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Institutional Review Board

Student Researcher’s Guide to the IRB

REVISED FORMS AVAILABLE RIGHT SIDE BAR (PDF NOT CURRENTLY AVAILABLE)

REVISIONS TO FEDERAL REGULATIONS (COMMON RULE) IMPLEMENTATION BEGINS JANUARY 21, 2019

 

This guide was designed to introduce students to the High Point University Institutional Review Board. It contains basic information relevant to most student research projects that involve human participants. Please keep in mind this is a summary; more detailed information can be found in the IRB Procedures.

What is an “IRB”?
How do I know whether my project requires IRB review and approval?
What is required for IRB Submission?
What kind of review is required for my study?
How do I determine whether my study falls into the “Exempt” or the “Expedited” review category?
What happens after I have submitted my Protocol Application?
What happens after I receive approval from the IRB?


What is an “IRB”?

Institutional Review Boards (IRBs) have been established by the federal government to protect the rights and welfare of human participants in research activities. The IRB ensures that physical, psychological, and social risks to research participants are minimized, and that the risks associated with the research are commensurate with the importance of the research and/or the knowledge to be gained. Consistent with the ethical principles of The Belmont Report, the IRB also ensures that research participants receive accurate, complete information about the nature of the research and any associated risks, as well as their rights as research participants. In addition, the IRB reviews human research activities to ensure that the University, affiliate institutions, and investigators are compliant with the ethical standards and the regulations governing human participant research. These regulations are summarized in the Code of Federal Regulations (referred to as The Final Rule; 45 CFR 46) from the U.S. Department of Health and Human Services and from the Food and Drug Administration (21 CFR 50 and 21 CFR 56).


How do I know whether my project requires IRB review and approval?

High Point University IRB reviews all projects that meet two criteria: (1.) The project must be “research”, and (2.) the project must include “human participants”.

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 (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generated identifiable private information or identifiable biospecimens.”

Many classroom projects that are designed solely to instruct students about research methods and data collection procedures would not require IRB review because they would not result in generalizable knowledge. However, such projects should be supervised by a faculty member and should follow some basic procedures such as the development of an “introductory script” to inform anyone who participates that this is a student project and that they are not obligated to participate.

If you have questions as to whether a project requires IRB review, please contact the IRB Chair, Dr. Kimberly Wear (kwear@highpoint.edu).


What is required for IRB Submission?

Students are encouraged to serve as Principal Investigators for research projects. However, all student projects must be supervised by a faculty member. Faculty supervisors must review and sign all applications.

All materials are submitted electronically to the IRB Chair, Dr. Kimberly Wear (kwear@highpoint.edu). Forms can be found to the right on this website. A complete application should include:

  • Complete Protocol Application Form (with signatures of investigators, faculty advisors/sponsors, etc.)
  • Completion reports for CITI training for all investigators, faculty advisors/sponsors, and key personnel (i.e., research assistants).
  • Informed consent form
  • Recruiting materials (i.e., scripts, flyers, letters)
  • Research instruments (i.e., surveys, questionnaires, interview questions) and materials (i.e., images, word lists)

 

Training

All investigators and key personnel involved in the research (including faculty advisors/sponsors) are required to complete specific research ethic courses using the Collaborative Institutional Training Initiative Program (CITI) on-line training program. The courses are designed for four basic user groups: biomedical researcher (includes health science), social and behavioral researcher, IRB member, and student researcher. The training can be found at https://www.citiprogram.org/.

You will first have to register with CITI. You will be required to select a participating university (HPU), provide your name and email address (you will need to enter your name as you would like it to appear on your completion report), create a username and password, and provide some information requested by the university. Once you have received an email of confirmation from CITI, you can log in. You will be asked several questions about the type of training you need to complete. Those in red and bold below are the required courses for all personnel.

      • Question 1 (Basic Human Subjects Research Course). Your response to this question selects the course based on the type of human subjects activities involved in your research and the role you will have in that research. Most students will select “Students conducting no more than minimal risk research.” If you are involved in more than minimal risk research, you will need to select the most appropriate type of research (biomedical or social/behavioral research). Only members of the IRB Committee would select that group (no students are members of the committee).
      • Question 2 is the Good Clinical Practice course. Most students will select “Not at this time.” If you are involved with research that involves medical devices or investigational drugs, then you will need to select the appropriate course. Your faculty supervisor can aid you in this choice.
      • Question 3 (Responsible Conduct of Research (RCR) Course). Select the appropriate research area (typically either biomedical or social and behavioral).
      • Question 4 is for research with animals, you should not check any option in this section.
      • Question 5 is for biosafety and biosecurity. This is only necessary for some protocols. Your faculty supervisor will tell you if your protocol would require any courses and which would be most appropriate.
      • Question 6 Information Privacy Security (IPS) Course. Select IPS for Students and Instructors.
      • Question 7. Choose yes only if you are an HPU Pharmacy Student.
      • Question 8. Choose yes only if you are an HPU Physician Assistant Student.
      • Question 9. Choose yes only if you are an HPU Athletic Training Student.
      • Question 10. Choose yes for Conflicts of Interest (COI).

Each of the modules below have a quiz associated with the. Students must pass each module quiz with at least an 80% score, which is considered passing by CITI. Completed training certificates must accompany the protocol application and should include at least the Belmont Report/CITI Course Introduction and Students in Research modules. Therefore, it suggested that students print the completion report and keep of copy for record purposes. Student certification is valid for one year from the date of completion.

