5/17/02
( Please also see separate section, below, on: Requirements of Researchers )
"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 for purposes of this policy, 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. [45 CFR 46.102 (d)]" from University Policy Statement 00-03, Paragraph 3110 .
"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 person, or (2) identifiable private information. [45 CFR 46.102 (f)]" University Policy Statement 00-03, Paragraph 3120
"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. [45 CFR 46.102 (i)]"
University Policy Statement 00-03, Paragraph 3130
A quorum of the IRB shall be 51% of the currently appointed, voting membership. If a member has resigned or the membership has expired and a replacement has not yet been appointed that membership shall not count in the determination of a quorum. To make final determinations on research protocols, the quorum must include: at least one member whose primary interests are in science, one member whose primary interests are in non-scientific areas, and one of the community members of the IRB. When a member recuses himself or herself from voting and leaves the meeting, the quorum must be counted whether the issue is raised by a member or not.
The Chair of the IRB shall be elected by a majority vote at the first regular meeting of the Academic Year and shall serve for a period of one year. The Vice Chair shall be elected by a majority vote at the first meeting of the Academic Year and shall serve for a period of one year. The Vice Chair is considered to be the Chair-Elect, and is confirmed to the Chair by election. If the above-described succession of Vice Chair to Chair is not confirmed, a Chair or a Vice Chair may succeed himself or herself in the same office for one additional term.
All motions to approve protocol applications, to initiate, change, or delete Procedures, Forms, and Instructions, and to elect the Chair and Vice Chair shall be by a simple majority of the members present and constituting a quorum. A secret ballot on any issue or election may be requested by a motion and approved by a simple majority.
Whenever greater than minimal risk is inherent in a human subject research project (Standard Review) the review of that project by the IRB shall include at least one person with voting privileges conversant with the perspectives, needs, and concerns of the special population or situation. Researchers submitting protocol applications that require augmentation of the IRB shall be advised that a delay of the review may occur, if the special population or situation is one where a suitable person is not readily available to meet with the IRB. When regular members of the IRB are used to meet this requirement, it shall be noted in the minutes for the protocol discussed that the specific member has this additional function. Prisoners, pregnant women, handicapped persons, etc. are examples of special populations.
Augmentation of the IRB may be requested by the Administrator, by any member of an Expedited Review Subcommittee, by any member of a Standard Review "Lead Review Subcommittee", or by any other member of the IRB. It will be helpful if the request is made sufficiently in advance of the meeting in which the protocol application is to be discussed to provide a reasonable opportunity to accomplish the augmentation. In addition to the required augmentations which confer voting rights to the ad hoc Board members, any member of the IRB may request an expression of expert opinion by telephone, letter, personal attendance at the meeting, or other means, without voting privileges.
An IRB member is considered to be in a conflict of interest if the member's research protocol or the protocol of the member's student is being voted upon. The member may participate in the discussion, but must recuse and absent himself or herself from the meeting prior to the conclusion of the discussion, the framing of a motion, and the vote. There must be an opportunity for other members to comment on the application in the absense of the member with the conflict. There must be a quorum present in the meeting for a vote, i.e., after the member with a conflict has departed. Note: for Expedited Review no member with a conflict of interest will be appointed to a review subcommittee and, if the conflict is discovered later, such a member shall resign from the subcommittee.
Although space is limited, students and faculty conducting or sponsoring research with human subjects under review by the IRB are invited to attend the meeting in which their application will be discussed. Persons who wish to be oriented to IRB procedures may, space permitting, be present during meetings. All persons attending meetings shall request permission to attend from the IRB Chair, via the Office of University Research. When appropriate a "time certain" for discussion of the visitor's application shall be included in the agenda. When possible the order of business shall consider the attendance of visitors.
It is the intent of the IRB to acquaint itself with the local research context by interviewing the visiting applicants and sponsors.
Unless otherwise ordered or requested, the federal regulations governing human subjects of research shall be those written in 45 CFR Part 46. However, in some circumstances a funding agency may request that the regulations relating to that agency be adhered to. Since all federal agencies accept the "Common Rule," the regulations of 45 CFR Part 46 will also apply. See: Code of Federal Regulations .
