be an employee of MCH, have an affiliation agreement with MCH or is an approved established scientist with TTUHSC.

4. CATEGORIES OF RESEARCH REVIEW Three categories of review are recognized by federal regulations. Rules for submission in each of these categories may be found elsewhere in this policy. a) Exempt: A project that is exempt from IRB review does not require further regulatory review, including continuing review. A study may be deemed exempt by the Expedited Review Committee. Although federal regulations do not require continuing review for an exempt study, Medical Center Hospital does require an annual report of these studies, in order to present all IRB activity in an annual report to the MCH Board.


b) Expedited: Expedited review can be carried out by the Expedited Review Committee. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. The review process involves the same criteria as full committee review, and continuing review must occur at least on an annual basis after approval.

c) Full Board: Research must be reviewed at a convened meeting of the IRB. The IRB determination requires a majority vote by a quorum of the full IRB committee with continuing review at least annually.

5. APPLICATION FOR APPROVAL OF INVESTIGATION

a) Each investigator proposing to undertake the use or clinical investigation of any product or device or any project or study requiring IRB approval shall first submit the following in writing to the IRB:

i) Information regarding the purpose of the investigation or study

and the need therefore.

ii) Identification of any reasonable data information about the product or device to be investigated.

iii) Information regarding whether or not the product or device has

been approved or permitted by the FDA for the intended or proposed use in the investigation or study.

iv) A brief description of any prior investigations of the product or

device including its safety and effectiveness.

v) Anticipated benefits to the subjects.

vi) Reasonable alternative treatments or procedures.

vii) Reasonably foreseeable potential risks or discomforts to the subjects.

viii) Provisions made for the protection of the welfare of the

subjects.

ix) A protocol or investigational plan.


x) A copy of the proposed informed consent. (If applicable)

xi) Proposed time periods for continuing reports to the IRB.

xii) The identity of the sponsor, if any, and whether or not

payments or other remuneration will be made or given to any investigator by the sponsor.

xiii) Methods or procedures for selecting subjects and whether or

not the investigation will purposefully involve children, pregnant women, handicapped or economically or educationally disadvantaged persons.

xiv) A completed, signed “summary of proposed investigation or

study” form (obtained from the IRB coordinator in the medical staff office of the Hospital).

xv) The identity, professional training and qualifications of the

investigators, including current CITI training.

xvi) Such other information as the IRB may require.

b) The IRB may waive or modify any such requirement. 6. SUBMISSION OF APPLICATIONS

a) Applications for approval of investigations shall be submitted to the coordinator of the IRB (located in the medical staff office of Medical Center Hospital) or to the Administrator/CEO of the Hospital. Applications submitted to the Administrator/CEO shall be promptly forwarded to the Coordinator of the IRB.

b) Each Application shall be submitted at least twenty-one (21) days

prior to the meeting of the IRB at which such application will be considered.

c) The Coordinator of the IRB shall distribute a complete copy of all

applications to the Scientific Review Committee and where appropriate, to the Operations Team, with the exception of studies deemed to be exempt or expedited.


7. SCIENTIFIC REVIEW COMMITTEE

a) The IRB shall have a Scientific Review Committee. The purpose of the Scientific Review Committee is to assist the IRB by examining and reviewing the ethical issues and the science of each proposed investigation or study prior to the presentation to and consideration of such investigations or studies by the entire IRB.

b) The Committee shall consist of the Chief Medical Officer of Medical

Center Hospital, the attorney member of the IRB, a physician member of the IRB, and a member of the IRB who is familiar with scientific investigations, processes and procedures. The Chairperson of the IRB shall, at the first meeting in each calendar year, appoint the members and the chairperson of the Committee. Members and the chairperson shall serve terms of one (1) year and may be reappointed to successive terms. Vacancies may be filled by the chairperson of the IRB. Each member may vote and two (2) members shall constitute a quorum. The Committee may appoint the Coordinator of the IRB or any other employee of the Ector County Hospital District as coordinator/secretary of the Committee. Such person may not vote.

c) The application for approval and all supporting documentation for

each investigation or study requiring approval by the IRB shall be submitted to the Committee by the Coordinator of the IRB at least 15 days prior to the regular or special meeting of the IRB at which such investigation or study will be considered. The Committee shall meet promptly to examine and review the ethical issues and the science of each such investigation or study. In examining and reviewing ethical issues, the Committee shall consider the risks to subjects, the anticipated benefits to the subjects and others, the adequacy of disclosures made in the informed consent, payments to be made by sponsors to investigators, and any other matters deemed relevant by the Committee. In examining and reviewing the science of investigations or studies, the Committee shall consider the significance of the investigation or study, the importance of the knowledge that may be expected to result, the design of the investigation or study, any relevant statistical analyses involved in or to result from the investigation or study, and any other matters deemed relevant by the Committee.


d) The Committee may obtain assistance and advice from physicians (who need not be members of the medical staff of Medical Center Hospital), persons with special or scientific knowledge or information, nurses, technicians, and other persons and written sources deemed relevant or useful by the Committee or any of its members. The Committee may also require that the principal investigator, clinical research coordinator or applicant meet with it.

e) The Committee shall meet as often as necessary to perform its

responsibilities. The Coordinator of the Committee shall arrange for and schedule the meetings.

f) The Committee shall complete its examination and review prior to

the next meeting of the IRB and shall make a report with appropriate recommendations to the IRB. The Committee shall endeavor to make its report in writing but under extenuating circumstances the chairperson or other member of the Committee may make an oral report to the meeting of the IRB. The report shall indicate the number of members who voted for or against report. The report, if written, shall be timely delivered by the Committee to the Coordinator of the IRB.

g) The following need not be examined or reviewed by the Committee:

i) Applications for or investigations or studies granted expedited

reviews;

ii) Applications for investigations or studies involving only the review of and collection of data from health care records of patients of the Ector County Hospital District and its facilities.

