REVIEW OF RESEARCH
401 Research Exemption from IRB Review
403 Initial Review – Criteria for IRB Approval
406 Adverse Events
407 Unanticipated Problems & Protocol
Deviations
410 Study Recruitment & Advertisements
SOP: 401
Version No:
1 Effective
Date: |
research exempt from irb review |
Supercedes
Document Dated: |
All research involving the collection of data, through intervention or interaction, with living individuals or human tissues, will be reviewed by the IRB. An Investigator is NOT empowered with the ability to make the determination of whether a research project is exempt from IRB review. It is the Investigator’s responsibility to forward any human participant research project to the IRB and it is the IRB’s responsibility to determine if the research project is exempt from review. The IRB Chairperson or Vice-Chairperson makes the determination of exemption based on regulatory and institutional criteria except as specifically noted below.
When a
research project is reviewed under exempt criteria, the review takes into
consideration the level of risk involved as well as ethical concerns that may
pose potential harm to a participant. If
the reviewer finds that the ethical issues pose more than a minimal risk to the
participant but the type of research falls within the exempt criteria, it is at
the discretion of the IRB Chairperson to determine that the project will be
reviewed as either expedited or by the convened IRB.
Research projects in which the only involvement of human participants will be in one or more of the following categories are exempt from IRB review under the following conditions:
1.1.1 Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. Research on regular and special education instructional strategies,
b. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Norman Campus IRB Note: Classroom
evaluation activities do not require submission of an application to the IRB
when assessment involves regular classroom activities and results of the evaluation
process are intended to be used for the sole purpose of informing teaching
practices of the instructor.
1.1.2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
1.1.3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt, if:
a. The human subjects are elected or
appointed public officials or candidates for public office; or
b. Federal statute(s) require(s) without
exception that the confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter.
Norman Campus IRB Note:
Research activities that are requirements of a course and are being conducted
for the purpose of learning research skills only are not required to be
submitted to the IRB for review except under the following conditions:
·
The research
involves greater than minimal risk,
·
The research
is conducted with the intention to publish or disseminate results (i.e. thesis
or dissertation),
·
Participants
are members of a vulnerable population (see SOP 501),
·
The study
will solicit sensitive information, unless results are reported anonymously, or
·
Any
disclosure of participants' responses could reasonably place participants at
risk of criminal or civil liability or be damaging to the participants'
financial standing, employability, or reputation.
1.1.4. 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 subjects cannot be identified, directly or through identifiers linked to the participants.
Norman
Campus IRB Note:
·
Research involving the use of publicly available existing data
that does not include personal identifiers does not require submission of an
application to the IRB.
·
Behavioral research
1.1.5. 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:
a. Public benefit or service programs;
b. Procedures for obtaining benefits or
services under those programs;
c. Possible changes in or alternatives to
those programs or procedures; or
d. Possible changes in methods or levels
of payment for benefits or services under those programs.
1.1.6. Taste and food quality evaluation and consumer acceptance studies:
a. If wholesome foods without additives are consumed, or
b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The
IRB Chairperson, Vice-Chairperson, or IRB member designee will review research
projects meeting exempt criteria; these projects will not require convened IRB
review. The IRB Chairperson or
Vice-Chairperson will document the appropriate exempt criteria in the file
folder. Written documentation indicating
the project meets exempt criteria and that the research may begin will be sent
to the investigator.
1.3 Exempt Research Annual Verification
The
status of research projects that originally qualified for exempt status will be
determined on an annual basis. The IRB
will send a letter to the Investigator to determine if the research project
remains active and continues to meet the qualifications for exempt status.
These policies and procedures apply to Investigator claims for exemption from IRB review.
IRB Chairperson, IRB
Vice-Chairperson, or IRB member designee is responsible for the review and
determination of exempt research projects.
This SOP affects all other SOPs.
401-A Exempt Criteria List
401-A-1 Claim of Exemption Checklist for Staff
7.1
Exempt
Review / Determination Procedure
Research projects that claim exempt status will be reviewed by the IRB Education Coordinator to confirm that Investigator has completed HRPP education requirements and forwarded to the IRB Coordinator.
The IRB Coordinator provides to the IRB Chairperson or designee the item for review as follows:
7.1.1 Upon initial review of the research project, the IRB Chairperson may request verification and/or additional Information from the Investigator in order to determine exemption. This request will be communicated to the Investigator in writing.
7.1.2 If the research project meets exempt criteria 1-6 as stated in Section 1.1 of this policy, the IRB Chairperson will stamp it approved, indicate the exempt criteria number, then forward the research project to the IRB Coordinator.
7.1.3 If the research project fails to meet the criteria for exemption, the IRB Chairperson will determine that the project requires approval under expedited criteria as referenced in SOP 402 or requires convened IRB review.
7.1.4 The IRB Coordinator is responsible for recording the date of the exempt determination in the database, generating an anniversary date for renewal, generating the approval letter, and forwarding the letter to the Investigator.
7.2
Renewal
of Exemption Procedure
The IRB will send a letter to the Investigator on
an annual basis to determine if the research project remains active and
continues to meet the qualifications for exempt status.
7.2.1 Within eleven months from the original approval date, the IRB staff will generate a notification letter to the Investigator.
7.2.2 The Investigator must respond to the IRB noting if the project remains active and if changes have occurred that could change the qualifications for exempt status.
7.2.3 If the Investigator does not respond by the anniversary date of the original approval, the IRB Coordinator will present the file to the IRB Chairperson for inactivation.
7.2.4 The IRB Coordinator is responsible for recording the date of inactivation in the database, generating the inactivation letter, and forwarding the letter to the Investigator.
|
SOP: 402 Version No:
1 Effective
Date: |
Expedited
Review |
Supercedes
Document Dated: |
The
categories of research that may be reviewed by the IRB Chairperson or designee
through an expedited review procedure include research activities that (1)
present no more than minimal risk to human subjects, and (2) involve only
procedures listed in one or more of the specific categories listed in the
regulations at Federal Register Volume 63, No 216.
1.1 Research Categories Eligible for Expedited Review
(1)
Clinical studies of drugs and medical devices only when condition (a) or (b) is
met.
(a) Research on
drugs for which an investigational new drug application (21 CFR Part 312) is
not required. (Note: Research on marketed drugs that significantly increases
the risks or decreases the acceptability of the risks associated with the use
of the product is not eligible for expedited review.)
(b) Research on
medical devices for which (i) an investigational device exemption application
(21 CFR Part 812) is not required; or (ii) the medical device is
cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
(2)
Collection of blood samples by finger stick, heel stick, ear stick, or
venipuncture as follows:
(a) From healthy,
non-pregnant adults who weigh at least 110 pounds. For these subjects, the
amounts drawn may not exceed 550 ml in an 8 week period and collection may not
occur more frequently than 2 times per week; or
(b) From other
adults and children2, considering the age, weight, and health of the
subjects, the collection procedure, the amount of blood to be collected, and
the frequency with which it will be collected. For these subjects, the amount
drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and
collection may not occur more frequently than 2 times per week.
(3)
Prospective collection of biological specimens for research purposes by
noninvasive means.
Examples: (a) hair
and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need for 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 collection 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 washings; (j) sputum collected after saline mist nebulization.
(4)
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 cleared/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
strength testing, body composition assessment, and flexibility testing where
appropriate given the age, weight, and health of the individual.
