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IRB Procedures

Institutional Review Board Procedures

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The High Point University Human Participants Institutional Review Board (IRB) safeguards the welfare and rights of human participants in research conducted by faculty, adjunct faculty, staff, and students.  The IRB has authority to review and approve, require appropriate modifications to, or disapprove human participant research in accordance with 45 Code of Federal Regulations, Part 46 and High Point University policy.  The University subscribes to the ethical principles of respect for persons, beneficence, and justice outlined in the Belmont Report and therefore elects to apply federal regulations to all of its human participant research regardless of source of support.

Federal regulations define “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” “Human participant” is defined as “a living individual about whom an investigator (whether professional or student) conducting the research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

Faculty Teaching vs. Research Related Activities

Some teaching-related activities are sufficiently research-related that they raise questions for faculty about what does or does not come under the province of the IRB. The following guidelines are based on the federal definition of research as “a systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.” As a general rule, if the activity results in public displays (e.g., Honors Day presentations, conference presentations) or publication (i.e., journals or books), the research is considered to contribute to generalizable knowledge.  Refer to Chart 1 for help.

Please note if the activity does not require IRB approval, the results cannot ever be used outside the class for which they were collected. In other words, the IRB cannot retroactively approve a study for future use.

If the activity does not require IRB approval, the faculty member should ensure risks to participants are minimized and reasonable in relation to anticipated benefits. In addition, identifying information from the participants should be kept private.

Application for Research Project Review

Every research project review shall begin with the submission by the investigator of a completed Application and Protocol Form, all required attachments, and a current certificate of education in the responsible treatment of human participants.

Length of Project

An investigator may request up to a three year term for the project. The IRB has the authority to determine the approval period based on the application. If a project is approved beyond a one-year limit, an annual continuing review form must be completed.

Exempt from Review

Federal guidelines and University policy permit certain types of research to proceed without IRB approval.  The determination whether any particular research project qualifies as “exempted” must be made by the Chair of the IRB usually after consultation with at least two members of the IRB.  Investigators do not have discretion to make this determination.  Investigators who believe their research projects should be classified as “exempted” must secure approval from the Chair of the IRB.  The following research activities normally fall under the exempt classification:

Research that is conducted in established or commonly accepted educational settings, involving normal educational practices (e.g., curricular changes, teaching styles).

Research that involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior, and the information taken from these sources is recorded in such a manner that the participants cannot be identified either directly or indirectly. (This category does not include personality tests.)

Research that is not exempt under above, but whose human participants are elected or appointed public officials or candidates for public office; or federal statue(s) require (s) without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.

Research that involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens.  These are from sources that are publicly available, or the information in them is recorded in such a manner that the participants cannot be identified either directly or indirectly.

Research that is designed to study, evaluate, or otherwise examine a public benefit or service program.

Research that involves taste and food quality evaluations or consumer acceptance studies in which only wholesome foods without additives are consumed; or if a food is consumed that contains an additive food ingredient or an agricultural chemical or environmental contaminant, these are at or below levels considered safe by the Food and Drug Administration, the Environmental Protection Agency, or the U.S. Department of Agriculture.
To apply for Exemption status, investigators must submit a completed Application and Protocol Form citing the reason for exempt status to the IRB office.  The IRB office will verify the completion of all applications and materials before forwarding them to the IRB Chairperson, or designated Committee Member, for review.  The IRB may approve, approve pending modifications, defer, or request that the study be reviewed through expedited procedures or by the Committee.  Request for exemption must be approved prior to initiation of the research or contacts with participants.  With exempt approval, the study is not subject to continuing review requirements.

Any changes made to the approved exempted research request must be submitted for review by the IRB prior to implementation.

Expedited Review

Expedited review does not mean “fast”; rather, certain research, that meets the specified criteria may be reviewed by the IRB Chairperson or designated Committee Member, not at a convened Committee meeting.  All expedited protocols must be reviewed by the IRB at least annually.  The IRB will provide expedited review for proposed research that presents no more than minimal risk to human participants and consists of:

Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).

Research employing survey, interview, oral history, focus group, program evaluation, human factors, or quality assurance methods.

Other research for which expedited review is authorized by the U.S. Department of Health and Human Services.

No expedited review shall be available if identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Investigators should remember that even though research may be eligible for expedited review it still remains subject to the requirements of informed consent.

Every expedited review shall be conducted by the IRB Chairperson, or by one or more experienced Committee Members designated by the Chairperson, in accordance with 45 CFR 46.