8. IRB OPERATIONS TEAM

a) The IRB shall have an Operations Team. The Team shall consist of not less than six (6) members and not more than eight (8) members. Membership shall include representatives from nursing, nursing education, the laboratory, the business office, health information management, and the pharmacy. At least three members of the Team, including the representative from pharmacy, shall be members of the IRB. The Coordinator of the IRB shall act as secretary of the Team. The Coordinator may not vote.


b) The Chairperson of the IRB shall request the appropriate department director from each of the departments represented on the Operations Team to appoint a representative from that director’s department to serve as a member of the Operations Team. The Chairperson of the IRB shall ensure that all members of the Operations Team are appointed by the first meeting of each calendar year. Members shall serve a term of one (1) year and may be reappointed to successive terms. Vacancies may be filled by the Chairperson of the IRB in coordination with the appropriate department director. Each member may vote. There shall be two co-chairs of the Operations Team. One co-chair shall be the Chief Medical Officer of Medical Center Hospital, or his or her designee who is also an employee of Medical Center Hospital. The other co-chair shall be a representative from the pharmacy, and it is not necessary that the representative from the pharmacy serving as co-chair be an employee of Medical Center Hospital.

c) All investigations or studies requiring approval by the IRB and which

may affect operations in or employees of Medical Center Hospital shall be submitted to the Operations Team no later than the Friday before the regular meeting of the IRB at which such investigation or study is to be considered. Any such investigation or study which will be considered at a special or called meeting of the IRB shall be submitted to the Operations Team at least five (5) days before such special or called meeting. The Team shall review each investigation or study referred to it for the purposes of determining and evaluating (i) how and in what manner such investigation or study will affect operations in any department or area of the hospital; (ii) whether Hospital employees will participate or assist in any such investigation or study and the number of such employees; (iii) whether any employees will require any additional education or training and if so, what kind and by whom; (iv) whether Hospital resources, such as the laboratory or radiology will be used; (v) the estimated cost to the Hospital of any such investigation or study; and (vi) any other issues pertaining to the Hospital operations deemed relevant by the Team.

d) The Team may obtain assistance and advice from appropriate

Hospital employees including but not limited to department and divisional directors whose departments or divisions may be affected by any such investigation or study. The Team may also require that the principal investigator or clinical research coordinator meet with the members.


e) The Team shall complete its review and evaluation prior to the next

meeting of the IRB and shall make a report with appropriate recommendations to the IRB. The Team shall endeavor to make its report in writing but under extenuating circumstances the chairperson of the Team may make an oral report to the meeting of the IRB.

f) The compensation to be received by Medical Center Hospital and

the treatment of patient accounts are further described in MCH Policy 2059.

9. EXPEDITED REVIEW COMMITTEE

Annually, the chairperson of the IRB shall appoint three experienced members of the IRB to an expedited review subcommittee. This committee will be comprised of the IRB chair, the Chief Medical Officer, and a 3rd experienced member of the IRB. The Expedited Review Committee will review requests for exempt or expedited status. Any physician or investigator desiring an expedited review of a proposed investigation or study shall first submit a written request to the subcommittee. The request shall include the following:

a) Information regarding the proposed investigation or study and the

need therefore; b) Identification of and reasonable data and information about the

investigation or study involved; c) Anticipated benefits to the subjects; d) Reasonably foreseeable potential risks and discomforts to the

subject; e) Provisions for the protection of the welfare of the subjects; f) A copy of the proposed Informed Consent; if expedited, unless

application is accompanied by a request for waiver. g) The identity, professional training and qualification of the investigator

or physician;


h) Any emergency IND number obtained from the FDA; and i) Such other information as the subcommittee may require.

i) The subcommittee shall promptly review the request and may exercise all of the authorities of the IRB (except that the subcommittee may not disapprove the research) subject to such terms and conditions as the subcommittee deems proper. The subcommittee may invite other members of the

Board or individuals with competence in special areas to assist in the review. The subcommittee may elect to take no action and refer the request to the IRB.

ii) The PI shall keep the subcommittee advised of the results of the investigation or study and of any problems or hazards

which arose. The material reviewed by the subcommittee and the reports from the physician shall be submitted to the next meeting of the IRB for its further action.

iii) The subcommittee may suspend or terminate approval of any

such application or project for any of the reasons set out in Section 12. In such event it shall follow paragraph b of Section 12.

iv) The subcommittee shall promptly report, in writing, to the Coordinator of the IRB all requests it has approved. Such

reports will be distributed to each member at the next meeting of the IRB.

10. REVIEW OF APPLICATIONS

a) The IRB shall review all applications and supporting or relevant documentation, any report and recommendations from the Operations Team and any report and recommendations from the Scientific Review Committee.

b) The IRB may (1) approve the investigation as proposed in the

application; (2) approve the investigation subject to such modification or terms and conditions as it deems appropriate; (3) table the application pending receipt of additional information; or (4) disapprove the proposed investigation.


c) The IRB shall notify the investigator in writing of the results of its review. If an investigation is approved by the IRB, a copy of the approved consent form or forms to be used in the investigation shall be returned to the investigator with the IRB approval and date noted on the form or forms by the IRB Coordinator.

d) The IRB may require the investigator to appear in person to discuss or answer questions about the proposed investigation.

e) Investigations approved by the IRB may be subject to further review

and approval, modification or disapproval by the Ector County Hospital District and/or Medical Center Hospital. However, neither the District nor the Hospital may approve the investigation if it has not been approved by the IRB through the normal or expedited review procedures.

