Source: https://www.lynn.edu/university-policies/volume-i-governance-and-administration/human-subjects-research-irb-policy
Timestamp: 2018-10-19 20:49:25
Document Index: 223391585

Matched Legal Cases: ['art 46', 'arts 50', 'art 160', 'art 164', '§46', '§46', '§ 46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46', '§46']

Human Subjects Research (IRB) | Lynn University, Florida
This Policy describes the procedures the Institutional Review Board (IRB) at Lynn University will follow when reviewing research with human subjects in compliance with federal requirements for the protection of research subjects. For information on the federal regulations, please refer to the United States Department of Health and Human Services Regulations, Protection of Human Subjects: Title 45, Code of Federal Regulations, part 46 (45 CFR 46), revised June 18, 1991, December 28, 2000, August 14, 2002, and 21 CFR parts 50 and 56 [Food and Drug Administration Regulation on Protection of Human Subjects]. Also see the Health Insurance Portability and Accountability Act (HIPAA) of 1996; the Privacy Rule (also known as Standards for Privacy of Individually Identifiable Health Information) is in Title 45 of the Code of Federal Regulations, Part 160 and Subparts A and E of Part 164.
Lynn University is committed to a policy of safeguarding the rights and welfare of all human subjects in research. As standards for the ethical treatment of human subjects, the University accepts the principles set forth by the national Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in its report Ethical Principles and Guidelines for the Protection of Human Subjects of Research (commonly known as the Belmont Report) and Title 45, section 46 of the U.S. Code.
Principal Investigator means a person who has ultimate administrative and fiscal authority in conducting and coordinating a research project.
Co-Investigator means a person who conducts research for a given project but does not have ultimate administrative or fiscal responsibility.
Institution means any public or private entity or agency (including federal, state, and other agencies), and in particular Lynn University.
Legally Authorized Representative means an individual, judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
A Minor generally means a person who is under the age of 18 who is not an emancipated minor except for certain purposes as specified by law.
Research Subject to Regulation, and similar terms, is intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department’s or agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
Human Subject means a living person about whom an investigator (whether professional or student) conducting research obtains: (a) Data through intervention or interaction with the individual, or (b) 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 to obtain the information to constitute research involving human subjects.
Protected Health Information (PHI) means health information transmitted or maintained in any form or medium that: (a) identifies or could be used to identify an individual; and (b) is created or received by a healthcare provider, health plan, employer or healthcare clearinghouse; and (c) relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of healthcare to an individual.
I. Purpose of the IRB
The Lynn University Institutional Review Board (IRB) is an independent ethical review committee mandated by the U.S. Department of Health and Human Services (DHHS). The IRB’s purpose is to review research proposals for compliance with federal regulations and ethical principles to insure that human research subjects are adequately protected from harm, and that they give voluntary, informed consent to their participation.
The IRB and Lynn University research activities are subject to review by a variety of agencies, chief among them is the Office for Human Research Protections (OHRP). The Office of Academic Affairs, under the direction of the Vice President for Academic Affairs, is the administrative office responsible for the University’s system of protections for human research participants.
II. Role and Authority of the IRB
The Lynn University IRB is established under authority delegated by the Board of Trustees to the President of Lynn University and under the governing federal regulations outlined above.
Vested with the ethical imperative to safeguard the rights and welfare of human subjects in research studies at Lynn University, the IRB has jurisdiction over any research project that involves or has the potential to involve human beings as the subjects of research and that is proposed to be carried out by a member of the Lynn University community (including faculty, students, staff, and administrators), or proposed to be carried out on Lynn University property, or that involves members of the Lynn University community as subjects of the research.
Specifically, the IRB has the authority to approve, require modifications, or disapprove proposals for research on human subjects conducted at Lynn University, or conducted by members of the Lynn University community (including faculty, students, staff, and administrators) so as to assure protection of human subjects in three major areas:
The procedures do not place the subject at risk, include no unnecessary risks and minimize potential risks to subjects;
The subject is informed about the purpose and intent of the research along with the necessary and sufficient details, including description of the risks or discomforts and the anticipated benefits, to assure voluntary and informed consent; and
Privacy of the subjects and confidentiality of subject data are adequately protected.
Where the participants are members of a vulnerable population, the IRB determines whether appropriate additional safeguards are in place to protect the rights and welfare of these research participants.
