BASED ON POLICY NUMBER AND TITLE:
13-8-0 INSTITUTIONAL REVIEW BOARD
The Institutional Review Board (IRB) for Human Subjects Research at Trident Technical College (TTC) is responsible for overseeing procedures for carrying out the College’s commitment to protect the welfare of human subjects used in research in compliance with federal and state statutes and regulations.
The role of the IRB is to review proposed research projects that involve the use of human subjects; ensure that the individuals involved in the project are treated ethically; ensure that all subjects are provided with substantial information about the study; ensure that all subjects consent to their involvement in the study; ensure that the persons who are conducting the research are qualified to do so, and ensure that all private information is handled with confidentiality. The IRB is authorized to review, approve, require modifications in, or disapprove research activities conducted by or through the College using human subjects.
A. Federal regulations specify that Institutional Review Boards (IRB) must be made up of a minimum of 5 voting members and must include:
1. A scientist
2. An individual with expertise in a non-scientific area
3. An individual not affiliated in any way with TTC
B. Alternates and non-voting members may also be appointed, with alternates authorized to vote at convened meetings only in the absence of the member for whom they are the designated alternate.
C. All members are appointed by the College President.
D. The IRB is composed of members with varying backgrounds and expertise in special areas to ensure adequate and thorough review of the research. Consultants may be used to review proposals for which additional expertise is needed.
IRB MEMBER TRAINING:
All IRB members are required by federal regulations to undergo formal training at the time of their initial appointment. The Trident Technical College Institutional Review Board Charter and Standard Operation Procedures lists tutorials that satisfy the training requirement.
IRB members must provide documentation to the IRB chair that they have completed human subjects training. (See form entitled, Documentation of Education on the Protection of Human Subjects.)
MANAGEMENT OF THE IRB:
A. The President has delegated authority to the Vice President for Education to appoint the IRB Chair and IRB members. The IRB Chair is appointed annually and has authority to sign all IRB action items.
B. The IRB Vice Chair is a voting member of the IRB and presides over all convened IRB meetings in the absence of the Chair. The Vice Chair has authority to sign all IRB action items in the absence of the Chair.
C. Members and alternates of the IRB shall be appointed for tenure of three (3) years. Terms of services may be renewed at the discretion of the Vice President for Education.
D. IRB members do not receive compensation for their service.
E. Liability coverage for IRB members is provided through TTC’s liability insurance coverage, whether or not the IRB member is an employee of TTC.
F. Consultants with competence in special areas may be used when deemed appropriate.
According to the Code of Federal Regulations 45 CFR Part 690, the following definitions apply:
Research is defined as, “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (Generalizable knowledge is roughly defined as results of a study that are to be published, printed in a paper or otherwise implied to have implications beyond the test population.)
Human Subject is defined as, “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
All research involving human subjects conducted at or sponsored by TTC, TTC employees, TTC students and/or student/faculty collaborative research under the auspices of the College must be submitted for review to the IRB.
Any TTC employee submitting a proposal to a federal agency for a project involving human research must complete required forms and receive IRB approval prior to submitting an application for funding.
In conducting the initial review of proposed research, the IRB must obtain information in sufficient detail to make the determinations required under HHS regulations at 45 CFR Part 46.111. Materials should include:
1. The full protocol;
2. A proposed informed consent document;
3. Any relevant grant applications;
4. The investigator’s brochure (if one exists); and
5. Any recruitment materials, including advertisements intended to be seen or heard by potential subjects.
6. Proof of IRB approval from the home institution or agency, if the research does not originate at TTC. When a TTC employee seeks to conduct research as part of the course of study for an advanced degree, proof of IRB approval from the home institution is particularly important and generally is secured before the TTC IRB reviews the proposed project.
Unless the primary reviewer system is used, all members will receive a copy of the complete documentation. These materials shall be received by members sufficiently in advance of the meeting date to allow review of this material.
When the IRB uses a primary reviewer system, the primary reviewer should do an in-depth review of all pertinent documentation. All other IRB members should at least receive and review a protocol summary (of sufficient detail to make the determinations required under HHS regulations at 45 C.F.R. Part 46.111), the proposed informed consent document, and any recruitment materials, including advertisements intended to be seen or heard by potential subjects. In addition, the complete documentation should be available to all members for review.
