Misc. Issues including FERPA and A/V Guidance (Section 6)

6.1 What is FERPA and does it apply to research?

• The Federal Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of student records, both financial and academic. FERPA laws apply to research projects.
• The Registrar's Office is responsible for KSU records. FERPA protected records being obtained from a non-KSU source must adhere to that site's requirements - we recommend getting site approval.  
• Student records are not to be retained and used for purposes other than what they've been approved and should be deidentified at the earliest time allowed by the research; this includes use of student email addresses. 
• If you will be using FERPA protected information as part of your study, we recommend working with FERPA officers in advance of submitting your IRB application. 
• KSU records are to be obtained from the Registrar even when the researcher has legitimate access such records; this helps ensure the same rules are equally applied. One exception is obtaining individual course records, such as course grades or assignment grades, with student consent and when instructors agree to provide data. 
  • It is also important that you are obtaining a verifiable signature when conducting consent; signed consent sent is preferred. Other methods of verification may be considered during the course of IRB review.  
  • The data request form is to be used to obtain records from the Registrar. 
• When requesting data or developing a consent form it is important to use the correct data terminology. For example, "GPA" stated alone could mean many things - GPA within major, term GPA, overall GPA - and your request may get denied for being too broad. 
• When using KSU email lists, do not send more than the minimum number of emails necessary to achieve your N. For example, if 100 participants are needed and you expect a 10% response rate, no more than 1,000 recruitment emails should be sent. If response rate is lower than exepcted, other simialryl sized waves of recruitement emails may be used. 

6.2 Should I submit an amendment or a new application?

• The general rule is that if you change any two of the three Ps (purpose, population, procedure) with one amendment request you need to submit a new application. If you change any two of the three over multiple amendment requests or if you are unsure if you need to submit a new application or an amendment, please contact the Office of Research Compliance.

6.3 Amendments

• All amendments to currently approved human subjects research studies must be approved by the IRB prior to implementation except those that are made to avoid apparent immediate harms.
• If a change needs to be made to eliminate apparent immediate harms to a subject or group of subjects the researcher must make the necessary change(s) to protect the safety, wellbeing, and welfare of the subjects and may do so without prior IRB review. Any such changes must be reported to the IRB as soon as is reasonably possible.
• The criteria for reviewing amendments are the same as initial review criteria.
• Major amendments to full board projects must be reviewed by the full board. Minor amendments to full board projects can typically be reviewed through an expedited process.
• Changes that increase the initial level of approval will need to be re-reviewed through the appropriate expedited or full board process. The IRB will need to understand the status of currently enrolled subjects and whether they will be contacted to complete the new or revised procedure(s). Example, if blood draws are added to a study that was exempted under the benign behavioral interventions category, that study can no longer be considered exempt and will need to be reviewed through an expedited or full board process; blood draws are not considered benign behavioral interventions.
• When amending a project it is important to consider how the change affects other parts of the project – it is not uncommon for the IRB to request revised recruitment and consent materials that were not included with the initial submission.

6.4 Does Title IX apply to research?

• Yes, you must follow KSU Title IX policy.