Definitions

Key Criteria for Human Subjects Institutional Review Board (IRB) Approval

I. Statement of Applicability and General Policies

A. Applicability

B. Ethical Principles

C. The Institution's Policy

II. Implementation

A. Responsibilities of Research Investigators

B. IRB Structure

C. IRB Authority and Responsibilities

D. IRB Procedures

III. Confidentiality

Appendix A-Policy for Informed Consent

The Schools and Colleges of the University of Massachusetts hereby give assurance that they will comply with the Office of Human Research Protection (OHRP) regulations for the Protection of Human Research Subjects (45 CFR 46, as amended) as specified below.

DEFINITIONS

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) data through intervention or interaction with the individual

(2) identifiable private information.

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.

IRB Approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

KEY CRITERIA FOR IRB APPROVAL

The IRB shall determine that all of the following requirements are satisfied in order to approve the research application:

(1) Risks to the subjects are minimized: (I) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risks, and (ii) whenever appropriate, by using procedures already performed on the subjects for diagnostic or treatment purposes.

(2) Risks to the subjects must be reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.

(3) Selection of subjects must be "equitable".

(4) Informed consent must be obtained from each prospective subject or a legally authorized representative, (except in specified limited circumstances where waivers may be granted).

(5) Informed consent must be appropriately documented.

(6) Where appropriate, there must be adequate provision to protect the privacy of subjects and to maintain the confidentiality of data.

(7) Where subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards must be included to protect the rights and welfare of subjects. Such subjects include children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

In addition, the IRB has an institutional responsibility to flag institutional administrative issues and to coordinate its review process with other necessary administrative or legal reviews, where institutional interests are involved.

I. STATEMENT OF APPLICABILITY AND GENERAL POLICIES

A. Applicability

1. Except as noted in Section 2 below, this Assurance is applicable to all activities which, in whole or in part, involve research with human subjects if:

a. the research is sponsored by any funding agency including this Institution, or

b. the research, involves the use of this institution's nonpublic information to identify or contact human research subjects or prospective subjects.

2. Sections II.A. 7-12 of this Assurance are not applicable to the research activities listed above if the only involvement of human subjects will be in one or more of the categories exempted or waived under 45 CFR 46.101.(b) and the exemption is granted pursuant to Section II.C.1 below.

B. Ethical Principles

1. Research personnel on the University of Massachusetts Campus are guided by and reaffirm their commitment to the ethical principles regarding all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects in Research (the "Belmont Report").

2. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) will be met for all applicable HHS-funded research and all such requirements, except for the requirements for reporting information to HHS, will be met in other funded human-subject research without regard to the source of funding.

3. It is the responsibility of the various Schools or Colleges through their own IRB to monitor non-funded faculty and student research according to the principles set forth in this document.

C. The Institution's Policy

1. The Institution acknowledges and accepts responsibility for protecting the rights and welfare of human subjects of research covered by this assurance.

2. The Institution's research policy provides that all research covered by this assurance will be reviewed and approved or exempted by the IRB which has been established under an assurance of compliance negotiated with OHRP. The involvement of human subjects in research covered by this policy will not be permitted until the IRB has reviewed and approved or exempted the research protocol and informed consent has been obtained in accord with and to the extent required by 45 CFR 46.116. Certification of the IRB's review and approved or exemption for all OHRP-funded research involving human subjects will be submitted to OHRP with the application or proposal for funding as required by the funding agency and in all cases no later than 60 days following submission of the application. Furthermore, the IRB's review of research on a continuing basis will be conducted at appropriate intervals but not less than once per year.

3. The Institution's policy requires that, unless the research has been specifically exempted by the IRB or informed consent has been specifically waived by the IRB in accordance with 45 CFR 46.116, no research investigator shall involve any human being as a subject in research unless the research investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.

4. The University bears full responsibility for the performance of all research involving human subjects, covered by this assurance, and also bears full responsibility for complying with federal, state and local laws as they may relate to research covered by this assurance.

5. Non-funded faculty and student research is reviewed by separate Human Subject Review Boards (HSRB) established for this purpose in the various Schools and Colleges. Stipends, fellowships and the like provided to a student by or through the University will not be considered funding for research the student may carry out. Within their defined areas, all HSRB's in Schools or Colleges have the responsibility and authority, in accordance with the policies contained in this Assurance, to review, approve, disapprove, exempt or require changes in research activities involving human subjects.

6. The University has provided and will continue to provide both meeting space for the IRB and sufficient staff to support the IRB's review and record keeping duties.