11. APPROVAL OF INVESTIGATIONS AND AGREEMENT OF INVESTIGATORS

a) Each investigator who undertakes an investigation approved by the IRB thereby agrees:

i) To conduct the investigation according to and in compliance

with (a) the application submitted pursuant to Section 4a), including but not limited to the summary form, which shall serve as “the investigator’s statement”, the protocol or investigational plan, (b) any modifications or terms and conditions required by the IRB, and (c) applicable regulations for protecting the rights, safety and welfare of subjects under the investigator’s care. Changes in approved investigations or studies may not be initiated without IRB approval except where necessary to eliminate apparent immediate hazards to the subject.

ii) To conduct the investigation according to and in compliance

with these policies and procedures.

iii) To maintain sufficient records to clearly describe the results of the study. Such records, not including identifiers of the subjects, shall be available to the IRB.

iv) To furnish timely periodic reports to the IRB as required by the

IRB. Failure to furnish timely reports will result in suspension


of the investigation or study to the extent subjects will not be endangered or placed at risk.

v) To meet with the IRB to assist it in reviewing the investigation.

b) Periodic reports shall be made by the investigator at such time and

intervals as may be required by the IRB but not less often than annually.

c) Periodic reports by the investigator shall include:

i) The number of subjects participating in the investigation.

ii) Any benefits observed during or derived from the

investigation.

iii) Any adverse reactions, harm and discomfort to the subjects not already reported to the IRB.

iv) Any deviations from or changes in the investigation as

approved by the IRB.

v) All unanticipated problems involving risks to the subjects or others.

vi) Any new findings developed during the course of the

investigation which may relate to a subject’s willingness to continue to participate.

vii) Any newly discovered evidence or information not considered

at the time the investigation was approved relating to risks to the subjects or the anticipated benefits of the investigation.

viii) Such other information as may be requested by the IRB.

d) Reports to the IRB shall be submitted to the Administrator/CEO of

Medical Center Hospital or the Coordinator of the IRB (located in the medical staff offices of Medical Center Hospital).

e) The IRB may observe or have third parties observe the investigation

or research.


f) The IRB will continue to review the investigation until such time as it is terminated, permanently suspended, or completed.

g) The IRB shall report to the Administrator/CEO and any applicable

administrative agency (i) unanticipated problems involving risks to subjects or others and (ii) serious or continuing non-compliance with Federal Regulations or the requirements of the IRB.

h) The investigator shall cease any investigation if the hazards are

found to outweigh the potential benefits. 12. DISAPPROVAL

a) The IRB may disapprove a proposed investigation for any of the following reasons:

i) The application is not complete.

ii) The rights and welfare of the subjects will not be adequately

protected.

iii) The application contains untrue statements of material facts or omits information required to make a valid assessment of the proposed investigation.

iv) There is reason to believe that the product or device is unsafe

or ineffective for use in the proposed investigation.

v) The application contains insufficient information to determine that the risks to the subjects are reasonable in relation to the anticipated benefits.

vi) The plan or proposed investigation is not reasonable or

adequate to determine whether the product or device is safe or effective in a clinical situation.

vii) The investigator does not have the necessary training or

qualifications to assure the investigation will be conducted properly and to assure due regard for the safety and welfare of the subjects.


viii) The available facilities and support staff at the Ector County Hospital District or Medical Center Hospital are not sufficient so that the safety and well being of the subjects may be potentially compromised or data and information may not be completely or properly evaluated.

ix) Any other reason deemed appropriate by the Board.

b) If the IRB disapproves a proposed investigation it shall notify the

investigator in writing of its decision.

c) The IRB shall include in its written notification a statement of the reasons for its actions. The IRB shall give the investigator an opportunity to respond in person or in writing.

13. STUDY CLOSURE, SUSPENSION OR TERMINATION OF APPROVAL Studies which have been approved by the IRB may be closed by the investigator, the sponsor, the IRB, TTUHSC, or by an affiliated entity. When the decision to permanently or temporarily close a study is made by the investigator, an affiliated entity, or the study sponsor, the PI must promptly notify the IRB through the IRB Coordinator and include a summary of findings to date. Completed Studies Studies that have been completed, including final data analysis, and are closed at the local research site, will be designated as “Completed”. The PI shall submit the “Study Closure Report” to the IRB, which will include the total number of subjects, any major problems, and a summary of the findings. A manuscript may be substituted for the summary of the findings. Once a study is designated “Completed”, any links (codes, etc.) between the data and identifiers must be destroyed and well as any videos, tapes, etc. that were targeted for destruction at the completion of the study. Study materials must be stored for a minimum of 3 years, and must be stored as long as additional applicable federal or contractual regulations stipulate. Once the IRB has sent a written acknowledgment that the study is designated “Completed”, no further actions are necessary by the PI.

a) No further research activity is permitted for studies which are administratively closed. Any further activity on such studies will require the submission of a new application to the IRB.


b) The IRB may suspend or terminate approval of an investigation any time after it has begun for any of the following reasons:

i) The investigation is not being conducted in accordance with

the IRB’s requirements.

ii) The investigation is associated with unexpected serious harm to subjects.

iii) Experience obtained during the course of the investigation or

newly discovered evidence or information not considered at the time the investigation was approved indicates that the risks to the subjects outweigh the potential benefits.

iv) The investigator has refused to cooperate with the Board or to

provide requested or required information to the Board or to provide timely reports to the Board.

v) Evidence of misrepresentations of material facts in the

applications or periodic reports.

vi) Evidence of unethical conduct by the investigator.

vii) The original investigator(s) who initiated the investigation cannot or will not continue to perform in the capacity of investigator and a suitable qualified replacement is not available.

viii) The available facilities or support staff at the Ector County

Hospital District or Medical Center Hospital are no longer sufficient so that the safety and well being of the subjects may be potentially compromised or data and information may not be completely or properly evaluated.

ix) Loss of sponsor.

x) The investigator has failed to maintain required or adequate

records.

xi) Any other reason deemed appropriate by the board.


c) If the IRB terminates or suspends its approval of an investigation it shall notify the investigator, Medical Center Hospital (through the Administrator/CEO), any sponsor and any applicable regulatory agency, as appropriate, in writing of its decision. The IRB shall include in its written notification a statement of the reasons for its actions, the duration and conditions of any suspension and the terms and conditions, if any, under which the IRB will permit the investigation to resume. The IRB shall give the investigator an opportunity to address the concerns of the committee in person or in writing, either before or after the termination or suspension.