Federal regulations allow the IRB to categorize research studies according to the risks associated with the research and to provide different levels of review based on the degree of risk. There are three (3) types of review: Exempt, Expedited Review, and Full Review. In this situation, “expedited” does not mean “faster;” it simply refers to specific categories of research. The first step in the process is for the principle investigator/project director to study the definitions of the three types of review and determine under which category the intended research falls.
Regardless of which category of review is warranted, the Principal Investigator or Project Director must complete specified forms and submit them to the IRB Chair.
PROCEDURES FOR INITIAL REVIEW OF RESEARCH
The IRB will follow the following procedures for conducting its initial review of research:
Applications are reviewed by the IRB Chair, compliance staff or other primary reviewer designated by the IRB Chair. After the initial review, the reviewer determines the appropriate level of review (administrative, expedited and full board).
Projects eligible for administrative review (using exempt categories found at 45 CFR 46.101(b)) may be reviewed and approved by the primary reviewer. While continuing review is not required in this category, any changes in the approved project must be submitted to ensure further administrative status.
Projects eligible for expedited review must be reviewed and approved by the primary reviewer and one other IRB member.
All others will be referred for Full Board review.
A. Exempt Review
There are six categories of review that meet the federal definition of exempt. Most research projects conducted by TTC faculty, staff or students constitute little or no risk to participants and will be deemed exempt from a full review by the IRB.
Research activities in which the only involvement of human participants will be in one or more of the following categories are considered exempt. Each of the categories is quoted from 45 CFR Part 46.101(B), and is followed by an explanatory paragraph.
1. "Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular or special education instructional strategies, or (b) research on the effectiveness of or on the comparison among instructional techniques, curricula, or classroom management methods."
Explanation: The purpose of this category is to exempt research on educational practices, in an educational institution. This category does not extend to research conducted in a school setting not related to the instruction in that institution. For example, an evaluation of two methods of fourth grade classroom instruction in a local school district would qualify as exempt research. A sociometric survey of children's preferences for playmates in the same school, involving the same children, would not qualify as exempt research. As the example indicates, research on minor students can be exempt if it is educational research in the sense intended here.
2. "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
Information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants; and
a. Any disclosure of the participant's responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation."
Explanation: "Educational tests" refers to standardized tests used for educational purposes, such as a scholastic achievement test. It does not refer to personality tests or clinical evaluations. Survey or interview studies qualify as exempt unless the participants can be identified from the records, and there are risks to the participants due to the sensitive nature of their responses.
Studies of publicly observable behavior are exempt from Federal regulations unless there are potential risks of the type described and the data are recorded in a way that could be used to identify participants.
Trident Technical College interprets "public behavior" to mean behavior that is apparent to an unconcealed observer, without the use of any special or surreptitious equipment, such as binoculars, special microphones, or recording devices.
3. “Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph (2)(b) of this section, if:
The human participants are elected or appointed officials or candidates for public office; or
a. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.”
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 the participants cannot be identified, directly or through identifiers linked to the participants."
Explanation: Historical, literary, and journalistic research of the type described earlier as being excluded typically would also be described by point 4.
Situations arise in which records may be excerpted from a data source that does contain identified, sensitive information, but are provided to the investigator without identifiers. For instance, physicians might be asked to provide case summaries without identifiers. Such studies may be exempt, providing that the person excerpting the records already has authorized access to them for research purposes, and the investigator has no access to the original records.
"Existing" means that the data are "on the shelf" at the time the researcher develops a proposal for their use. Use of data not already on the shelf is not eligible for exemption.
5. "Research and demonstration projects which are conducted by or subject to the approval of the US Federal 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; or (c) possible changes in or alternatives to those programs or procedure; or (d) possible changes in methods or levels of payment for benefits or services under those programs."
Explanation: The "US Federal department or agency heads" referred to are federal, not state, local, or college. This category of exempt research refers to activities sponsored by federal agencies to evaluate their own benefit or service programs.