In addition, the benefits of the research must outweigh the risks to the subjects. The IRB measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects. The researcher is required to provide the supporting documentation. For Lynn University, the IRB is the only authorized University committee to make this determination. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination or approval includes a statement of the reasons for the IRB’s action and is reported promptly to the investigator, appropriate institutional officials, and pertinent external bodies.
The IRB is responsible for review of Applications and Research Protocols required for all new research. The IRB determines intervals of periodic review (continuation/renewal), and, where appropriate, determines that adequate provisions are in place for monitoring the data collected to ensure the safety of subjects. The IRB is responsible for review of procedural revisions, advertisements to recruit subjects, and reports of adverse events and project termination. In addition, for research activities involving Protective Health Information (PHI), the IRB acts as the institution’s Privacy Board (required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA)) to review and approve the proposed access, use, and disclosure of the PHI. Where applicable, The IRB will determine whether research subjects are required to sign an authorization for the use and disclosure of their PHI, or if one of the exceptions to the authorization requirements applies. Examples of these exceptions include waivers of authorization and the use of de-identified data or limited data sets.
III. Statement of Research Principles
The following are the principles governing Lynn University in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research.
Research must be justifiable for its scientific or other meaningful purpose or value.
Even if an inquiry has scientific or other value, it must not be pursued if the benefit is outweighed by risk to the subject.
The research must be conducted by sufficiently competent and knowledgeable people.
The research must be conducted under a sound design, suited to the nature of the study.
Informed consent is a process ensuring ethical conduct of research. No person should serve as the subject of research unless he or she, or an authorized or legal representative, has given voluntary consent after being fully informed of the nature, risks, and benefits of the study and their rights as participants. Additional safeguards must be included in the study to protect the rights and welfare of subjects.
Participation as a subject in a research study should be voluntary, and care should be exercised to ensure that subtle pressures are not used to obtain participation.
Care must be taken throughout the duration of the research study (and sometimes beyond) to ensure against the risk of harm to subjects, either physical or emotional.
Research must be terminated if there arises a serious risk of harm to subjects, either physical or emotional.
The subject should be entitled to withdraw from participation in a research study at any time.
IV. IRB Membership & Meetings
A. IRB Membership
IRB members are selected for their experience, expertise, diversity and breadth in backgrounds and represent individuals with primary concerns in both scientific and non-scientific areas.
The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Every nondiscriminatory effort will be made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. Additionally, the IRB shall not consist entirely of members of one profession.
In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
The Vice President for Academic Affairs shall appoint members to the Lynn University IRB to ensure compliance with federal and state requirements and institutional policies.
The IRB shall include at least five (5) members. The Chair is selected annually from among the sitting members of the IRB and is appointed by the Vice President for Academic Affairs. The Chair serves a one (1) year term. Service as the Chair will be limited to one year terms and will rotate amongst members of the committee. If the position of Chair becomes vacant, a new Chair shall be elected at the next scheduled meeting.
At the option of the IRB, a Vice Chair may be elected from among the IRB members to assist the Chair in performance of duties.
Deans of the Colleges in the University (or their designated representatives);
Coordinators of the Ph.D. Programs (or their designated representatives);
The General Counsel; from a non-scientific area (or a designated representative);
One non-affiliated University member from the community at-large: A non- affiliated member means an IRB member who is not affiliated with or employed by the University, nor part of the immediate family of a person who is affiliated or employed by the University;
Members of the full-time teaching faculty from each of the Lynn University discipline areas;
Representatives are elected by members of the discipline areas for a 3-year term** and must be approved by the Vice President for Academic Affairs.
The Chair shall preside over meetings of the IRB.
Each application, request or report pertaining to a research proposal shall be identified by an IRB Number that begins with the year of initial submission, followed by three digits. For example, the first application submitted in the year 2016, has the seven digit assigned IRB number of: 2006001 and the second application has the IRB number of 2016002. A record is maintained on each IRB project, appropriately labeled with an IRB number.
Assign review to IRB members for applications and research proposals and other requests or reports that do not require a convened full-board review.
The Chair shall forward all applications and IRB report forms to the Office for Academic Affairs for records maintenance at the end of the Calendar year (June 30). (See Records Maintenance)
All formal correspondence, decisions and recommendations in the name of the IRB shall include the IRB number and bear the signature of the Chair. The Chair shall forward all communications to the Office for Academic Affairs for records maintenance at the end of the Calendar year (June 30).
