Institutional Review Board (IRB) on the Protection of Human Subjects in Research Policy & Procedural Manual
(Approved by the KSC IRB 01/17/2019. Revised in Response to Final Common Rule Amendment Published January 19, 2017 in the Federal Register (for Implementation by January 21, 2019)
- Policy Statement
- 1.0. Initial Review of Research.
- 2.0 Continuing Review of Research.
- 3.0 Reporting Findings and Actions of the IRB to Investigators and Institution
- 4.0 Procedures to Determine Continuing Review Timeline
- 5.0 Procedures to Determine Need for Verification from Sources other than Investigator
- 6.0 Procedures for Protocol Modifications
- 7.0 Procedures for Ensuring Prompt Reporting
- 7.1 Unanticipated Problems
- 7.1.2 IRB Review of Unanticipated Problems
- 7.1.3 Reporting of Unanticipated Problems to Institutional Officials, OHRP, or External Entities
- 7.2 Suspension or Termination
- 7.3 Serious or Continuing Non-compliance
- 7.3.2 Relationship of IRB-Related Non-compliance to the Institution’s Research Misconduct Policy
- 8.0 Instructions for extramural researchers (Incorporated by addendum 10/30/14)
Keene State recognizes the need for investigations in which human beings serve as research subjects. The College is also cognizant of its responsibility for ensuring that the privacy, safety, health and welfare of subjects are adequately protected. An Institutional Review Board (IRB) has been established to review and approve the adequacy of human subject protection. Additionally, the College has established a Federal Wide Assurance with regard to the conduct of human subjects research. Although the terms of the Assurance apply specifically to federally-funded research projects, the College chooses to have all research projects involving human subjects reviewed in the same general manner. However, in the case of non-federally-funded projects, the IRB may apply flexibility in its approach to reviewing, approving, and monitoring studies at its discretion, consistent with the revised Common Rule published January 19, 2017.
Regardless of source of funding, the College policies regarding human subjects research are guided by The Belmont Report, a federal government document that charges each investigator who is conducting human subject research with the responsibility of demonstrating respect for persons, beneficence (maximizing benefits and minimizing risks), and justice.
It is the policy of Keene State College that all research involving human subjects will adhere to the following principles:
• Participation in any research project must be voluntary,
• The risks of participation must be acceptable when measured against the possible benefits to the participant or by the importance of the knowledge gained,
• Research and training activities involving human subjects must be supervised by a qualified person,
• All research programs that involve human subjects must be reviewed and approved by the IRB prior to initiation of the protocol.
Human Subjects Research Defined
Virtually all federally funded research with human subjects is governed by federal regulations patterned on those of DHHS (Department of Health and Human Services,) described at 45 CFR 46, and known as “the Common Rule.”
There are several key definitions used by the IRB and the KSC campus community to determine applicability of this policy/procedure.
The federal code defines research as: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
The federal code specifically identifies several activities which are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. (2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required or authorized by a public health authority. These activities are limited to those necessary to allow a public health authority to identify, monitor, assess or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance. (3) Collection and analysis of information, biospecimens or records by or for a criminal justice agency for activities authorized by law or court order solely for the purposes of criminal justice or investigations. (4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions.
Further, this federal code defines a Human Subject as:
(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
(2) Intervention includes both physical procedures by which information or biospecimens are
gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
(3) Interaction includes communication or interpersonal contact between investigator and subject.
(4) 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
(5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
(6) An identifiable biospecimen is abiospecimen for which the identity ofthe subject is or may readily beascertained by the investigator orassociated with the biospecimen.
Other important definitions may be found in the Glossary at the end of this document.
Who Must Submit Protocols
At Keene State College, all research conducted by faculty, staff, and guests of the college that conforms to these definitions in the Common Rule must be submitted for review by the IRB regardless of funding source: federal, state, local, private or unsponsored. The Keene State College IRB reviews protocol applications from all disciplines. In accordance with the Federal-Wide Assurance issued to Keene State College by the Office for Human Research Protections (OHRP), all human subjects research funded by the federal government must be performed in accordance with 45 CFR 46. In addition, the actions of Keene State College officials, researchers, and staff must conform to all applicable federal, state and local laws and regulations.
Student research: Not all research activities conducted by students meet the above definitions of “human subjects research.” For example, students may engage in research activities that are primarily learning opportunities (e.g., exploring the application of research methods) rather than being intended to generate generalizable knowledge. Those types of activities would not require review by the IRB. However, student researchthat meets the above definitions of human subjects research (e.g., honors, capstone, or other projects intending to contribute to generalizable knowledge) must be submitted for review.Furthermore, student research involving human subjects must be supervised by a Keene State College faculty advisor who will assume the responsibility for ensuring that all research procedures comply with federal, state and college policies designed to protect human participants.