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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture."
The following five categories of research are not exempt, and always require review.
- Research involving prisoners;
- Studies of pregnant women where the focus of the research is on pregnancy and/or the fetus;
- Research on fetuses in utero;
- Research on minor children unless the research qualifies as educational research in the sense of items 1 and 2 above, or where the research does not involve direct interaction with the child; and
- Research using non-public records.
B. Expedited Review
Federal regulations provide for expedited review (administrative review not involving a full IRB) if the research involves no more than minimal risk and falls within one of the nine specific categories of expedited research.
To determine whether or not research falls under the category of exempt or expedited and therefore qualifies for administrative review by the IRB chairperson or designated reviewer, rather than the full IRB Board, project directors (PD) or principal investigators (PI) must complete the TTC form entitled, Exemption Screening Questions and thoroughly review certain websites. The Trident Technical College Institutional Review Board Charter and Standard Operation Procedures lists websites that will facilitate the process.
If the project falls under the category of Exempt or Expedited, a Request for Administrative Review of Human Research form must be completed and sent directly to the Chair of the IRB at least 14 workdays prior to the date the research activity is to begin.
Even if a project is determined exempt or expedited, consent forms must be obtained from all research participants (or the signed informed consent of parents or legal guardian if the participant is less than 18 years of age.) The Trident Technical College Elements of Informed Consent contains a sample consent form that may be modified to suit individual projects and a Consent Form Checklist.
Research activities involving "no more than minimal risk" and in which the only involvement of human participants will be in one or more of the following categories may be reviewed using an expedited procedure by the Institutional Review Board Chair. Each of the categories is quoted by the Federal Regulations at 45 CFR Part 46, and followed by an explanatory paragraph.
1. "Collection of data from voice, video, digital or image recordings made for research purposes"
Explanation: Because recordings made of participants are de facto identifiable, research involving these techniques which would otherwise be exempt are eligible for minimal risk review using the expedited procedure. Such studies will be approved if the researcher outlines appropriate mechanisms to minimize the risks of invasion of privacy and breach of confidentiality.
2. "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, evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: some research in this category may be exempt from the HHS regulations, 45 CFR Parts 46.101 (b)(2) and (b)(3), for the protection of human participants. This listing refers only to research that is not exempt.)"
Explanation: Much behavioral research that does not qualify from exemption may be reviewed as minimal risk using the expedited procedure. This category is designed to accommodate research activities that pose no more than minimal risk to participants and that are not eligible for exemption. Please note that this category now includes minor participants.
3. "Medical research with minimal risk:
a. Clinical studies of drugs and medical devices only when either of the following conditions is met:
- 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 minimal risk review.)
- Research on medical devices for which:
i. an investigational device exemption application (21 CFR Part 812) is no 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
b. "Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
i. From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, 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
ii. From other adults and children, considering the age, weight, an health of the participants, the collection procedure, the amount of blood to be collected and the frequency with which it will be collected. For these participants, 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."
Explanation: This category allows minimal risk review of activities involving invasive blood draws from healthy normal participants and from non-healthy, pregnant, and minor participants within certain limits. Unless the researcher can demonstrate that infants and other minors would undergo a blood draw as a part of a "routine" physical examination, blood draws from healthy minors will not be reviewed as minimal risk using the expedited procedure.
c. Prospective collection of biological specimens for research purposes by noninvasive means.
Example: Hair and nail clippings.
d. "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 minimal risk review. This includes studies of cleared medical devices for new indications."
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 participant or an invasion of the participant's privacy;
Weighing or testing sensory acuity;
Magnetic resonance imaging;
Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual."
Explanation: The examples listed are neither exclusive nor exhaustive. This category may be applied to research involving prospective collection of data for research purposes using non-invasive methods in addition to those listed as examples.
4. "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, 45 CFR Part 46.101(b)(4), for the protection of human participants. This listing refers only to research that is not exempt.)"
Explanation: This category allows the prospective use of data collected for non-research purposes. Data include information from medical records, insurance claim data, educational testing data, and other non-public information in identifiable form. Data set linkages could be considered in this category. The researcher must demonstrate that sufficient measures will be used to protect the confidentiality of the data to minimize the risk to participants of inadvertent disclosure.
