Guidelines for Submitting Research Protocols to Barry University Institutional Review Board
These guidelines comprise an overview of how and where to submit a research proposal for review by the Institutional Review Board (IRB). The Barry University document, Policy and Procedures for the Protection of Human Subjects in Research (see Faculty Handbook), provides in depth information concerning the principles, definitions, policies, and implementation procedures for the protection of human subjects, based on compliance with the U.S. Department of Health and Human Service's regulations.
- WHO should submit
- WHAT to Submit
- WHERE to Submit
- WHEN to Submit
- Decisions & Appeals
- Follow Up
- General Guidelines for Protocol Submission
(Appropriate forms can be downloaded)
- Consent of Subjects
WHO should submit
Any research involving human subjects which is conducted under the auspices of Barry University must meet the requirements of Barry University for the protection of human subjects. In some instances, compliance with the human subjects policies of the federal government and other agencies may be required. Accepting funds or utilizing subjects and/or other resources from an outside agency obligates the researcher to abide by the policies of that agency in addition to those of Barry University. This includes human subjects Protocols.
Research activities covered by this policy include the following:
- the research that is sponsored by this institution, or research that is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or in which he or she has authorization to list this institution as his or her university affiliation, or
- research that is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
- research that involves the use of his institution’s non-public information to identify or contact human research subjects or prospective subjects.
- excepted from this policy is research specified as exempt for 45 CFR 46.101.b and/or research conducted by students as exercises in courses designed to reach research methodology, provided that the research is not to be disseminated beyond that class, external funding is not involved, and the appropriate School or Department ensures human subject protection through its own internal review processes and informed consent procedures consistent with 45 CFR 46.
WHEN to submit
In order for your protocol to be reviewed during a particular month, your materials must be submitted no later than the first Friday of that month (see IRB homepage for dates). The above materials may be submitted in person or they may be sent through campus mail to the office of the Vice President for Academic Affairs. PROTOCOLS MUST BE RECEIVED NO LATER THAN 12:00 PM ON THE FIRST FRIDAY OF THE MONTH.
The IRB meets from 1:00 to 4:00 P.M. on the third Wednesday of most months of the year. Investigators are encouraged to attend the IRB meetings in order to clarify any particular aspect of their protocol.
Where to filewww.irbnet.org
Decisions and Appeals
Investigators will be notified in writing of the IRB's decision regarding any research protocol involving human subjects. The submitted protocol will be placed into one of the following categories based on the IRB's decision:
- Exempt. An exempt research protocol is that which falls under a category that is exempt from IRB review as described by the Code of Federal Regulations, Title 45, Part 46. (https://wayback.archive-it.org/) Such research includes several forms of educational research, anonymous or non-sensitive social survey involving adults, observational research involving adults, anonymous archival research, study of public records, and study of programs under the Social Security Act or other public benefits or social service programs. Note: It is the policy of Barry University that ALL research associated with Barry University be submitted for full IRB review. If a research protocol is deemed exempt during the full review, no further IRB action or annual review is required. If changes are made to the protocol, it is the responsibility of the investigator to contact the IRB chair who will determine whether the protocol remains in exempt status.
- Approved*. An approved research protocol is one that assures the protection of the
rights and safety of human subjects. Research may proceed once approval has been made by the IRB. It
is the responsibility of the investigator to submit an annual report to the IRB, and report any changes
made to the protocol, and report any injury or unanticipated problems involving risks that occurred
during the research.
* IRB approval of a protocol signifies approval only of the procedures for protecting the rights and safety of human subjects. Evaluation of other aspects of the research (e.g., subject matter, methodology, or experimental design) does not fall within the purview of the IRB.
- Accepted pending changes. A protocol will be accepted once the required changes are made to the protocol. A list of required changes will be sent to the investigator. The appropriate changes must be submitted to the IRB chair before approval can be given. Research cannot proceed until the required changes are met.
- Rejected. The IRB rejects a research protocol when: 1) risks to subjects are greater than minimal or are unreasonable relative to the benefits; 2) rights of the subjects are not protected; 3) subject selection is inequitable; 4) inappropriate consent forms or no consent forms are included; 5), inadequate provisions are made to protect the privacy of the subjects; 6) the protocol involves coercion of subjects; or 7) pertinent information necessary for review is missing. A rejected protocol may be resubmitted as a new protocol for full IRB review.
Any decision reached by the IRB may be appealed by the investigator. (See the Policy and Procedures for the Protection of Human Subjects in Research section in the Faculty Handbook.) If the investigator anticipates that objections may be raised about the protocol, the IRB chair may be consulted beforehand to prevent delays in the approval process.
Investigators are required to report to the IRB any adverse effects, additional risks, or injury to human subjects occurring during the course of the research. The IRB will conduct continuing review of ongoing research at least once a year.
General Guidelines for Protocol Submission
(Appropriate forms can be downloaded)
All proposals submitted to this committee must adhere to the following outline of information:
- Title of Project
- Principal Investigator(s) include School and Department, mailing address, email address and phone number. Principal investigator may be a student or faculty. ( If Barry student or faculty, include student number or faculty number.)