(5)
Research involving materials (data, documents, records, or specimens) that have
been collected, or will be collected solely for non-research purposes (such as
medical treatment or diagnosis). (NOTE: Some research in this category may be
exempt from the HHS regulations for the protection of human subjects. 45
CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6)
Collection of data from voice, video, digital, or image recordings made for
research purposes.
(7) 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 employing survey, interview, oral history,
focus group, program evaluation, human factors evaluation, or quality assurance
methodologies. (NOTE: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45
CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is
not exempt.)
Norman
Campus IRB Additional Clarification:
Behavioral
research involving deception may qualify for expedited review provided that it
meets the following criteria:
·
The
description of the study contains no false statements, but may omit specific
information that may bias responses,
·
It involves
no greater than minimal risk,
·
It does not
involve protected groups,
·
It does not
involve material that is sensitive or personal in nature, and
·
A debriefing
is provided at completion that explains fully the purpose of the study and
gives the participant the opportunity to withdraw his/her participation by
means of requesting that his/her data be withdrawn from the study.
(8)
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 subjects have been enrolled
and no additional risks have been identified; or
(c) where the remaining research
activities are limited to data analysis.
(9) Continuing review
of research, not conducted under an investigational new drug application or
investigational device exemption where categories two (2) through eight (8) do
not apply but the IRB has determined and documented at a convened meeting that
the research involves no greater than minimal risk and no additional risks have
been identified.
Minimal risk is defined as “...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….”
A. Activities listed in Section 1.1 should not be deemed to be of minimal risk simply because they are included on the list of eligible research. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. Expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Furthermore, the expedited review procedure may not be used for classified research involving human subjects.
The IRB
Chairperson or designee may exercise all of the authorities of the IRB, except
that he/she may not disapprove the research.
A research project may be disapproved only after review by the convened
IRB.
When
the expedited review procedure is used, the IRB office will inform the
Investigator of the Chair’s expedited review decision including notification of
the qualifying category for expedited review. All regular members will be
informed of the actions taken by the IRB chairperson or designee at their next
convened meeting as the meeting agenda will reflect those items approved under
an expedited review. IRB discussion will be limited unless there are questions.
If the
study qualifies for expedited review, the IRB Chairperson or designee will
document his/her determination of risk.
The
minutes will include documentation of the studies that were reviewed via
expedited review and any issues resolved relating to questions that IRB members
had concerning the research reviewed.
A. Conditional approval pending minor revisions, clarification: Revisions to consent documents and other documentation or clarifications submitted as a result of full IRB review and as a condition to final approval may be reviewed by the IRB Chairperson or his/her designee. However, the convened IRB should review responses to requests that require judgments not allowable under the expedited review procedure; i.e. responses to DSMB plans, major rewrites to the informed consent document, rationale for the number or type of study participants being sought.
B. Continuing
Review: The IRB Chair, or designee,
may use the expedited review procedure for Continuing review of research
previously approved by the convened IRB where:
(a) 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) no subjects have been enrolled and
no additional risks have been identified; or
(c) the remaining research activities
are limited to data analysis.
C. Initial review of serious adverse event and safety reports (SAEs): The IRB Chairperson, or designee, will review summaries of safety reports and reports of serious adverse events. If the IRB Chairperson determines that action is needed to protect the safety of research participants due to the nature or frequency of reported adverse events, he/she may take such action to the convened IRB or designated Data Safety Monitoring Board subcommittee, which will review the adverse events and study in question to determine action, if any, by the IRB. If the IRB Chairperson determines that the information reviewed in the SAEs poses an immediate threat to study participants, he/she may take immediate action such as suspending enrollment or discontinuing study treatment.
D. Amendments:
These include revisions to the consent form, translations of the consent form,
advertisements, or minor changes to the previously approved project that do not
involve more than minimal risk to participants.
Any protocol revision that entails more than a minimal risk to the
subjects must be reviewed by the full IRB at a convened meeting.
E. Advertisements: The IRB Chairperson, or designee, may approve new or revised recruitment advertisements or scripts.
F. Revisions to informed consent documents: Minor changes to informed consent documents that do not affect the rights and welfare of study participants, or do not involve increased risk or significant changes in study procedures may be reviewed and approved by the Chairperson/designee.
G. Miscellaneous items: These items do not include amendments, adverse events or continuing reviews but may include protocol deviations, discussion topics such as an audit result, Investigator question or Investigator correspondence. Miscellaneous items may be reviewed and approved by the IRB Chairperson or designee if it does not increase risks to participants.
These policies and procedures apply to all research submitted to the IRB(s) that qualifies for expedited review.
IRB Coordinator is
responsible for the initial identification of submissions that qualify for
expedited review. IRB Chairperson (or designee) is responsible for making the
final determination of eligibility.
IRB Chairperson (or
designee) is responsible for conducting expedited review.
IRB Coordinator is
responsible for posting of the expedited reviews to the agenda/minutes for
presentation and review by the IRB members.
Expedited Review: 45 CFR 46.110
This SOP affects all other SOPs.
402-A Expedited Review Categories
7.1 IRB Chairperson or designee determines risk according to the Research Categories listed in this policy. The IRB Chairperson considers the methods used to conduct the research, recruitment practices, participant population, confidentiality of data, involvement and training of the research staff and feasibility of the study when considering if a study is minimal risk.
7.2 IRB Chairperson or designee may exercise all of the authority of the IRB, except that only the convened IRB may disapprove a research proposal. The IRB Chairperson or designee may request changes or approve the research proposal.
7.3 IRB Coordinator provides to the IRB Chairperson or designee the item to be reviewed and the tools to conduct the review.
7.4 IRB Chairperson or designee documents in writing his/her determination of risk on the IRB Application Form by stamping and initialing his/her approval, including the assigned expedited number. The IRB Coordinator posts the expedited review research proposal to the next appropriate Board agenda.
7.5 IRB Chairperson or designee documents in writing his/her minor revisions inside the file folder on the yellow note sheet or, if revisions are approved, stamps and initials his/her approval on the IRB Application Form, amendment form, adverse events and safety reports and miscellaneous item.
7.6 IRB Chairperson (or designee) reviews minor changes in research, revisions to informed consent documents, adverse events and safety reports, and advertisements.
7.7 If minor changes or revisions entail more than minimal risk, IRB Chairperson documents on the yellow note sheet to assign to full IRB review. The IRB Coordinator posts the revision to the next appropriate Board agenda.
7.8 If minor changes are approved, IRB Chairperson stamps and initials his/her approval on the revised document. The IRB Coordinator posts the approval to the next Board agenda and generates an approval letter.
7.9 Once the Chairperson or designee approves the expedited study, the IRB Coordinator posts the expedited review research proposal to the next appropriate Board agenda thereby informing all regular members of the review and approval.
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IRB Chairperson |
||
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Upon completion of the review, add the study to the next IRB Meeting Agenda/Minutes and indicate the outcome. |
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SOP: 403 Version No:
1 ·
Effective Date:
|
Initial Review - Criteria
for IRB Approval |
Supercedes
Document Dated: |
All research projects that intend to enroll human participants must meet certain criteria before study-related procedures can be initiated. The criteria are based on the principles of justice, beneficence and autonomy as discussed in the Belmont Report and are specified below. In addition, certain other criteria that are unique to The University of Oklahoma may apply and must be met as well.
No Investigator has a right to conduct research within this
institution. Rather, it is a privilege
granted by society as a whole and the Board of Regents of the
The IRB evaluates each project on an individual basis in order to assess whether the Investigator is providing all of the necessary services in an effort to protect the participant. This may include research staff, social support services, counseling, ancillary care, equipment, and training provided by the Investigator to external or internal entities involved in the research project.