1. "Continuing review of research previously approved by the convened IRB as follows:
i. the research is permanently closed to the enrollment of new participants;
ii. all participants have completed all research-related interventions; and
iii. the research remains active only for long-term follow-up of participants; or
b. where no participants have been enrolled and no additional risks have been identified; or
c. where the remaining research activities are limited to data analysis."
Explanation: Researchers who wish to have their applications for continuing review of projects previously reviewed by the IRB will have to demonstrate that the above conditions have been met.
2. "Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 5 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."
Explanation: This category applies to situations in which the full IRB conducts a continuing review of a study and determines that the following activity poses only minimal risks.
C. Full Review
All research conducted by faculty, staff, or students that is not eligible for exempt review or
minimal risk review must be reviewed by the full board. If your project does not qualify for an administrative review, Principal Investigators and Project Directors must follow the protocol for applying for a full board review. The form entitled, Request for Full IRB Review, must be completed and a Full Review must be conducted at a properly convened and attended meeting of the IRB.
Proposals considered to need Full Review should be sent directly to the IRB at least 28 workdays prior to the date the research activity is to begin.
Full Board Review is review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in non-scientific areas. Those projects slated for Full Board review will be assigned to a primary and secondary reviewer. These reviewers will review the protocol and contact the PI for any additional information or needed revisions. The primary or secondary reviewer will then present the application to the Board in the absence of the PI. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
The IRB may only approve an application when its decision is based on consideration of the following:
- Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by federal regulation.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by federal regulation.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
PROCEDURES FOR CONTINUNG REVIEW OF RESEARCH
Procedures which the IRB will follow for conducting its continuing review of research:
With the exception of projects approved administratively (see procedure #1), the IRB is required to reevaluate research projects at intervals appropriate to the degree of risk but not less than once a year. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the IRB will determine the appropriate approval period. The approval letter from the IRB will indicate the expiration date.
A “Continuing Review Request Form” can be accessed on the TTC website.
Reminders will be sent to the Primary Investigator several weeks prior to the expiration date.
Continuing review of research shall be substantive and meaningful. The IRB will ensure that the criteria set forth by HHS regulations at 45 C.F.R. Part 46.111 are satisfied at the time of continuing review. The procedures for continuing review by the convened IRB may include a primary reviewer system.
In conducting continuing review of research not eligible for expedited review, all IRB members shall receive and review a protocol summary and a status report on the progress of the research that includes:
1. The number of subjects accrued;
2. A summary of any adverse events or unanticipated problems;i
3. A summary of any withdrawal of subjects from the research or complaints about research since the last IRB review;
4. A summary of any relevant recent literature, findings obtained thus far, amendments or modifications to the research since the last review;
5. A summary of any relevant multi-center trial reports, and any other relevant information, especially information about risks associated with the research; and
6. A copy of the current informed consent document.
At least one member of the IRB (i.e., a primary reviewer) also shall receive a copy of the complete protocol including any modifications previously approved by the IRB. Furthermore, upon request, any IRB member may have access to the complete IRB protocol file and relevant IRB minutes prior to or during the convened IRB meeting.
The minutes of IRB meetings shall document separate deliberations, actions, and votes for each protocol undergoing continuing review by the convened IRB.
When reviewing research under an expedited review procedure, the IRB Chair (or designated IRB members) shall receive and review all of the above-referenced documentation, including the complete protocol.
All changes in the project that deviate from the original submission must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the subjects.
This approval is sought by submitting a completed modification form to the IRB for review and approval. The form is available on the TTC website. This form may not be used for requests for continued approval.
PROCEDURES FOR REPORTING OF IRB FINDINGS
Procedures which the IRB will follow for reporting its findings and actions to investigators and the institution:
The Principal Investigator will be notified in writing of IRB approval or disapproval. Any departmental or center IRB liaison or advisor will be copied. If the project is externally funded, the Sponsored Programs Administrator will be copied. The approval documents will contain the relevant federal regulation citation, the approval date, the expiration date and the IRB file number.