7. The University encourages and promotes constructive communication among the research administrators, department heads, research investigators, clinical care staff, HSRC's, IRB and other institutional officials and human subjects as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.

8. Documentation of IRB activities as prescribed by 45 CFR 46.115 will be maintained.

9. The Institution will comply with the policies set forth in 45 CFR 46 Subpart B (additional protections pertaining to research, development, and related activities involving fetuses, pregnant women, and in vitro fertilization of human ova), with the policies set forth in 45 CFR 46 Subpart C (additional protections for prisoners involved in research), and with the policies set forth in 45 CFR 46 Subpart D (additional protection for children involved in research).

10. In addition to complying with the requirements of 45 CFR 46, the Institution will consider additional safeguards in research, when that research involved children, individuals institutionalized as mentally disabled, and other potentially vulnerable groups.

11. The Institution will comply with the requirements set forth in 45 CFR 46.114 regarding cooperative research projects. When research covered by this assurance is conducted at or in cooperation with another entity, all provisions of this assurance remain in effect for that research. The Institution may accept, for the purpose of the meeting the IRB's review requirements, the review of an IRB established under another assurance of compliance given to OHRP.

12. The Chairperson of the Institution's IRB shall provide each individual conducting or reviewing human subject research with a copy of this assurance of compliance and a copy of any future modification which may be made to this assurance, with the exception of changes in IRB membership.

II. IMPLEMENTATION

A. Responsibilities of Research Investigators

1. Determination of human subject involvement/consultation with IRB

a. Research investigators shall make an initial determination whether research will involve human subjects as defined in 45 CFR 46.102.

b. When it is not clear whether research involves human subjects as defined in 45 CFR 46.102, research investigators will seek assistance from the Institution's IRB in making this determination.

2. Submission of application and protocol

a. Research investigators will be responsible for insuring, in connection with all research involving human subjects, that an application and protocol are submitted to the IRB, except that all non- funded faculty and student research involving human subjects shall be submitted to the relevant School or College review board.

b. Research investigators will prepare and submit to the IRB an appropriate application (for review or exemption) and a protocol giving a complete description of the proposed research. In the application and protocol, research investigators will make provisions for the adequate protection of the rights and welfare of prospective research subjects and insure that pertinent laws and regulations are observed.

c. If the application requests exemption, the research investigator will document the request with appropriate information and references to 45 CFR 46.101.

d. Research investigators will include samples of proposed informed-consent forms (and assent forms as may be appropriate for studies involving children) with the protocol.

3. Submission of a supplement to an original application or protocol to the IRB.

Research investigators will be responsible for submitting a supplement to the original application or protocol to the IRB when

a. it is clearly proposed to involve human subjects, and the previous activity had no plans or had indefinite plans for the involvement of human subjects, or

b. it is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by the IRB.

4. Complying with IRB decisions.

Research investigators will be responsible for complying with all IRB decisions, conditions and requirements.

5. Obtaining informed consent.

(Appendix A, attached to these standard operating procedures, provides detailed guidelines for obtaining informed consent. Investigators should refer to this appendix for further details and for a sample informed consent form.)

a. Research investigators are responsible for obtaining informed consent (and assent of children, as applicable) in accordance with 45 CFR 46, and for insuring that no human subject will be involved in the research prior to the obtaining of the consent.

b. Unless otherwise authorized by the IRB, research investigators are responsible for insuring that legally effective informed consent will

(1) be obtained from the subject or the subject's legally authorized representative;

(2) be stated in language understandable to the subject or the representative;

(3) be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and

(4) not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.

6. Providing basic elements of informed consent.

a. Unless otherwise authorized by the IRB, research investigators at a minimum shall provide the following information to each subject:

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

c. A description of any reasonably foreseeable risks or discomforts to the subject;

d. A description of any benefits to the subject or to others which may reasonable be expected from research;

e. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

f. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

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

h. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and

i. 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 that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

7. Providing additional elements of informed consent.

When required by the IRB, the research investigator will provide appropriate additional elements of information to each subject, including but not limited to:

a. 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;

b. Anticipated circumstances under which the subject's participation may be terminated by the research investigator without regard to the subject's consent;

c. Any additional costs to the subject that may result from participation in the research;

d. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

e. A statement that any 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; and

f. The approximate number of subjects involved in the study.