14.0 PROTOCOL DEVIATIONS Protocol deviations are unplanned or unforeseen changes in the implementation of an IRB-approved protocol. They generally refer to a modification of procedures that has already occurred for a single subject; they are not intended to modify the protocol. All protocol deviations are to be reported to the IRB along with a plan of correction to minimize the possibility of recurrence of the deviation. Minor protocol deviations will typically be acknowledged by a single reviewer, but will be available for review by all IRB members. Major protocol deviations will typically be deliberated by the full board at a convened meeting of the IRB.

14.1 Minor Protocol Deviations

Minor protocol deviations include: • Deviations that do not increase the risk to the subjects; • Deviations that do not affect the scientific validity of the study; • Deviations that do not result from deliberate misconduct of the investigator; • Deviations that do not necessitate any change to the approved protocol.

Examples of minor deviations include delayed follow-up visits (if no medication, treatment, or supervision is missed) short delays in the delivery of medication, or extra compensation inadvertently given to a study subject. Minor protocol deviations should be reported to the IRB promptly, generally within thirty (30) days of the study team becoming aware of the deviation.

14.2 Major Protocol Deviations These deviations must be reported to the IRB by the PI within ten (10) working days from when the PI becomes aware of them, and more quickly if serious harm results. Major protocol deviations include, but are not limited to:


• Deviations that increase the risk, including any deviation that results in a change in a subject’s medical status; • Deviations that cause physical, mental, or psychological harm to a subject or otherwise impede a subject’s rights; • Deviations that damage the scientific integrity of the study; • Deviations as a result of deliberate misconduct on the part of the investigator; • Deviations that cause the study to be seriously or continuously out of compliance with federal, state, or TTUHSC regulations; • Failure to follow a corrective action plan.

Examples of major deviations include:

• Enrolling subjects who do not fulfill inclusion/exclusion criteria; • Subjects receiving any research-related activity prior to approved informed consent being obtained; • Observed inappropriate consent procedures • Not reporting serious, unexpected adverse events; • Variations in use of study device or in dispensing, dosing, or storing of research medications; • Loss or corruption of study data; • Incorrectly performing or missing tests or procedures required by the protocol; • Premature “unblinding” of a subject; • Anything identified by study personnel or a sponsor monitor that may affect the safety of a subject or integrity of data.

Questions about whether or not to report any particular occurrence may be directed to the respective IRB Administrator or Chair. However, study team members are urged to err on the side of caution if there is a question about whether or not to report a particular occurrence to the IRB. Protocol deviations will be reviewed as part of the research compliance audit process. 15. ADVERSE OR UNANTICIPATED EVENTS

a) Each investigator shall report to the IRB any adverse or unanticipated event arising out of his or her investigation or study in the hospital. The report shall be on a form approved by the IRB, available on the web site of the IRB or from the IRB coordinator in the Medical Staff office, and shall be given to the IRB coordinator within two (2) business days after the investigator first learns of the event. A report may be given electronically, by facsimile, or delivery of the form to the Coordinator.


b) As used in this policy:

i) A “serious adverse event” means an event resulting in death,

a life-threatening experience, prolongation of hospitalization, a persistent or significant disability, incapacity or defect, the possibility based on appropriate medical judgment of medical or surgical intervention, and any other event which might be significant to the health, safety or welfare of a human subject.

ii) An “unanticipated event” means an event which has an

adverse effect on the health, safety or welfare of a subject and which was not previously identified in, or the nature, severity or frequency of which was not consistent with the protocol or investigation plan.

c) After the approval by the IRB of an investigation, the investigator

shall furnish the IRB with a copy of all communications and documents received from or sent to the sponsor, the FDA or any other entity in any way related to adverse or unanticipated events arising out of the investigation or the safety of the drug, device or product involved in the investigation. The communications and documents shall be furnished to the IRB Coordinator in the medical staff office within seven (7) business days after their receipt by the investigator.

d) The IRB Coordinator shall promptly forward to the chairperson of the

IRB all reports, communications and documents received by the Coordinator from an investigator. The reports, communications and documents shall be reviewed by a committee of not less than three (3) members (including the chairperson) appointed as necessary and from time to time by the chairperson. The committee shall report orally to the IRB on the information reviewed and make recommendations deemed appropriate by the committee related to any investigation or study then in progress in the hospital.

16. EXEMPT STUDIES a) The determination of whether a study qualifies for exempt status at

MCH must be made by the Expedited Review Committee. The designation must be granted prior to the research commencing. IRB approval may never be granted for research already in progress or completed.


b) Federal regulations 45 CFR 46.101(b) provide for six specific

categories of activities that may qualify as exempt. Exempt status will never apply to research involving prisoners.

i) Research conducted in established or commonly accepted

educational settings, involving normal educational practices such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

ii) Research involving the use of educational tests (cognitive,

diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:

(a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) Any disclosure of the human subject’s responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

iii) Research involving the use of educational tests (cognitive,

diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under the previous category of this section, if:

(a) The human subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

iv) Research involving the collection or study of existing data,

documents, records, pathological specimens, or diagnostic


specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

v) Research and demonstration projects which are conducted by

or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) Public benefit or service programs; (b) Procedures for obtaining benefits or services under those programs; (c) Possible changes in or alternatives to those programs or procedures; or (d) Possible changes in methods or levels of payment for benefits or services under those programs.

vi) Taste and food quality evaluation and consumer acceptance

studies. If the research application does not meet the criteria for exempt status, the IRB Office will provide written notice to the PI specifying the additional information needed and stating the appropriate category for review (e.g., expedited or full board). The Expedited Review Committee retains the right to refer any application for expedited or full board review, even if it appears to meet the qualifications for exemption. 17. EXPEDITED REVIEW

a) Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed 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.