- Faculty Sponsor (If applicable). Include School and Department, mailing address, email address and phone number. Faculty member who supervises the research of a student assumes responsibility for accurate completion of the protocol and consent form, and for the annual report to the IRB.
- Funding Agency Name and address of funding agency, if funding is being solicited.
- Proposed Project Dates Projected dates of the beginning and completion of the proposed research. Please
allow time for approval when determining your start date. It is best if the end date you choose is one
year after the start date.
IMPORTANT NOTE: Do not begin the process of data collection until you have received formal approval by the IRB. Failure to do so may result in disapproval of the project in question.
- ABSTRACT (200 words or less)
In nontechnical terms, summarize the problem being addressed. State general goals as well as the specific aims of the study. Include the general methods to be used, with emphasis on sampling procedure and data collection.
- RECRUITMENT PROCEDURES
Explicitly describe how participants will be enlisted for your study. (If participants are patients in a hospital setting, they should be contacted by someone from that setting to ask if they would be willing to talk with you about being in your study. If you are a staff member in that setting, you may contact them directly.) If participants are potentially vulnerable to an undue influence, explain the safeguards you will take to protect their rights. (See the Policy and Procedures for the Protection of Human Subjects in Research section in the Faculty Handbook.) If using an advertisement to solicit participants, include the wording to be used in the ad.
Explicitly describe everything the participants will be asked to do so that the IRB can evaluate risk/stress. Do not refer the reader to an attached Methods section from a thesis. The IRB does not evaluate the appropriateness of the methodology except to determine the relative risks to participants and how it impacts completeness of the consent form in explaining risks and requirements.
- ALTERNATIVE PROCEDURES
Before the potential participant agrees to participate in the study, explain what other choices (for treatment, medication, exercise regime, etc.), if any, are available. Remember, an alternative to your study is that the potential participant may withhold participation.
Avoid exaggerating benefits in order to encourage participation. For example, if direct benefit to the subject is minimal or absent, use a general statement such as: "Although there may be no direct benefit to you, it is hoped that the research may help us learn more about the benefits of physical activity."
Give your appraisal of any risks that might be involved and how they will be minimized. Minimal risk means 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.
- ANONYMITY AND CONFIDENTIALITY
If the study is indeed intended to be anonymous, no names or other identifiers may be collected on any of the instruments used. You must include a cover letter (as opposed to a signed consent form) stating that the data will be completely anonymous, explaining that no names will be requested. Confidentiality (see below) is generally assured when the data are collected anonymously. If names are required for any purpose in the process of data collection, the study is not anonymous. You must, in this case, indicate how you will protect the participant's confidentiality. For example: "Data will be coded so that no names will be used. Findings of the study will be published using group averages. No one will be identified by name."
Policy concerning identifying links
In instances where identifiers linking research participants and their data exist, special efforts must be taken to keep such identifiers apart from the data in order to provide confidentiality of participants. To safeguard participant identities, researchers should separate signed consent forms from the data and store the consent forms, together with codes or other identifiers, in a locked file cabinet. It is imperative that the signed consent forms and codes or other identifiers not be located with stored data. Consent forms must be retained by investigators for a period of five years. If the investigator leaves Barry University prior to the end of the five years, consent forms must be kept at Barry University (NOTE: This statement does not address retention of data.). If participants will be audio- or videotaped, state what will happen to the tapes once the study is completed.
Consent of Participants
All participants in research should know the following:
- That they will be participating in research
- That their participation is voluntary
- Exactly what they will be asked to do
- How much time will be involved
- Approximate number of participants in the study
- That they may decline or discontinue participation at any time without negative consequences
- Any potential risks and what assistance will be provided in the event of injury
- How their confidentiality will be maintained when results are reported
- Who is conducting the study, and who will be available to answer questions about the study (faculty sponsor's name and number must be included)
- Fate of any audio- or videotapes used, following completion of the study
Verbal Consent/Cover Letter
If the proposed research entails no risk to the participant AND anonymity is intended, a signed consent form should NOT be used. You must instead include in your IRB application a cover letter for the participant to read. This must contain all the usual elements of a signed consent form (other than the issue of confidentiality), except for the signature line, and must be submitted in lieu of the standard written consent form.
Written and Signed Consent
To ensure that the consent form is complete, use the Consent Form Checklist. If you plan to enlist children 7-17 years of age, include both a parental consent form (the signature of one parent is required) and a children's assent form. If the participant is a minor child under age 7, only consent of the parent or legal guardian need be obtained. In the case of research involving FDA-regulated products, information that the FDA and the study sponsor may inspect records identifying participants must be clearly presented.
The consent form must be free of any exculpatory language through which the participant is made to waive any legal rights, including any release of the investigator, the sponsor, the institution, or its agents from liability for negligence.
The consent form must include a place for signatures of the participant and the primary investigator.
All records relating to the research must be retained for at least five years after completion of the data collection. All records (including consent forms), including audio- and videotapes that have not been destroyed and transcribed notes from recordings must remain accessible for IRB inspection.