Instructors who routinely implement class projects which are not necessarily meant to contribute to generalizable knowledge, and involve no greater than minimal risk, do not need to have these protocols reviewed by the IRB. However, if the instructor believes that one or more of such projects may result in publication or wide dissemination, a blanket IRB approval may be requested for the class as a whole. This would presume relative uniformity in the basic structure of the projects being conducted by individuals or groups in the class (e.g., all the projects will involve paper and pencil educational tests and all research participants will be 18 years of age or older.) Such blanket approvals will be in lieu of multiple individual or group project requests.Unless significant changes are made to the assignment, Course Approvals can be extended by submitting a renewal application.
All KSC faculty, students, and staff wishing to conduct human subjects research are advised of their responsibilities to complete training in accordance with Keene State College’s Mandatory Research Integrity Training Policy (CITI), which is located on the OSPR website. The KSC IRB will not approve a protocol without proof of training.
Federal regulations require all IRB records to be retained for at least three years, and records relating to the human subjects research conducted to be retained for at least three years after completion of the research. All records must be accessible for inspection and copying by authorized federal officials at reasonable times and in a reasonable manner. Keene State College investigators are reminded of the College’s policy on Research Data Retention and Access, which places additional record retention obligations on researchers conducting externally sponsored research.
Keene State College IRB Procedural Manual
Federal regulations at 45 CFR 46.108(a)(3) and (4) require institutions to have written IRB procedures covering the following areas:
- Procedures which the IRB will follow for conducting its initial review of research;
- Procedures which the IRB will follow for conducting its continuing review of research;
- Procedures which the IRB will follow for reporting its findings and actions to investigators and the institution;
- Procedures which the IRB will follow for determining which projects require review more often than annually;
- Procedures which the IRB will follow for determining which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review;
- Procedures which the IRB will follow 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 the 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; and
- Procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, any Department or Agency head, and the Office of Human Research Protections (OHRP) of: a. Any unanticipated problems involving risks to subjects or others (hereinafter referred to as unanticipated problems); b. Any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB; and c. Any suspension or termination of IRB approval.
This procedural manual is put forth and implemented by the IRB of Keene State College to ensure that, per OHRP guidance, an independent observer could understand how the IRB operates and conducts its major functions. It addresses specifically the above seven procedural areas.
1.0. Initial Review of Research.
The Office of Sponsored Projects & Research serves as the intake-point for protocol submission, and forwards protocols to the IRB Designated Reviewer(s) for review. Initial review of research protocols may be handled in one of several ways, determined by the IRB Designated Reviewer(s). Most applications submitted to the Keene State College IRB qualify for either exemption or expedited review. Those that do not qualify for these two lower levels of review must undergo full IRB review by a quorum of IRB members at a convened meeting.
1.1 Protocol Submission and Processing for Review
In order to ensure their protocol is reviewed at the next available convened meeting, investigators must submit their complete protocol materials (required forms and attachments are located on the OSPR website) to IRB@keene.edu at least three weeks prior to the posted meeting date. The IRB@keene.edu email address is monitored by OSPR staff. When a new protocol is received for initial review, OSPR staff will initiate the creation of a protocol record (on the KSC Q-Drive) which will be maintained throughout the life of the protocol in coordination with the IRB Chairpersons. This includes entry of key information into the IRB database, electronic storage of protocol documents including requests for initial and continuing review, requests for modifications, and IRB actions taken (e.g., approval/disapproval communications).
Investigators must submit, at minimum, the following items for review:
- Appropriate IRB request for approval form (Initial Review, Continuing Review, Course Approval, or Amendment)
- Advertisements/recruitment materials that will be used to solicit participation in the study
- Informed consent documents reflecting the exact language that will be used to obtain participant consent. See OSPR website for guidance and templates.
- HIPAA Authorization Form, if applicable.
- Printed materials used for data collection (such as survey instruments or measures)
Generally within one week of receiving the protocol, the OSPR will inform the IRB Designated Reviewer(s) and make the materials available for review. The IRB Designated Reviewer(s) will review the protocol to see if it is exempted, eligible for expedited review, or must be subject to full board review.
1.2 Determinations Required for Approval
In order for a protocol to be approved, the review process must determine that all of the following requirements have been satisfied:
- Risks to human subjects have been minimized
- Risks are reasonable in relation to any anticipated benefits/importance of knowledge to be gained
- Selection of research subjects is equitable
- Informed consent procedures are appropriate
- Informed consent will be documented in an appropriate manner
- When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure safety of subjects
- When appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of the data
- For purposes of conducting the limited IRB review the IRB shall make the following determinations:
- Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained
- Broad consent is appropriately documented or waiver of documentation is appropriate
- If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When the research involves subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decisions-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of those subjects.
1.3 Exempt Determination
Some forms of research which meet the definition of “human subjects research” contained in 45 CFR Part 46 are nonetheless exempt from IRB review under the regulation. Upon submission, a protocol may be determined by the IRB chairperson(s) to be exempt from IRB review if it meets any of the following exemption criteria described in 45 CFR Part 46.