b) The categories in this list apply regardless of the age of subjects, except as noted.

c) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

d) The expedited review procedure may not be used for classified research involving human subjects.

e) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

f) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories:

i) Clinical studies of drugs for which an investigational new drug application is not required, provided, however, research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.

ii) Clinical studies of medical devices for which an investigational

device application is not required or the medical device is cleared or approved for marketing and the device is being used in accordance with its cleared or approved label.

iii) Collection of blood samples by finger stick, heel stick, ear stick

or venipuncture, provided the amount drawn from healthy non-pregnant adults who weigh at least 110 pounds may not exceed 550 ml in an 8-week period and collection may not exceed two times per week, and from others the amount drawn may not exceed the lesser of 50 ml or 3 ml per Kg in an 8-week period and collection may not exceed two times per week.


iv) Noninvasive collection of biological specimens, as for example

hair, nail clippings or saliva.

v) Collection of data through noninvasive procedures routinely employed in clinical practice and not involving general anesthesia or sedation, x-rays or microwaves. Examples include sensors applied to surface of the body, magnetic resonance imaging, electrocardiography and moderate exercise.

vi) Research involving data, documents, records or specimens

that have been or will be collected for non-research purposes (such as medical treatment or diagnosis).

vii) Collection of data from voice, video, digital or image

recordings made for research purposes.

viii) Research on individual or group characteristics or behavior and research employing survey, interview, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies.

ix) Continuing review of research already approved by the IRB (a)

where no new subjects can be enrolled, the subjects have completed all research related interventions and the research remains active only for long term follow-up of subjects or (b) where remaining activities are limited to data analysis.

x) Continuing review of research where categories (i) through (ix)

do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified; provided this category shall not apply to research conducted under an investigational new drug or device exemption.

xi) Projects or studies which involve only observations of,

interviews with or obtaining information from patients or employees of the Ector County Hospital District or its facilities.

18. FULL BOARD


Review of research by the full Board may occur only at convened meetings of the IRB at which a quorum and at least one non-scientific member of the Board are present. Studies are determined to require full Board review based on the potential level of risk (minimal, greater than minimal) to human subjects as determined by the Board. Any proposed studies using investigational drugs or devices; approved drugs or devices in unapproved categories; or vulnerable populations, e.g. prisoners, pregnant women, or children,) will always require full board review. The Board may request the PI to be present at the IRB meeting at which his/her protocol is being presented in order to answer any questions the IRB may have.

The full Board review process includes the following components:

a) IRB Chair or designee shall present each protocol for review to the IRB. Clarification and discussion by the full Board will take place. Existence of a quorum and at least one non-scientific member of the IRB will be required for any vote by the full Board.

b) A majority vote of the voting members is required to formalize IRB

decisions. IRB review will result in one of the following actions: a) Approval

The IRB may only approve an application when the requirements for approval stated in 45 CFR 46.111 are satisfied. These requirements are summarized as follows:

i) Risks to subjects are minimized.

ii) Risks to subjects are reasonable in relation to anticipated benefits.

iii) Selection of subjects is equitable.

iv) Informed consent will be sought from each prospective subject or

representative.

v) Informed consent will be appropriately documented as required by

federal regulation.

vi) Plans for data monitoring are included when appropriate.

vii) Adequate provisions are in place to protect the privacy of subjects and

the confidentiality of data.

viii) Additional safeguards have been included to protect the rights and


welfare of vulnerable subjects when necessary.

When a study is approved by the IRB, information regarding the risk level assigned by the IRB and the required frequency of continuing review will be provided in writing to the PI. The investigator will also be informed that he/she is required to promptly report to the IRB any changes in research activity and any unanticipated problems involving risks to subjects. b) Study Tabled A study may be tabled under the following circumstances:

i) Numerous greater than minor changes required or incomplete

application.

ii) IRB members or consultants not available for review.

iii) Necessary documentation from other pertinent committees, e.g.

Operations Committee, or Scientific Review Committee, has not

been provided.

NOTE: All studies that are tabled at a full Board meeting will require subsequent full Board review unless substantial changes place them in a different category. c) Study Disapproved The IRB may vote to disapprove a study and determine that there will be no further review of this application. The IRB shall provide the PI with written notification of the reasons for its decision. The PI may request reconsideration of the IRB’s decision in writing within ten (10) days of the date of notice. The PI shall provide a rationale for the request to reconsider and any other relevant supporting documentation. The PI may also address the IRB in person. The IRB shall notify the PI in writing of its decision after reconsideration and the reasons for its decision. No further request for reconsideration by the PI is permitted following the final decision by the IRB. Pursuant to the regulations in 45 CFR 46.112 and 21 CFR 56.112, Medical Center Hospital officials can not approve research if it is disapproved by the IRB. 19. EMERGENCY USE

The use in an emergency of drugs and devices (“test articles”) not approved for marketing by the FDA does not require review and approval


by the IRB. “Emergency” means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval. However, prior to or within five (5) days after the emergency use of a test article, the investigator shall by written notice to the Coordinator of the IRB (located in the medical staff office of the Hospital) document and describe the emergency situation and the proposed use or past use of the test article. The Coordinator shall promptly refer the notice to the Chairperson of the IRB and the members of the Expedited Review Subcommittee. The Chairperson of the IRB or the subcommittee, after reviewing the notice, shall in writing advise the investigator of the receipt of his or her notice of the emergency use of the test article, and if any subsequent use of the test article is anticipated, that the investigator should submit an application to the IRB for normal review before its next use. The Chairperson of the IRB or of the subcommittee shall report orally to the IRB at its next meeting on the emergency use of the test article.

