Last Revised: 10.2015
Prior Version: 7.2007
Initial Protocol Review and Approval
Definitions
Department of Health and Human Services (DHHS) is the United States government's agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
Federalwide Assurance (FWA) is a written agreement that establishes standards for human subjects’ research as approved by the Office for Human Research Protections and is executed by the institutional official.
Human Subject (or Participant): As defined by DHHS: a human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102(f))
Identifiable. Federal regulations define identifiable to mean that the identity of the individual subject is or may readily be ascertained by the investigator or may be associated with the information.
Institutional Review Board (IRB) is an administrative body established by a local institution to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of the institution.
Interaction: Includes communication or interpersonal contact between an Investigator or his/her research staff and the research participant or their private identifiable information.
Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subjects’ environment that are performed for research purposes.
IRB of Record is a term utilized when an institution assumes the IRB responsibilities for a human subject research protocol conducted at another institution. An IRB Authorization Agreement signed by institutional officials at both institutions is required.
IRB Authorization Agreement is a formal agreement between CWRU and another institution that allows the CWRU IRB to serve as the IRB of Record for protocols at that institution.
Office for Human Research Protections (OHRP) is the division of DHHS responsible for providing leadership on human research participant protections and implementing a program of compliance oversight for DHHS (45 CFR 46).
Private Information: Includes information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information, which has been provided for specific purposes by an individual, and the individual can reasonably expect will not be made public (e.g., 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 be considered information to constitute research involving human participants.
Research: As defined by DHHS any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Research Activities Involving Human Subjects: Activities that meet the DHHS definition of “research” and involve “human subjects” as defined by DHHS. The definition of research and human subjects must consistently reference the same set of regulations (i.e., DHHS) and cannot reference the definition of research from one set of regulations, and the definition of a human subject from the other.
Criteria by which Persons are Considered Engaged (Agents) in Research
Research under the auspices of CWRU includes research conducted at this organization, conducted by or under the direction of any employee or agent of this organization (including students) in connection with delegated organizational responsibilities, conducted by or under the direction of any employee or agent of this organization using any property or facility of this organization, or involving the use of this organization's non-public information to identify, contact, or study human subjects.
Employee or Agent. For the purposes of this document, employees or agents refers to individuals who: (1) act on behalf of the organization; (2) exercise organizational authority or responsibility; or (3) perform organizationally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving payment or other compensation.
Engagement. The institution is considered engaged in a particular non-exempt human subject research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
How to Determine Whether an Activity is Human Research
The purpose of this series of questions is to provide support for individuals in determining whether an activity is Human Research or how it is regulated.
1. Research as Defined by DHHS Regulations
· Is the activity an investigation?
§ Investigation: A searching inquiry for facts; detailed or careful examination.
· Is the investigation systematic?
§ Systematic: Having or involving a system, method, or plan.
· Is the systematic investigation designed to develop or contribute to knowledge?
§ Designed: observable behaviors used to develop or contribute to knowledge.
§ Develop: to form the basis for a future contribution.
§ Contribute: to result in. Knowledge: truths, facts, information.
· Is the knowledge the systematic investigation is designed to develop or contribute generalizable?
§ Generalizable: Universally or widely applicable. (This concept implies that the knowledge gained will be shared with others so that it may be applied in these other settings.)
2. Human Subject Under DHHS Regulations
· Is the investigator conducting the Research gathering data about living individuals?
3. Human Subject Under DHHS Regulations
· Will the investigator gather that data through either of the following mechanisms? (Which mechanism(s) apply?):
§ Physical procedures or manipulations of those individuals or their environment for research purposes (“intervention”).
§ Communication or interpersonal contact with the individuals ("interaction”).
4. Human Subject Under DHHS Regulations
· Will the investigator gather data that is either? If yes, which category(s) apply?
§ The data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place (i.e. “Private information”).
§ Individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will NOT be made public, such as a medical record (i.e. “Private information”).
· Can the individuals’ identities be readily ascertained or associated with the information by the investigator (i.e. “Identifiable information”)?
If all items under 1, 2, and 3 or 1, 2, and 4 as listed above are “yes,” then the activity is Human Research under DHHS regulations.
If the activity is Human Research under DHHS regulations, it is Human Research under organizational policy. This means that the research and this university is engaged in Human Research
Evaluation of Proposed Research for Scientific and Scholarly Validity
The University evaluates proposed research for scientific or scholarly validity.
· The [appropriate Dean or department chair assure scientific or scholarly review and oversee the conduct of human research in their department or school.
· Deans and Department Chairs affirm that each human research study proposed to be conducted in their department or school can be done responsibly by the study team using the resources described in the proposal.
· Scholarly or scientific review of proposed research addresses the following issues, at a minimum:
o Does the research use procedures consistent with sound research design?
o Is the research design sound enough to yield the expected knowledge?
The scientific review is documented and communicated to the IRB through the sign-off process and attestation. If the IRB has questions regarding the scientific or scholarly merit, process, etc. these are referred back to the reviewing Dean/Chair for further input.
