IRB Policies and Procedures

I. GENERAL POLICIES AND PROCEDURES

A. Belmont Report
B. 45 CRF Part 46

II. RESPONSIBILITIES OF RESEARCH INVESTIGATORS

A. Consulting with Department Human Subjects Committees
B. Requesting an Exemption
C. Preparing of Research Protocol
D. Submitting a Supplement to an Original Protocol to the IRB
E. Complying with IRB Decisions
F. Obtaining and Documenting Informed Consent
G. Data Storage and Confidentiality
H. Retention of Data
I. Addressing Concerns of Subjects
J. Submitting Progress Reports on Research
K. Submitting Injury Reports and Reports of Significant Problems Involving Risks
L. Reporting Changes in the Research
M. Reporting the Completion of the Study or Prompt Request for Continuation

III. THE REVIEW PROCESS AND IRB CONCERNS

A. Types of Review
1. Full Review.
2. Expedited Review.
3. Exempt Review.
B. Criteria for Approval
1. Minimal Risk
2. Informed Consent
a. Elements for consent
b. Exemption from Consent Requirements
c. Exemption from Written Consent
C. Other Considerations
D. Minors as Subjects
E. Prisoners or Other Incarcerated Individuals as Subjects

IV. RESPONSIBILITIES OF THE IRB

A. IRB Membership
B. Convened Meetings
C. Decisions and Feedback to Investigators
D. Suspension or Termination of Research (45 CFR 46.113)
E. IRB Records TULANE UNIVERSITY GUIDELINES FOR NON-MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS

I. GENERAL POLICIES AND PROCEDURES

The Tulane University Uptown campus and its employees are required to comply with certain policies and procedures as published in the Federal Register by the Department of Health and Human Services (DHHS) 26 January 1981 - 45 CFR Part 46 regarding the rig hts and welfare of human research subjects. Any and all research involving human subjects that is conducted by (or on) members of the Tulane University community requires that all such projects first gain the approval of an Uptown Tulane University Insti tutional Review Board (IRB). Approval from the Institutional Review Board is necessary not only for externally funded research, but for the broad spectrum of human-subjects investigations that occur at Tulane.

School and Department human subjects committees do not have the authority to approve research or to grant exemptions. Only the Uptown IRB or the Downtown IRB of the Tulane University Health Science Center (TUHSC IRB) have such authority. Further, the Up town IRB may not approve research that involves medical procedures or devices; research proposals with such features should be submitted to the TUHSC IRB (Consult www.som.tulane.edu/irb for more information). A ny nonmedical research conducted by (or on) members of the Uptown Campus should be approved by the Uptown IRB.

Research is defined as a systematic investigation designed to develop and contribute to generalized knowledge. Specifically, projects involving the use of human subjects require approval if one or more of the following apply: (a) the research is sponsored by this institution; (b) the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities; or (c) the research is conducted by or under the direction of any empl oyee or agent of this institution using any property or facility of the institution; or (d) the research involves the use of this institution's nonpublic information to identify or contact human research subjects or prospective subjects.

A. Belmont Report

This institution is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Prin ciples and Guidelines for the Protection of Human Subjects of Research. The Belmont Report may be accessed on-line at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

B. 45 CRF Part 46

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 DHHS-funded research and, except for the requirements for reporting information to DHHS, all other research without regard to source of funding. The Title 45, Part 46 of the CFR may be accessed on-line at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

In consultation with the Department Chair (or, where appropriate, Program Director or Dean), individual research investigators are responsible for determining whether research involves human subjects as defined by CFR regulations (45CFR 46.102). "Human s ubjects" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. When in doubt, investiga tors should consult the IRB. Links to the CFR and the Belmont Report appear above in Section I.

A. Consulting with Department Human Subjects Committees

Several Uptown Departments and Schools (e.g., LAS Psychology; LAS Sociology; the School of Social Work) have committees on human subjects. These committees' memberships may include persons more familiar with federal regulations than individual investigat ors, and who have experience anticipating concerns expressed by the IRB. These committees also may be able to advise investigators regarding the appropriateness of requests for exempt or expedited review, rather than full committee review. Investigators therefore are encouraged to solicit feedback and approval from such committees prior to submission to the IRB. Some Departments and Schools may require approval at that level before submission to the IRB.