In reviewing the proposed research, the reviewers may exercise all of the authorities of the IRB, except that they may not disapprove the research.  A research activity may be disapproved only after the full IRB review.  Proposed research shall be deemed approved by the IRB when it is approved by the Chairperson and the designated Committee Member(s).  Investigators shall receive both an e-mail and hardcopy notification of approval, and faculty supervisors shall be promptly notified by e-mail.  No human participants may be enrolled or recruited prior to receipt of written final approval of the application from the IRB.

Expedited approval actions shall be summarized in writing by the Chairperson or the designated Committee Member.  These summaries shall be delivered to all IRB members prior to each IRB meeting (held monthly during the academic year), at which time any IRB member may request a full IRB review and reconsideration of any expedited review action.

Full Committee Review

The standard review requires one or more experienced primary reviewers, designated by the Chairperson to conduct an in-depth examination of the Application and Protocol Form, all required attachments submitted by the investigator, and any additional documents submitted by the investigator at the request of the primary reviewer(s).  These materials shall fully disclose any risks to participants or others and any risks of noncompliance.

The primary reviewer(s) shall then write memos to the IRB summarizing the proposed research and appraising the risks involved.  The memos shall contain a recommendation that the IRB approve the research, approve the research provided that certain modifications are made in the protocol or in the proposed informed consent process, or disapprove the research.

The reviewer memos, the Application and Protocol Form, the proposed informed consent document, and any other documents specified by the primary reviewer, shall then be submitted to all IRB members at least five business days prior to a regular monthly or specially scheduled IRB meeting.

At such an IRB meeting, at which a majority of the IRB members are present, (an IRB quorum), the IRB shall fully consider the proposed research and the recommendation of the primary reviewers.  Proposed research shall be approved by a majority vote of the IRB quorum.  Should the quorum fail during the meeting (e.g., loss of a majority through recusal of members with conflicting interests or early departures), the IRB shall not take further action or votes unless the quorum is restored.

The deliberation, action, and vote on each proposed research by the IRB quorum shall be recorded in the meeting minutes.  The recorded vote shall include the number of members voting for, against, and abstaining.

Proposed research shall be deemed approved by the IRB when it is approved by the IRB quorum.  Investigators shall receive both an e-mail and hardcopy notification of approval, and faculty supervisors shall be promptly notified by e-mail.  No human participants may be enrolled or recruited prior to receipt of written final approval of the application from the IRB.

Umbrella Review

As part of a research course (for example, PSY 311 or 312), students may conduct individual research projects involving human participants.  Due to the nature of the course and time constraints, the IRB will allow faculty teaching these courses to apply for an umbrella review that would describe the methods most likely to be used in the students’ research projects.  These methods may be based on past experience with students in these courses. The protocol can be submitted prior to beginning the course.  Protocols should be submitted each time the course is taught. Any student who designs a study that deviates from this umbrella protocol will be required to submit a separate and complete protocol for approval. Once the course is finished, investigators must submit a Continuing Review/Study Closure form.

If you would like to view examples of these types of protocol applications, please select one of the links below:

Example umbrella protocol application #1

Example umbrella protocol application #2

Continuing Review

Except those approved by the IRB as exempt, Federal regulations require periodic review of all research involving human participants at an interval appropriate to the level of risk, but not less than annually.  A continuing review shall be performed once a year by the IRB for every ongoing human participant research project.  A continuing review for a project eligible for expedited review shall be conducted by expedited review, in the same fashion as the initial review.

The IRB shall determine if any human participant research project that will continue for more than one year requires a continuing review more often than annually.  Such a project shall be scheduled for more frequent reviews in accordance with a schedule that the IRB determines to be appropriate for that particular project.  In the course of each continuing review, the IRB shall consider whether the project requires verification from other sources other than the researcher that no material changes have occurred since prior IRB review.

The IRB must review each research project under the same approval criteria as the initial review (see HPU IRB Policy, page two):

  •  Risks to participants are minimized…
  •  Risks to participants are reasonable in relation to anticipated benefits…
  •  Selection of participants is equitable.
  •  Informed consent will be sought…
  •  Informed consent will be appropriately documented…
  •  When appropriate…adequate provision for monitoring the data…
  •  When appropriate…adequate provisions to protect the privacy and confidentiality…

Investigators must submit a Continuing Review Form one month prior to the expiration of their approval.  If the project is completed prior to the annual review, this form will serve as the notification for the IRB.

Based on its review, the IRB may require that the research be restricted, modified, or halted.  Alternatively, special precautions or IRB imposed restrictions may be relaxed.