This assessment will be ascertained using the initial IRB application which includes the protocol, outside IRB approval letters, letters of support, advertisements, and all other supporting documents. The IRB will consult the Investigator for additional information regarding necessary services.
During the course of review by the IRB, the research project will be evaluated to determine whether it provides adequate resources to protect the rights and welfare of participants.
In
order for a research project to be approved, the IRB must find that:
A. Risks to participants are minimized:
· By using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk, and
· Whenever appropriate, by using procedures already being performed by or on the participants for diagnostic or treatment purposes.
B. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may be expected to result.
· In evaluating risks and benefits, the IRB will consider those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that participants would receive even if not participating in the research).
· The IRB will also consider the data and safety monitoring plan, if applicable. The IRB will suggest a DSMP to the Investigator, if applicable, to ensure patient safety.
C. Selection of participants is equitable.
§ The IRB should take into account the purpose(s) of the research, the setting in which the research will be conducted and the inclusion/exclusion criteria so that fair and equitable burdens and benefits are maximized. The IRB should evaluate the recruitment practices and also any payments to participants. The IRB should also be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.
D. Informed consent/assent will be sought from each prospective participant or the participant's legally authorized representative, in accordance with and to the extent required by appropriate local, state and federal regulations.
E. Informed consent/assent will be appropriately documented as required by local, state and federal regulations.
F. If the protocol has, or has the potential to have, higher levels of risk, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
G. Where appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of identifiable data.
H. When some or all of the participants, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence or for participants found at international sites, additional safeguards have been included in the study and in the IRB review process, to protect the rights and welfare of these participants.
I. Studies are reviewed at periods appropriate to the degree of risk research participants are exposed to due to their participation in the study, but at least annually.
1.2 Other Criteria
The IRB
may require verification of information submitted by an Investigator. The need
to verify any information will be determined by the IRB at a convened meeting
or at the discretion of the Expedited reviewer. The purpose of the verification
will be to provide necessary protection to participants when deemed appropriate
by the IRB.
The
criteria used to determine whether third-party verification is required may
include:
·
Investigators that conduct studies that involve a potential high risk
to participants,
·
Studies that involve vulnerable populations,
·
Investigators who conduct studies that involve large numbers of
participants, and
·
Investigators selected at the discretion of the IRB.
Projects that need third party verification, from sources other than
the Investigator that no material changes have occurred since previous IRB
review was determined, will have such assessment performed as necessary.
Under authority granted by the Board of Regents of The University of
Oklahoma, the Senior Vice President and Provost of the Health Sciences Center
and the Senior Vice President and Provost of the Norman campus may enter into
joint review arrangements, rely upon the review of another qualified IRB, or
make similar arrangements for avoiding duplication of effort as allowed and
upon modification of the institutional Federal-wide Assurance agreements
(FWA). For example, projects determined
to have a conflict of interest, IRB review may be waived and delegated to
Western Institutional Review Board (WIRB).
A. Determination of Reviewing
Campus
The
reviewing campus shall be determined in the following manner:
1.
For medical or clinical studies involving human participants, the
Oklahoma City Campus IRB will review for both campuses.
2. For all other research activities,
determination of the reviewing campus is based on the home campus of the
Investigator unless it involves clinical procedures that are outside of the
expertise of the Norman Campus IRB. For
example, a Norman Campus Investigator from the
2.
Each campus shall have the right to require review by its own IRB
regardless of this policy, provided that the decision is stated in writing and
presented to the IRB Chairpersons of both IRBs.
1.5 Review of Research
Conducted by Persons Carrying Appointments from
Research
carried out by individuals with
1.6 Length
of Approval
Once
approved by the IRB, the IRB must determine the appropriate length of the
approval. This is the maximum number of
days that the IRB feels is appropriate for the study to continue without full
review of the research. Federal
regulations do not allow for this approval period of time to exceed 365 days.
1.
If the IRB determines that the risk to participants is appropriate
based on the procedures outlined in the protocol and that the majority of
potential risks is currently known, then approval will be granted not to exceed
one year.
2.
If the IRB determines that the study involves a high degree of risk
and/or the stage of the research is such that many of the potential risks are
not yet known, then approval may be granted for a shorter amount of time. The
duration of approval will vary depending on the type of study, the projected
enrollment, the study population, etc.
The duration of approval and research for such determination will be
noted in the IRB minutes. The IRB will
also ensure that an appropriate data safety monitoring system is in place.
3.
Certain types of research will not fit clearly into one of the above
categories. These may include Phase I
research studies, special treatment
1. All cancer-related studies will be reviewed by the Cancer Center Scientific Review Committee (SRC) prior to submission to the IRB.
2. Investigator-initiated studies which plan to utilize the General Clinical Research Center (GCRC) which are not cancer related will be presented for scientific merit review to the General Clinical Research Center Advisory Committee (GAC) before submission to the IRB.
3.
All studies utilizing the OKC or
4. The Institution will utilize the expertise and knowledge of the IRB to review proposed research for either scientific merit or scholarly review for the following human research activities:
a. Investigator-initiated studies that are not utilizing the GCRC,
b. Studies that are not cancer related,
c. All other research projects that require scientific merit or scholarly review.
Scientific or scholarly review of proposed research activities by the IRB will be assessed for merit using a scientific review checklist. Comments and recommendations by the IRB will be made in writing to the Principal Investigator. When necessary, the IRB will obtain additional expertise from a consultant(s). Such a consultant will be independent of both the investigator and the protocol.
These policies and procedures apply to all IRB staff and IRB members and to research submitted to the IRB.
IRB Coordinator is
responsible for ensuring that IRB members have all the tools and resources they
need to complete their research reviews.
IRB Chairperson (or
designee) is responsible for providing IRB members adequate submission review
training and ongoing guidance, and for selecting primary and secondary
reviewers with the relevant expertise to perform reviews and make necessary
recommendations on approval decisions by the IRB.
IRB Reviewer is responsible
for conducting a thorough review, securing appropriate consulting expertise as
needed, and making appropriate approval recommendations for consideration by
the IRB.
IRB Education Coordinator is
responsible for the initial and continuing education of the IRB Board members.
This SOP affects all other SOPs.
403-A IRB
New Study Reviewer Sheet
403-A-1
Proposal Review Form
7.1.1 The IRB Coordinator receives new application documents and checks for accuracy of information, as well as all required documents are submitted. The IRB Coordinator makes an initial assessment of the study to determine if it requires review by expedited procedures or a convened IRB. The study is either assigned to the next appropriate agenda or given to the Chair for review.
7.1.2 The IRB Chairperson, or designee, reviews the content with consideration of the risk/benefit analysis, the design in the selection of subjects, and the inclusion of required information elements in the informed consent according to federal ‘Common Rule’ regulations, The Belmont Report, as well as local and state regulations. If the study requires full Board review, the IRB Chairperson remits back to the IRB Coordinator, who in turn assigns the study to the next appropriate Board agenda.
7.1.3 The IRB Chairperson may require verification of information submitted by an Investigator. This information may be obtained from third party persons such as the sponsor, other institutions participating in the research and other IRBs reviewing the research. The IRB Chairperson will document this verification on the yellow note sheet in the file or may dictate a note to file.
7.1.4
As noted, the University of Oklahoma Senior Vice
President and Provost of the
7.1.5 The IRB Coordinator ensures in advance that the IRB Chairperson and all reviewers receive an agenda for each IRB meeting, copies of the previous IRB meeting minutes, and copies of all agenda items to be reviewed at the meeting.