8. Documentation of informed consent.

a. Research investigators will be responsible for insuring that informed consent is documented by use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the IRB as provided for in Section II.C.3 below. In research involving children, the research investigator will be responsible for insuring that assent of the child is documented as may be required by the IRB.

b. Research investigators will insure that each person signing the written consent form is given a copy of that form.

c. The University requires its investigators to obtain a written consent document that embodies the elements of informed consent required by 45 CFR 46.116; this form may be read to the subject or the subject's legally authorized representative, but in any event, the research investigator will give either the subject or the representative adequate opportunity to read the form before signing it. More detailed guidelines for obtaining informed consent and a sample informed consent form are attached as Appendix A.

9. Retention of signed consent documents.

Research investigators are responsible for retaining the copies of consent documents including signatures of the human research subjects in a manner approved by the IRB for at least six (6) years after completion of the research project. Such documents are deemed to be the property of the Institution.

10. Submission of progress reports on the research.

Research investigators are responsible for reporting the progress of the research to the IRB, as often as and in the manner prescribed by the IRB but no less than once each year. The IRB will review these progress reports as submitted administratively or by assigning primary review to a member of the committee for report to full committee. In the event that no progress report is received by the committee within 1 year of approval, the committee shall request in writing such a report from the principal investigator.

11. Submission of reports on injury and on unanticipated problems involving risks.

a. Research investigators are responsible for reporting promptly to their department heads and the IRB any injuries to human subjects.

b. Research investigators are responsible for reporting promptly to the department heads and the IRB any problems unanticipated in the application or protocol which involve increased risks (including without limitation risks of physical, psychological, social or economic harm) to the human research subjects or others.

12. Reporting changes in the research.

a. Research investigators are responsible for reporting promptly to the IRB proposed changes in a research activity.

b. Changes in research during the period for which IRB approval has already been given shall not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

13. Reporting of noncompliance.

Both research investigators and department heads are responsible for reporting promptly to the IRB any serious or continuing noncompliance with the requirements of this assurance or the determinations of the IRB.

14. Attending IRB meetings.

To facilitate the review of research and the protection of the rights and welfare of human subjects, research investigators are encouraged to attend the IRB meetings when invited by the IRB.

B. IRB Structure

1. The Institution's IRB structure was originally established to comply with governmental regulation requiring peer review of funded research involving the use of human subjects. It functions under the general oversight of the Provost and Senior Vice Chancellor for Academic Affairs.

2. IRB membership requirements for the University of Massachusetts IRB.

a. The IRB is composed of members, appointed by the Provost and Senior Vice Chancellor for Academic Affairs on consultation with the Academic Deans, from diverse disciplines in order to promote complete and adequate review of research activities covered by this assurance; it has the professional competence necessary to review the specific research activities which will be assigned to it.

b. The IRB is sufficiently qualified through the experience and expertise of its members and the diversity of the members' backgrounds, including the racial and cultural backgrounds of members and sensitivity to such issues as community attitudes, so as to promote respect for its advice in safeguarding the rights and welfare of human subjects.

c. The IRB will include both male and female members.

d. The IRB will include members representing a variety of professions and disciplines.

e. The IRB will include at least one member whose primary expertise is in a non-scientific area.

f. The IRB includes at least one member who is not otherwise affiliated with the Institution and who is not a part of the immediate family of a person affiliated with the Institution.

3. Appointments to membership.

a. Members of the IRB shall be appointed by the Provost and Senior Vice Chancellor for Academic Affairs on consultation with the Academic Deans. Each member shall serve for a term of one year, or until such member dies, resigns, or is removed for cause, whichever shall occur first. The term of membership shall begin on July 1 of each year. Members may be re-appointed, without limit to the number of terms, and without interruption of continuity of service. Failing timely notice to the contrary, re-appointment of members shall be assumed.

b. Vacancies which may occur among the membership of the IRB shall be filled by the Provost and Senior Vice Chancellor for Academic Affairs in consultation with the appropriate academic Dean in accordance with the provisions for appointment of members to full terms, except that persons appointed to fill vacancies shall serve only until June 30. Persons so appointed are eligible for re-appointment to full terms of service.

(1) A member may resign by delivering his/her written resignation to the Chairperson of the IRB. Such resignation shall be effective upon receipt, unless specified to be at some other time. An acceptance of the resignation shall not be necessary to make it effective unless it so states.