(1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods.
(2) Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of 3 criteria are met:
1) the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
2) any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
3) the information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (which relate to there being adequate provisions for protecting privacy and maintaining confidentiality) AND the research is not subject to subpart D (which pertains to Children).
(3) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
1) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects;
2) Any disclosure of the subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
3) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7) [which states: When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.]
(4) Secondary Research Use of Identifiable Private Information and Identifiable Biospecimens for which Consent is Not Required . Secondary research uses of identifiable private information or identifiable biospecimens is exempt if at least one of the following criteria is met:
1) The identifiable private information or identifiable biospecimens are publicly available; OR
2) The information is recorded by the investigator in such a way that the identity of the subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and the investigator does not contact subjects, and the investigator will not re-identify subjects; OR
3) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA (i.e., the use is regulated for purposes of “health care operations” or “research” or for “public health activities and purposes” as those terms are defined at 45 CFR part 164); OR
4) The research is conducted by or on behalf of a federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with certain federal statutes
(5) Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency.
Applies to research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads.
Applies to activities that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including, but not limited to: procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and Food Quality Evaluation and Consumer Acceptance Studies
This exemption applies if wholesome foods without additives are consumed, or 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 FDA or approved by the EPA or the USDA’s Food Safety and Inspection Service.
(7) Exemption Category 7 applies to storing and maintaining identifiable private information/specimens for secondary research for which broad consent and limited IRB review are required and the following criteria are met:
1) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §46.116(a)(1)-(4), (a)(6), and (d);
2) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §46.117; and
3) If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(8) Exemption Category 8applies to secondary research studies that involve use of identifiable private information/specimens, provided the following criteria are met:
1) Broad consent for storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1)-(4), (a)(6), and (d);
2) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
3) An IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7), and to make the determination that the research to be conducted is within the scope of the broad consent; AND
4) The investigator does not include returning individual research results to subjects as part of the study plan. However, it is permissible under the exemption to return individual research results when required by law regardless of whether or not such return is described in the study plan.
Exemption category 8 could apply if the investigator obtains appropriate broad consent from the subject in addition to the consent to an original specific study, and then proceeds to use the data/specimen in secondary study.
Only the IRB or its chairpersons may determine whether a study or research protocol qualifies for exemption. Therefore, the investigator must file an IRB application even in situations where s/he believes the human subjects research may qualify for an exemption. If a protocol is determined to be exempt from IRB review, the appropriate rationale/category will be recorded in the official record. The IRB designated reviewer, IRB chairperson, or OSPR designee will then forward a letter of exemption to the investigator. The investigator should not begin the research until he or she receives an approval letter. A copy of the letter and any other documentation will be placed on the Q-drive in a folder with the rest of the files associated with the protocol.
A project that has been determined to be exempt from IRB review does not require further review unless the relevant details of the project change in a way that makes it ineligible for the exemption categories above.
1.4 Expedited Review
The HHS Secretary maintains a list of research that may be reviewed through expedited procedures, and periodically updates that list at least every 8 years. The types of research contained on the list are by default deemed to be minimal risk studies. The current list is available on the OHRP website (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html ). However, as the list is intended to be periodically updated, it is not incorporated into this policy. Instead Keene State College’s IRB procedures will be adjusted as necessary to accommodate any changes to the list over time.
Expedited Review Procedures may be used for the following:
i. Some or all of the research appearing on the list described in the above paragraph, unless the reviewer determines that the study involves _more than minimal risk_;
_(ii) Minor_ _changes in previously approved research during the period for which approval is authorized; or_
(iii) Research for which limited IRB review is a condition of exemption under §ll.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
A study is deemed to be minimal risk and thus eligible for expedited reviewif the study only involves activities on the HHS Secretary’s list unless the reviewer determines and documents that the study involves more than minimal risk. IRBs are required to document their rationale when they override the presumption that studies on the Secretary’s expedited review list involve greater than minimal risk**.**
1.4.2 Expedited Review Procedure
When a protocol is reviewed by the expedited procedure, the category of eligibility will be recorded in the official record. The KSC expedited review procedure consists of a review by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Expedited reviews may be conducted on a rolling basis, and need not coincide with a convened meeting. The same determinations required for approval listed in 1.2 Determinations Required for Approval apply.
1.4.3 Range of Actions Which May Be Taken
The IRB reviewer conducting the expedited review may exercise all of the authorities of the IRB (listed under 1.5 Full Board Review, Range of Actions Which May be Taken by the IRB at a Convened Meeting), except that they may not disapprove research. A research activity may be disapproved only after review by the convened IRB. Thus, if an expedited reviewer cannot approve a protocol, it will be deferred for review at a future convened IRB meeting.