20. INFORMED CONSENT

a) No investigator shall involve a human being as a subject in a research or study project unless the investigator has either obtained the written informed consent of the subject or the subject’s representative or informed consent is not required under Section 19 of this policy.

b) Per 21 CFR 50.25, Each informed consent shall include the

following:

i) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

ii) A description of any reasonably forseeable risks or

discomforts to the subject.

iii) A description of any benefits to the subject or to others which may reasonably be expected from the research.

iv) A disclosure of appropriate procedures or courses of

treatment, if any, that might be advantageous to the subject.


v) A statement describing the extent, if any, to which

confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.

vi) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

vii) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.

viii) A statement that participation is voluntary, that refusal to

participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

c) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

ix) A statement that the particular treatment or procedure may

involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

x) Anticipated circumstances under which the subject’s

participation may be terminated by the investigator without regard to the subject’s consent.

xi) Any additional costs to the subject that may result from

participation in the research or project.

xii) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.


xiii) A statement that significant new findings developed during the

course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.

xiv) The approximate number of subjects involved in the study.

xv) The informed consent requirements in these regulations are

not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective.

xvi) Nothing in these regulations is intended to limit the authority of

a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.

d) The information that is given to the subject or the subject’s

representative shall be in plain language understandable to the subject or the representative and written in the individual’s primary language if it is other than English.

e) An investigator shall seek such consent only under circumstances

that provide the subject or the subject’s representative sufficient opportunity to read the form, to consider whether or not to participate and that minimize the possibility of coercion and undue influence.

f) It shall be the duty of the investigator to obtain an informed consent

in compliance with this Section. The IRB may observe or have a third party observe the informed consent process.

g) A copy of the consent form signed by the subject or the subject’s

representative shall be given to the person signing the form.

h) The IRB shall approve the form of all informed consents prior to their use and may require that information, in addition to that mentioned above, be given to the subjects, especially if in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects. If the consent form is in a language other than English, the credentials of the translator for that form shall be


furnished in writing to the IRB at the time the form is submitted for approval.

i) All consents shall be in writing, signed and dated. If signed by a

representative, a description of such representative’s authority to act for the individual must also be included.

j) At least one (1) signed consent form shall be placed in each

subject’s medical record and retained by Medical Center Hospital, in written or electronic form, for a period of three (3) years after the expiration date of such consent, or if it has no expiration date, for a period of three (3) years after the subject ceases to be an active inpatient or outpatient participant in such investigation or study at Medical Center Hospital.

21. EXCEPTIONS FROM INFORMED CONSENT

a) The IRB may approve a process which waives the requirement to obtain informed consent provided that the IRB finds and documents the following, in accordance with 45 CFR 46.116(d): i) The research involves no more than minimal risk to the

subjects; ii) The waiver will not adversely affect the rights and welfare of

the subjects;

iii) The research could not practicably be carried out without the waiver;

iv) When appropriate, the subjects will be provided with pertinent information after participation.

b) Informed consent need not be obtained if, prior to the use of a

product or device under investigation, both the principal investigator and a physician who is not otherwise participating in the investigation certify in writing all of the following:

i) The subject is confronted by a life threatening situation

necessitating the use of the product or device under investigation.


ii) An effective informed consent cannot be obtained from the subject because of an inability to communicate or other reason.

iii) There is not sufficient time to obtain consent from the subject’s

representative.

iv) There is no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

c) The documentation required in sub-paragraph 17 a) shall be

submitted to the IRB within five (5) working days after the first use on the subject of the product or device under investigation.

d) Informed consent need not be obtained for investigational in vitro

diagnostic devices used to identify chemical, biological, radiological, or nuclear agents if, prior to the use of such a device, both the responsible investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

(i) The subject is confronted by a life-threatening situation

necessitating the use of the investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear agent that would suggest a terrorism event or other public health emergency.

(ii) Informed consent cannot be obtained from the subject

because there was no reasonable way for the person directing that a specimen be collected from the subject to know, at the time the specimen was collected, that there would be a need to use the investigational in vitro diagnostic device on that subject’s specimen and time is not sufficient to obtain consent from the subject without risking the life of the subject.

(iii) Time is not sufficient to obtain consent from the subject’s

representative.

(iv) There is no cleared or approved available alternative method of diagnosis, to identify the chemical, biological, radiological,


or nuclear agent that provides an equal or greater likelihood of saving the life of the subject.

If, however, the use of the investigational device is, in the opinion of the responsible investigator, required in order to preserve the life of the subject, and time is not sufficient to obtain certification by the independent physician in advance of using the device, then certification by the responsible investigator shall be made and, within five working days after the use of the device, its use and compliance with subparagraphs (i) through (iv) of this paragraph 18 c shall be reviewed and evaluated in writing by a physician who is not participating in the investigation of the device.

e) The documentation required in subparagraph 18 c shall be

submitted to the IRB within five working days after the first use of the device on the subject.

f) The responsible investigator must disclose the investigational status

of the in vitro diagnostic device and what is known about the performance characteristics of the device as well as the results of any tests in a report to the subject’s health care provider, if known to the investigator, and in any report to public health authorities. The report to the IRB and to the subject’s health care provider and to any public health authorities shall include the information required in subparagraph 15 b) (i) through (v) and (vii) through (xiii). The report to the IRB shall describe the procedures that will be used by the investigator to provide this information to each subject or the subject’s authorized representative at the same time the information is provided to the subject’s health care provider and any public health authority.