All applications for approval of human subjects research protocols are received only in the Office of University Research in Foundation 310. The University program of protection of human subjects of research consists of the training component, the information component, the review components, and the monitoring component. There are three categories of review:
Each application shall consist of the following elements:
All members of the IRB will receive a copy of all materials submitted for Standard Review. All three members of Expedited Review Subcommittees will receive a copy of all materials. The review of research that may be exempt from the regulations is conducted by the Administrator based on a complete Administrative Review application package.
The complete record of a protocol shall consist of:
IRB records are to be retained in the Office of University Research for three years after the expiration of approved protocol or approved renewal application. Applications that are disapproved are to be retained for three years after the date of the meeting in which the application was disapproved.
The record of the conduct of a research project remains the responsibility of the researcher. All materials generated from human subjects, such as completed consent forms, screening data, original surveys, questionnaires, documents, physiological data, etc. must be retained by the researcher for a minimum of three years from the end of the research, unless an appropriate justification for earlier or later destruction is provided and approved by the IRB.
All applications are given a preliminary review for completeness of the application by the Office staff. If the applicant is present, the missing items will be identified and the application returned to the person for submission when complete. If the applicant is not (or no longer) present, the application will be held in the office for pick-up or sent through campus mail to the agreed upon address.
| Category | Copies Submitted | Schedule |
|---|---|---|
| Standard | 17 | Applications received by the Last Thursday of preceding month are agendized for the next monthly meeting on 2nd Thursday of month. Agendas and application materials sent to all IRB members two weeks prior to meeting. |
| Expedited | 6 | Applications sent to subcommittee within one working day. Subcommittee reports within 10 working days. |
| Administrative | 1 | Administrator reports within 2 working days. |
Standard Review is the responsibility of all members of the IRB. Proceedings are conducted by the Chair inquiring of any IRB members present in the meeting if there are concerns with any element of the application. The application form questions are reviewed seriatim, then the consent documents and recruiting materials, then the letters of support and permission, concluding with the faculty sponsor statement, if any.
The CSULB IRB does not use a "primary review" system. However, when deemed appropriate to the fullness of the agenda, the Chair may direct that the IRB Administrative Coordinator shall designate three-member review teams to "lead" the discussion of an application. Such teams will prepare written comments for distribution to the other members, who will have the same materials for their own review. The IRB Administrative Coordinator shall insure that the members with the appropriate expertise are designated as Lead Reviewers on each application.
The IRB Administrative Coordinator shall note all substantive comments regarding the application made during the meeting or provided to the Chair or the IRB Administrative Coordinator by absent members or by Lead Review Teams and provide them to the Chair as a motion is made. The specific comments to be included in the motion shall be read. As the motion is constructed the following considerations are determined by the member making the motion and the member seconding the motion. Only members present may vote.
| Type of Action | Clarifications and Modifications | Reviewer of Modifications | Assignment Options and Follow-Up |
|---|---|---|---|
| Approval | Non-substantive, Low-risk Substantive | Administrator or Chair | Informal Monitoring, shorter approval period, Data & Safety Monitoring Board, waiver of signed consent. (These options are defined later.) |
| Approval | Medium & High risk Substantive | Three member subcommittee | |
| Deferral | Conceptual | Full IRB | Approve or Disapprove |
| Disapproval | Chair represents IRB |
Expedited Review is defined in University and federal policy; see: "Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure" and is conducted by three-member subcommittees of the IRB. The categories of research eligible for Expedited Review are also available through a link from the Instructions for the Standard/Expedited Review Form. The Application asks for a description of the kind of research and the nature of the risk.