7.1.6 The IRB Coordinator in advance of the IRB meeting forwards an agenda to the IRB Chairperson to designate primary and secondary reviewers for each item to be reviewed at the meeting. The IRB Coordinator inserts the name of each primary and secondary reviewer in the agenda and forwards the agenda to each assigned reviewer.
7.1.7 The IRB Reviewer examines each assigned agenda item and reports their conclusions to the IRB Chairperson and other IRB members at the Board meeting. The IRB Coordinator notates their conclusions in the Board meeting minutes.
7.1.8 All expedited proposals follow the expedited process outlined in SOP 402.
SOP: 404
Version No:
1 Effective Date: |
·
· Continuing Review |
Supercedes
Document Dated: |
The IRB conducts continuing review of research taking place within its jurisdiction at intervals appropriate to the degree of risk. Periodic review of research activities is necessary to determine whether approval should be continued or withdrawn. All research involving human participants must be reviewed no less than once per year.
IRB approval may be withdrawn at any time if warranted by the conduct of the research. The regulations authorize IRB to establish procedures for the concurrent monitoring of research activities involving human participants.
IRB approval for the conduct of a research project may be revoked if the risks to the participants are determined to be unreasonably high, for example, more than an expected number of adverse events, unexpected serious adverse events; Investigator and/or research staff has not completed the education requirements or evidence that the Investigator is not conducting the investigation in compliance with IRB or Institutional guidelines.
Such findings may result in more frequent review of the research project to determine if approval should be withdrawn or enrollment stopped until corrective measures can be taken or the research project terminated.
The IRB
must conduct continuing review of research projects for purposes of renewal of
the IRB approval period, at intervals appropriate to the degree of risk, which
is determined at the initial review, but not less than once per year. “Not less
than once per year" means that the research must be reviewed and approved
on or before the one‑year anniversary of the previous IRB review date,
even though the research activity may not have begun until some time after IRB
granted approval.
Investigators
or qualified designees are required to submit a periodic report prior to the
expiration of the research project or as specified by the IRB, but at least
once per year.
Norman
Campus: The report should be filed
with the IRB office approximately 45 days before the research project approval
period ends.
There
is no grace period extending the conduct of the research beyond the expiration
date of IRB approval. Extensions beyond
the expiration date will not be granted. If the IRB Application for Continuing Review
(Progress Report) and other supporting documents are not received as scheduled,
the Investigator must stop enrollment and research project activities until
reports are reviewed and approved. The
IRB will notify the Investigator to stop research project activities.
However, if the Investigator is in communication with the IRB, the
Continuing Review Report or other report is forthcoming, and in the opinion of
the IRB Chairperson, participants in the research project would suffer a hardship
if medical care were discontinued, appropriate medical care may continue beyond
the expiration date for a reasonable amount of time. However, new participants
cannot be enrolled.
The IRB will address on a case-by-case basis those rare instances where
failure to enroll new participants would seriously jeopardize the safety or
well being of an individual. Prospective
research data cannot be collected nor can research-related procedures be
performed until a Continuing Review Report is reviewed and approved.
Continuing
review must be substantive and meaningful. When considering whether or not to
renew a research project, the IRB revisits the same criteria used to grant
initial approval. Therefore, the IRB (or
the reviewers for protocols reviewed under an expedited procedure) must
determine that:
· The risks to participants continue to be minimized and reasonable in relation to the anticipated benefits;
· The selection of participants continues to be reasonable in relation to anticipated benefits;
· Informed consent continues to be appropriately documented;
· Provisions for safety monitoring of the data are adequate;
· Protections to ensure the privacy of participants and confidentiality of identifiable data, and
· Safeguards for vulnerable populations are appropriate;
· The Investigator is providing all of the necessary services to conduct the research project;
Because it may be only after
research has begun that the real risks can be evaluated and the preliminary
results used to compute the actual risk/benefit ratio; the IRB can then
determine whether or not the research project can be renewed at the same
risk/benefit ratio, or if new information has changed that determination.
In
order to determine the status of the research project, the following will be
revisited:
1.3.1 Consent document: each member of the IRB shall review the currently approved consent document and ensure that the information is still accurate and complete. Any significant new findings that may relate to the participant’s willingness to continue in the research project should be provided to the participant in an updated consent document or discussed with the participant.
1.3.2 Current approved protocol including any amendments to the protocol since initial review: each member of the IRB shall receive the currently approved protocol including any amendments previously approved by the Board. Amendments and changes to a research protocol should be submitted as generated during the course of the research project.
1.3.3 Application for Continuing Review: all IRB members shall receive a Continuing Review report prepared and submitted by the Investigator along with the number of participants entered to date and since the last review. The Continuing Review report shall summarize:
o adverse event experiences,
o any unanticipated problems involving risks to participants or others
o any withdrawal of participants from the research or complaints about the research,
o a summary of any relevant recent literature,
o interim findings and amendments or modifications to the research since the last review,
o any relevant multi-center trial report, any other relevant information, especially information about risks associated with the research,
o a copy of the current informed consent document
o and provide a reassessment of the risk-to-benefit ratio. See the Adverse Event policy 406 (Adverse Events).
Continuing review of DSMB-monitored clinical trials: when a clinical trial is subject to oversight by a DSMB whose responsibilities include review of adverse events, interim findings and relevant literature (e.g., DSMB’s operating in accordance with the National Cancer Institute Policy for Data and Safety Monitoring of Clinical Trials), the IRB conducting continuing review may rely on a current statement from the DSMB indicating that it has reviewed research project-wide adverse events, interim findings and any recent literature that may be relevant to the research, in lieu of requiring that this information be submitted directly to the IRB.
The IRB must still receive and review reports of local, on-site related, serious and unanticipated problems involving risks to participants or others and any other information needed to ensure that its continuing review is substantive and meaningful.
As an outcome of continuing review, the IRB may require that the
research be modified or halted altogether.
If it is recommended that the research project be terminated or
suspended, the IRB will address and describe how the Investigator will proceed
with termination taking into account the rights and welfare of the current
participants (if applicable). The IRB
may need to impose special precautions or relax special requirements it had
previously imposed on the research project.
A
research project that was originally reviewed using the expedited review
procedure may receive its continuing review on an expedited basis. Additionally, a research project that was
reviewed by the convened IRB that has not been awarded funding, or remains open
only to data analysis may be reviewed using an expedited review.
The IRB
Chairperson or designee conducts the review on behalf of the full IRB using the
same criteria for renewal as stated in section 1.3 of this policy. If the reviewer feels that there has been a
change to the risks or benefits, he or she may refer the research project to
the convened IRB for review.
These policies and procedures apply to all research submitted to the IRB.
IRB Staff is responsible for
notifying investigators to submit their continuing review reports.
HRPP Director is responsible
for establishing and implementing processes for making research renewal
decisions.
IRB is responsible for
timely and thorough review of the Application for Continuing Review,
communication to the Investigator of any needed changes, and approval prior to
the expiration date.
OHRP Guidance on Continuing Review
5. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
302-B Application
for Continuing Review
601-V Continuing
Review Reminder Notice Letter
601-W Continuing
Review Final Notice Letter
7.1 Continuing review of research is conducted
at intervals appropriate to the degree of risk, but not less than once per
year. Research must be reviewed and
approved on or before the one‑year anniversary date of the previous IRB
review date.
7.2 The anniversary date is determined at
initial review depending on the level of risk.