22. AUTHORIZATIONS AND WAIVER

a) Medical Center Hospital may not use or disclose protected health information without a written authorization meeting the requirements of this section. An authorization for the use or disclosure of protected health information for research investigation or study may be combined with the informed consent required in Section 17.

b) Medical Center Hospital and/or any investigator may condition the

provision of research related treatment on providing an authorization


for the use or disclosure of protected health information related to such research.

c) All such authorizations shall be retained as provided in

subparagraph i) of Section 17. d) Each authorization shall contain the following:

i) A description of the information to be used or disclosed that

identifies the information in a specific and meaningful fashion.

ii) The name or other specific identification of the person, or class of persons, authorized to make the requested use or disclosure.

iii) The name or other specific identification of the person, or

class of persons, to whom the covered entity may make the requested use or disclosure.

iv) A description of each purpose of the requested use or

disclosure. The statement “at the request of the individual” is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose. The statement “for research” is also a sufficient description.

v) An expiration date. The statement “end of research or study

project”, “none”, or similar language is also sufficient.

vi) Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative’s authority to act for the individual must also be provided.

vii) A statement that the individual may revoke the authorization at

any time by delivering written revocation to the investigator or any co-investigator or the Hospital’s Health Information Management department. The authorization shall also state that revocation of the authorization shall terminate the individual’s participation in the investigation or study.


viii) A statement that the provision of research related treatment is conditioned on furnishing a signed authorization and that the provision of such treatment may be terminated if the authorization is revoked.

ix) A statement that information disclosed pursuant to the

authorization may be subject to redisclosure by the recipient.

e) The authorization shall be written in plain language and a signed copy shall be provided to the individual. The authorization shall be written in the individual’s primary language if it is other than English. If the authorization is in a language other than English, the credentials of the translator for that form shall be furnished in writing to the Expedited Review Committee of the IRB for its approval prior to the use of the form.

f) Medical Center Hospital may use or disclose protected health

information for research without an authorization provided the IRB approves and documents a waiver of such authorization and the Hospital obtains from the investigator or co-investigator’s representations that:

i) Use or disclosure is sought only to review protected health

information as necessary to prepare a research protocol or for similar purposes preparatory to research, such protected health information is necessary for the research purposes and none of such information will be removed from the Hospital; or

ii) The use or disclosure is only for research on the protected

health information of decedents and such information is necessary for the research purposes.

g) Documentation of a waiver required in sub-paragraph f) above must

include the following statements or assurances:

i) The date on which the waiver was approved;

ii) The use or disclosure of such information involves no more than a minimal risk to the privacy of individuals based on (a) an adequate plan to protect identifiers from improper use and disclosure, (b) an adequate plan to destroy identifiers consistent with the conduct of the research (unless there is a


health or research justification for retaining identifiers or retention is required by law), and (c) adequate written assurance that such information will not be reused or disclosed to any other person or entity except for oversight of the research or for other research for which use or disclosure would be permitted by this policy.

iii) The research could not practicably be conducted without the

waiver;

iv) The research could not practicably be conducted without access to and use of the protected health information;

v) A brief description of the protected health information for

which use or access has been determined to be necessary by the IRB.

vi) The waiver has been reviewed and approved by the IRB

under either the normal or expedited review procedures set forth in this policy.

h) The documentation of the waiver must be signed by the chairperson

or other member, as designated by the chairperson, of the IRB. 23. SAFEGUARDS FOR CHILDREN

a) As used in this policy:

i) “Assent” means a child’s affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent.

ii) “Children” means persons who have not attained the legal age

for consent to treatments or procedures involved in clinical investigations.

iii) “Parent” means a child’s biological or adoptive parent.

iv) “Permission” means the agreement of parent(s) or guardian to

the participation of their child or ward in a clinical investigation. Permission must include the elements of informed consent described in Section 23.


v) “Guardian” means an individual who is authorized under

Texas law to consent on behalf of a child to general medical care when general medical care includes participation in research. A guardian also means an individual who is authorized to consent on behalf of a child to participate in research.

vi) “Minimal risk” means that the probability and magnitude of

harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

b) Clinical research involving children as subjects must fall within one

of the categories set forth in sub-paragraphs c), d) or e) below.

c) Any clinical investigation in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds and documents that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians.

d) Any clinical investigation in which more than minimal risk to children

is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, may involve children as subjects only if the IRB finds and documents that:

i) The risk is justified by the anticipated benefit to the subjects;

ii) The relation of the anticipated benefit to the risk is at least as

favorable to the subjects as that presented by available alternative approaches; and

iii) Adequate provisions are made for soliciting the assent of the

children and permission of their parents or guardians.

e) Any clinical investigation in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a


monitoring procedure that is not likely to contribute to the well-being of the subject, may involve children as subjects only if the IRB finds and documents that:

i) The risk represents a minor increase over minimal risk;

ii) The intervention or procedure presents experiences to

subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

iii) The intervention or procedure is likely to yield generalized

knowledge about the subjects’ disorder or condition that is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and

iv) Adequate provisions are made for soliciting the assent of the

children and permission of their parents or guardians.

f) The IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of providing assent, the IRB must take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in clinical investigations under a particular protocol, or for each child, as the IRB deems appropriate.

g) The assent of the children is not a necessary condition for

proceeding with the clinical investigation if the IRB determines:

i) That the capability of some or all of the children is so limited that they cannot reasonably be consulted, or

ii) That the intervention or procedure involved in the clinical

investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation.

h) Even where the IRB determines that the subjects are capable of

assenting, the IRB may still waive the assent requirement if it finds and documents that:


i) The clinical investigation involves no more than minimal risk to

the subjects;

ii) The waiver will not adversely affect the rights and welfare of the subjects;

iii) The clinical investigation could not practicably be carried out

without the waiver; and

iv) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

v) The IRB also must determine that the permission of each

child’s parents or guardian is granted except:

vi) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient, if consistent with Texas law, for clinical investigations to be conducted under sub-paragraphs c) or d) above.

vii) Where clinical investigations are covered by paragraph e)

above and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child if consistent with Texas law.

j) Permission by parents or guardians must be documented in accordance

with and to the extent required by Section 23 or elsewhere in this policy. k) When the IRB determines that assent is required, it must also determine

whether and how assent must be documented in the medical record. l) The IRB must determine at the time of its initial review of any proposed

investigation or study involving children that such investigation or study complies with this Section 23 and any other applicable provisions of this policy.