1.5 Full Board Review
Protocols that do not meet the criteria for either an exemption or expedited review must be reviewed at a convened meeting of the IRB.
1.5.1 Convened Meeting Schedule
Keene State College’s IRB typically meets monthly during the academic year and on an as needed basis during the summer months. Anticipated meeting dates are posted on the OSPR website when they become available from the IRB Chairperson. Investigators should plan ahead to ensure timely review of their research protocol, and are reminded that no research involving human subjects may commence without written IRB approval.
1.5.2 Full Board Review Procedures
At least one week prior to each convened meeting the OSPR and/or the IRB Chairperson will distribute the agenda for the upcoming meeting, along with an electronic copy of all protocol materials to the IRB members for review.
Keene State College does not utilize a primary reviewer system, and thus all IRB members receive complete documentation for each protocol on the agenda.
The IRB may, it its discretion, invite individuals with competence in special areas to assist in the review of these issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Each convened meeting agenda includes a report on any protocols reviewed and approved through expedited review procedures since the last convened meeting, and the report document clearly lists the identifying information for these protocols [Protocol #, title, investigator, expedited reviewer, action taken]. All IRB committee members have access to the full protocol materials for the items on the report (via CANVAS), should they have concerns or need further information.
• Quorum: Each convened meeting will be held with a majority of IRB members present. Additionally, no convened meeting will proceed without the presence of the non-scientist member. It is acceptable for members to be present via conference call, so long as s/he has received the pertinent material in order to fully participate in the meeting. Any committee member wishing to attend a specific meeting via conference call should notify the IRB Chairperson so arrangements can be made to accommodate this.
• Minutes: Meeting minutes for each convened meeting will be created by the IRB
and reflect the following key elements per OHRP guidance:
Establishment of a quorum.
- The names of members present will be recorded, along with identification of presence of any special membership roles (e.g., non-scientist; prisoner advocate, etc.).
- If members leave the meeting or recuse themselves during portions of the meeting, the minutes will reflect this to document the maintenance of a quorum.
- If a quorum should fail during a meeting (e.g., loss of a majority of IRB members through recusals, early departures, or absence of non-scientist) the committee will take no further actions or votes on protocols until a quorum can be restored.
- If a member is participating via conference call, this shall be noted along with the fact that s/he has met the criteria for doing so.
For each protocol under review the following will be reflected separately in the minutes:
Recusals of any member(s) deemed to have a conflict of interest in relation to a particular protocol under review. Such individuals will not participate in initial or continuing review of the project, and will absent themselves from the meeting room while the IRB reviews the protocol;
Summary of discussion, including any controverted issues;
Actions Taken : votes will be recorded in a manner that demonstrates a quorum was present during the vote, such as in the following examples:
Total = 6; Vote: For-5, Opposed-0, Abstained-1.
Total = 6 (1 member recused and did not vote); Vote: For-4, Opposed-1, Abstained-0.
Actions taken are by majority vote of the quorum present.
Determination of Level of Risk For each protocol, the IRB committee’s determination as to whether the research poses no more than minimal vs. greater than minimal risk to participants will be specifically recorded.
Determination of approval period. Maximum approval is for 12 months. The IRB will indicate in the approval letter the expiration date of the approval and forward that information to OSPR who will send a reminder to the investigator two months prior to the indicated expiration date. This correspondence will be considered a courtesy reminder only, and the obligation to ensure timely filing of paperwork to extend the approval period (if necessary), will remain with the investigator. The IRB may assign shorter approval periods in instances where the risk associated with a protocol is high and/or the protocol has a high risk in relation to its potential benefits. In deciding the frequency of continuing review the IRB may consider:
- The nature of any risks posed by the research project;
- The degree of uncertainty regarding the risks involved;
- The vulnerability of the subject population;
- The experience of the investigators in conducting research;
- The IRB’s previous experience with the investigators (e.g., compliance history, previous problems with the investigator obtaining informed consent, or prior complaints from subjects about the investigator);
- The projected rate of enrollment; and
- Whether the research project involve novel interventions.
Special waivers or conditions: For protocols seeking a waiver or modification of standard written informed consent procedures, the minutes shall reflect the discussion and action taken on such a request. Additionally, if the IRB wishes to place any specific conditions on the approved protocol (such as a need for periodic verification or monitoring of protocol implementation) this will be specified in the minutes.
1.5.3 Range of Actions which May be Taken by IRB at a Convened Meeting: The IRB may take any of the following actions on a protocol undergoing initial or continuing review, or for protocol changes undergoing review at a convened meeting:
Approval: Approval signifies that the IRB determined that the protocol as submitted met all the requirements for approval listed above in section 1.2 Determinations Required for Approval. A Record of Review Research approved by the IRB may (in rare instances) be subsequently disallowed by institutional officials if it is deemed incongruent with the mission or values of the institution.
