Health Sciences IRB
FAQ: Other
Note: If you would like additional questions/answers on this page, please submit questions to the HSIRB office at irb@missouri.edu or by calling (573) 882-3181.
About the IRB
- What is the IRB?
- What is research?
- Do I need IRB approval?
- How do I create an account?
- I have an account and want to start a research project, what is the next step?
- How long does it take for an exempt study to be reviewed?
- How long does it take for an expedited study to be reviewed?
- How long does it take for a full-board study to be reviewed?
About IRB Applications
- How do I know if my study is exempt?
- How do I know if my study can be expedited?
- Should I fill out the medical or the behavioral application?
- I want to create a database, which application should I complete?
- I would like to do a case review/report. What do I need to do?
- How do I know what type of consent to use?
- Do I need a protocol? What should I include?
- Do I need a HIPAA form?
- How do I know which HIPAA to choose?
- I submitted my application and want to make changes but it won"t open.
- When can I start enrolling subjects?
- How do I know when I have approval?
- How long is the approval good for?
Amendments
- I have an approved study but would like to change something. Do I need to do anything?
- I started an amendment but I can not find it.
- My sponsor has sent an amendment. How long do I have before I need to submit it?
- There is a new risk. Should I contact participants right away?
- I want to increase the enrollment- do I need to change any supporting documents?
Continuing Review (CRR)
- How will I know when to complete a continuing review?
- I want to create a CRR but the computer won"t let me.
- I want to change my study; can I do this on the CRR?
Adverse Events/Deviations/and Unanticipated Problems
- What is an unexpected (adverse) event and do I need to report this?
- I did something different than what the approved protocol states. Should I report this?
- Do I need to track events that are not reportable?
- My sponsor wants me to report an offsite event that doesn"t meet criteria.
- Is there a time frame for submitting reportable events?
Informed Consent
- I would like to enroll people under the age of 18. Do I need to do anything special?
- Who can consent participants?
- Who is required to sign the written consent?
- When is someone considered incompetent?
- Who needs to be present if the subject is incompetent?
- What do I do if the person does not speak English?
- I need to re-consent participants; can I do this at their next appointment?
HIPAA
- I am doing a retrospective chart review. Do I need a HIPAA form?
- When should I amend my HIPAA?
- What is the difference between who may receive information and who may disclose it?
The VA
- Is there any special paperwork for the VA?
- Is the consent different for the VA?
- Is HIPAA different for the VA?
- How do I submit to the VA Research and Development Office?
- Whom do I contact if I have questions?
Compensating Participants
- Is there special paperwork for compensating subjects?
- Is there a rule of how much I can give to a subject?
- Can I pay the subject for completing a study?
Other
- Where can I find a list of the HS IRB board members?
- What is a source document?
- How long do I need to keep my records?
Note: If you would like additional questions/answers on this page, please submit questions to the HSIRB office at irb@missouri.edu or by calling (573) 882-3181.
Here are some sites that may answer your questions.
- FDA Guidance for Institutional Review Boards and Clinical Investigators 1998 Update - http://www.fda.gov/oc/ohrt/irbs/default.php
- OHRP Guidance Topics by Subject - http://www.hhs.gov/ohrp/policy/index.php
Last Updated: October 17, 2012