The Chair shall maintain a list of IRB members for each academic year and include the following: (a) a list of IRB members identified by name; (b) earned degrees; (c) representative capacity; (d) indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations; and (e) any employment or other relationship between each member and the institution. (See 45 CFR §46.103).
In instances where a project is funded or sponsored by the Federal Government changes in IRB membership must be reported to the Department or Agency head, unless in accord with §46.103(a), the existence of a DHHS-approved assurance is accepted. In this case, change in IRB membership must be reported to the Office for Protection from Research Risks, National Institutes of Health, DHHS.
The IRB will conduct at least two scheduled IRB Meetings annually. However, proposals for review will be reviewed on a continuous basis and proposals may be submitted when they are ready for review.
The Chair will forward all proposals to each IRB member no later than one week prior to convened meetings. Communications to investigators shall be made in writing, within 5 working days of the IRB meeting.
The IRB will notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (45 CFR § 46.109)
The IRB Chair will keep all IRB members advised of actions which use the expedited review procedure and applications through regular reporting at convened meetings for approved expedited reviews, exemptions, continuation, procedural revisions, and advertisements to recruit subjects, and reports of adverse events and project termination.
The IRB shall meet and conduct business at least twice a year, or more often at the call of the chairperson. Electronic submission of applications will be accepted on a rolling basis.
Except for where expedited review is appropriate under HHS regulations at 45 CFR 46.110(b)(1), initial and continuing reviews of research will be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.
Procedures for IRB Meetings
Principal Investigators and Co-Principal Investigators may attend the IRB meeting upon the invitation of the Chair to provide information to the members, but they may not be present during the final discussions and vote.
IRB members may not participate in the initial review or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Examples of such conflicts of interest could include: a member of the IRB who serves as an investigator on research under consideration by the IRB; or a member who holds a significant financial interest in a sponsor or product under study.
At its discretion, the IRB may invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available to the IRB. Individuals invited to assist in review at the discretion of the IRB shall not vote.
(45 CFR §46.115 IRB records) Attendance shall be recorded. Agenda Items include:
New Business: Reports or IRB Committee Review and Action (include Assigned IRB Number, title, and author). Provide Records of Actions, Discussion and Resolution of Controverted Issues:
Application and Protocol for Review of Research Involving Human Subjects for a New Project (IRB Form 1)
Application to Continue (renew) a Previously Approved IRB Project (Form 2)
Application for Procedural Revisions of or Changes in Research Protocol and/or Informed Consent for IRB Form 1 of a Previously Approved Project (IRB Form 3)
Report on Unexpected Adverse Event, Serious Injury, or Death (IRB Form 4)
Applications and Protocol for Requests for Exemptions (IRB Form 5)
Applications and Protocol for Expedited Reviews (IRB Form 6)
Request for Approval of Advertisements to Recruit Subjects (IRB Form 7)
Report of Termination of IRB Projects (IRB Form 8)
Adjournment and Announcement of Next Meeting Date
Parliamentary procedures follow Robert's Rules of Order.
A quorum of the IRB shall consist of at least 1/2 of the current membership. Furthermore, it shall consist of at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Should the quorum fail during a meeting, the IRB may not take further actions or votes unless quorum can be restored.
Voting on matters shall be by viva voce (by the voice), or "show of hands," general (unanimous) consent unless someone objects, or by request for a secret (written) ballot by any single member of the committee.
Proxy Voting. A proxy is a power of attorney given by one member of the committee to another to vote in his/her behalf.
All actions shall require affirmation of a majority of a quorum of the current membership except in the following instances where two-thirds of the majority is required.
Motions Requiring a Two-thirds of the majority include but are not limited to the following:
Amend any Rules of Order, previously adopted;
In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
The IRB may consult outside experts, target populations, and others to assist in decision-making during the review process when deemed necessary.
V. Criteria for IRB Approval of Research
In order to approve research covered by this Policy, the IRB will determine that all of the following requirements are satisfied:
A. Risks to Subjects are Minimized
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. Minimal risk implies that the likelihood and degree of harm or discomfort expected as a result of the research are not greater than the risks encountered during the course of daily activity or during the course of routine physical or psychological examinations. Such risk considerations should not be limited to physical risk alone, but should also consider emotional and psychological risk, personal risk, and possible insurability risk.