If disapproved, the reasons for the action will be detailed in the written correspondence.
Conditions of Approval
Approval of a project by the IRB only signifies that the procedures adequately protect the rights and welfare of the subjects and should not be taken to indicate College approval to conduct research.
Approval of a project by the IRB applies only to the procedures submitted in the application. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of human subjects (See “Modifications”). The investigator must also report to the IRB any problems that arise in connection with the use of human subjects.
If an approval is granted with contingencies, those contingencies must be satisfied (reviewed and approved) prior to beginning the project.
Approval for projects is valid only until the expiration date.
The IRB Committee Chairman and the IRB members receive a monthly report detailing all new IRB submissions.
PROCEDURES FOR DETERMINING WHICH PROJECTS REQUIRE REVIEW MORE THAN ANNUALLY
The IRB must conduct continuing reviews of protocols at intervals appropriate to the degree of risk, but not less than once per year. “Not less than once per year" means that the research must be reviewed on or before the one-year anniversary date of the previous IRB review, even though the research activity may not begin until some time after the IRB has given approval.” All human subjects research activities are subject to audit at anytime by the IRB.
In determining the appropriate interval for the continuing review of a protocol, the IRB shall take into consideration the level of risk involved in the study, as well as the risk/benefit ratio. The primary reviewer of the protocol shall indicate the interval for continuing review on the Reviewer’s Comment Form. If the application requires full board review, this recommendation will be reviewed during the review. The terms of the protocol approval include the interval for continuing review and will be communicated to the investigator in writing in the study approval letter.
During a continuing review, the IRB considers the information provided by the researcher on the Continuing Review Request form, the report of findings to date, and the current informed consent document (if applicable), as well as any other requested information, to determine whether to extend approval for another 365 days (or any other stipulated time period up to 365 days in length).
PROCEDURES FOR DETERMINING WHICH PROJECTS REQUIRE VERIFICATION FROM SOURCES OTHER THAN INVESTIGATORS THAT NO MATERIAL CHANGES HAVE OCCURRED SINCE PREVIOUS IRB REVIEW
The IRB may, at its discretion, determine that information need be sought out from sources other than the investigator to verify that no material changes have occurred since previous IRB review.
The IRB may request verification from sources other than the researcher that no material changes have occurred since the initial or previous continuing review if, (i) the study is complex, involving unusual levels or types of risk to the subjects, (ii) the researcher has failed previously to comply with the IRB's requirements or 45 CFR Part 46, or (iii) there exist reasons to have concerns about possible material changes occurring without IRB approval.
PROCEDURES FOR ENSURING PROMPT REPORTING TO THE IRB OF PROPOSED CHANGES IN A RESEARCH ACTIVITY, AND FOR ENSURING THAT SUCH CHANGES IN APPROVED RESEARCH, DURING THE PERIOD FOR WHICH IRB APPROVAL HAS ALREADY BEEN GIVEN, MAY NOT BE INITIATED WITHOUT IRB REVIEW AND APPROVAL EXCEPT WHEN NECESSARY TO ELIMINATE APPARENT IMMEDIATE HAZARDS TO THE SUBJECT
All changes in the project that deviate from the original submission must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the subjects.
This approval is sought by submitting a completed modification form to the IRB for review and approval. The form is available on TTC’s website. This form should describe all changes and be accompanied by all appropriate documentation (including the approved consent form). The amendments may not be implemented by the investigator prior to review and approval by the IRB. The investigator will be contacted in writing once the modification has been approved. This topic is covered in IRB training and the Investigator Handbook.
PROCEDURES FOR ENSURING PROMPT REPORTING TO THE IRB, APPROPRIATE INSTITUTIONAL OFFICIALS, AND THE DEPARTMENT OR AGENCY HEAD OF (i) ANY UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS OR ANY SERIOUS OR CONTINUING NONCOMPLIANCE WITH THIS POLICY OR THE REQUIREMENTS OR DETERMINATIONS OF THE IRB; AND (ii) ANY SUSPENSION OR TERMINATION OF IRB APPROVAL.