In order to assess the risks and benefits of the proposed research, the IRB must determine that:
· The research uses procedures consistent with sound research design; and
· The research design is sound enough to reasonably expect the research to answer its proposed question.
In making this determination, the IRB may draw on its own knowledge and expertise, or the IRB may draw on the knowledge and expertise of others, such as reviews by a funding agency, or departmental review.
Policy
The CWRU IRB will be constituted and review research involving human subjects according to federal regulations. The CWRU IRB reviews research to ensure that study participants’ rights and welfare are adequately protected. Meetings of the IRB conform with federal regulations and guidelines for the review of research.
Full or Convened IRB Meetings
The CWRU IRB meets monthly unless there are no protocols for review. Protocols may be submitted to the IRB at any time; however, protocols that require review by the full board must usually be submitted to the IRB office at least 14 days before the next convened IRB meeting.
Initial Review: The IRB office receives all protocols via the electronic IRB submission system. Upon receipt, the full IRB is informed that there is a protocol or protocols eligible for full review has been electronically forwarded to IRB members for review. IRB members are also informed that said protocol(s) have been added to the meeting agenda. Primary and secondary reviewers are assigned in order to lead discussion for the upcoming full board meeting.
Every CWRU IRB member has access to the entire protocol application (investigator checklist and research plan), proposed informed consent and/or assent documents, recruitment materials, all other documents attached to the protocol (i.e., brochures, scripts, flyers, etc.), and federal grant applications (if applicable).
All IRB members are required to review the material in enough depth to be familiar with them and prepared to discuss them at the convened meeting as well as complete a reviewer checklist. During the fully convened IRB meeting, the IRB can make the following determinations for initial review:
● To initially approve the protocol
● To require the protocol’s investigators to submit changes/clarifications/confirmations for full review or for confirmatory review
● To table the protocol to be considered at a later convened IRB meeting
● To disapprove the protocol
Criteria for IRB Approval of Research
Initial Review Procedures: Except for research that is exempted or waived under 45 CFR 46.101(b) or 45 CFR 46.101(i), all non-biomedical human subject research conducted under the auspices of CWRU will be reviewed by the IRB. For the IRB to approve research it must determine that all of the following requirements are satisfied per 45 CFR 46.111:
● 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 subjects for diagnostic or treatment purposes.
● Risks are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result.
● Selection of subjects is equitable, taking into account the purposes of the research and the setting in which it is conducted.
● Informed consent will be sought from each prospective subject or the subject’s legally authorized representative in accordance with 45 CFR 46.116.
● Informed consent will be appropriately documented in accordance with 45 CFR 46.117.
● The research plan appropriately monitors the data collected to ensure safety of subjects.
● The subject’s privacy is appropriately protected and confidentiality of the subject’s data is maintained.
● Appropriate safeguards are included to protect the rights and welfare of subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, decisionally impaired, mentally disabled persons, or economically or educationally disadvantaged persons.
IRB Actions
For protocols requiring approval by the Full Board, the IRB will set conditions for the approval of research at a convened meeting. In cases where the convened IRB requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the IRB under HHS regulations at 45 CFR 46.111, IRB approval of the proposed research will be deferred or tabled, pending subsequent review by the convened IRB of responsive material.
Only when the convened IRB stipulates specific revisions requiring simple concurrence by the investigator and approves the study on the condition that the investigator concur, will the IRB Chair, Vice Chair, another IRB member or IRB staff, subsequently approve the revised research protocol on behalf of the IRB.
The IRB has established the following categories of actions to be taken on new protocols reviewed at a convened IRB meeting:
Approved: The protocol is approved as submitted with no changes. Approval is usually for one year; however, under certain circumstances (e.g., in high risk studies in which the risks and benefits of the approved research cannot be fully anticipated), the IRB may limit the approval interval to a shorter period of time (less than 12 months) and require that the research be reviewed after a specific number of subjects are enrolled/studied.
Modifications Needed to Secure Approval, Pending Expedited Review: The protocol is approved pending receipt and review of additional information, which can include minor clarification or modification of the checklist, protocol, consent form, or supporting materials. To qualify for this category, the requested changes must be clearly delineated and not require substantial changes to the protocol or consent form. Written notification of required modifications will be sent to the investigator. The investigator must provide a point-by-point response to all the issues raised by the Board. If a consent form is modified, the new consent form must be attached. The responses and requested modified documents will be reviewed by the Chair, Vice Chair or another IRB member or designee, on behalf of the IRB and, if appropriate, the approval will become effective.
Deferred or Tabled: A protocol is deferred when the changes proposed or questions raised by the Board are significant enough to warrant re-review of the protocol at a subsequent Board meeting.
The investigator will receive notification of the issues the IRB needs addressed or changed. If a protocol is deferred it means that it will be reconsidered by the IRB. In addition to deferring the protocol, the IRB may ask for additional review by expert consultants outside of the IRB.