Steps to get IRB Review
The IRB meets monthly to review proposals received during the previous month.
Now that you know that you need IRB review, you need to follow these steps to get your research project reviewed by the IRB.
Step 1: Complete the Mandatory Online Certification for Researchers
Mandatory online certification is required for all researchers or investigators submitting a proposal to the IRB.
You will be required to certify completion of training when you submit your proposal.
Step 2: Complete an application for human subjects research.
Complete the appropriate sections on the Research Project Form.
Step 3. Prepare an Informed Consent Document
Research activities involving human participants often require an informed consent given to participants. Informed consent should include the following information:
- The document describes, briefly and simply, what the research is about.
- It tells the subjects what they will be asked to do and for how long.
- It explains any risks and benefits. If there is no direct benefit to the subject, the document should explain what the study hopes to discover and why.
- If you promise to protect your subjects’ identity, you must describe how you will do this. If it is impossible for you or anyone else to link the data you collect to a specific person, then you may promise to guarantee your subjects’ anonymity. However, in most cases it will be possible to use your records to identify a subject. In that case, the most you can promise is to keep the subjects’ personal information private to the extent allowed by law.
- The document describes any compensation the subject will receive and conditions under which no payment or partial payment will be made.
- The document makes it clear that participation is voluntary.
- It tells subjects that they may skip questions or withdraw from the study at any point without penalty.
- It gives the subjects the names, addresses, and telephone numbers or e-mail addresses of persons to contact if they have questions or concerns about the study. The IRB asks that name, address, and telephone number or e-mail address be included for the investigator and his or her faculty advisor (if the investigator is a student).
- It tells subjects that if they have questions or concerns about their rights as a participant in the research study, they may also contact the IRB chair.
- It does not contain “exculpatory language.” Subjects must not be asked to waive (or appear to waive) any of their legal rights, nor may they be asked to release the investigator, any funding organization, or Bellevue College from liability for negligence. By signing the consent document, the subject is not “signing away” any rights. Their signature merely indicates that the subject has read the document or has had it read to him/her, has had a chance to discuss it with the investigator, and understands it.
Information in the consent document should be presented to prospective subjects “in a language they can understand.” The reading level of the consent form should match the reading level and background of the subjects. In some cases the document may need to be translated into another language. It is best to use simple declarative sentences and avoid abstract, academic words and phrases. It is best to construct the consent form using “you” rather than “I” because it may be unclear whether “I” refers to the investigator or to the subject. Use large print and wide margins for readability. Internal subheadings will always make the form more readable.
If the prospective subject uses a language that the investigator does not speak, it might be necessary to have a translator present who will go over the document point-by-point with the subject. If the prospective subject speaks English but does not read it, the investigator may be the one to go over the document orally with the subject.
The federal regulations emphasize that an investigator should get signed consent. If a subject is a minor (a person under age 18 in Washington, or below the age of majority in the state or country where s/he lives), the signed consent of a parent or legal guardian is required. Ordinarily the investigator should give one (signed) copy of the consent form for the subject to keep, and retain another (signed) copy with the project records.
In unusual circumstances, the IRB may waive some points that are usually covered in the consent document. In some cases the IRB may determine that your research is “exempt” under Federal Guidelines, which may mean that you will not need to employ a consent form. But it is in your interest to submit a consent form anyway to avoid unnecessary delays in reviewing your application.
Examples of consent forms:
- Research Study Assent Form Under 18 Years of Age
Form to provide information and acquire consent from research participants under 18. This form is to be used with the Research Student Parent Permission form.
- Research Study Consent Form
Form to provide information and acquire consent from research participants.
- Research Student Parent Permission Form
Form to provide information and acquire consent from research participants under age 18 through their parents or guardians. This form is to be used with the Research Study Assent form under 18 years of age.
- Elements of Informed Consent
Informed consent form must include these elements in sequential order and in language which the participants can understand.
Step 4: Submit Proposal Form
IRB, Office of Effectiveness and Strategic Planning
3000 Landerholm Circle SE Rm A202
Bellevue WA 98007-6484
Communications regarding proposals are conducted via e-mail.
Step 5: Maintain records and annually renew authorization if needed.
Once you receive word (via email or letter) that your project has been approved by the IRB or IRB Chair, you can proceed. If the project was not deemed exempt, then you will need to seek annual renewal for the duration of your project using the Annual Review Form.
It is important to note that if you want to make any changes to a study that has already been approved by the IRB, you need to notify the IRB using the Research Modification Form.
If, in the course of a study something negative happens to a subject then you must notify the IRB using the Adverse Incident Reporting Form. The IRB is then required by law to notify the Federal Office of Human Protection (OHRP) of the incident and what course of action was taken. Please note that this process must be followed regardless of the perceived seriousness of the incident, or whether or not you agree with the subject that something negative has occurred. If the subject reports an incident, then you must follow up with it.
You should keep all records related to the use of human subjects (signed informed consent forms, returned surveys, developed datasets) according to the college’s retention schedules.
Step 6: Submit a Close Out Form
Once you have finished gathering and analyzing data, you will need to submit a Research Closure Form to the IRB. This notifies the IRB that its oversight responsibilities are over. Exempt studies do not require submission of this form. Download the Closure Form.