At the time of approval, the research project is given an
approval-through date and recorded in the IRB database. Investigators or qualified designees are
required to submit an Application for Continuing Review report before the
expiration of the study or as specified by the IRB, but at least once per year.
Norman Campus: the report should be filed with the IRB
office 45 days before the end of the research project approval period.
7.3 Monthly reports from the IRB database are
generated based on the expiration date.
The report lists the Continuing Reviews due by the month of
expiration. First reminder notices are
generated from the database 90 days prior to expiration with a due date of the
15th of the month or the next business day.
7.4 Final reminder notices are generated 2-3 days after the first due
date with a new due date within 7 days.
If after 7 days the Investigator fails to submit the Continuing Review
report the Investigator is notified by email and/or telephone calls.
7.5 Federal regulations do not allow for a grace period or extension
of the approval period. If the
Continuing Review is not reviewed and approved by the end of the approval
period the Investigator may not continue enrollment or other research activity. The Investigator is responsible for notifying
the IRB if there is a need to continue enrollment of new participants for their
safety and well being.
7.6 When the Continuing Review report is received in the IRB office,
it is first reviewed for completeness and triaged for type of review. All Expedited Continuing Reviews are given
to the IRB Chairperson for review. The
Continuing Reviews for the convened IRB are added to the next appropriate
meeting agenda for review.
7.7 IRB members are given a Continuing Review Worksheet to ensure
meaningful and substantive review. All
documents included with the Continuing Review Report will be provided to all
IRB members. This includes the
Continuing Review report, protocol, consent form(s), Research Authorization
forms, and all documents as outlined in the Continuing Review report.
7.8 Review by the Convened IRB: the convened IRB reviews all
documents at the meeting and makes recommendations for approval, contingent
approval, deferral or disapproval as follows:
o Approval: if the IRB approves the Continuing Review without revisions, the IRB Coordinator generates an approval letter for signature by the IRB Chairperson.
o Contingent Approval: if the IRB determines minor changes are required, the IRB Coordinator generates a Contingent Approval letter notifying the Investigator of the requested changes. When the changes are returned, the IRB Coordinator reviews the changes for completeness. The IRB Coordinator notates any deficiencies or discrepancies for the IRB Chairperson and forwards the Continuing Review report to the IRB Chairperson for review. If the board requested changes are not received before the expiration date, the IRB Coordinator will generate a notice of expiration letter.
o Deferral: the IRB may determine that substantive clarifications or modifications regarding the protocol or informed consent documents are required. In these cases the IRB will defer approval, pending subsequent review by the convened IRB of responsive material. The IRB Chairperson will contact the Investigator concerning the details of the deferral and will draft the deferral letter.
o Once changes are received in the IRB office, the IRB Coordinator will place the Continuing Review on the next appropriate meeting agenda. The IRB Coordinator will evaluate whether there will be a lapse in IRB approval. If there will be a lapse in IRB approval, the IRB Coordinator will print the Notice of Expiration letter for signature by the IRB Chairperson.
o Disapproval: the IRB may identify serious concerns for participant safety or Investigator compliance. In these cases, the Board will disapprove the research. The IRB Chairperson will draft the disapproval letter and the IRB Coordinator will generate the disapproval letter for transmittal to the Investigator
7.9 Expedited Review of Continuing Reviews: the IRB Chairperson reviews all continuing review documents received and will either approve or contingently approve the Continuing Review. The IRB Chairperson may also determine that the Continuing Review should be presented for review by the convened IRB. The IRB Chairperson may not disapprove a Continuing Review.
o Approval: if the IRB Chairperson approves the Continuing Review without changes, the IRB Coordinator generates an approval letter for signature of the IRB Chairperson.
o Contingent Approval: if the IRB Chairperson determines that minor changes are required, the IRB Coordinator generates an email to notify the Investigator of the contingent approval and the revisions requested by the IRB Chairperson. If the IRB Chairperson determines that the convened Board should review the Continuing Review, the IRB Coordinator will assign the item to the next appropriate meeting agenda.
7.10 Determination of Approval & Expiration Dates: following approval of a research project, the approval and expiration dates are determined as shown in the following examples:
IRB
Action: Approval
Convened
IRB Meeting Date:
Approval Date:
Expiration Date:
IRB Action: Contingent Approval
Convened IRB Meeting Date:
Date
revisions returned:
Approval
Date (by Chairperson):
Approval Date:
Expiration Date:
IRB
Action: Deferral
Convened
IRB Meeting Date:
Requested
revisions submitted:
Resubmitted
to convened IRB:
IRB Action: Contingent Approval
Requested
revisions submitted:
Approval
Date (by Chairperson):
Approval Date:
Expiration Date:
SOP: 405
Version No: 1 Effective Date: |
·
AMENDMENTS
|
Supercedes Document Dated: |
1.1
Definitions of Minor
Modifications
Modifications that do not materially affect an assessment of the risks
and benefits of the study or substantially change the specific aims/design of
the study will be considered minor and will qualify for expedited review. Examples of minor modifications include, but
are not limited to:
·
Addition of research activities that would be considered exempt or
expedited if considered independent from the main research protocol;
·
Minor increases or decreases in the number of participants;
·
Narrowing or broadening the inclusion criteria;
·
Changing the dosage form (i.e. tablet to capsule or oral liquid) of an
administered drug provided that the dose and route of administration remains
constant.
·
Decreasing the number of biological sample collections, provided that
such a change does not affect the collection of information related to safety
evaluation.
·
Increasing or decreasing the number of study visits, provided the
decrease does not affect the collection of information related to safety
evaluations;
·
Changes to improve the clarity of statements or to correct
typographical errors, provided that such a change does not alter the content or
intent of the statement;
·
Addition or subtraction of qualified investigators and/or study sites;
·
Minor changes specifically requested by the IBC, RSO, SCR, VA R&D
or any other campus-based, University committee that has jurisdiction over research.
Changes in approved research, during the period for which approval has
already been given, may not be initiated without prior IRB review (full,
expedited review, or exempt as appropriate) and approval, except where
necessary to eliminate apparent immediate hazards to human participants.
Investigators must submit requests for changes to the IRB in
writing. Upon receipt of the protocol
change, the IRB Chairperson or designee will determine if the revision meets
the criteria for minimal risk. If the
change represents more than a minimal risk to subjects, it must be reviewed and
approved at a convened meeting of the appropriate IRB. Minor changes, involving no more than minimal
risk to the subject, will be reviewed by the expedited review procedure. (SOP
402)
Amendment requests must be submitted by completing an IRB Protocol
Modification Form. Documentation should be included with the completed form
indicating the requested revision(s) and must clearly outline the requested
revision(s).
In evaluating the IRB Protocol Amendment Form and the documentation,
the IRB chairperson or designee will consider expedited review or full Board
review. Expedited review will be utilized for amendments involving minor, or
minimal risk, revision(s). Full Board review will be required for any major,
controversial, or questionable revision(s).
The IRB may require
verification of information submitted by an Investigator. The purpose of
verification will be to provide necessary protection to participants when
deemed appropriate by the IRB.
These policies and procedures apply to all HRPP staff, Investigators and research staff and IRB members.
3. RESPONSIBILITY
IRB Coordinator is
responsible for ensuring that the IRB Chairperson has all the tools and
resources needed to complete the initial review of the Protocol Modification.
IRB Chairperson or designee
is responsible for determining expedited review or Full Board review of the IRB
Protocol Modification.
IRB Member (Reviewer) is
responsible for presenting the Protocol Modification at the next convened
meeting.