B. Selection of Subject is Equitable
In making this assessment, the IRB will 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 minors, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Investigators should detail any extra precautions taken to safeguard the rights and welfare of subject populations.
C. Informed Consent and Assent
Informed consent has been obtained and appropriately documented from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required set forth in the General Requirements for Informed Consent section of this Policy.
D. Subject Safety
Where applicable, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. The IRB will review who has been identified as having the primary responsibility for analyzing individual events to determine whether the study should be modified to minimize risk to current or future research subjects.
E. Privacy of Subject
When appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
F. Vulnerable Subjects
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as minors, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. A full description of safeguards to ensure the fair and equitable treatment of these subjects and protect their rights and welfare can be found in the Department of Health and Human Services Office for Human Research Protections Code of Federal Regulations.
G. Required IRB Training
Lynn University offers an IRB training course through the phrp.nihtraining.com. This training is up-to-date and meets the federal requirements for training in human subjects protections. Completion of this training is required for individuals participating in the IRB process, including investigators.
VI. IRB Application Instructions
The Lynn University IRB will review and have authority to approve, require modifications in, or disapprove all research activities covered by this document. All proposals for human subjects’ research must be submitted to the IRB for review and approval in accordance with the application instructions below. No involvement of human subjects may take place prior to formal, written notification from the IRB.
A submission for review by the IRB must be prepared for each research study using human subjects or human materials. All of the appropriate forms must be neatly typed and accurately completed. The IRB review cannot be accomplished unless all of the sections are completed. Any application that is not completed properly will be returned, possibly resulting in a delay in the review process.
Application materials (IRB Forms) are available on the myLynn portal.
Submissions to the IRB are accepted in electronic format. Please follow the instructions for completing the forms that are in PDF format.
All new research projects require the submission of IRB Form 1 (IRB Application and Research Protocol for Review of a New Project). In addition, either Form 2 (Request for Exemption) or Form 3 (Expedited Review) is to be completed and submitted along with Form 1 if the investigator believes the proposal qualifies for:
An Exemption from Federal Regulations as noted in 45 CFR §46.101(b), exempt from full board or expedited review; or
An Expedited Review as noted in CFR 45 §46.110, for certain kinds of research involving no more than minimal risk.
Note: Institutional Research surveys are not subject to IRB review.
VII. Levels of IRB Review
A. Convened Full Board Review of New Research Projects
A Full-Board Review occurs when the application and research protocols (Form 1) involve more than minimal risk to research participants or vulnerable populations of research participants (other than minors when the protocol qualifies for expedited review) and are reviewed by the IRB at a convened meeting. Full board review is required for studies that involve greater than minimal risk or vulnerable populations that require special protection by the IRB. These populations include, but are not limited to: pregnant women, human fetuses and neonates, prisoners, and minors.
Examples of greater than minimal risk are:
A clinical interventional study that randomly assigns human subjects to alternative experimental or placebo groups; and
Studies involving sensitive information connected to personal identifiers.
Researchers intending to conduct research which will require full IRB review/discussion should submit their research protocols to the IRB Chair at least two weeks prior to the board’s next scheduled meeting. All submissions to the IRB are done electronically and are immediately distributed to the committee for review. Therefore, IRB notifications are rolling. Only those proposals that do not obtain consensus votes or have an IRB member indicate that they wish a formal discussion would be held for the full board meeting. Notification from the IRB will also occur in an electronic format.
To submit a full-board research protocol to the IRB, the following materials must be submitted electronically to the IRB Chair:
Electronically signed IRB Application and Research Protocol (IRB Form 1) - all pages must be completed;
Consent Form and other requested materials and attachments; and
Advertisement for Subject Recruitment, if applicable (IRB Form 7).
In determining whether an IRB application and research is subject to full IRB review, the IRB will utilize the Office for Human Research Protections decision charts.