(2) The Provost and Senior Vice Chancellor for Academic Affairs may remove members for cause following consultation with the Chairperson of IRB. Causes for removal will include, but need not be limited to: a member's non-feasance, his/her knowing participation in IRB decisions involving conflict of interest, and violation of the confidentiality of IRB activities.

c. Members shall not be compensated.

d. A Chairperson shall be appointed by the Provost and Senior Vice Chancellor for Academic Affairs in the same manner as members are appointed. The Chairperson shall preside at all meeting of the members. The Chairperson may appoint a member of the IRB to serve as Chairperson in his/her absence.

e. As required, the Chair of the IRB shall have the authority to appoint temporary, ad hoc members to the committee. These ad hoc members shall be appointed: 1) when specific expertise not otherwise found on the committee is needed to review as specific proposal; 2) when more than one IRB members is a principal investigator on a proposal requiring full committee approval. Ad hoc members shall serve for only one meeting, unless requested to remain in service by the Chair.

C. HSRC Authority and Responsibilities

1. IRB review and exemption or approval of research.

a. The IRB will have the responsibility to review and the authority to exempt, approve, require modification in (to secure approval) , or disapprove all proposed activities or proposed changes in previously approved activities covered by this Assurance. Research covered by this Assurance that has been approved or exempted by the IRB may be subject to further appropriate review and approval or disapproval by Institutional officials. However, these officials will not approve the research if it has not been approved by the IRB.

b. The IRB shall exempt research from compliance with Section II.A. 7-12 of this Assurance if the IRB determines that such research falls within one or more of the categories exempted or waived under 45 CFR 46.101.

c. The IRB approval of research shall be based on a determination that the following requirements are satisfied:

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

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB will not consider long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment, the IRB will take into account the purposes of the research, the setting in which the research will be conducted, and the population from which subjects will be recruited.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.

(6) Where appropriate, the research plan will make adequate provisions for monitoring the data collection to ensure the safety of subjects.

(7) Where appropriate, there will be adequate provisions for protecting the privacy of subjects and maintaining the confidentiality of data.

2. Documentation of Informed Consent

a. In accord with 45 CFR 46.117, the IRB will require documentation of informed consent by use of a written consent form, or may waive the requirement for the research investigator to obtain a signed consent form for some or all subjects, if the IRB determines that

(1) the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; each subject will be asked whether the subject wants documentation linking the subject with the research and the subject's wishes will govern; or

(2) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

b. When the documentation requirement is waived, the IRB may require the research investigator to provide subjects with a written statement regarding the research.

3. Waiver or Alteration of Informed Consent

The IRB may approve a consent procedure which does not include, or which alter, some or all of the elements of informed consent, or waive the requirement to obtain informed consent, only if the IRB acts in accordance with 45 CFR 46.116(c) and (d).

4. Frequency of Review

a. The Institution's IRB will determine, in its review of research protocols, which projects will require IRB review more often than annually.

b. Convened meetings of the Institution's IRB will occur quarterly and more frequently

(1) at the call of the chairperson when the chairperson judges the meeting to be necessary or advantageous; or

(2) at the call of the chairperson upon receipt of a joint written request of three or more members.

5. Continuing Review

The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year, and the IRB may observe or have a third party observe the consent process and/or the research.

6. Verification of Change

The IRB will determine which projects need verification from sources other than the research investigators that no material changes have occurred since previous IRB review.

7. Suspension or Termination of Approval

The IRB has the authority to suspend or terminate its approval of research, and report such action to appropriate authorities, in the event that the IRB determines that research is not being conducted in accordance with requirements of the IRB, or has been associated with unexpected serious harm to subjects.

8. IRB Records

a. The IRB will prepare and maintain adequate documentation of IRB activities, including the following:

(1) Copies of all applications and research protocols reviewed, scientific evaluations, if any, that accompany the protocols, approved sample consent documents, progress reports submitted by research investigators and reports of injuries to subjects.

(2) Minutes of IRB meetings which will be in sufficient detail to show the names of persons attending 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 dissenting reports and opinions. If a member in attendance has a conflicting interest regarding any project, minutes will show that this member did not participate in the review, except to provide information requested by the IRB.

(3) Records of continuing review activities.

(4) Copies of all correspondence between the IRB and the research investigators.

(5) A list of IRB members as required by 45 CFR 46.103(b)(3).

(6) Written procedures for the IRB as required by 45 CFR 46.103(b)(4).

(7) Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).

b. The IRB will provide for the maintenance of records relating to a specific research activity for at least 3 years after termination of the last IRB approval period for the activity.

c. IRB records will be accessible for inspection and copying by authorized representatives of OHRP at reasonable times and in a reasonable manner, or will be copied and forwarded to OHRP when requested by authorized HHS representatives.

D. HSRC Procedures

1. Receipt of application and protocol.

The IRB chairperson or administrative assistant will receive all applications (for exemption or approval) and protocols from the principal investigators.