Conditional Approval Pending Verification(s): The IRB may approve research with conditions if, given the scope and nature of the conditions, the IRB is able, based on the assumption that the conditions are satisfied, to make all of the Determinations Required for Approval (section 1.2). When conditional approval is granted, the minutes should specify the individual charged with reviewing additional information/materials submitted by the investigator to confirm that all conditions have indeed been met. This may be the IRB Chairperson or his/her designee or a designee from the Office of Sponsored Projects and Research (for minor administrative changes). No research may commence prior to this confirmation that all conditions have been met. If the IRB Chairperson/designee is not able to confirm that the conditions have been met, then the approval does not go into effect.
The IRB may require the following as conditions of approval of research:
Confirmation of specific assumptions or understandings on the part of the IRB regarding how the research will be conducted (e.g., confirmation that the research excludes children);
Submission of additional documentation (e.g., certificate of ethics training);
Precise language changes to protocol or informed consent documents; or
- Substantive changes to protocol or informed consent documents along with clearly stated parameters that the changes must satisfy.
Deferral: The IRB may defer a protocol’s review until a future convened meeting in instances where the IRB (a) is unable to make the required determinations about research risks and benefits, the adequacy of privacy and confidentiality protections, or the adequacy of the informed consent process because the research protocol provides insufficient information related to these aspects of the research, and (b) is unable to specify changes to the research protocol that, if made, would allow the IRB to make these required determinations.
Disapproval: Disapproval signifies a protocol did not meet the Determinations Required for Approval (section 1.2). When a protocol has been disapproved by the IRB, no other institutional representative can overturn the disapproval. The IRB is the final decision making body regarding disapprovals.
2.0 Continuing Review of Research.
The purpose of continuing review of a previously approved protocol is to determine whether there is any new information that would cause the IRB to reconsider its previous assessment regarding the Determinations Required for Approval (see section 1.2).
Continuing review is NOT required for:
- Studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects;
- Research reviewed by the IRB in accordance with the limited IRB review;
- Research that has progressed to the point that it involves only data analysis or accessing follow-up clinical data from procedures the subjects would undergo as part of clinical care.
The Request for Continuing Review and Approval form is designed to assist the IRB in this continuing review determination, and captures the following key information:
• Number of Subjects accrued
• Summary of any unanticipated problems and available information on adverse events. In many cases the summary may 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.
• Summary of any withdrawal of subjects from the research since the last IRB review.
• Summary of any complaints about the research since the last IRB review.
• Summary of any recent literature that may be relevant to the research and any amendments or modifications to the research since last IRB review (note, all modifications/amendments must receive IRB prior approval).
• Any other relevant information (including multi-center reports), especially information about risks associated with the research.
• Copy of current informed consent form, and any newly proposed consent document.
2.1 Timing of Continuing Review
Continuing review of research protocols (when required) will occur at least annually or at a shorter interval as determined during the initial review. It is the investigator’s responsibility to submit the continuing review application in sufficient time to allow the IRB committee to act upon it given their upcoming schedule, generally at least 6 weeks prior to the protocol’s expiration date. If for any reason a continuing review is unable to be completed by the protocol’s current expiration date (i.e., it becomes evident there will be a “gap” in approval), the research activities must cease until such time as approval is secured.
2.2 Continuing Review Procedures
The method of continuing review will depend on whether or not the protocol is eligible for expedited review, or if it must be reviewed at a convened meeting of the full board. Procedures in each instance are outlined below.
2.2.1 Full Board Continuing Review Procedure
Protocols requiring continuing review by the full board will be reviewed at a convened meeting at which a majority of the IRB members are present, including at least one member whose primary concerns are in nonscientific areas, unless the research qualifies for review under an expedited review procedure (45 CFR 46.110). In order to complete the continuing review, the IRB will receive a copy of the complete protocol including any modifications previously approved by the IRB. If requested, any IRB member may have access to the complete IRB protocol file and relevant past IRB minutes prior to or during a convened meeting at which a particular protocol is undergoing continuing review.
2.2.2 Minimal Risk Studies Eligible for Expedited Continuing Review Procedure
Some studies originally approved via a full board review may be eligible for expedited continuing review if 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._If the research is being reviewed under the expedited review procedure, the category of expedited review eligibility will be recorded along with the name of the individual conducting the expedited review. The expedited reviewer (IRB chair or designated IRB member) will receive the same materials described in section 2.0 Continuing Review of Research to review, and may have access to any previous records relating to the protocol as necessary to complete the continuing review.
2.3 Range of Actions for Continuing Review
The range of possible actions taken either by the full board or an expedited reviewer performing a continuing review is the same as for initial reviews under similar review categories (see sections 1.4 Expedited or 1.5 Full Board).