The IRB Administrative Coordinator selects the subcommittees based primarily on expertise required for the given application, and secondarily based on workload among IRB members and extended absences of members from the campus. Subcommittees are encouraged to communicate among the members via email and telephone. Each member of the subcommittee provides the IRB Administrative Coordinator with written comments on the application, indicating those concerns which must be addressed and those which are recommendations to the applicant. The IRB Administrative Coordinator compiles the comments and provides them to the applicant. See "Reports," below.
| Type of Action | Clarifications and Modifications | Reviewer of Modifications Assignment | Options and Follow-Up |
|---|---|---|---|
| Approval | Non-substantive, Low-risk Substantive | Administrator or Chair | Informal monitoring, shorter approval period, waiver of signed consent. (These options are defined later.) |
| Referral | to Standard | Full IRB | |
| to Admin Rev. | Administrative Review | ||
| Deferral | Substantive and Conceptual | to same subcommittee |
Administrative Review provides a review of the applicant's claim for exemption under the federal regulations. All regulations governing Informed Consent and venue permission/approval apply, nevertheless. The Administrator provides requests for clarification and modification on the standard response form.
| Type of Action | Clarifications and Modifications | Reviewer of Modifications Assignment | Options and Follow-Up |
|---|---|---|---|
| Approval | Non-substantive, Low-risk Substantive | Administrator or Chair | Informal monitoring, shorter approval period, waiver of signed consent. (These options are defined later.) |
| Deferral | Substantive and Conceptual | pending receipt of clarifications and modifications | |
| Referral | to Standard | Full IRB | |
| to Expedited Review | subcommittee |
If in an emergency situation, such as a civil disaster or medical emergency on the campus or in the region, in which a faculty member or student believes that legitimate research could be conducted regarding the emergency situation consistent with and not interfering with the activities of civil or University authorities, the researcher must consult immediately with the Director of University Research who shall make a determination of the category of review that would be required based on the risk to research subjects. The IRB and the Administrator will take all reasonable measures to have a complete review of the appropriate category conducted and the results reported to the researcher as quickly as possible. Research shall not commence until the review is complete and approval given. Additional guidance regarding emergency medical care is available at:"OPRR REPORTS".
Prior to approval of any category of protocol involving human subjects, the IRB shall review all applications for internal and external funding (whether funded or not) that are associated with the specific human subject protocol. A member of the IRB, other than the Director, Office of University Research, may be designated to read the funding application together with all subsequent modifications and agreements with the funding agency relating to the conduct of the project involving human subjects. The review of the funding application shall be directed to forming an opinion whether the application and associated documents is consistent with the protocol.
If in the opinion of the IRB a line of research with inherent risks of a serious nature should be approved for a period less than one year, the IRB shall direct that the approval letter contain a statement that the approval is for a lesser, defined period and specific that renewal of the protocol will require either reapplication or a request for renewal, indicating the reason for the shorter approval period.
Waiver of the requirement for signed informed consent may be granted when fully justified in writing in the protocol application or by modification request. Signed consent may be waived for Standard protocols only by the full IRB; signed consent may be waived for Expedited protocols by the subcommittee of the IRB reviewing the application; the Administrator may approve such requests for Administrative Review protocols.
The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
If the circumstances of any review require that on-site observation of pilot studies, venues, equipment, or other facilities and components of the research project be accomplished, or if the full IRB wishes to convey a point of concern personally and interactively, a special subcommittee of as many members as is considered necessary and appropriate may be created to carry out the observation or to convey the message. Such Special Review subcommittees are appropriate for Initial Review, Continuing Review, and responses to reports of adverse events.
Understanding that applicants may have miscategorized their application, any member performing a review function in the full IRB, Expedited Category subcommittee, or the Administrator reviewing Administrative Review applications may recommend to the Chair reassignment of the application to a different category, providing reasons for the recommendation in writing.
Three kinds of continuing review take place under the aegis of the IRB:
Researchers wishing to make modifications to their approved protocols, within the one-year approval period, may submit a Modification form to the Administrator. The Administrator reviews the modification and, if the change does not materially alter the risks to human subjects or significantly change the scope of the research, the Modification may be approved by the Administrator. If the Administrator believes that the change will affect the risks or scope, the Chair and Vice Chair of the IRB must be consulted and, acting as a subcommittee of the IRB, they may approve the modification or refer the question to the full Board for review. The researcher will be asked to incorporate the change into the approved protocol text, indicating revision dates on each revised page, and provide a copy to the Administrator.