2. Determination of review procedure.

The IRB chairperson or his/her designee will determine whether the application and protocol meet the criteria necessary for an expedited review process or require full board review.

3. Expedited review.

a. The eligibility of some research for review through the expedited procedures is in no way intended to negate or modify the policies of the Institution or the other requirements of 45 CFR 46.

b. The IRB may use an expedited review procedure to review research which involves no more than minimal risk to the subjects and in which the only involvement of human subjects will be in one or more of the following categories carried out through standard methods:

(1) Collection of hair and nail clippings (in a nondisfiguring manner), deciduous teeth, and permanent teeth (if patient care indicates a need for extraction).

(2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.

(3) Recording of data from subjects 18 years of age or older by the use of non-invasive procedures routinely employed in clinical practice, including the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. Also included are such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radio-activity, diagnostic echography, and electroretinography. Not included is exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

(4) Collection of blood samples by venipuncture, in amounts not exceeding 450 millimeters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

(5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

(6) Voice recordings made for research purposes such as investigations of speech defects.

(7) Moderate exercise by healthy volunteers.

(8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

(9) Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

(10) Research on drugs or devices for which an investigational new drug exemption or any investigational device exemption is not required.

(11) Any other category specifically added to this list by HHS and published in the Federal Register.

c. The IRB may use the expedited review procedure to conduct continuing review of research originally approved by the expedited procedure and to review minor changes in previously approved research during the period for which approval is authorized.

d. Expedited review will be conducted by the IRB chairperson or by one or more of the experienced IRB members designated by the chairperson to conduct the review.

e. The IRB member(s) conducting the expedited review may exercise all of the authority of the IRB, including without limitation the authority to approve, to require modification (to secure approval) or to exempt research from review, except that the reviewer(s) will refer any research protocol which the reviewer(s) would have disapproved to the full committee for review. The reviewer(s) may also refer other research protocols to the full committee whenever the reviewer(s) believes that full committee review is warranted.

f. When the expedited review procedure is used, the IRB chairperson or member(s) conducting the review will inform IRB members of research protocols which have been approved or exempted under the procedures.

4. Full committee review.

a. Applications (for approval or exemption) and copies of informed consent forms will be distributed to all members of the IRB prior to the meeting. The Chair shall designate a "Primary Reviewer" for each proposal submitted for full committee review. The complete protocol will be distributed to the primary reviewer and to all committee members prior to the meeting.

b. When it is determined that consultants or experts will be required to advise the IRB in its review of a protocol, the application and protocol will also be distributed to the consultants or experts prior to the meeting.

c. All IRB initial review and continuing review of research originally approved by full committee review will be conducted at convened meetings and at timely intervals.

d. A majority of membership of the IRB constitutes a quorum, and a quorum is required in order to convene a applications.

e. An IRB member whose concerns are primarily in non-scientific areas must be present at a convened meeting before the IRB can conduct its review of research.

f. For a research protocol to be approved it must receive the approval of a majority of those members present at the convened meeting.

g. No IRB may have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

5. IRB Notification to Research Investigators.

a. The IRB will notify the research investigators in writing of the IRB's decisions, conditions and requirements. (Appendix B).

b. The IRB will also provide to the research investigator reasons for the IRB's decision to disapprove a research protocol and an opportunity for the research investigator to respond.

6. Internal Policies of the IRB

The IRB may establish such internal operating policies as seem appropriate and necessary which do not otherwise conflict with this Assurance or 45 CFR 46 and/or FDA Compliance Program Manual. Lacking such policies, IRB procedures (unless decided otherwise by a majority vote of the IRB) will be in accordance with procedures for boards as described in the most recent edition of Robert's Rules of Order.

III. CONFIDENTIALITY

Deliberations and decisions of the IRB and substantive information associated with specific projects or research activities acquired by the members in the course of IRB business shall be considered confidential, to the extent permitted by Massachusetts law, except insofar as the dissemination of information regarding research projects or activities and IRB deliberations, decisions, and recommendations to appropriate Institutional officials is required to effectuate or support the policies or interests of the Institution.

Appendix A-Policy For Informed Consent

In accordance with the regulations of the Office of Human Research Protection (OHRP) Regulations for the Protection of Human Subjects 45 CFR 46, the University of Massachusetts requires all investigators performing studies involving human subjects to obtain written consent from such subjects.

Instructions for preparing an informed consent that includes the basic elements as required by Federal regulations can be found at http://www.umass.edu/research/comply/IRBsubmission.htm.