B. Requesting an Exemption

At Tulane, all research involving human subjects requires IRB review and approval before research activities begin. This requirement includes all studies, regardless of degree of risk or whether the project receives intramural or extramural funding. Simpl e, low risk studies such as anonymous surveys may qualify as exempt from IRB review under federal regulations (under 45 CFR 46.101b). However, exemptions can only be granted by the IRB. Investigators at Tulane may not declare their own studies exempt, no r may a Department/School Human Subjects committee do so. The federally defined categories of exempted research appear in IIIB. To request an exemption, the investigator should complete the form at http://www.som.tulane.edu/researchadmin/forms

C. Preparing of Research Protocol

Research investigators shall prepare a protocol giving a complete description of the proposed research. In the protocol, research investigators shall make provisions for the adequate protection of the rights and welfare of prospective research subjects an d insure that pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is exempt from IRB approval and oversight. Research investigators shall include samples of proposed informed consent forms with the protocol, when applicable. More detail on preparation of the protocol appears in Section III.

D. Submitting a Supplement to an Original Protocol to the IRB

Research Investigators shall be responsible for submitting a supplement to an original protocol to the IRB when the involvement of human subjects changes from that which was initially approved by the IRB. These changes do not extend the approval period o f the protocol, which normally is the one year maximum.

E. Complying with IRB Decisions

Research investigators shall be responsible for complying with all IRB decisions, conditions and requirements. In those instances when an applicant is not satisfied with the Committee's decisions, he/she may again appeal to the Committee on Use of Human S ubjects or may request a special hearing for consideration by the full Committee membership.

F. Obtaining and Documenting Informed Consent

Research investigators are responsible for obtaining informed consent in accordance with federal regulations 45 CFR 46.116 and for insuring that no human subject will be involved in the research prior to the obtaining of the consent. Researchers should retain consent forms for at least 3 years, in a location separate from data. Details on Informed Consent appear in IIIb2

G. Data Storage and Confidentiality

If confidentiality is promised, identifying information should not be stored with research data, whether storage is electronic or on paper. If such storage is necessary, every effort should be made to protect it through the use of passwords, locked compu ters, locked cabinets, etc. While data should be kept as long as possible, identifying information should be destroyed as soon as practical.

Audio or video tapes present special concerns because participants can be easily identified. If any disclosure of the participants' identities could reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial st anding, employability, or reputation, the tapes must be transcribed or coded and destroyed as soon as possible. Tapes which, although the subjects are identifiable, would not harm the participants may be retained; however, the consent to tape form must b e clear regarding the disposition of the tapes (i.e., the date by which the tapes will be destroyed or that the researcher does not intend to destroy the material).

H. Retention of Data

Records relating to research conducted shall be retained for at least 3 years after completion of the research or publication of the results. However, as noted in the preceding section, identifying information should not be retained if researchers have p romised confidentiality.

I. Addressing Concerns of Subjects

Behavioral research sometimes requires availability of qualified professionals who can deal with psychological stress to participants.

If a subject wishes to voice complaints or concerns, he/she should contact the Chairman, Vice-Chairman or Secretary of the Committee on Use of Human Subjects. If not satisfied with the Committee's opinion, he/she may refer concerns to the Office of the As sociate General Counsel (504) 588-5031. Subjects wishing to study the University's Institutional Assurance filed with the Department of Health and Human Services may request a copy of the policy from the Office of the Senior Vice President for Health Scie nces. This document is also available from the IRB web site at http://www.som.tulane.edu/irb

J. Submitting Progress Reports on 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 per year.

K. Submitting Injury Reports and Reports of Significant Problems Involving Risks

Research investigators are responsible for reporting promptly to the IRB any injuries to human subjects which occur at local sites. In addition, any injury which occurs at a distant site must be reported if the adverse event is:

1. possibly or probably study-related, unexpected and not disclosed in the consent form; or

2. the event is more severe or occurs more frequently than described in the consent form.

