Investigator Quick Guide

This guide is intended to provide investigators with a quick overview of the COUHES process.

Top of Form

  1. Does your study involve research, AND use human subjects, AND is it carried out under the auspices of MIT?

Yes.   Your study probably requires COUHES approval. Go to #2.
No.   COUHES approval is not required
 

  1. Is your study carried out as part of your administrative responsibilities at MIT, AND are the data you are collecting non-sensitive, AND will the data be used for MIT purposes only?

Yes.   COUHES approval is not required
No.   COUHES approval is required. Go to #3
 

  1. Does your study involve more than minimal risk?

Yes.   A standard application to COUHES is required. Go to #4
No.   An exempt application is generally required. Go to #5.
 

  1. A standard application is reviewed by the full Committee at its regular monthly meetings. The application must be submitted by the meeting deadline.

 

  1. An exempt application is sufficient if the study involves only minimal risk AND falls within the definition of exempt status research. Exempt applications are reviewed by the Chairman of COUHES and may be given expedited review independent of the regularly scheduled COUHES meetings.

 

  1. You will need to obtain informed consent from all study subjects in advance of their participation in your study. For research requiring a standard application written informed consent is required. Use of the COUHES templates is recommended. For research requiring an exempt application written informed consent may be waived.

 

  1. Have you and all study personnel completed human subjects training?

No.   All study personnel must complete the training before the research can begin
Yes.   Human subjects training must be updated every three years.
 

  1. Does the principal investigator or any key personnel involved in the study have any financial interest in the research?

No.  
Yes.   You must complete a Disclosure of Financial Interest Supplement for each individual with an interest.
 

  1. Is your study sponsored by, or are you conducting your study for, MIT Medical or an MIT Health Plan, or are you conducting your study in partnership with any non-MIT healthcare providers (e.g., a hospital or clinic or health insurance company)?

      Yes. HIPAA may apply. Go to #10.
      No.   HIPAA does not apply.
     

  2.  Does your study involve the use of protected health information?
    Yes.   If you are sharing protected health information with your collaborator, then the HIPAA privacy regulations apply and you will either have to de-identify the data or get written authorization from each subject for the release of this information.
    No.  HIPAA may not apply.  Go to #11.
     
  3. Does your study involve the use of a “limited data set”?

    Yes.  Consult with Bradley Abruzzi in the MIT Office of General Counsel at 253-4466.
    No.  HIPAA does not apply.
     

  4. COUHES approval is valid for 1 year. Will your proposed study last for more than 1 year?

Yes.   You will need to complete a Continuing Review Questionnaire every year.
No.   Your study will automatically be terminated at conclusion of your study.

 

If you have any questions contact the COUHES office at 253-6787.