The IRB will attempt to review any full-IRB research proposal and respond with a decision within thirty (30) days of receipt of the proposal. When a proposal is submitted, it is checked for completeness. If not complete, it is returned to the principal investigator. If complete, it will be circulated to the members of the IRB for review at a convened meeting. At the meeting of the IRB, the proposal will be evaluated for the extent to which it provides for the protection of human subjects, demonstrates scientific merit and meets the criteria set forth in the Criteria for IRB Approval of Research section above. A majority of the members of the IRB must be present at a convened meeting, including at least one member whose primary concerns are in nonscientific areas. In order for the application to be approved, it must receive the approval of a majority of those members present at the meeting. The IRB chair will notify the investigator of the outcome of the full review.
B. Expedited Review of New Research Projects
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. Federal regulations make provisions for certain categories of research to be reviewed through an expedited procedure if the research involves no more than minimal risk. Expedited review is intended to enable the University to conserve administrative resources, provide timely reviews and focus the convened meetings of the IRB on those research activities involving greater risks or ethical complexities. In addition, the IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval.
Research protocols that qualify for expedited review must meet two conditions: (a) the research must be determined to be minimal risk; and (b) all proposed research activities must be included in the list of eligible categories of expedited research as established by the DHHS for this purpose (see hhs.gov). See also the Office for Human Research Protections expedited review decision chart.
Under expedited review procedures, reviews may be carried out by the IRB Chair, or at the discretion of the Chair, by one or more experienced reviewers designated by the Chair from among members of the IRB. The expedited reviewer possess all the same authorities as the full IRB to approve, modify, or conditionally approve the proposed research activities, except the authority to disapprove a research activity. A research activity may be disapproved only after review in accordance with the ordinary, non-expedited procedure set forth in 45 CFR 46.108(b).
To submit an expedited research protocol to the IRB, the following materials must be submitted electronically to the IRB Chair:
Consent Form and other requested materials and attachments;
Completed Request for Expedited Review (Form 3); and
Advertisement for Subject Recruitment, if applicable (Form 7)
Under normal circumstances, the Chair or other assigned reviewer(s) is able to review protocols in this category within 10 business days after receipt of a substantively complete protocol.
C. Exemption Procedures for Review of New Projects
Exempt research activities involve no more than minimal risk and may include classroom studies, surveys, observation of public behavior, the non-invasive collection of physiological data, and the analysis of existing data that involves human subjects. Research that includes both exempt and non-exempt categories is not exempt. More detailed information regarding exempt research activities may be found at 45 CFR §46.101(b). Irrespective of whether a study is exempt from full review, it must meet accepted standards of protection of privacy and a subject’s right to refuse participation without penalty.
IRB exemption reviews may be carried out by the IRB Chair, or at the discretion of the Chair, by one or more experienced reviewers designated by the Chair from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in CFR 45§46.108(b).
Completed Request for Exemption (Form 2) - an exemption from Federal Regulations as noted in 45 CFR §46.101(b), exempt from full board or expedited review; and
Under normal circumstances, the Chair or another member, and generally not exceeding 3 IRB members, is able to review protocols in this category within 10 business days after receipt of a substantively complete protocol. In determining whether an IRB application and research is exempt from full IRB review, the IRB Chair or other IRB member will utilize the Office for Human Research Protections decision charts. If the activity does not qualify for exemption, the IRB Chair or a designee notifies the investigator in writing or via email. If the IRB Chair, or designee, determines that an application does not qualify for exemption, the application will be processed either through Expedited Review or by full IRB review.
The IRB reserves the right to request the investigator to provide additional information concerning applications or reports.
D. Other IRB Reviews
Training or Center Grants
When training grants are submitted and some projects are expected to involve human subjects, the training grant will be reviewed by the IRB Chair, or at the discretion of the Chair, by the full board or by one or more experienced reviewers designated by the chairperson from among members of the IRB. A certification of IRB review and approval will be sent to the funding agency. (Note: Training and Center grants will be reviewed even though specific research projects for trainees or sub-projects are not fully described in the application. When IRB approval is provided for such applications, it will be contingent upon each project director submitting a complete or updated Application and Research Proposal (From 1) to the IRB prior to the initiation of their particular project.)
The investigator is responsible for ensuring that all subprojects supported by the training grant are also submitted for full IRB review prior to initiation. The annual continuing review of the training grant requires submission of a list of subprojects that involve human subjects and documentation that they have been reviewed by the IRB.