L. Reporting Changes in the Research

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

M. Reporting the Completion of the Study or Prompt Request for Continuation

Approval is for a maximum of 12 months. For studies completed within 12 months, the research investigators should submit the study completion form. For studies intended to extend beyond the approval period, research investigators should submit the conti nuation form at least 8 weeks prior to the expiration date. Both forms may be downloaded from the office of the Uptown Office of Research Administration: http://www.som.tulane.edu/researchadmin/forms/irbforms.htm

A. Types of Review

The Uptown IRB conducts three types of review. Forms for each type of proposal and supplemental forms are available at the website of the Uptown Office of Research Administration: http://www.som.tulane.edu/researchadmin/forms/irbforms.htm

1. Full Review. Proposals that involve more than minimal risk, such as those using experimental manipulations, nonanonymous participant responses, dependent populations (e.g., prisoners), or children, require full committee review. A quorum of the committee must co nvene to deliberate such proposals. Typically, these meetings are held on a monthly basis.

To be considered for full review at the next convened meeting, 9 copies of the proposal must be submitted to the Uptown Office of Research Administration at least 10 working days prior to the scheduled meeting. If the investigator is not a full-time memb er of the faculty, the faculty sponsor form should be attached to all copies of the protocol. All IRB members will review the proposal, with two members designated to present the proposal to the Committee. After the meeting, the Chair and Administrativ e Liaison will send a letter to the investigator. The letter either will indicate approval for the proposal or will specify the concerns and questions raised by the Committee.

2. Expedited Review. Some research activities may be reviewed through an expedited procedure. An expedited review does not require a full committee vote, but may be conducted by the Chair of the IRB without a convened meeting. Three copies of the proposal must be submitted to the Uptown Office of Research Administration. If the investigator is not a full-time member of the faculty, the faculty sponsor form should be attached to all copies of the protocol. The Chair typically will reach a decision within 5 working days of receiving the protocol, and will send a letter to the investigator. The letter either will indicate approval for the proposal or will specify the concerns and questions raised by the Committee.

In order to be eligible for an expedited review, research activities must involve no more than minimal risk and the only involvement of research subjects must be in one of ten categories identified by DHHS. Only the six categories that do not inv olve medical procedures are used by the Uptown IRB.

_____(A3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need f or extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the colle ction procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth w ashings; (j) sputum collected after saline mist nebulization.

_____(B4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be clear ed/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strengt h testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

_____(C5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

_____ (D6) Collection of data from voice, video, digital, or image recordings made for research purposes.

_____ (E7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employ ing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

_____ (F8) Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subje cts have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

3. Exempt Review. Six categories of research are exempt per CFR 45 Sec 46.101 (b), from oversight by the Institutional Review Board. Three copies of the proposal must be submitted to the Uptown Office of Research Administration. If the investigator is not a full-time mem ber of the faculty, the faculty sponsor form should be attached to all copies of the protocol. The Chair typically will reach a decision within 5 working days of receiving the protocol, and will send a letter to the investigator. The letter either will indicate approval for the proposal or will specify the concerns and questions raised by the Committee.

Research involving minors may be considered for exemption only if it meets the stated conditions under category 2 (see below Section D All other research involving minors requires "Full Review." Federal regulations explicitly hold that determination o f "exempt" status resides with a University-wide IRB. Neither individual researchers or departmental/school human subjects committees legitimately may designate research as exempt. The exemption categories are as follows:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies; or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the s ubjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

3. 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 paragraph (b)(2) of this section, if: (i) the human sub jects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and the reafter.

4. 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 subje cts cannot be identified, directly or through identifiers linked to the subjects.

5. 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefi ts or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultura l chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

B. Criteria for Approval

1. Minimal Risk

Minimal risk, as defined by DHHS, "means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or p sychological examinations or tests." (45 CFR 46, 102g).

2. Informed Consent

The provisions for informed consent require that all investigators must obtain legally effective informed consent from the human subject or the subject's legally authorized guardian. In obtaining the informed consent, the researcher must seek informed con sent under circumstances that ensure that the subject has adequate time to consider carefully whether or not to participate, that there has been no coercion or unfair inducement to participate, that the research is described to the subject in language und erstandable to that subject and that no informed consent document includes language through which the subject waives any legal rights or which in any way releases the researcher, sponsor and institution from its liability for negligence.