A researcher may make immediate, temporary changes to eliminate apparent immediate hazards to subjects.
All letters of approval for all research protocols, whether Administrative Review, Expedited, or Standard, shall contain the following citation: "No changes to the protocol other than those noted below (in the letter) shall be initiated without prior written permission from the Director, Office of University Research or the Chair of the IRB."
All IRB approvals are for one year at a time. Renewal Annual Reports are required for projects involving human subjects extending beyond one year. The Report summarizes the past year's activities and requests extension of the approval for up to one more year.
A project will require a complete reapplication after five years.
Renewal Annual Reports are due to the Administrator two weeks before the meeting for the month in which the protocol anniversary occurs.
Reports for protocols which were originally Administrative Review protocols are reviewed by the Administrator. Reports for protocols which were originally Expedited Review are reviewed by a subcommittee comprised of the Administrator, the Chair, and the Vice Chair. Reports for protocols which were originally Standard Review are reviewed by the full IRB. In each situation, if the reviewer(s) believe that the report warrants review by the full IRB, it may be referred. Researchers shall indicate changes to the original approved protocol as well as submit any changed documents, consent forms, survey instruments, etc.
When an adverse event or an instance of violation of or non-compliance with federal or University regulations is reported to the Office of University Research, the Administrator shall notify the Chair and Vice Chair of the IRB. Acting as a subcommittee of the IRB, these three shall investigate the event, provide advice to the researcher, suggest changes to the protocol, and/or recommend cessation of activities. Modifications to a protocol made in the wake of an adverse event shall be reviewed by the full IRB. The IRB may take any appropriate action to revise the protocol or to suspend or terminate the research. See below.
The subcommittee shall inform the IRB of the event at the next regular meeting or convene a special meeting, if the circumstances warrant. The Administrator, or the Chair in the absence of the Administrator, shall promptly inform the Provost and the Head of the funding agency, if any, and the Office for Human Research Protections, U.S.D.H.H.S, of any such unanticipated problems involving risks to human subjects or of any serious or continuing violation of or non-compliance with 45 CFR 46 or the requirements and determinations of the IRB, as well as of any suspension or termination of IRB approval. Such reports will normally be made within 48 hours.
All letters of approval for all research protocols, whether Administrative Review, Expedited, or Standard, shall contain the following citation: "The researcher is instructed to inform the Director or Senior Assistant Director, Office of University Research, in writing (email is acceptable) within twenty-four hours of any adverse event in the conduct of research involving human subjects. The report shall include the nature of the event, the names of the persons affected, the extent of injury or breach of security, if any, and any other information material to the situation."
The IRB may suspend a previously approved protocol awaiting clarifications and modifications. If the IRB finds that the risk to human subjects is significantly greater than estimated at the time of approval, and with little prospect of remedy, the IRB may rescind the approval of a protocol. The IRB may rescind approval of a protocol for cause, i.e., egregious and willful departure from the terms of the approved protocol, violations of regulations, or non-compliance with regulations. The IRB may also ask that a Data and Safety Monitoring Board be formed to monitor the research.
The IRB may wish to conduct "informal observation" of IRB approved research projects. Typically, this would be done by the Chair, Vice Chair, or an IRB member from the same college as that in which the research is taking place. The objective of informal monitoring is to establish the "presence" of the IRB in the practical situation, to provide the observer with insight into the relationship between the written protocol and the actual carrying out of the project, and to verify that the protocol is being followed. When informal observations reveal significant anomalies and the appearance of misconduct (violations and non-compliances), the matter must be referred to the Director, Office of University Research and the IRB Chair.
The Secretary of the IRB shall keep Minutes of the meetings which shall be distributed to all members, the Academic Senate, and the Office of the Provost, as well as to any academic department requesting them. The minutes shall contain:
The IRB Administrative Coordinator obtains from IRB Minutes and meeting notes the requested clarifications and modifications for Standard Reviews. For Expedited and Administrative Reviews the IRB Administrative Coordinator collects the reviewer comments from the response form sent to and returned from each reviewer. The IRB Administrative Coordinator compiles the comments and requests and transmits them to the applicant on a Modifications memorandum by email, fax, post, or in person. If original documents are requested, these must be delivered to the Office, otherwise, changes to wording of protocol applications may be returned by email, fax, or in person.