This SOP affects all other SOPs
302-C Protocol
Modification Form
7.1 IRB Coordinator initially reviews and triages the amendments for expedited review or full Board review. IRB Coordinator forwards the IRB Protocol Modification Form and the documentation to the IRB Chairperson for expedited review. If the IRB Coordinator is not certain if an amendment requires full Board review, the Chairperson will make that determination.
IRB Chairperson indicates expedited review by stamping and initialing the IRB Protocol Modification Form for approval, or by using the yellow note sheet to make revisions or to forward for full Board Review.
IRB Coordinator examines the IRB Protocol Modification for approval and examines the yellow note sheet for revisions or for a notation to forward for full Board Review.
In the case of expedited review, the IRB Coordinator prints the approval letter and presents it to the Chairperson for signature.
In the case of convened Board review, IRB Coordinator places the amendment on the next appropriate agenda for full Board review.
IRB Member (Reviewer) presents the IRB Modification to the full Board for discussion and approval or for revisions.
IRB Coordinator prints the appropriate letter based upon the Board action and presents it to the Chairperson for signature.
|
SOP: 407 Version No:
1 Effective
Date: |
UNANTICIPATED PROBLEMS AND PROTOCOL
DEVIATIONS
|
Supercedes
Document Dated: |
The Institutional Review Board (IRB) requires Investigators to promptly report any unanticipated problem that involves risks to participants or others. Unanticipated problems are any unforeseen event or events that may involve risks or affect the study or welfare of participants or others, or that may affect the integrity of the research. These events can occur in both biomedical and social/behavioral research. Generally, the type of risks involved in these events can be physical, emotional, social, financial, or legal. They may directly involve individuals participating in the research study or individuals indirectly involved as part of the research team, and/or affect the integrity of the study.
Also, the Institutional Review Board (IRB) requires Investigators to promptly report protocol deviations. Protocol deviations are events that are a departure from the specific protocol procedures approved by the IRB. Protocol deviations may or may not place participants at risk.
Specific Policies
1.1 Unanticipated Problems and Protocol Deviations
Unanticipated problems will be reported to the IRB by the Investigator explaining the occurrence and if applicable an explanation as to how to avoid future occurrences. If other entities are involved, it is the responsibility of the Investigator to notify them of the occurrence. The event will be reviewed by an IRB Chairperson, sent to the convened IRB for review if deemed necessary by the IRB Chairperson, and assessed for necessary action that may need to be taken. The range of actions may include, revisions to the protocol, audit of the research site, institution of a schedule of continuing review that is more frequent than on an annual basis or additional protective procedures requested by the IRB (i.e. observation of the informed consent process).
It is within the authority of the IRB to institute
IRB site visits to ensure investigator/clinical team integrity if the IRB
receives an excessive number of unanticipated problems, protocol deviations, or
if the IRB suspects noncompliance or improprieties on the part of the
Investigator and/or clinical team.
Examples of Protocol Deviations:
· Participants who have been enrolled in a research project but failed to meet all of the inclusion criteria.
· Participants who sign an outdated or unapproved version of the informed consent document.
·
Participants who are seen outside of the timeframe as
specified by the protocol.
·
Incorrect dosage of the drug administered to the
participant.
These policies and procedures apply to all research submitted to the IRB.
IRB
Chairpersons are responsible to review reports and forward to the convened IRB
when appropriate.
45 CFR 46.103,109
21 CFR 56.108, 109
This SOP affects all other SOPs
407-A Unanticipated
Problem Report Form
407-A-1
IRB Form For Reporting Unanticipated Problems in Human
Subjects
407-B Protocol
Deviation Report Form
7.1
Reporting
Requirements for Unanticipated Problems
Unanticipated problems that occur during the course of a research study must be submitted to the IRB using the appropriate form for each campus. Information will include a summary of the problem or incident and a description of the corrective action that will be taken to alleviate a future occurrence of the problem.
In cases where a modification to the protocol is necessary to correct the deviation, a protocol modification form should also be submitted to the IRB for review and approval.
7.2 The
HRPP and IRB staff, and IRB members will immediately report to the HRPP
Director unanticipated problems. The
HRPP Director communicates this information to the appropriate IRB Chairperson,
Director of Compliance. An audit is
conducted and results reported to all parties.
The IRB makes recommendations for corrective action. Members of the audit team conduct a follow up
meeting to assure corrective actions are completed.
The HRPP Director will report to OHRP, FDA and the sponsor as appropriate. The HRPP Director provides follow up information when necessary or as requested by OHRP and FDA.
7.3 Review Procedures for Unanticipated
Problems
The IRB Chairperson will
initially review unanticipated problems on an expedited basis. The IRB
Chairperson will either approve the information submitted or request revision
or additional information from the Investigator.
If the IRB Chairperson
determines that convened IRB review is appropriate, the item will be placed on
the next meeting agenda for convened Board review. The IRB will either approve
the item as presented or request revision or additional information from the
Investigator.
|
SOP: 408 Version No:
1 Effective
Date: |
Study completion |
Supercedes
Document Dated: |
The completion or termination of a study is a change in activity and therefore must be reported to the IRB. A notice of closure to the IRB is used by the IRB to close its files but more importantly to provide pertinent information to the IRB in its evaluation and approval of related studies. Completion or termination of a study may be reported to the IRB on a Final Closure Report or the Application for Continuing Review.
1.1 Determining When a Project May be Closed
A. Investigator initiated protocols may be closed when individually identifiable follow-up data are no longer being collected on participants and analysis that could indicate new information has been completed.
B. Multi-site industry studies may be closed when the Investigator submits his/her final report.
1.2 Final Closure Reports Defined
Final closure reports should
be submitted within thirty (30) days after completion or termination of the
study. The IRB Chairperson will review all reports of study completion and, if
needed, request further information from the Investigator to clarify any
questions that may arise.
B.
Continuing Reviews Submitted as Final Closure Reports
The continuing review form may also represent an avenue for final
closure. This form requests specific
information from the investigator and should be submitted accordingly.
These policies and procedures apply to all research submitted to the IRB.
IRB Coordinator is
responsible for ensuring all study completion documentation is received,
reviewed, presented to the IRB, and filed appropriately.
This SOP affects all other SOPs.
302-B Application for Continuing Review
302-F Final Closure Report
7.1.
Convened Board and Expedited
Projects
7.1.1. The Final Closure Report is accepted by the IRB during mid-cycle of the project. An Application for Continuing Review is accepted during the anniversary period at the time the study must receive continuing review and re-approval from the IRB. These reports are processed similarly in the IRB.
7.1.2. Final Closure Reports will be submitted to the IRB by the Investigator within 30 days after completion or termination of the study. The IRB coordinator will review all reports of study completion and, if needed, request further information from the Investigator to obtain missing data or to clarify any questions that may arise.
7.1.2 The final closure report will then be reviewed and approved for closure by the IRB Chairperson. The IRB Coordinator will change the study status in the IRB database and update the next meeting agenda to reflect the study closure.
7.1.3 The IRB coordinator will generate a final closure letter and present it to the IRB Chairperson for signature. The IRB Coordinator will send the letter to the Investigator and file the final closure report and a copy of the final closure letter in the study file.
7.1.4 The file will be stamped with the inactivated date on the front cover and filed in a separate area for inactivated study files.
7.2.1 Once each year the IRB will send the Investigator the Protocol Exempt Status letter. The Investigator will indicate on the letter if the study is currently active or has been terminated and return the letter to the IRB.
