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Notice for Active Studies: Prospective and Pending Submissions

Please be aware that when you submit an Amendment Request, Continuing Review, etc. for an active study it will trigger a re-assessment of your protocol to ensure compliance. This means that our office will ensure you have answered the new questions under the "Protocol Components" tab (if applicable) and "Consent" tab. In addition, if you are still enrolling subjects, you will be required to update your consent form(s) for new subjects to include the new required elements of consent.

New Basic Elements of Informed Consent:

a)  Key Information: Per the revised regulations, the informed consent process must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant in understanding the reasons why one might or might not want to participate in the research. This part of the consent process must be organized and presented in a way that facilitates comprehension. To accomplish this, a section is added to the beginning of the informed consent form that is used to facilitate this process. This is termed as "Key Information".  How each Principal Investigator applies the key information requirement, and to what level of detail, will depend on the complexity of the research.  The preamble to the revised Common Rule suggests the following five elements be included as the key information summary:

  • A statement that the project is research and participation is voluntary
  • A summary of the research, including:
    • Purpose
    • Duration
    • List of procedures
  • Reasonable, foreseeable risks or discomforts
  • Reasonable, expected benefits
  • Alternative procedures or course of treatment, if any

The key information serves as a summary of information the additional details provided under the various headers throughout the consent form - the details under those  individual headers should remain in the consent form.  This change was intended to ensure prospective participants are receiving the most important information up front, instead of that key information being buried in long and overly complex documents.

b)  Explicit statement about whether the research involves any plans for the future use of the private information and/or specimens collected also needs to be included. It is recommended this be added under the 'Confidentiality' section. Only one of the following should be added (*Note: This statement needs to be consistent with the response under the 'Privacy and Confidentilaity' tab of your application):

  • A statement that data and, if applicable, specimens will not be stored or distributed for future research studies.
  • A statement that data and, if applicable, specimens will be de-identified, and could be stored and distributed for future research studies without additional informed consent.
  • A statement that identifiable data and, if applicable, specimens will be stored and distributed for future research studies without additional informed consent.

Additional elements of informed consent - one or more of the following elements of information, when appropriate.

1) When the study involves the collection of identifiable biospecimens, the following elements of consent are required:

  • A statement indicating whether the participants biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit;
  • A statement indicating whether the research will or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen [DNA]).

2) When your research involves clinically relevant results:

  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions

**When you submit, please include comments regarding current status of research (e.g., still enrolling subjects, closed to enrollment, etc.) within your ‘Investigator Response’ box. Note: You are not required to submit an amendment just for the purpose of updating your application to address the above - this information should be added whenever you submit your next amendment or at the time of your continuing review.

[Refer to 45 CFR 46.116(a),(b) (9,) (c)(7), (8) and (9) of the revised Common Rule.]

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