Converting Studies from IRBaccess to UTRMS-IRB

1. Update proposal as required (see below for additional information).
2. Download all most recently approved study documents from IRBaccess.
3. Navigate to UTRMS-IRB and find the study you will be converting (Tip: the study number in UTRMS-IRB will be the same study number in IRBaccess, without the dashes).
4. Open the study by clicking on the study title – this will take you to the study workspace.
5. Click on Create Modification/CR/Closure.
   
   1. Choose "Modification and Continuing Review" as the purpose of the submission.
   2. Select "Other parts of the study."
      Note: To list current and new study team members, also choose "Study team member information."
      
   3. Click Continue.
   4. Continuing Review/Study Closure Information: Complete the Continuing Review information.
      
      Note: Only attach supporting documents if appropriate for the Continuing Review, general study documents will be attached later in the process.
   5. Modification Summary, Summarize the Modifications: Include "Convert study from IRBaccess to UTRMS-IRB."
      
      Note: If you will be making modifications to the currently approved research, provide a brief summary if any additional changes.

      If your study was originally approved prior to January 21, 2019 and you need to update your protocol and consent form to comply with the new common rule, add the following (as applicable to your research) to the Summarize the Modification section:
      “Update consent forms to new common rule (as required):

      1. Add key information page to consent form
      2.  Add information regarding future use of data/biospecimens.
      3. Add information regarding commercialization.
      4. Add information regarding disclosure of clinically relevant information.
      5. Add information regarding whether research will involve whole genome sequencing to consent form."

      For more information on the common rule transitions see the "Informed Consent Document Changes for New Common Rule" section below.

   6. Click Continue - you will then be directed to the overall study SmartForm. Follow instructions on updating the SmartForm in the table below.
      
   7. Once the SmartForm is updated (following instructions in the table below), Click Finish and on the study workspace, Click Submit to submit the Modification and Continuing Review action.

Although all active studies will be converted into the new system, there will be a handful of manual changes you will have to make when you submit your first Modification and Continuing Review in UTRMS-IRB. An inventory of these changes is listed below.

With the launch of UTRMS-IRB, the IRB office is also implementing new protocol/proposal templates and supplemental proposal forms. The research team converting current protocols/proposals to the new template should be able to copy/paste most of the text information and can complete the rest of the form by simply checking boxes (instructions appear at the top of each template document). All expedited and full board studies originally approved prior to January 21, 2019 will be required to convert their existing study proposals into the new proposal template and applicable supplemental proposal forms.

For all expedited and full board studies originally approved after January 21, 2019, it is recommended that you convert the study proposal to the new templates as they are built to be more collaborative.

Studies that were originally approved prior to January 21, 2019 will need to transition to the New Common Rule. This transition is likely to affect informed consent document/parental permission forms as additional elements are now required in some instances. See below for an outline of changes that may need to be made to the current informed consent document/parental permission forms. Please update your consent forms as needed and submit the revised consent forms with your Modification and Continuing Review submission in UTRMS-IRB.

I. Key Information

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. The key information section is required for consent forms with 4 or more pages.

Researcher Action:

Insert the following at the beginning of the consent form and revise to include study applicable information:

"Things you should know:

• The purpose of the study is to [briefly describe study purpose].
• In order to participate, you must be [briefly describe eligibility criteria].
• If you choose to participate, you will be asked to [do what, when, where, and how]. This will take [state period of time].
• Risks or discomforts from this research include [briefly describe most likely risks or state that the risks involved in this study are not greater than everyday life].
• The possible benefits of this study include [provide a description of potential benefits to subjects or state that there is no direct benefit for participating in this study].
• Taking part in this research study is voluntary. You do not have to participate, and you can stop at any time.

More detailed information may be described later in this form.

Please take time to read this entire form and ask questions before deciding whether to take part in this research study."

II. Future Use

Notice of future use of identifiable private information or identifiable biospecimens.

Researcher Action:

Update consent form to state whether de-identified information or biospecimens could be used for future research without additional consent. Add one of the following:

Option 1:

"We will share your data or samples with other researchers for future research studies that may be similar to this study or may be very different. The data or samples shared with other researchers may include information that can directly identify you. Researchers will not contact you for additional permission to use this information."

Option 2:

"We will share your data or samples with other researchers for future research studies that may be similar to this study or may be very different. The data or samples shared with other researchers will not include information that can directly identify you."

Option 3:

"The data or samples that we will collect about you will not be shared with any other researchers."

III. Commercialization

If applicable, include a statement that identified or de-identified biospecimens may be used for commercial profit and whether the subject will share in the profit or not. Only include one of the following if you are collecting biospecimens as part of your research procedures.

Researcher Action:

Update consent form to state whether or not a subject will share in commercial profit. Add one of the following:

Option 1:

"Your samples may be used for commercial profit and there is no plan to share those profits with you."

Option 2:

"Your samples may be used for commercial profit and there are plans to share those profits with you. [Explain profit sharing plan]."

IV. Clinically Relevant Research Results

If applicable, include a statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

Researcher Action:

Update consent form to state whether or not the results will be disclosed and under what conditions. Add the following, if applicable:

"As part of this study, we may learn medically relevant information about you. If we learn something that you and your doctor did not know, we will [describe process to relay health information]."

V. Whole Genome Sequencing

If applicable, for research involving biospecimens, include a statement that the research will or might include whole genome sequencing.

Researcher Action:

Update consent form to state that whole genome sequencing may occur (consider that sequencing may take place in the future if specimens are to be shared). Add one of the following:

Option 1:

"The samples collected during this research may have genetic information created from them. The researchers do not plan to sequence your whole genome from this sample."

Option 2:

"The samples collected during this research may have genetic information created from them. The researchers plan to sequence your whole genome from this sample. [Explain what genetic information will be used, generated, or obtained].

A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that we get from his research.
• Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

All health insurance companies and group health plans must follow this law by and all employers with 15 or more employees must follow this law.

Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance, nor does it prohibit discrimination on the basis of a genetic disease or disorder that you already know about."