3.0 Reporting Findings and Actions of the IRB to Investigators and Institution
Actions and findings of the IRB, including the outcome of any initial review, continuing review, modification request, inquiry or investigation, suspension or termination actions will be communicated to investigators in writing. Investigators are encouraged to keep complete records of all communications relating to their human subjects research protocols. Key communications to institutional officials (e.g., regarding unanticipated problems, non-compliance, suspensions, or terminations) will be provided in writing as outlined in section 7.0 Procedures for Ensuring Prompt Reporting.
4.0 Procedures to Determine Continuing Review Timeline
Federal regulations require the IRB to conduct “continuing review” of ongoing research which was not originally approved through expedited procedures, including multi-year studies, no less than annually. The IRB sets the next review date at the time of initial approval based primarily on the degree of risk of the study: the higher the risk, the earlier the IRB may set the expiration date of the initial approval. Other factors include the nature of the study and the vulnerability of the subject population. In most cases, the OSPR will notify the investigator of the expiration date for “re-approval,” via a reminder notice sent to the principal investigator approximately two months in advance of the actual expiration date.
5.0 Procedures to Determine Need for Verification from Sources other than Investigator
The IRB will assess whether a project needs any additional monitoring procedures to ensure the safety of the participants and adherence with the protocol approved by the IRB (i.e., that no material changes have occurred since the most recent review). These determinations generally will be based on the degree of risk in the study, past history of non-compliance by the investigator indicating a need for additional monitoring, or where concerns about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or other sources. Appropriate safeguards could include monitoring of the consent process, observation of the research procedures, or review of research related results.
6.0 Procedures for Protocol Modifications
Requests for modifications to currently approved protocols, research instruments, or to the informed consent process must be submitted to the IRB for review and approval prior to implementation. Minor changes that do not increase the risk to participants may receive an expedited review per the eligibility criteria established for the continuation of expedited review studies (see section 1.4 Expedited Review).
Modifications that increase the risks to GREATER than minimal are forwarded to the full IRB committee for review.
Changes to approved protocols cannot be implemented prior to IRB review and approval except when necessary to eliminate immediate hazards to the subject.
Any unanticipated risks to subjects, emergency changes in procedures, adverse events, or instances of noncompliance with college, state or federal regulations must be reported immediately to the IRB for appropriate and timely resolution.
Requests for modifications can be requested at any time or along with requests for continuing review if a study is about to expire. Investigators can specify the proposed modification(s) in terms of participant enrollments, instruments, or any proposed changes in the scope of the project, research methods, risks and benefits, or informed consent, as applicable in the designated section of the Request for Continuing Review form (if requesting changes at the point of renewal), or via the Request for Protocol Amendment Form (if requesting at times other than renewal).
Changes in the risks, benefits, or research procedures may require modifications to the consent form and may, in some cases, warrant the re-consenting of participants already in the study. Revised consent forms that are proposed for use must be submitted with the modification request. The date of approval of the modification does not change the date by which the regularly scheduled re-approval review of the project is to be completed.
If a modification involves the changing of principal investigator(s), a letter from the original investigator indicating the need for the change plus a letter from the new investigator accepting responsibility for the research or study should be included along with the modification.
All requests for modifications will be reviewed at a convened IRB meeting, unless expedited review is appropriate under 45 CFR 46.
7.0 Procedures for Ensuring Prompt Reporting
Federal regulations and the terms of our Federal Wide Assurance require prompt reporting to the Office of Human Research Protections (OHRP) and other applicable agencies heads of the following:
• Any unanticipated problems involving risks to subjects or others
• Any suspension or termination of IRB approval
• Any serious or continuing noncompliance with federal policy or the requirements or determinations of the IRB;
Keene State College investigators are therefore required to report relevant information to the IRB so that appropriate action and reporting to college and federal officials can occur in a timely fashion.
7.1 Unanticipated Problems
Definition: OHRP considers unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:
unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Examples of unanticipated problems might include, but are not limited to, complications or complaints occurring during the research or any problem that presents changes in the risk-benefit ratio and affects the rights, welfare or safety of subjects, a breach in confidentiality or privacy, problems with recruitment and/or the consent form process, or noncompliance with federal regulations or IRB policies.
7.1.1 Reporting Unanticipated Problems to the IRB: When unanticipated problems meeting the three above criteria are encountered, Keene State College investigators must report in writing the nature of the problem to the IRB promptly. While federal regulations do not define the term “promptly,” for this purpose it will generally mean within two weeks of the investigator becoming aware of the problem for less serious incidents, and within one week in the case of serious incidents. In addition, sound practice dictates that any serious adverse event (injury or physical or emotional harm to a participant) that occurred unexpectedly should be reported immediately to the IRB. Incident report forms are available in the compliance area of the OSPR web page. A separate report must be filed for each incident, and should include the minimum following information:
appropriate identifying information for the research protocol, such as the title, investigator’s name, and the IRB project number;
a detailed description of the adverse event, incident, experience, or outcome;
an explanation of the basis for determining that the adverse event, incident, experience, or outcome represents an unanticipated problem; and
- a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem.
