Mission Statement

Friends Research Institute Institutional Review Board (IRB) fosters a research environment that promotes protecting the safety, rights, and welfare of individuals recruited for or participating in research conducted by Friends Research Institute.
Business Meeting
The IRB strives:

  • To promote ethical use of human subjects in research and to facilitate human subjects research by providing guidance and education to FRI investigators, research officials and IRB members;
  • To assure the protection of research participants’ rights, safety, and welfare; and
  • To ensure compliance with regulatory and ethical obligations concerning human subjects research.

IRB Website and Resources:  To learn more about the IRB and how to submit a study for review, please use the side menu to the left.  All of the forms needed for submission and maintenance of a study protocol can be downloaded from “Forms/Templates.”  If you have questions regarding the information on this site, refer to “Contacts.”

Friends Research Institute IRB operates under the Federal Wide Assurance, FWA 00002948, issued by the Office for Human Research Protections (OHRP).

Full Board Review

In reviewing research protocols involving human participants, an Institutional Review Board (IRB) can employ one of three types of review procedures, including exempt, expedited, or full board review, in compliance with the Department of Health and Human Services (DHHS) regulations for the protection of human participants.  Research that involves prisoners, is more than minimal risk, or is not covered by the expedited review or exempt categories will require full board review.

At FRI, full IRB review is required for most new studies to ensure a thorough review and to provide the greatest protection to our research participants. It is also required for most continuing reviews as well as for many amendments.

The IRB will conduct a systematic review of the submitted material, discussing the risk/benefit analysis, informed consent, selection of subjects, privacy and confidentiality, monitoring and observation, additional safeguards, recruitment methods, methodology, and the purpose and background of the protocol.  Once the risks have been identified, the IRB will assess whether the research presents greater than minimal risk, and the timeframe for continuing review.  Typically, the IRB will review a minimal risk study once a year and a greater than minimal risk study every six months.

To apply for full board review, the investigator must submit a complete application, including supporting documentation such as:

  • Protocol;
  • Consent forms;
  • Recruitment materials;
  • Surveys or interview questions;
  • Letters of agreement or other supporting documents to assure the IRB that appropriate coordination has been done with the outside organization or facility that will be used as a research site;
  • Supplemental applications, if the research involves a vulnerable population.

In a full board review, the IRB can vote to approve, approve with contingencies, disapprove, or defer a review until another meeting.

Materials should be submitted to the IRB office approximately 3-4 weeks prior to the next IRB meeting.

Expedited Review

Expedited review is for research activities that involve no more than minimal risk to human subjects and fall into designated categories. The Code of Federal Regulations [45 CFR 46.102(l)] defines minimal risk as meaning that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

Examples of research that may be reviewed by expedited review include (but are not limited to):

  • The collection of data through non-invasive procedures.
  • Research on individual or group behavior characteristics.
  • The collection of data from voice, video, or imaging recording made for research purposes.
  • Minor changes in previously approved research during the approval period.
  • Continuing review in certain circumstances.

In an expedited review, the standard requirements for informed consent and continuing review still apply.  The reviewer, who is either the IRB Chairperson or his/her designee, may exercise all of the authorities of the IRB except that s/he may not disapprove the research; ‘proposed disapprovals’ will be referred to the full board for review and disposition.  Additionally, the full IRB must be notified of all protocols approved using the expedited review process, and thus the full IRB has the authority to question any approval granted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.  In addition, the expedited review procedure may not be used for classified research involving human subjects or for research involving prisoners, as noted below.

To apply for an expedited review, the investigator must submit a complete application, including supporting documentation such as:

  • Protocol;
  • Consent forms;
  • Recruitment materials;
  • Surveys or interview questions;
  • Application for Expedited Review;
  • Supplemental applications, if the research involves a vulnerable population.

Expedited review applications are accepted whenever an investigator submits them and are reviewed outside of the regular IRB meeting time.

Research Involving Prisoners

Expedited Review will not be conducted for the initial review of research involving prisoners.

Expedited Review will not be conducted for continuing review unless the following conditions exist:

  • Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
  • Where no subjects have been enrolled and no additional risks have been identified; or
  • Where the remaining research activities are limited to data analysis.

Exempt from IRB Review

In order for a study to qualify for exempt review, the study must fall into one of six categories defined in the federal regulations (45 CFR 46.101).  These categories represent studies that present minimal risk to participants. Although the category is called “exempt,” at FRI the determination of exemption must be made by the IRB Chairperson or his/her designee.

If the project is found to be exempt, it will not need to follow continuing review procedures and the other requirements of 45 CFR 46 unless significant changes are made to the research protocol.  Research involving vulnerable participant populations, as well as survey research involving children, is not exempt from federal regulations

Some examples of exempt level research are:

  • Anonymous surveys;
  • Interviews of adults about non-sensitive topics;
  • Educational tests;
  • Observation of public behavior.

To apply for an exempt review, the investigator must submit a complete application for exemption, including supporting documentation, as applicable:

  • Protocol;
  • Consent form, information sheet;
  • Recruitment materials;
  • Surveys or interview questions;
  • Application for Exemption from IRB Review.

Exempt review applications are accepted whenever an investigator submits them and are reviewed outside of the regular IRB meeting time.

Additional Regulatory Protections for Children and Prisoners

Federal regulations allow for additional protections for vulnerable populations.  The categories of research that can NOT be exempt are as follows:

  • Research involving prisoners;
  • Research involving survey or interview of children;
  • Research involving the observation of public behavior of children, unless the investigators do not participate in the activities being observed.

IRB Fees

Generally, fees are not charged for IRB review, as the fees are included as part of FRI’s indirect fees.  However, Principal Investigators who are not employed by FRI or do not submit grants through FRI, and choose to use FRI IRB reviewing services will be charged based upon the following fee schedule:

Full IRB Review
Initial Review of Protocol:  $2,000
Continuing Review:  $700
Amendment:  $500

Expedited Review
Initial Review of Protocol:  $1,100
Continuing Review:  $400
Amendment:  $400