Any unanticipated, serious, or continuing problems encountered regarding risks to subjects must be reported by the investigator immediately but not later than 10 days following the event. This should be reported to the Regulatory Compliance Office via the “Adverse Event Report Form”. The form is available on TTC’s website.
Deviation from the previously approved protocol, failure to fully disclose information relevant to the IRB review, or conducting human subjects research prior to IRB approval are examples of non-compliance. If non-compliance is suspected or reported, an investigation will be initiated by the IRB. At the conclusion of the investigation, the IRB will meet to examine the results of the investigation and define the allegations, if any. The researcher will be informed of the allegations and given ample time to respond. The IRB will then review the relevant information and make a determination regarding non-compliance. When non-compliance is found, the IRB and Trident Technical College will take appropriate action including, but not limited to, halting the research, assuring remedial action regarding any breach of regulatory or institutional human subject protection requirements, and addressing the question of the investigator's fitness to conduct human subject research.
The IRB Officer will report in writing within 10 working days to the IRB Chairperson, relevant Department or Agency Head (sponsor), any applicable regulatory body, and OHRP, any report of adverse events and/or determinations of suspensions, terminations and/or serious or continuing non-compliance as mandated in the Federal Regulations.
ACTIONS OF THE IRB:
The IRB may take one of the following four actions in regard to the proposed protocol and consent form: Approved, Approved Subject to Restrictions, Tabled, or Disapproved.
Approved: When a protocol has been approved, the Chair completes the “Action of the IRB” form, signs and dates it, and distributes one copy of the form to the principal investigator, the IRB files, and, if appropriate, the performance site. It is the responsibility of the PI to give each subject an explanation to questions ensuing from participation in the research project following its conclusion.
Approved Subject to Restrictions: If the protocol is approved subject to restrictions, then the Chair completes the “Action of the IRB” form, signs and dates it, and distributes it to the PI. The PI then must respond to the restrictions as indicated by the IRB. Upon receipt and approval of the responses, the restrictions are removed and the protocol is then processed as an approved protocol and distributed as described above.
Tabled: Tabled action means that the protocol was not sufficiently complete for the IRB to reach a final decision. In this case, the PI or PD is notified by the Chair of the IRB and the additional information necessary for completion of the IRB review is requested. In the case of a tabled protocol, the PI may be invited to attend an IRB meeting to present/clarify the protocol for the Board.
Disapproved: If the protocol is disapproved, the PI or PD will be informed in writing of the reasons for disapproval. The PI may revise and resubmit his/her protocol for another review.
DOCUMENTATION OF IRB ACTIVITIES:
The IRB prepares and maintains adequate documentation of all IRB activities, including:
1. Copies of all research proposals reviewed, approved sample consent documents, and continuing reports submitted by investigators
2. Detailed minutes of IRB meetings which document, among other things:
a. Separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB;
b. The vote on all IRB actions including the number of members voting for, against, and abstaining. In order to document the continued existence of a quorum, OHRP recommends that votes be recorded in the minutes using the following format: Total = 15; Vote: For-14, Opposed-0, Abstained-1
3. Records of continuing review activities, updated consent documents and summaries of on-going project activities (Consent documents are stamped to show IRB approval and date of approval expiration)
4. Copies of all correspondence between IRB and the investigators
5. Any statements of significant new findings (unanticipated risks or adverse reactions) provided to subjects
6. Adverse reactions reports and documentation that the IRB reviews such reports.
7. Emergency use reports
8. General project information provided to subjects (e.g., fact sheets, brochures)
These documents and records shall be retained for at least three (3) years after completion of the research.
In addition, the IRB maintains a permanent record of the list of current IRB members, written procedures for the IRB, and self-assessments.
All forms submitted or retained as evidence of informed consent must be preserved by the investigator indefinitely. Should the PI leave TTC, signed consent forms are to be transferred to the IRB Chair.
Note: For a more detailed discussion of all procedures related to the functioning of the TTC IRB, refer to the Trident Technical College Institutional Review Board Charter and Standard Operation Procedures.
i In many cases, such a summary could be a simple brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and any investigator brochure.