7.2.2 Upon receipt of the letter from the Investigator, the IRB will process the letter based upon the response given. If the Investigator indicates the study is active the letter is filed in the study file.
7.2.3 If the Investigator indicates the study has been terminated the letter will be presented to the Chairperson for approval. The termination will be recorded in the next appropriate agenda/minutes for reporting to the IRB.
8.
PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
|
SOP: 409 Version No:
1 Effective
Date: |
Categories of
Action |
Supercedes
Document Dated: |
As a result of its review, the IRB may decide to approve or disapprove the proposed research activity, or to specify modifications required to secure IRB approval of the research activity. Except when the expedited review procedure is used, these actions will be taken by a vote of a majority of the regular and alternate members present, except for those members present but unable to vote in accordance with IRB's conflict of interest policies. When reviewed via expedited review, the IRB Chairperson or designee can take any of the following actions except to disapprove a study.
1.1 Determinations
The IRB may make one of the
following determinations as a result of its review of research submitted for
initial review or for continuing review:
A.
Approval: The protocol and accompanying documents are
approved as submitted. Final approval will commence on the day the study is
approved by an action of the convened IRB or IRB Chairperson or designee and
expire within one (1) year of the meeting date that the project was approved or
contingently approved.
The conditions for continued approval, and the time frame (if any)
within which they must be met will be clearly stated in the approval
letter. If the conditions of the
approval are not met, approval may be withdrawn.
B. Contingent Approval:
Specific modification of a protocol or accompanying document(s) is
required. Changes will be voted upon
during IRB’s meeting, as well as the terms of approval. Such specific changes
must be clearly outlined by the IRB. The Investigator will be informed in
writing of the required changes and requested information and must provide the
IRB with the changes or information.
The IRB Chairperson or his/her designee has the authority to review the
information via expedited review unless the IRB requires or the IRB Chairperson
decides that the material or information be reviewed by the convened IRB, the
primary reviewer or another individual delegated by the IRB to review the
response. Upon satisfactory review,
approval will be issued as of the date that the requested information or
materials are approved. However, the
expiration date of IRB approval will be based on the anniversary date of the
initial IRB review. Participants must
not be recruited into the study until final approval has been issued.
C. Deferral:
Significant questions are raised by the proposal or the information provided is
inadequate to assess risk/benefit ratio requiring its reconsideration by the
convened IRB after additional substantive information is received from the
Investigator and/or Sponsor. The Investigator will be informed in writing of
the IRBs concerns and requested information and be given the opportunity to
respond to the IRB with the changes or information.
D. Disapproval: The
proposal fails to meet one or more criteria used by the IRB for approval of
research. Disapproval cannot be given through the expedited review mechanism
and may only be given by majority vote at a convened meeting of the IRB. The Investigator will be informed in writing
of the IRBs concerns and requested information and be given the opportunity to
respond to the IRB. Disapproval of a study by the IRB cannot be overturned by
the University administration.
These policies and procedures apply to all research submitted to the IRB.
IRB Chairpersons and HRPP
Director is responsible for ensuring that all IRB decisions and actions are
based on institutional and regulatory requirements.
IRB Chairpersons are
responsible for ensuring the appropriateness of all IRB decisions and actions.
This SOP affects all other SOPs.
None
7. PROCESS
OVERVIEW
7.1.1 As a result of its review of research submitted for initial or continuing review, the IRB may decide to approve, disapprove, or defer the proposed research activity, or to contingently approve by specifying modifications required to secure IRB approval of the research activity. These actions will be taken by a vote of a majority of the regular and alternate members present except for those members who have recused themselves in accordance with IRB's conflict of interest policies.
7.1.2 When reviewed via expedited review, the IRB Chairperson or designee can take any of the following actions except to disapprove a study.
7.1.3 At the time the motions are made during the convened IRB meeting, the IRB Coordinator records the determinations made utilizing the IRB database. In addition to recording the determinations noted below the IRB Coordinator will record in the IRB database the voting results, including number for and against; names of members making the motions, the name of any members abstaining.
7.1.4 Approval: The protocol and accompanying documents are approved by the convened IRB as submitted with no changes. Approved by Board is the motion designated by the IRB Coordinator in the IRB database for Approval.
The protocol and accompanying documents are approved under expedited review by the IRB Chairperson as submitted with no changes. Approved by the Chair is the motion recorded by the IRB Coordinator in the IRB database for approval.
Final approval will commence on the day the study is approved by an action of the convened IRB or IRB Chairperson or designee and expire within one (1) year of the meeting date, but not later than the day preceding the date of review. The research may proceed as soon as the Investigator receives the IRB approval letter for the study. The IRB Coordinator is responsible for recording the approval date and expiration date in the IRB database and for generating an approval letter.
7.1.5 Contingent Approval: The protocol and accompanying document(s) are determined by the convened IRB to be approval with minor changes required. The required minor changes may be reviewed under expedited review by a designated reviewer.
The minor changes must be specific and clearly delineated by the IRB. The minor changes and terms of approval will be voted upon during the convened IRB meeting. The motion of contingent approval is recorded by the IRB Coordinator in the IRB database as Contingently Approved by Board. The IRB Coordinator is responsible for recording the contingent approval date and for generating a contingent approval letter.
The IRB Chairperson or his/her designee has the authority to review the information via expedited review unless the IRB requires that the material or information be reviewed by the full IRB, the primary reviewer or another individual delegated by the IRB to review the response.
The board requested information received from the Investigator must provide the IRB with all of the required changes or information in order for final approval to be granted. Upon satisfactory review, final approval will be issued as of the date that the requested information or materials are approved. However, the expiration date of IRB approval will be based on the anniversary date of the initial IRB review. Subjects must not be recruited into the study until final approval has been issued.
For studies reviewed and given contingent approval by the IRB Chairperson under expedited review criteria, the IRB Chairperson will note the requested changes in the file. The IRB Coordinator will delineate in writing the minor changes requested by the IRB Chairperson. Upon satisfactory review, final approval will be issued as of the date that the requested information or materials are approved. Approved by the Chair is the motion recorded by the IRB Coordinator in the IRB database for approval.
An Investigator is given 60 days to respond to the IRB. If the requested information is not received, the project will be withdrawn by the IRB.
7.1.6 Deferral: A motion of deferral is made when significant questions are raised by the IRB concerning the protocol, pending receipt of substantive information from the Investigator and/or sponsor. The motion of deferral is designated in the IRB database as Deferred by Board. The IRB Coordinator is responsible for recording the Deferral Date in the database. The IRB Chairperson is responsible for promptly contacting the Investigator and for drafting the deferral letter for the IRB Coordinator.
An Investigator is given 60 days to respond to the IRB. If the requested information is not received, the protocol will be withdrawn by the IRB.
7.1.7 Disapproval: A motion of Disapproval is made by the convened IRB when the protocol fails to meet one or more criteria used by the IRB for approval of research. Disapproval cannot be given through the expedited review mechanism and may only be given by majority vote at a convened meeting of the IRB.
The motion of disapproval is designated in the IRB database as Disapproved by Board. The IRB Coordinator is responsible for recording the Date of Disapproval in the database. The IRB Chairperson is responsible for promptly contacting the Investigator and for drafting the disapproval letter for the IRB Coordinator.