IRB Incident Report Forms may be delivered directly to the IRB Chairperson or the Director of OSPR, or for convenience may be submitted via email to IRB@keene.edu, which is monitored by the OSPR staff.
7.1.2 IRB Review of Unanticipated Problems
Following receipt of an incident report, the IRB Chairperson or other designated member(s) acting on behalf of the IRB will review the information to determine whether any further actions, beyond any changes or amendments to the protocol that are proposed by the investigator, are warranted. Depending on the nature of the incident, the reviewer(s) of the incident report may elect to discuss the incident at a convened meeting of the IRB. The IRB or other designated member(s) acting on behalf of the IRB will consider whether the protocol still satisfies the requirements necessary for approval (minimization of risks, risks reasonable in relation to anticipated benefits, etc.). The IRB makes the final determination regarding the need to modify, suspend, or terminate the protocol, and must approve any changes.
7.1.3 Reporting of Unanticipated Problems to Institutional Officials, OHRP, or External Entities
If during its review of an incident an IRB determines the incident does not meet the definition of an “unanticipated problem” then no further reporting will occur. However, if review indicates the incident does meet the definition of an “unanticipated problem” then the IRB Chairperson will report the incident in writing to the appropriate College Officials, including at minimum: KSC President, Provost, Director of OSPR, and the investigator’s Dean. Additionally, OHRP and any Sponsoring Agency will be notified as required. Such reports will generally occur within one month of the IRB’s receipt of the report of the problem from the investigator, and will contain the following minimum information:
• Name of the institution (e.g., university, hospital, foundation, school, etc) conducting the research;
• Title of the research project and/or grant proposal in which the problem occurred;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the problem; and
• Actions the institution is taking or plans to take to address the problem (e.g., revise the protocol, suspend subject enrollment, terminate the research, revise the informed consent document, inform enrolled subjects, increase monitoring of subjects, etc.).
7.2 Suspension or Termination
In the event that the IRB finds it necessary to suspend or terminate a research protocol, the suspension or termination will be reported to college officials (KSC President, Provost, Director of OSPR, and investigator’s Dean), OHRP, and any Sponsoring Agency as required. Notification will include the following pertinent information:
• Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;
• Title of the research project and/or grant proposal that was suspended or terminated;
• Name of the principal investigator on the protocol;
• Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the reason for the suspension or termination; and
• The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.)
7.3 Serious or Continuing Non-compliance
The IRB may become aware of possible non-compliance by any of several venues. These may include:
• complaints or concerns from research participants, research staff or employees of the unit;
• audit findings;
• continuing reviews for re-approval;
• incident reports submitted by investigators; or
• quality improvement reviews conducted by the IRB.
Reports of possible non-compliance may be forwarded to the Keene State College IRB by phone, email, or in writing by utilizing the contact information posted in the Contacts section of the OSPR website. Both the IRB Chairs and the Director of Sponsored Projects are available to receive such reports.
Anyone, regardless of affiliation, who suspects non-compliance may submit a complaint or concern. The person submitting the report may be asked to describe the problem or the concern in writing, unless the person chooses to remain anonymous.
7.3.1 Investigation of Possible Non-Compliance: Upon receipt of a report, the IRB Chairs will evaluate the concern and determine next steps. Minor violations may be disposed of administratively following an initial inquiry by the Chair or an IRB subcommittee. All serious or continuing noncompliance with regulations or the determinations of the IRB will be reported promptly to the IRB members at a full review meeting and to other college officials (KSC President, Provost, Director of OSPR, and investigator’s Dean), the federal Office of Human Research Protections (OHRP), and the federal Department or Agency Heads, as applicable. Examples of serious non-compliance include but are not limited to:
• serious violations discovered after completion of a protocol audit;
• instances where non-exempt research was conducted without IRB review and approval or
• without appropriate informed consent procedures;
• implementation of significant modifications without IRB prior approval;
• instances of repeated or multiple problems with noncompliance by investigators even after IRB warnings.
Allegations or any evidence of serious non-compliance will constitute sufficient cause for the IRB to initiate a protocol audit or investigation upon written notification to the principal investigator. Audits or investigations may be conducted by the IRB Chairperson or a subcommittee of the full IRB in a manner that will protect human subjects as well as the investigator’s rights to due process to include the right of appeal. The seriousness of the allegations and any preliminary evidence will determine whether or not a temporary suspension of the research should be imposed by the IRB pending a full inquiry and a final determination at a convened meeting.
When an allegation of possible non-compliance emerges, the inquiry/investigation process of the IRB will include the following stages:
The Complaint or Concern: Review by the IRB Chair to determine seriousness and validity (i.e., if true, would this allegation meet the criteria for serious non-compliance?).
Initial Inquiry: Administrative review by the IRB Chair or a Subcommittee with notification to investigator of complaint or concerns. May result in minor corrective actions for resolution, or referral to full IRB at a convened meeting.