The Administrator shall communicate by standard letter to all applicants when the application has been approved. The IRB may make specific changes to the standard letter in the motion to approve. The standard letter requires that all researchers report immediately to the Office of University Research any adverse events affecting human subjects of the research.
The IRB Annual Report, specified in the University Policy Statement 00-03, is distributed to the Academic Senate, Office of Academic Affairs, and other offices that request it.
All members of the IRB must complete the Responsible Conduct of Research Orientation module on Protection of Human Subjects by the end of their first semester of membership. In addition, the Administrator will provide information to members about off-campus training opportunities, particularly those sponsored by the OHRP and PRIM&R.
Persons who are "key" participants in research projects funded by the federal government, particularly U.S.D.H.H.S. agencies, are required to complete the RCR Orientation module on Protection of Human Subjects as soon as possible after being identified and notified by the principal investigator of the research project in which they participate.
Detailed instructions regarding the completion and submission of applications to the IRB for approval of research protocols are provided in the IRB Manual. Please see Section I. through N. and Sections P., R., and T. particularly. The instructions below are detailed separately from these sections because they affect both the submission and review of applications.
Federal regulations require that researchers maintain the original signed Informed Consent documents for three years after the termination of the research. As a thumb rule, the period extends three years from the expiration date of the approved protocol or approved renewal. In addition, federal regulations require that all other records developed in the course of the research with human subjects be retained by the researcher for a minimum of three years after the termination of the research, unless directed otherwise by a federal funding agency or the IRB.
See the "Checklist" at Informed Consent Process
Upon review of an application, the IRB will provide the applicant with a list of mandatory and suggested changes to the protocol application and to the associated documents, including the Informed Consent documents. Researchers are to submit the corrected copy of protocol and the Informed Consent documents to the Office of University Research for final review. The Informed Consent documents, when finally approved must indicate clearly in the header or footer of each page the approval (or renewal) and expiration date of the protocol as follows: "Approved from mm/dd/yy to mm/dd/yy by the CSULB IRB." Informed consent statements provided on the internet shall contain the same information.
All human subjects are to be provided with a copy of the informed consent document approved for the research project in which they participate. The research principal investigator or co-investigator in charge of recruitment of subjects shall sign each copy of the consent document provided to human subjects when directed by the IRB. When the IRB directs that the subjects be tested for depth of understanding of the consent document, the researcher shall keep either a written record or audio tape of the process for each participant.
Researchers must provide additional information to human subjects as the research proceeds when that information is material to the individual subject's decision to participate or continue participation. The IRB may direct the researcher to do this, but the timely informing of subjects is the responsibility of the researcher whether or not the IRB has made this a requirement. When information arises from an adverse event or other unanticipated result of the research, the researcher shall communicate this information to the Director, Office of University Research, as soon as possible, using Campus Police as the conduit, if necessary.
All California Laws regarding the disclosure of information received from persons, including those engaged as human subjects of research, are to be complied with. Persons engaged in research who are also "mandatory reporters" of abuses to or crimes of children or adults are to be disclosed in the protocol application. The IRB may ask for a reference to the applicable State law.
The California Public Records Act applies to research with human subjects as follows. Under the California Act certain kinds of medical and personal information are excluded. However, most IRB records may be made available for public review upon request following University implementation guidelines relating to FOIA. See also: the federal Freedom of Information Act (FOIA)
The Belmont Report principle of "Justice" requires that the burden of research which benefits many or all segments of society shall fall on all such segments as closely as possible to a proportionate share. Accordingly, where women or minorities or minors are seen as significant beneficiaries, they are to be included as subjects in the research. If this is not possible, the reasons shall be given as justification. Additional guidance can be obtained at: "Inclusion of Women and Minorities as Participants in Research Involving Human Subjects - Policy Implementation Page" .