To submit a research protocol involving training or center grants to the IRB, the following materials must be submitted electronically to the IRB Chair:
A copy of the complete proposal/grant as it was submitted to the funding agency;
Electronically signed IRB Application and Research Protocol (IRB Form 1), Form 2 (Request for Exemption) or Form 3 (Expedited Review) if applicable – all pages must be completed;
Advertisement for Subject Recruitment, if applicable (Form 7).
Preliminary/Indefinite Plans
The IRB will preliminary review research proposals under the following circumstances: (a) where there is no immediate involvement of human participants, such as grant proposals planned for submission; or (b) where the research Application and Research Protocol (Form 1) is not complete and a preliminary review is desired. Generally, the review is conducted by the IRB Chair, or at the discretion of the Chair, by the full board or by one or more experienced reviewers designated by the Chair from among members of the IRB.
Upon completion of the review, a letter advising to proceed with the funding request, request for further information or further development of the proposal will be sent to the investigator. In cases of a funded project, upon funding, a detailed protocol describing the research (including the informed consent process and research instruments) must be reviewed and approved by the IRB (as a full, expedited or exempt study), pending the nature of the investigation.
To submit a preliminary research plan to the IRB, the following materials must be submitted electronically to the IRB Chair:
A cover Letter requesting a Preliminary Review and Purpose;
An electronically signed IRB Application and Research Protocol (Form 1), Form 2 (Request for Exemption) or Form 3 (Expedited Review) if applicable, all pages must be completed; and
Application to Continue or Renew a Previously Approved Project
The IRB will conduct continuing review of research covered by this Policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research CFR 45 §46.109)(e).
The Lynn University IRB determines that adequate provisions are in place for monitoring the data collected to ensure the safety of subjects. Following initial approval, the researcher must seek review for projects at the intervals mandated by the IRB, not to exceed one year. The researcher is expected to forward Form 4 in a timely manner, allowing the IRB to review the project well before it expires, thus avoiding an interruption in research. Failure to seek continuing review may jeopardize present and future projects.
For projects that require a Convened Full-Board Review, the researcher forwards Form 4 and an updated consent form to the IRB no later than two months prior to the due date for renewal.
If a research proposal was authorized by expedited review, or the researcher believes the renewal qualifies for expedited review, the researcher forwards Form 4 and an updated consent no later than one month prior to the due date for renewal.
If a research proposal was authorized for exempt status, the researcher forwards IRB Form 4 and an updated consent no later than one month prior to the due date of the anniversary of initial approval.
VIII. IRB Action & Length of Approval
The investigator will be notified in writing (print or electronic) of the IRB’s action on his/her research proposal. These actions include:
Full Approval: The IRB approves the proposed purpose and design as described in the application for a period of one (1) year to conduct the approved research study. The investigator is responsible for informing the IRB in writing of any change or modification made to the study after approval is secured and/or continuing progress reports may be required.
Contingent Approval: An application receiving contingent approval requires addition information or minor revision. When the requested changes have been made, the IRB Chair has the authority to provide full approval.
Deferred: Applications that are deferred require significant revision and must be resubmitted for IRB review.
Disapproval: This is a rare action and is taken only when, in the judgment of IRB members, the risks of the research outweigh the benefits to study participants, or other, significant problems exist specific to the proposed study.
Suspension or Termination: The IRB has the authority to suspend or terminate any research project, including projects with full approval, that is not being conducted in accordance with the IRB’s decisions, conditions, and requirements, or when unexpected serious harm to human subjects has been discovered. The investigator will receive a written explanation of the decision for suspension or termination. Any suspension or termination of approval will be determined by the committee as a whole, shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator and appropriate University officials.
IX. Unanticipated or Unexpected Adverse Event
An “Unanticipated or Unexpected Adverse Event” refers to an adverse event or other problem arising during the research the specificity or severity of which is not consistent with information already provided to the Lynn University IRB. Adverse events are categorized as follows.
Adverse Events - Undesirable and unintended, though not necessarily unanticipated, injuries or physical or emotional consequences for the subject.
Serious Adverse Events - Adverse events which are fatal or life-threatening; that result in significant or persistent disability; that require hospitalization, or represent a significant hazard or potentially serious harm to research subjects or the researchers and their staff.
Unanticipated Problems - Specific events experienced by subjects or developments that occur during implementation of research protocols that suggest the potential for increased risk to research subjects or the researchers and their staff.