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Document IRB decisions in the minutes. Review pending items weekly and communicate to Investigators and Research Staff, the requests of the IRB |
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SOP: 410
Version No: Effective
Date: |
study
recruitment
and
Advertisements
|
Supercedes
Document Dated: |
Generally, the
IRB discourages Investigators from enrolling themselves, his/her students, or
his/her employees in the Investigator’s own studies, but will review the matter
on a case-by-case basis. The IRB will
consider the degree of risk, likelihood of benefit, and protections from
coercion or undue influence in deciding whether to allow such recruitment. Recruitment of the Investigator, his/her
students, or his/her employees is not allowed unless specifically approved by
the IRB.
The IRB does not
allow bonus payments to Investigators or study personnel as incentives for
participant recruitment.
Potential
research participants may be identified through any of the following
methods:
Private Medical Information: A common method of identifying potential
research participants is to review medical records, clinical databases, patient
registries, and psychosocial screening databases. This method allows the Investigator to review
records and identify eligible participants.
The IRB/Privacy Board must review and approve all such methods of
obtaining private medical information prior to initiation.
Referring Physicians: Referrals from treating physicians can be
useful in identifying potential trial participants. Referring physicians who
have been provided with general information about a research project may inform
their patients that a research project is available and provide the patients
with contact information to learn more about the project and whether they might
be eligible.
Advertisements: The IRB and the FDA considers direct
advertising for study participants to be the start of the informed consent and
participant selection process. Direct
advertising for research participants, (i.e. advertising that is intended to be
seen or heard by prospective participants to solicit their participation in a
study), is not in and of itself, an objectionable practice.
Direct
advertisements that are intended for prospective participants include, but are
not necessarily limited to the following:
o Newspaper
o Radio
o TV
o Bulletin boards
o Posters
o Flyers
o Emails
Direct
advertisements do not include:
participant or Investigator interviews, communications intended to be seen or
heard by health professionals, such as ‘Dear Doctor’ letters (or communication
with other types of practitioners for the purpose of soliciting assistance in
identifying research participants), and doctor-to-doctor letters (even when
soliciting for study participants), news stories or publicity intended for
other audiences such as financial page advertisements directed toward
prospective investors.
Direct
advertisements must be reviewed and approved by the IRB as part of the package
for initial review.
In a limited
number of circumstances, advertisements pertaining to human participant
research being conducted by OU faculty may also be reviewed by the Office of
Public Affairs (PA).
1.1.1 The
IRB review must review study recruitment methods and advertisements prior to
their use by the researcher, usually as part of the initial review and approval
of the research project. It is the
responsibility of the Investigator to include recruitment methods in the IRB
application and submit the proposed advertisements at the time of the initial
submission or as a modification of an approved protocol. All such documents must be reviewed and
approved prior to use in the recruiting process.
1.1.2 The IRB must review direct advertising to
assure that it is not unduly coercive and doesn’t overstate the potential
benefits of the research beyond what is outlined in the consent and the
protocol. This is especially critical
when a study may involve participants who are likely to be vulnerable to undue
influence. Advertisements should be
limited to the information necessary for potential participants to make an
informed decision.
1.1.3 When direct advertisements are not included
in the initial project plan and are not submitted to the IRB at the time of
initial submission, but the Investigator later decides to advertise for
participants, the direct advertisements must be submitted to the IRB as an
amendment to the ongoing research project.
1.2.1 The individual name or specific office or department
and the accurate address and telephone number of the Principal Investigator as
well as the location of the research and the person to contact for further
information;
1.2.2 Wording that effectively communicates the purpose of
the research, and in summary form the eligibility criteria that will be used to
admit participants into the study; and
1.2.3 A straight-forward and truthful description of the
benefits (payments or free treatment is not to be overstated or the main focus)
to the subject from participation in the study and the duration of the study
and treatment.
1.2.4 When appropriately worded, the following items may be included in advertisements.
a. The name and address of the principal investigator
and/or research facility;
b. The condition under study and/or the purpose of the
research;
c. In summary form, the criteria that will be used to
determine eligibility for the study;
d. A brief list of participation benefits, if any;
e. The time or other commitment required of the
participants; and
f.
The location of
the research and the person or office to contact for further information.
1.3 Advertisements to recruit participants should
not:
1.3.1
Mislead participants;
1.3.2
Claim, either explicitly or implicitly, that the
drug or device is safe or effective for the purpose under investigation, or
that the drug or device is in any way equivalent or superior to any other drug
or device;
1.3.3
Imply the research or investigator has a unique or
special skill, remedy or treatment;
1.3.4
Should not promise “free medical treatment,” when
the intent is only to say participants will not be charged for taking part in
the investigation. Advertisements may
state that participants will be paid, but should not emphasize the payment or
the amount to be paid, by such means as larger or bold type.
1.3.5
Include monetary amounts as rewards or inducements
to participate (it may, however, mention there will be compensation for the
participant’s time or travel).
1.4 E-mail Distribution List Advertisements
Advertisements in which the Investigator wishes to utilize campus-wide e-mail distribution list will adhere to the following guidelines:
1.4.1
The IRB number
should be located in the lower left corner of the recruitment notice.
1.4.2
Graphics may not
be included.
1.4.3
The Investigator
should include a description of the study for the email subject line of the
recruitment notice.
1.4.4
The Investigator
should include on the Protocol Modification Form which groups should receive
this recruitment notice (faculty, staff, and /or students).
1.4.5
The Investigator
should provide a name and e-mail address of the person(s) to whom potential
participants may respond.
1.4.6
The Investigator
shall submit a Protocol Modification form with the proposed e-mail recruitment
notice to the IRB. The recruitment
notice should appear exactly how it will appear in the e-mail.
1.4.7
The IRB staff is
authorized to forward e-mail to the distribution list moderators. Norman Campus IRB Investigators submit
directly to the distribution list moderator.
1.4.8
Internet Advertising-The Investigator initiates
the posting of a study on the internet-this type of advertising requires prior
IRB review and approval.
1.4.9
The sponsor initiates the posting of the study on
the internet- this type of advertising does not require IRB approval.
1.5 All Advertisements
These policies and procedures apply to all advertisements that pertain to human participant research.
The IRB will be responsible for reviewing recruitment
methods and all direct advertisements submitted by the Investigator that
pertains to research projects involving human participants.
The Oklahoma City Campus IRB will be responsible for
submitting approved e-mail ads to the OUHSC Distribution List Moderator.
FDA Information Sheets-Guidance for Institutional Review Boards and Clinical Investigators-Recruiting Study Subjects 1998 Update
This SOP affects all other SOPs.
410-A INFORMATION SHEETS-Guidance for Institutional
Review Boards and Clinical Investigators 1998 Update.
Norman Campus IRB:
All
advertisements will be submitted to the Norman Campus IRB for review and
approval prior to submission to PA. This pertains to advertisements that will
be distributed off campus as well as on campus. After receipt of advertisements
from the Investigator, the IRB staff will obtain IRB approval before submitting
advertisements to PA; investigators must not submit advertisements directly to
the PA Office.
OUHSC
Campus IRB:
In rare circumstances, recruitment/advertising
materials will require Public Affairs review (e.g. participant interviews for
advertising purposes). These types of
recruitment/advertising methodologies will be forwarded to PA by the OUHSC IRB
staff. After review of the materials by
PA (and the required revisions received from the PI), the items will be sent to
the Chair for review and approval.
7.1 For details regarding interaction with PA and the
advertisement approval process, refer to SOP 602E Public Affairs.
7.1.1 Advertisements received with the initial submission
of full board studies will be reviewed by the convened IRB.
7.1.2 Advertisements received with the initial submission
that meet the criteria for expedited review will be reviewed by the IRB
Chairperson.
7.1.3 The IRB Chairperson will review advertisements
received as an amendment to an ongoing research project.