Protocol Amendments/Alterations

Each revision to a research protocol shall be incorporated into the written protocol, to assure that there is only one complete protocol, with revision dates noted on each revised page and on the first page of the protocol itself.

IRB project approvals shall advise investigators that any proposed material changes in research activity must be promptly reported to the IRB and that such changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to participants.

IRB project approvals shall also advise investigators that they should report promptly to the IRB any unanticipated or undisclosed problems involving risks to participants or others, or any serious or continuing noncompliance with the protocol or with the requirements or determinations of the IRB.
The IRB has the authority to suspend or terminate approval of research that has been associated with noncompliance to Federal regulations, ethical principles outlined by the Belmont Report, University policy, or unexpected serious harm to participants or others.  When the IRB takes such action, it is required to provide a statement of reasons for the action and to promptly report this action to the Investigator and the Vice President for Academic Affairs.

Conflict of Interest

No IRB member shall participate in the IRB’s initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB.  Unless requested by the IRB to be present to provide information, IRB members with conflicting interests must be absent themselves from the meeting room when the IRB reviews research in which they have conflicting interests.  Their absence shall be reported in IRB meeting minutes.

Reporting

The IRB Chairperson shall ensure prompt reporting, within 30 days, to the IRB, appropriate University officials, the Office for Human Research Protections of the U.S. Department of Health and Human Services and any other appropriate entities of any unanticipated problems involving risk to participants or others, or any serious or continuing noncompliance with 45 CFR, Part 46, or the requirements or determinations of the IRB, or any suspension or termination of IRB approval.

IRB Composition

The IRB must have at least five members, with varying backgrounds and professional competence to promote complete and adequate review of research commonly conducted under the auspices of the University.  The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants.  The Chairperson and board members shall be appointed annually by the Vice President for Academic Affairs.  The Chairperson may designate another committee member to conduct necessary business in their absence.  The IRB must not consist entirely of men or women; at least one member shall be primarily concerned in a scientific area and at least one member shall be primarily concerned in a nonscientific area; and at least one member shall be unaffiliated in any way with the University.  The IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB.  These individuals may not vote.  No IRB member may participate in the review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

Timetable

The IRB meets monthly during the academic year (September through May) and as needed during the summer months of June, July, and August.  Other meetings may be called at the discretion of the Chairperson.

Training

The Office for Human Research Protections (OHRP) requires that all members of the University’s Human Participants Institutional Review Board and any individual conducting and/or supervising federally-funded research involving human participants complete a program of instruction on the responsible treatment of human participants.  All Investigators, Students, and Faculty Advisors who are conducting human participants research are required to complete the National Institutes of Health (NIH) on-line training course prior to submitting a research application protocol.  In addition, all Investigators, Key Study Personnel, Students, and Faculty Advisors must maintain a current education certificate on file with the IRB office. Certificates for all Investigators and Faculty Advisors are considered valid for three years. Certificates for Students must be renewed annually.

NIH On-Line Course

Records of the IRB

IRB records shall be retained for at least three years, and records relating to conducted research shall be retained for at least three years after completion of the research.  All records shall be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services at reasonable times and in a reasonable manner.

Informed Consent

The Belmont Report provides Investigators with basic ethical principles for conducting research.  The principle of “respect for persons” incorporates two ethical convictions.  First, individuals should be treated as autonomous agents; and second, persons with diminished autonomy are entitled to protection.

An autonomous individual is capable of establishing personal goals and completing actions toward those goals.  Others may respect an individual’s autonomy by taking into consideration an individual’s opinions and choices while refraining from obstructing those actions unless the actions are harmful to self or others.  In regards to research participation, respect for autonomy is addressed by giving an individual a choice to enter research voluntarily after being presented with adequate information.  This is the premise of informed consent.

For individuals who may have diminished autonomy as a consequence of age, maturity, or psychological state, Investigators must assure that additional protections are in place (e.g., permission from legally authorized representative). The Federal regulations provide additional guidance on including participants with diminished autonomy (e.g., children, cognitively impaired).

Informed consent is a process whose goal is to respect the research participant’s dignity. The process does this by attending to the participant’s right to deliberate and to make a knowing decision whether to cooperate with the Investigator’s research interest. High Point University requires that every researcher (faculty, staff, or student) secure the informed consent of any human participant used in research before involving that participant in the research project (except under very specific conditions, see next section on Waivers of Informed Consent). Every potential participant who is a physically and mentally able adult must provide consent to participate in the research prior to the initiation of the actual research. Federal regulations define an adult as anyone at least 18 years old. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. If a person varies from this norm due to age or disability, special safeguards, described later, are required.