In the event of an unanticipated or unexpected result, the investigator is required to submit a written report to the IRB via IRB Form 6. The time frame for the submission of the report is determined by the type of unanticipated or unexpected event that has occurred.
When an adverse event is serious and unanticipated, the principal investigator must submit IRB Form 6 within 24 hours or by the end of the next working day.
When an adverse event is serious but not unanticipated, the principal investigator must submit IRB Form 6 within five (5) working days.
When an adverse event occurs which is not serious but is unanticipated, the principal investigator must submit IRB Form 6 within 10 working days.
When an unanticipated problem occurs which does not meet the definition of an adverse event, the principal investigator must submit IRB Form 6 within 10 working days.
X. Proposed Changes to Research Protocol
The principal investigator is responsible for obtaining prior approval for proposed changes to an approved research protocol. Expedited review procedures may be used for certain kinds of research involving no more than minimal risk, and for minor changes in approved research (see CFR 45 §46.110). Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in CFR 45 §46.108(b). If the procedural change is judged to involve more than minimal risk, intentional deception, or questions pertaining to a protected population and does not meet the categories for exempt or expedited review it must be presented to a convened full review board for discussion and consideration of approval or non-approval. The IRB reserves the right to request the investigator to provide additional information concerning the application for a procedural change. After review, the IRB will send the applicant formal notification of IRB actions.
XI. IRB Documents and Records
Actions taken by the IRB and separate deliberations for each action;
Minutes of all convened IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. The recusal of any IRB members because of a conflicting interest shall also be documented when recording votes on IRB actions;
A list of IRB members in the same detail as described in §46.103(b) (3);
Written procedures for the IRB in the same detail as described in §46.103(b) (4) and §46.103(b) (5);
Statements of significant new findings provided to subjects, as required by §46.116(b) (5). CFR 45§46.116(b) (5) (Informed Consent). This is: A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
Required determinations and protocol-specific findings justifying those determinations for:
Waiver or alteration of the consent process. [45 CFR 46.116(c) and (d)];
Justification for the waiver of the requirement for written documentation of consent [45 CFR 46.117];
Research involving pregnant women, fetuses, and neonates. [45 CFR 46.204];
Research involving prisoners. [45 CFR 46.306];
Research involving children. [46 CFR 46.404-407];
The rationale for determining that risk associated with using a medical device in a study significant or non-significant (referred to as significant risk/non-significant risk device determinations); and
When the expedited procedure for review is used, documentation of discussions, decisions, and findings will be included in the protocol file.
The records required by this Policy shall be retained for at least 3 years, and records relating to research, which is conducted, shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the federal department or Agency at reasonable times and in a reasonable manner when applicable.
XII. Informed Consent
Except as provided elsewhere in this Policy, no investigator may involve a human being as a subject in research covered by this document unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative and at an appropriate reading level. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights or releases or appears to release the investigator, the sponsor, the University or its agents from liability for negligence.
For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws, which require additional information to be disclosed in order for informed consent to be legally effective.
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.
A written consent document that embodies the elements of informed consent as set forth in the Basic Elements of Informed Consent section above;
This form may be read to the subject or the subject’s legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
A short form written consent document stating that the elements of informed consent as set forth in the Basic Elements of Informed Consent section above have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
XIII. Institutional Endorsement
If a funding entity requires certification by an authorized official of Lynn University that the research involving human subjects for which application for support has been approved by an IRB, the IRB Administrator shall provide the requested information on behalf of Lynn University.
XIV. Periodic Review of the Approved Research
The principal investigator must inform the IRB in writing of the progress of the research one year after approval and, if necessary, apply for extension of the research using form IRB Form 4.
XV. Payment to Research Participants
It is not uncommon for subjects to be paid for their participation in research, especially in early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies must not be considered a benefit. Financial incentives are often used when health benefits to a subject are remote or non-existent. The amount and schedule of payment must be presented to the IRB at the time of the initial review. The IRB will review both the amount of the payment and the proposed method and timing of disbursement to assure that neither are coercive nor present undue influence.
Difficult questions must be addressed by the IRB when considering payment to research subjects. For example, how much money should research subjects receive, and for what should subjects receive payment, their time, the inconvenience, discomfort or some other consideration? The IRB must consider whether any aspect of the proposed remuneration will be an undue influence, thus interfering with the potential subject’s ability to give voluntary informed consent. In no case should remuneration be viewed as a way of offsetting risks; that is it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration. The same principle would apply to remuneration offered to parents whose children are prospective subjects.