IRB Investigation: Audit of protocol by IRB Chair or IRB Subcommittee with a report of findings at a convened meeting with notification to investigator. May result in major correction actions, suspension, or termination of study.
Appeal Hearing: Investigator responds in writing and/or in person at an IRB convened meeting.
- Final IRB Determination: Report of full IRB meeting with any corrective actions, resolutions or stipulations regarding the future of the research study or its termination if warranted.
Final reports detailing the implementation of corrective actions will be reported to the appropriate College and Federal Officials depending on the seriousness of the violations. In the event the IRB has determined that serious or continuing noncompliance has occurred, the IRB Chairperson will notify in writing the appropriate college officials (KSC President, Provost, Director of OSPR, investigator’s Dean), OHRP, and any Sponsor Agency, as appropriate. Such reports will include the following pertinent information:
• Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;
• Title of the research project and/or grant proposal in which the noncompliance occurred, or, for IRB or institutional noncompliance, the IRB or institution involved;
• Name of the principal investigator on the protocol, if applicable;
• Number of the research project assigned by the IRB and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
• A detailed description of the noncompliance; and
• Actions the institution is taking or plans to take to address the noncompliance (e.g., educate the investigator, educate all research staff, educate the IRB or institutional official, develop or revise IRB written procedures, suspend the protocol, suspend the investigator, conduct random audits of the investigator or all investigators, etc.).
Possible outcomes or corrective actions by the IRB may include:
• education requirements for the investigator and research staff engaged in the research;
• temporary or permanent suspension of the research and/or the investigator;
• random audits of the research or investigator;
• disallowance of research use of data collected; or
• other actions deemed appropriate by the IRB and communicated in writing to the investigator in a final notification.
7.3.2 Relationship of IRB-Related Non-compliance to the Institution’s Research Misconduct Policy
Investigators should be aware that some instances of non-compliance that come to light under this policy (e.g., via a whistleblower or through IRB audits) may also represent “research misconduct” under federal regulations and the Keene State College Research Misconduct Policy. Specifically, behaviors that are considered Research Misconduct in addition to representing IRB-related non-compliance include:
• Falsifications: – Substitutions of one subject’s record for another’s
– Changing research record to favor the study’s hypothesis
– Altering eligibility dates and eligibility test results
– Falsifying dates on patient screening logs
• Fabrications: – Not conducting interviews with subjects and creating records of the interview
– Making up patient visits and inserting that record into the medical chart
– Recording the results of follow-up visits with deceased subjects
When identified by the IRB, these types of incidents will be reported by the IRB Chairperson to the Research Integrity Officer of the institution for additional assessment/inquiry/investigation under the institution’s Research Misconduct Policy: http://www.keene.edu/grants/documents/FinalResearchMisconductPolicy.pdf.
8.0 Instructions for extramural researchers (Incorporated by addendum 10/30/14)
Extramural investigators desiring to conduct human subject research at Keene State College (hereafter “the College”), either by using the College’s facilities or by recruiting members of the College’s community as participants, are expected to demonstrate compliance with all relevant federal and state human subject regulations, including review and approval by their sponsoring or affiliated IRBs. To demonstrate said compliance, extramural researchers should submit a copy of the protocol submitted to their IRB along with a copy of the IRB’s Record of Review indicating that the protocol was approved. Approval by an extramural IRB does not necessarily replace review by the College’s IRB, however, and the College’s IRB may elect to do its own full review of the protocol.
Confidentiality of submissions to the IRB by extramural researchers
Members of the College’s IRB are expected to keep all information and documentation disclosed during the IRB review process confidential. These confidentiality requirements continue indefinitely.
Benign Behavioral Interventions are defined as “being brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Benefit refers to a valued or desired outcome, or an advantage. Benefits of research may accrue directly to the individual participating in the research, or benefit society as a whole, as is often the case in social, behavioral, and educational research. Payments for participation in research or other incentives are not considered and should not be described as benefits.
Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health related outcomes.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Interaction includes communication or interpersonal contact between the investigator and a subject.
Intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
Minimal Risk A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The federal code specifically identifies several activities which are deemed not to be research, including:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected. 2.Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Risk means the probability of harm, whether physical, psychological, social, legal or economic. Both the probability and magnitude of possible harm may vary from minimal risk to greater than minimal. Risks also include immediate risks of study participation, risks of breach of confidentiality, inadvertent disclosures, and risks of long-term effects.
Systematic investigations are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and reporting research findings.
Written, or in writing, refers to writing on a tangible medium (e.g., paper) or in an electronic format.
To avoid research being subject to two sets of rules during the life of the research, grandfathered research (originally reviewed under the pre-2018 requirements and continuing beyond January 21, 2019) will comply with the Final Rule (2018 requirements) on or after January 21, 2019.
* Portions of this text are from Kenyon College IRB. We gratefully acknowledge the work of our professional colleagues.