Institutional Review Board Student Researcher’s Guide to the IRB

Student Researcher’s Guide to the IRB

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”?

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 (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 obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

 

IRB review is required only when a project meets the criteria for both research and human participant involvement. For example, a project that only analyzes data from publically available databases would not require oversight because there is no interaction with the individuals who data are being studied, and the information being studied is not private.

 

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.

 

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

  • Complete Protocol Application Form (with signatures of investigators, faculty advisors/sponsors, etc.)
  • Training certificates 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)
  • Debriefing statement

 

Training

All investigators and key personnel involved in the research (including faculty advisors/sponsors) are required to complete specific research ethic courses using the CITI 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 name and email address, 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.

  • Question 1 is the type of learner group based on your role and type of human subjects activities you will conduct. 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 learner group most appropriate (biomedical or social/behavioral research).
  • 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.
  • Question 3 is a selection for Responsible Conduct of Research. This information will be covered in your selection for question 1 so you will select “Not at this time.”
  • Question 4 is for research with animals, you should not check any option in this section.
  • Question 5 is for biosafety and biosecurity, you should not check any option in this section.

 

Completed training certificates must accompany the protocol application. Student certification is valid for one year from the date of completion.

 

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 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.

 

Most student projects that are exempt fall into one of two categories: (1.) A relatively small number will qualify for the “education” exemption (research conducted with children or adults in a classroom setting); (2.) many more will qualify for the “tests, surveys, interviews, or observations of public behavior” exemption (for adults only).

 

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 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.

 

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 see 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 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). If the project is approved for more than one year (unusual for student researchers), an interim report must be submitted on the one year anniversary of your approval date found at the top of the approval letter and a completion report 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 any report. For consequences regarding failure to submit reports by the due date, please refer to the Compliance Policy section of the Procedures document.