a. Elements for consent

A statement of consent at a minimum should include:

i. Clear identification of the researcher(s), sponsorship, student status and faculty advisor (when applicable).
ii. A description of the procedures. Potential participants should know what they are expected to do, what types of questions they will be answering, and the like. If video- or audiotaping is intended, this fact should be disclosed at this time.
iii. A description of any foreseeable risks or discomforts.
iv. A description of any inducements, incentives, or conditions surrounding participation, with full disclosure of any terms of payment and conditions under which subjects would receive partial or no payment or remuneration.
v. A statement that participation is completely voluntary, that refusal to participate will involve no penalty, and that the subject may skip questions or discontinue participation at any time without penalty. Depending on the nature of the research, with drawal without penalty may involve receiving some payment for participating or other inducements. For studies involving student participation in exchange for course credit, students should be offered an alternative means to obtain course credit that doe s not require participation in research. Tulane's Department of Psychology has a policy that currently serves as a model for such alternatives: http://www.tulane.edu/~psych/StudentPar ticipantsPolicy.htm
vi. A statement describing how confidentiality of records identifying the subjects will be maintained.
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 later questions or concerns.
viii. An indication of whom to contact later for information or a research related problem (i.e., the researcher or faculty advisor). Depending on the nature of the research, the latter might need to include referrals to relevant mental health profession als.

Additional requirements may be applied to a particular research project, especially if the research may involve unforeseeable risk, or if early withdrawal from the study would be detrimental to the subject.

b. Exemption from Consent Requirements

The Committee on rare occasions can exempt the research from some or all of the above mentioned elements of informed consent under several conditions. For example, if the research could not be carried out without a waiver or alteration in the required in formed consent elements the committee could approve such a waiver as long as: i. The research involves no more than minimal risk to the subject;
ii. The failure fully to comply with the conditions of informed consent will not adversely affect the rights and welfare of the subject; and
iii. If possible, post-participation briefing of the subject is conducted.

c. Exemption from Written Consent

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

i. The proposed research presents no more than minimal risk and does not entail any procedures which would require written consent outside the research context.
ii. The only record linking the subject and the researcher would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
iii. Consent can be implied by a respondent's participation in a telephone survey or by the act of completing and returning a written survey.

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

C. Other Considerations

The following list is not exhaustive, but are typical considerations of the IRB and the Office of Human Research Protection:
1. Are both risks and anticipated benefits accurately identified, evaluated, and described?
2. Has due care been taken to minimize risk and maximize the likelihood of benefits?
3. Are the recruitment strategies appropriate? Are the incentives offered reasonable?
4. Are there adequate provisions to safeguard against coercion, implicit or explicit, of subjects to participate?
5. If the research will involve vulnerable populations, how will their interests be represented?
6. If the research involves children, has consent from their parents (and, if applicable, teachers or principals) been obtained? Is consent for children written in age-appropriate language?
7. What are the provisions to safeguard confidentiality? Would inadvertent disclosure or breach of confidentiality be harmful?
8. Does the research involve incomplete disclosure or explicit deception? Is it necessary?
If subjects are to be debriefed, how will it be done?
9. If the topic is potentially stressful, to whom will participants be referred?
10. How do subjects gain access to results?
11. Does the investigator (and the faculty sponsor) have the qualifications to conduct the research?
12. If video- or audio-recording is proposed, is consent for such procedures included? (See sample tape consent form on the website).

D. Minors as Subjects

The special vulnerability of children makes consideration of their involvement in research especially important. The federal government has developed special regulations for safeguarding the interests of children and protecting them from harm. With the exception of research exempt under Section I. B.2. (above), all research involving children must be reviewed by the full committee. Research that is contrary to the rights or welfare of child subjects is prohibited. A research protocol that involves mor e than minimal risk and offers no direct benefit to children is prohibited except under very specific circumstances defined in 45 CFR 46, Subpart D, "Additional Protections for Children Involved as Subjects of Research" at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#subpartd

Obtaining informed consent on behalf of the children by the parents or guardians is critical and required.

E. Prisoners or Other Incarcerated Individuals as Subjects

Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and non-coerced decision whether or not to participate as subjects in research, IRBs are required to provide addition al safeguards for the protection of prisoners. As detailed in the 45 CFR 46 Subpart C, these safeguards include but are not limited to the following issues. Researchers should refer carefully to the 45 CFR 46 ( http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#subpartc ), if they propose to study incarcerated individuals:

1. limitations on the type of research that can be conducted under 45 CFR 46.306 ( http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.306 ). For behavioral research, research with incarcerated persons may examine such topics as the causes and effects of incarceration provided that the research is no more than minimal risk

2. representation on the IRB by a prisoner advocate or prisoner, neither of whom is invested personally in the research.

