Institutional Review Board policies

 

IRB POLICIES AND PROCEDURES:

1.       Take the Human Subjects Training. Keep your certificate on file so you can provide it if necessary. You must complete the NIH Human Subjects training online and submit a printed copy of your certificate the FIRST time you apply for IRB approval. After that it is kept on file.

2.       Most projects we conduct will qualify for exemption from review. If you are doing research related to children or some other vulnerable audience you will need to receive Expedited or Full review.

3.       Exemption requires roughly two weeks to process from the time it is submitted to IRB. It can take longer so plan ahead.

4.       Submit the following to the Institutional Review Board via email:

  1. Exemption form
  2. A brief description of the project. The description should explain what your methods are/what participants will be asked to do and in what format. How participants will be recruited? How will anonymity will be maintained? How will data be kept secure and how will it be reported? This description should really give IRB an idea as to what is required of participants and how they will be treated in terms of research ethics.
  3. A sample instrument
  4. Security of Data Agreement. A signed form is required for each investigator on the project. A new agreement form should be submitted with each new application.
  5. Copy of NIH Training Certification, for each investigator (if not previously submitted)
  6. Either a signed consent form or a script for soliciting a waiver of consent. Examples of consent forms can be found here.

 

No paper copies should be submitted. No more than three separate files should be submitted via email.

 

1.       Please do not submit applications directly to IRB. They must first be reviewed by the Manship Screening Committee Member.

2.       Applications submitted by 12:30 p.m. on Monday, will be reviewed by week’s end. Applications received after that time will be reviewed the following week.

3.       Applications expire three years from the date of approval. Continuation Applications should be submitted to the IRB Office no later than two months before the date of expiration. You must also resubmit any significant changes to your instrument.

4.       All documentation of consent must be maintained for at least 3 years after the completion of a project. This is true for student and graduate student work as well.

 

GUIDELINES FOR GETTING IRB FOR CLASS PROJECTS:

1.       Start early. If you know that you plan to conduct research at some point in the semester you should plan ahead and allow at least 2 weeks from the time you submit IRB Exemption forms to the time you plan to begin data collection.

2.       All students, teaching assistants and the instructor of record, must complete the NIH Human Subjects Training and sign a Security of Data Agreement form.

3.       Follow the same basic template for faculty exemption of research above.

  1.  In the brief description of the project, including a description of the methodology it may be helpful to include the following paragraph for undergraduate courses: “This project is being conducted as a class assignment for COURSE NUMBER AND TITLE. All students will be working under the supervision of the professor, INSERT NAME. None of the findings will be published nor is the data meant to produce generalizable knowledge.
  2. For graduate courses, the following statement has worked in previous years:

 

1.       Student researchers enrolled INSERT COURSE NUMBER AND TITLE will be responsible for recruiting participants and for collecting and analyzing the data. The student researchers will be responsible for obtaining informed consent.

 

GUIDELINES FOR GETTING IRB FOR STUDENT THESES/DISSERTATIONS/EXTERNSHIPS:

1.       While you may be the faculty advisor, it is the students’ responsibility to make sure they have gone through the IRB process. With this in mind, students should be listed as the primary investigator with faculty as the Co-PI. Security of data agreement forms should be submitted for both.

2.       Please review project descriptions and consent forms carefully so as to help speed the process along.

3.       Prior to graduation, students should submit project completion documentation to IRB.