24. RESEARCH INVOLVING PREGNANT WOMEN OR FETUSES


a) Pregnant women or fetuses may be involved in research if all of the following conditions are met:

i) Where scientifically appropriate, preclinical studies, including

studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

ii) The risk to the fetus is caused solely by interventions or

procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;

iii) Any risk is the least possible for achieving the objectives of the

research;

iv) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means and her consent is obtained in accord with the informed consent provisions of Section 19.

v) If the research holds out the prospect of direct benefit solely to

the fetus and the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of Section 24 except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.

vi) Each individual providing consent under sub-paragraph iv) or

v) of this paragraph a) is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;


vii) For children as defined in Section 24 who are pregnant, assent and permission are obtained in accord with the provisions of Section 24.

viii) No inducements, monetary or otherwise, will be offered to

terminate a pregnancy; ix) Individuals engaged in the research will have no part in any

decisions as to timing, method or procedures used to terminate a pregnancy; and

x) Individuals engaged in the research will have no part in

determining the viability of a neonate. 25. RESEARCH INVOLVING NEONATES

a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:

i) Where scientifically appropriate, preclinical and clinical studies

have been conducted and provide data for assessing potential risks to neonates.

ii) Each individual providing consent under this section is fully

informed regarding the reasonably foreseeable impact of the research on the neonate.

iii) Individuals engaged in the research will have no part in

determining the viability of a neonate.

iv) The requirements of paragraph b) or c) of this Section 25 have been met as applicable.

b) Until it has been ascertained whether or not a neonate is viable, a

neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:

i) The IRB determines that:

(a) The research holds out the prospect of enhancing the

probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or


(b) The purpose of the research is the development of

important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; and

(c) The legally effective informed consent of either parent of

the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained in accord with Sections 20 and 25 except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

c) After delivery, a nonviable neonate may not be involved in

research unless all of the following additional conditions are met:

i) Vital functions of the neonate will not be artificially

maintained;

ii) The research will not terminate the heartbeat or respiration of the neonate;

iii) There will be no added risk to the neonate

resulting from the research;

iv) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and

v) The legally effective informed consent of both

parents of the neonate is obtained. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice, except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of


either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this sub-paragraph v).

26. TRAINING

a) Each new member of the IRB shall complete within 90 days of his or her appointment, the Collaborative Institutional Training Initiative (CITI) course offered by the Texas Tech Health Sciences Center, the computer based training course offered by the National Institutes of Health (NIH) or some similar or equivalent course or training approved by the IRB and furnish a certificate or other evidence of completion to the IRB coordinator. Otherwise, except for good cause acceptable to the IRB, such appointment will expire. Such training should be repeated every three (3) years.

b) Each principal investigator and co-investigator(s) and

members of the study team including research coordinators and research assistants, before commencing any investigation or study, shall complete the CITI course, the NIH course or some similar or equivalent course or training approved by the IRB and furnish a copy of a certificate or other evidence of completion to the IRB coordinator.

27. RECORDS

a) The IRB shall prepare and maintain adequate documentation of its activities, including the following:

i) Copies of the complete contents of all applications reviewed,

copies of all written reports from the Scientific Review Committee and the Operations Team, scientific evaluations, if any, that accompanied the applications, approved sample consent documents, progress reports submitted by investigators, and reports of adverse events and injuries to subjects.

ii) Minutes of the IRB meetings which shall be in sufficient detail

to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring


changes in or disapproving research; a written summary of the discussion of controverted issues and their resolution, and a summary of any oral reports by the Scientific Review Committee and the Operations Team.

iii) Records of continuing review activities.

iv) Copies of all correspondence between the IRB and the

investigators.

v) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications and licenses sufficient to describe each member’s chief anticipated contributions to IRB deliberations; any employment or other relationship between each member and the institution and confidentiality statements.

vi) A copy of this policy and all revisions and amendments.

vii) Statements of significant new findings developed during the

course of an investigation which may relate to a subject’s willingness to continue in the investigation.

b) The records of the IRB and investigator shall be retained after

completion or termination of each investigation in accordance with MCH Policy 1076 (or its successor). During the record retention period, the records shall be accessible for inspection and copying by authorized representatives of the Food and Drug Administration at reasonable times and in a reasonable manner.

28. RELATIONS WITH OTHER ENTITIES OR INSTITUTIONS

a) All other entities or institutions, such as Texas Tech Health Sciences Center, Permian Research Foundation, etc., performing investigations or studies in Medical Center Hospital shall comply with 45 CFR 46, 50 and 56 and other applicable Federal Regulations.

b) The IRB shall review not less than every two (2) years, all

agreements or arrangements for relying on another entity or institution’s institutional review board.

29. PAYMENTS


a) The IRB may apply for and/or accept any fees or remuneration

available or authorized in connection with any approved study or investigation. Such fees or remuneration shall be used to defray costs associated with the operation of the IRB, and/or may support research where a funding source is not available.

30. NATURE OF IRB AND LIABILITY

a) The IRB, the Operations Team and the Scientific Review Committee shall be considered “medical committees” under Texas law and “medical peer review committees” under Texas and federal law.

b) This policy, the failure to follow this policy and/or the violation of this

policy shall not create a cause of action against or impose any liability on the IRB, the Operations Team or the Scientific Review Committee or any member of or person assisting the IRB, the Operations Team, or the Scientific Review Committee.

31. REVIEW OF POLICY This policy shall be reviewed and, if necessary or appropriate, revised solely by the IRB not less than every two (2) years.

AUTHORIZING SIGNATURE(S)

Bruce Becker, IRB Chairperson IRB Chairperson


Bruce Becker, MD Chief Medical Officer


William W. Webster Chief Executive Officer

END OF POLICY

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