Researchers must ensure that the circumstances under which consent is sought will provide the participants (or their representatives) with sufficient opportunity to consider whether or not to participate in the proposed research. The circumstances must minimize the possibility that the participants will experience coercion or undue influence. The situation of the participants may, in certain cases, be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, age, associations with others, place of residence (prisons, mental hospitals) and mental or physical capacities. Participants in these categories need not be excluded from research; rather, researchers must make a special effort to ensure that potential participants are given every opportunity to exercise free choice in consenting to participate in a research project.

The informed consent document communicates to the prospective research participant the purpose, procedures, risks and benefits of the study; the participant’s rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the participant to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the participant and the researcher.  For elements of Informed Consent, see the Checklist on the last page of the Application and Protocol Form.

A copy of the Informed Consent must be given to each participant.

Obtaining Assent

If the participant is a minor, an assent form must be signed by those participants capable of reading and understanding a simplified version of the consent form to be signed by the parent or guardian. A copy of this assent form must accompany the protocol. For participants too young to read, but who are capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the protocol. The age, maturity, and psychological state of the participants must be taken into account by the researcher when creating an assent form or an oral presentation to obtain assent from minors.

Adolescent’s Written Assent: For junior high or middle school aged children, a child’s written assent is needed (in addition to parental or guardian consent), because children in this age group usually can read and comprehend a well constructed assent form (see sample). The researcher should use supplementary verbal explanations as needed.

Child’s Assent: For elementary school age children, the researcher should obtain, in addition to parental or guardian consent, the child’s assent to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question/answer setting is often the most useful form of communication. If the child is old enough to provide a signature, student researchers are required to obtain a signed assent.

Very Young Children: Researchers should give explanations that match the level of understanding for children below school age (infants, toddlers, preschoolers). In many instances, the child’s nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure. A verbal script must be submitted as part of the protocol as well as a written consent form to be signed by parents or guardians.

Parental Consent: All research participants under the age of 18 must provide written parental (or guardian) consent in order to participate in University-sponsored research projects.

Special Populations: Besides children, numerous other types of participants require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential participant. Federal regulations consider prisoners, the mentally disabled, and pregnant women to be “special populations,” and as such, are entitled to extra protection under the law. Other groups, such as racial minorities, the elderly, substance abusers, the economically disadvantaged, the very sick and the institutionalized are described as “vulnerable populations” and are extended similar protection when used as research participants. Researchers wishing to use these populations as research participants must contact the IRB Chair prior to protocol submission in order to determine what, if any, additional restrictions may be imposed in order to assure the protection of participants falling in the special/ vulnerable populations category.

Waivers of Written (not Oral) Informed Consent

There are two types of waivers or alterations to informed consent to consider when making a request to the IRB.

Process Waiver

Under this approval, the Investigator would not obtain informed consent from the participant.  There would not be an informed consent document reviewed and approved by the IRB.  However, research must meet certain conditions to be granted waiver.

1. Waiver for Research Activities Designed to Study Certain Aspects of Public Benefit or Service Programs.  The IRB may approve a consent procedure which does not include, or which alters, some of all of the elements of informed consent or waive the requirements to obtain informed consent entirely provided the IRB finds and documents that:

  • the research or demonstration project is to be conducted by or subject to the approval of State or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternative to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
  • the research could not practically be carried out without the waiver or alteration.

2. Waiver for Minimal Risk Studies. Additionally, the IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent entirely provided the IRB finds and documents that:

  • the research involves no more than minimal risk to the participants.
  • the waiver or alteration will not adversely affect the rights and welfare of the participants.
  • the research could not practically be carried out without the waiver or alteration.
  • whenever appropriate, the participants will be provided with additional pertinent information after participation.

Documentation Waiver

Under this approval, informed consent is obtained.  However, the requirement to obtain a signature from the participant is waived.  These circumstances are very limited.  The IRB must find either:

1. That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
2. That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

Waiver of written consent procedures does not imply waiver of the researcher’s responsibility to obtain consent from the participant.  In all cases, the researcher must provide the participant with a statement describing the research that includes all relevant elements of informed consent. The IRB requires that when the use of written informed consent is waived, a cover letter be given to the participants outlining the purpose and procedures of the project.

Oral Consent

If oral consent is necessary (e.g. due to limited literacy) the participant or their legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. The IRB may require that a witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The participant or their legal representative must receive a copy of both signed documents.

You may direct any questions to the chair of the IRB, Dr. Kimberly Wear (841-9246, kwear@highpoint.edu).

 

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