3. risks for participating are commensurate with risks experienced by nonprisoners

4. advantages for participation cannot be so great that participants could not reasonably withhold participation

A. IRB Membership

1. The Uptown IRB will have at least five voting members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted on the Uptown campus. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes. The primary concerns of at least one member must be in scientific areas wh ereas the primary concerns of at least one member must be in nonscientific areas. In addition, at least one member must be unaffiliated with Tulane (except by virtue of IRB membership) and may not be an immediate family member of a person who is affiliate d with Tulane. 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 institutional commitments and regulations, applica ble law, and standards of professional conduct and practice.

2. No IRB may have a member participate 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. Committee members who request review of their research will absent themselves from meetings. In the event that the Committee is reviewing proposed research of the Chair, the Vice-Chair will conduct the review in his or her absence.

3. An 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 with the IRB

4. The current IRB comprises 8 voting members, including a member of the clergy, a member of the university counsel's office, 3 social scientists, and 3 scientists (one unaffiliated with Tulane). Three members are women, and one is a member of an ethnic minority.

B. Convened Meetings

1. Research protocols scheduled for review shall be presented to all members of the IRB prior to the meeting. If the advise of consultants or experts will be sought, they should receive a copy prior to the meeting as well.
2. Although all members will read all proposals, one or two voting members will be designated reviewers who present the proposal at the meeting.
3. During the academic year, the IRB will meet on a monthly basis. During the summer, the IRB will convene on a need-only basis.
4. A majority of the membership of the IRB constitutes a quorum and is required in order to convene a meeting for the review of research protocols.
5. For a research protocol to be approved it must receive the approval of a majority of those members present at the convened meeting.
6. 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.
7. In cases where research activities were initially approved under expedited procedures and subsequently reviewed by non-expedited procedures, the decisions reached at the convened meeting shall supersede any decisions made through the expedited review.

C. Decisions and Feedback to Investigators

1. The Chair will record concerns voiced by the committee, and will confirm what actions the committee believes are required. These actions are:
a. approval
b. approval pending stipulated changes, in which the Chair is authorized to approve the revision
c. deferral of action pending receipt of additional information or because substantial changes are required. The convened committee will reconsider changes submitted by the last day of the month.
d. disapproval

2. The Chair will draft a memorandum to the investigator indicating the IRB's decision.
a. In the case of approval, the investigator will receive an approval number, duration of the approval, and list of responsibilities (e.g., to conduct the research as written; to inform the IRB immediately of any problems with the research pertaining to the rights of human participants).
b. In all other cases, the investigator will receive a description of the IRB's concerns and requests for modifications. He or she also will be invited to contact the Chair with concerns.

D. Suspension or Termination of Research (45 CFR 46.113)

All protocol deviations and/or instances of noncompliance with local, federal or IRB regulations must be reported to the IRB by the principal investigator as soon as the violations are discovered. The IRB shall have the authority to suspend or terminat e approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects; or if there has been serious or continuing non-compliance with the policies, requirements or determinations of the IRB. When the Chair exercises this authority on behalf of the Committee, the proposal will be re-reviewed and a decision reached by the full Committee at the next convened meeting. Any suspension or termination of approval shall inc lude a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institution officials, and to the Department or Agency head.

E. IRB Records

1. The IRB shall prepare and maintain adequate documentation of IRB activities, including the following:

a. Copies of all research proposals, approved sample consent documents, progress reports submitted by research investigators and reports of injuries to subjects.
b. Minutes and voting records of IRB meetings shall be in sufficient detail to show the names of attendees 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. If a member in attendance has a conflicting interest regarding any project, the minutes, and the voting record shall reflect that this member did not participate in the review, except to provide informati on as requested by the IRB.
c. Records of continuing review activities.
d. Copies of all correspondence between the IRB and the research investigators.
e. A list of IRB members as required by the regulations 45 CFR 46.103 (b) (3)
f. Written procedures for the IRB as required by the regulations 45 CFR 46.103 (b) (4).

2. The IRB shall 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. Minutes of all meetings and notifications to investigators concerning recommendations following reviews shall be kept in the IRB Office. The records of each Committee meeting shall be available for audit at any time by authorized representatives of DHHS or the FDA and forwarded to the DHHS or FDA when requested.