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Application 3 - Submission Package
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Request for No Human Subject Research Determination

E&I Form 11 plus the items requested on the form.  If a grant is involved, a copy of the grant narrative is required.  It is critical that the reviewer know the reason you are asking for a determination.


Request for Exemption Certificate

E&I Form 12 plus the items requested on the form.  A project description and the investigator’s resume are required.  The grant narrative, consent documents, a data management plan and study instruments may be necessary if applicable.


Request for Expedited Review

Every application consists of two parts. Study review and review of people and places.  Each has its own form and at the top of each form is a checklist of the materials needed.


The study  (Form 21B or 21C)

Every study has official documents such as a description or protocol defining its goals purposes and operations, recruitment materials, survey instruments, focus group introductions and target questions, and, perhaps, a grant application.

  • Form 21 is the master form for study submission.  21B is the version for SBER purposes.  21C is specifically for program evaluation.
  • Forms are needed to cover some regulatory topics.  
    • The 25’s are for special populations: 25B Pregnant Women, 25C Prisoners, 25D Children and 25A for employees
    • The 26 series is for consent waivers: 26A waiver frm consent, 26B from consent documenation
  • Consent documents or consent information or, if none, documentation of waiver of consent.
  • Grant application if federally funded (narrative areas only)

 

People and Places (Form 31B) 

A study with no people never gets done.  The IRB must consider the qualifications and experience of the investigator.  The investigator must have the authority to control the conduct of the study.  Co-Investigators do not exist.  The IRB will communicate with one person and will hold one person responsible. 

Sub-Investigators are people who are designated as able to make critical design or conduct decisions.  People hired to do a job (coordinators, interviewers, statisticians, etc.) who work within the protocol should not be sub-investigators.

Sites can vary from specific named schools to clinical sites to focus group venues across the country.  The IRB concern is for safety and appropriateness of the site for the subjects.  Many sites such as schools have their own access requirements that should be recognized.  Site forms are 32, 33, and 34.  Some institutions will require an IRB reliance agreement.  The E&I version is form 07.


Special Cases:
  • Project evaluators working as sub-contractors are usually the investigator for the research portion of the activity even if the person is not a named investigator on the grant or contract.
  • In the case of community based participatory research one person needs to be named as lead.  This person is the contact with the IRB and is responsible for assurances about compliance.  The investigator must be qualified by training and experience to conduct the study in question.

Every study takes place somewhere – even if it is the cloud.  The question for the IRB is the demands made on and the protection of subjects as a result of where the study takes place.

  • Physical places should be named.  If there is anything stigmatizing, private or unlabeled access might be important.
  • Internet based studies use sites with varying Terms of Service assuring various levels of privacy.
  • Generic descriptions are occasionally used.  Focus groups can be held in specialized focus group facilities, hotels, or schools but each must meet standards for safety.  It may be better to describe the features of acceptable sites rather than to name each one.

The question for E&I is our relationship with institutional sites.  The E&I policy is to recognize the authority of the institution or facility.  It is critical that they know that research is taking place and that they accept the review from our IRB.  We have several forms available depending upon the situation.  Form 32 is the most generic and best.  Form 33 is for satellite or additional performance sites.  Form 34 is specifically for schools.

Last Updated ( Monday, 10 April 2017 12:10 )