Renewing Training

Although your CITI training certificate may state a 3-year expiration, this is not true for students attending High Point University. Students must renew annually. Follow the instructions below to renew your certification.

  •  Log into your CITI account.
  • From the Main Menu, select the course on the left side that needs to be renewed.
  • The new page will have the completed course modules listed individually.  Select a module that needs to be renewed.
  • At the bottom of the module page, select the link to take the quiz for that particular module.
  • Once you have taken the quiz and passed, the date on the completed course page will update.
  • Repeat this for all modules required.
  • Submit the Completion Report (not the Completion Certificate) which shows your name and the renewed dates and score to the IRB.

Adding a Training Course

If you have a current training but need to add a new course (i.e., RCR or IPS), log into your CITI account. At the bottom of the page, select Add a Course or Update Learner Groups. Change your responses to the questions to add courses. For example, to add the IPS course, select IPS for Students and Instructors in question 6. Once you submit your new responses, the courses will appear in your course list. Complete the course and submit the training certificate to the IRB.


What kind of review is required for my study?

High Point University’s IRB makes a distinction between three types of reviews. Minimal risk studies that meet certain requirements can be reviewed through an “Exempt” or “Expedited” review process. Most student projects will fall into one of these two categories. Studies that are considered more than minimal risk require a “Full Board Review”, in which a committee evaluates the project during a monthly meeting and makes a determination s to whether participants are adequately protected from research risks.


How do I determine whether my study falls into the “Exempt” or the “Expedited” review category?

Exempt (Level 1)

Federal guidelines and University policy permit certain types of research to proceed without IRB approval.  The determination of whether or not any particular research project qualifies as “exempted” must be made by the Chair of the IRB usually after consultation with at least one member 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 written approval from the Chair of the IRB.  The following research activities normally fall under the exempt classification:

      • Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      • Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
        • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily be ascertained, directly or through identifiers linked to the subjects;
        • Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
        • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
      • Research involving benign behavioral interventions* in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
        • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily be ascertained, directly or through identifiers linked to the subjects;
        • Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
        • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
        • *benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (deceiving the subjects may not be used in this category)
      • Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
        • The identifiable private information or identifiable biospecimens are publicly available;
        • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
        • The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CRF 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
        • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et. seq.
        • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et. seq.
      • Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
        • Each Federal department of agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
      • Taste and food quality evaluation and consumer acceptance studies
        • If wholesome foods without additives are consumed, or
        • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
      • Storage or maintenance for secondary research for which broad consent* is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
      • Secondary research for which broad consent* is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
        • Broad consent* for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtain in accordance with §46.116(a)(1) through (4), (a)(6), and (d);
        • Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
        • An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
        • The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

*Broad Consent not currently adopted by HPU IRB

Expedited (Level 2)

Expedited review does not mean “fast”; rather, certain research that meets the specified criteria may be reviewed by the IRB Chairperson and/or designated Committee Member, not at a convened Committee meeting. The IRB will provide expedited review for proposed research activities that (1) present no more than minimal risk to human participants (what could be expected during daily life activities), and (2) involve only procedures listed in one or more of the expedited categories listed in the IRB Procedures document as authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included. Inclusion on this list merely means that the activity is eligible for review through an expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human participants.

Please note that a project cannot be expedited if identification of the participants and/or their responses would reasonably place them at risk for criminal or civil liability or would be damaging to their financial standing, employability, insurability, or reputation, or would be stigmatizing. Thus, whenever this type of sensitive information is to be collected, the researcher must ensure that reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

All expedited studies require signed informed consent from each participant, unless the IRB has granted a waiver. Even if a waiver of written, signed consent is granted, the informed consent information must still be presented to the participants.

Informed Consent Process

All investigators have an ethical responsibility to obtain a research participant’s voluntary consent to participate in a study. For studies that do not fall into one of the exempt categories, this process is facilitated by using a written consent form which must be reviewed by the potential research participant and then signed. Research activity cannot begin until the participant’s written informed consent is obtained.

 According to the Federal Regulations, a consent form must include specific elements. 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.  Please use examples posted on the IRB website.

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


What happens after I have submitted my Protocol Application?

The IRB Chair screens all protocol applications for completeness. If you are applying for exemption from further IRB review, the IRB Chair will review the protocol application. If you are applying for expedited review, two members of the IRB will review the protocol application and provide a written review to the IRB Chair. At this time, you may receive written notification of approval, request for more information, or request for changes that are required. The process takes approximately 2-3 weeks (may depend on the amount of information requested from investigator).


What happens after I receive approval from the IRB?

Protocols vary in length of approval (from 3 months to 3 years). If the project is approved for one year or less, a completion report must be submitted by the date of expiration (stated in the approval letter). Students and their faculty advisor/sponsor will receive email notification one month prior to the due date of their completion report. For consequences regarding failure to submit reports by the due date, please refer to the Compliance Policy section of the Procedures document.

Contact Us

Chair of the IRB: Dr. Kimberly Wear

kwear@highpoint.edu
(336) 841-9246

Forms

Complete each section of the appropriate form (no handwritten forms). Email the form and any supporting documentation necessary to kwear@highpoint.edu. Signatures should be scanned and included as part of the electronic submission if possible.

The PDF versions of these forms are best viewed with Internet Explorer. If the content in the form does not load, please save the file to your computer and open it with Adobe Reader.

Consent Templates