XVI. Lynn University Students as Research Subjects
It is the University’s general position that teachers should not use their own students as subjects in their research if it can be avoided. The University recognizes, however, that in some research situations, use of one’s own students is integral to the research. This is particularly true of research into teaching methods, curricula and other areas related to the scholarship of teaching and learning. The following are two models of research design that may be permissible to the IRB:
Collection of Data by Third Party: In situations where the activities to be undertaken by the students are not part of required class activities, and thus students may or may not choose to participate, the instructor/researcher should arrange to have the data collected by an independent third party, so that the instructor does not know who participated, and does not have access to the identifiable data or identity of participants for any purpose until grades have been assigned and entered; and
Collection of Data by Instructor/Researcher: In situations where the collection of data by a third party is not feasible, the IRB may approve the research if the student provides written consent to use his or her own data, e.g., test results, papers written, homework, etc., after grades are entered.
Note: The giving of course credit or extra credit to students who participate in research as part of a course requirement will be approved by the IRB only when alternative means of obtaining credit is made available to students who do not wish to volunteer as research subjects. The IRB will carefully review these alternatives to make sure that students are not being coerced into becoming subjects. The informed consent statement must make clear the consequences of withdrawing from a project prior to completion.
XVII. Research Completion
The principal investigator must inform the IRB in writing when the research project has been completed through the completion of IRB Form 8, accompanied by study completion documents and archival records.
Research studies can be deemed completed for a number of reasons, each requiring a different degree of IRB involvement. Most often, the investigator will close the study and the IRB’s role is passive, receiving study completion documents and archiving the records for the study. In some cases, the IRB must perform in a supervisory or disciplinary fashion and require that a study be ended.
XVIII. Non-Compliance
The IRB is responsible for determining the validity of all allegations of noncompliance with respect to human subjects research activities conducted under the auspices of Lynn University and, if found to be non-compliant, determining whether it constitutes non-compliance that is serious or continuing in nature. If it is determined that a research protocol is not in compliance with regulations, regardless of whether it received prior review and approval by the IRB, it may direct corrective action to be taken.
There are two levels of noncompliance:
Serious: non-compliance that may affect the rights and welfare of participants including: (i) conducting non-exempt human research without submitting an IRB protocol; (ii) actions that compromise confidentiality of the participants or the integrity or validity of the research; (iii) actions that harm the participants either physically, psychologically or emotionally; (iv) the use of subjects from federally identified protected groups, which were not identified on the IRB protocol; (v) failure to report serious events, unanticipated problems, or substantive changes to the proposed protocol to IRB; and
Continuing: a pattern or multiple instances of non-compliance that: (I) indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others; (ii) compromises the scientific integrity of a study such that important conclusions can no longer be reached; (iii) suggests a likelihood that noncompliance will continue without intervention; or (iv) involves frequent instances of noncompliance or a failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance.
All cases of non-compliance are to be reported to the IRB Chair on an immediate basis. Reports can be made by research subjects, members of the research team or anyone else familiar with the research project.
Whether action needs to be taken, and if so what form it will take. This can include requiring changes be made to the protocol, assigning a person to monitor the remainder of the research, requiring the researcher to undergo training, or suspension/termination of the research; and
A recommendation on whether any sponsoring federal agencies need to be informed.
For cases of Serious or Continuing noncompliance, the IRB Chair will report to the Vice President for Academic Affairs the non-compliance and the IRB’s decisions on remedial action. In cases of continuing non-compliance, the Vice President for Academic Affairs may revoke the research privileges of the individual at the University or institute other disciplinary actions. Although the IRB can suspend or terminate the research project only the Vice President for Academic Affairs may suspend the researcher’s ability to conduct research.
The IRB Chair will inform the principle investigator (and sponsoring agency if applicable) that a non-compliance report has been made. The IRB Chair will also determine whether the report is serious enough to merit suspension of the research.
The IRB Chair will investigate and determine whether the non-compliance is Serious or Continuing. In the case of Serious or Continuing non-compliance, the IRB Chair will call a meeting of the full IRB. The researcher will be given the opportunity to attend the meeting to present information, but may not be present while the IRB makes its decisions. At this meeting the following will be determined: