Texas Tech University

Revisions to Common Rule

Common Rule v. Final Rule

OHRP has released a revised Common Rule (45 CFR 46) and it will go into effect on January 21, 2019. Researchers will notice changes to the HRPP website, policies and procedures, and Cayuse IRB template.

This is a summary of the changes to the Common Rule (45 CFR 46) and the major impacts it will have on researchers. Researchers should become familiar with the revised document

Implementation of Final Rule
Pre January 19, 2019 Post January 19, 2019
Referred to as Common Rule Referred to as Final Rule

IRBs must follow one set of regulations. 

  • Researchers and IRBs cannot pick and choose specific regulations to apply to IRBs.
All research approved on or before Friday, January 18, 2019 will be reviewed and required to follow the Common Rule regulations. All research approved on or after Saturday, January 19, 2019 will be reviewed and required to follow the Final Rule regulations.
Researchers should continue to submit research team changes, modifications, renewals and incidents for any study that has received IRB approval prior to January 19, 2019.  
Cayuse IRB Logistics

IRB reviewers will not be reviewing submissions or approving IRBs during this transition.

December 17, 2018 – January 28, 2019.

Common Rule Final Rule

 Researchers that submit an IRB on the old template between December 4, 2018 – March 1, 2019 will be contacted by HRPP staff requesting that a new IRB be submitted on the new template.

  • Exempt research on the old template will still be approved during December 17, 2018 – January 18, 2019.

 The new Cayuse IRB template was launched on Friday, December 7, 2018. The new template follows the Final Rule.

  • Any research submitted on the new template between December 7, 2018 – January 18, 2019 will not be approved until January 19, 2019. This includes exempt research.

 IRBs that are unsubmitted on the old Cayuse IRB template will be administratively withdrawn on March 1, 2019.

  • The IRBs will remain in the researcher's archived tab in Cayuse IRB.
  • Researchers will be able to copy and paste from the old template into the new template that applies the Final Rule.
 

Transitioning IRBs from Common Rule to Final Rule

  • Any research that receives IRB approval prior to January 19, 2019 will remain under the current Common Rule and will not be transitioned to the revised Common Rule.
  • Researchers interested in transitioning their IRBs to the Final Rule regulations need to contact Dr. CassiDe Street before action is taken.
    • Process will not begin till June 1, 2019.
    • Longitudinal, federally funded, and collaborations projects may be difficult to transition to the Final Rule.
    • Dr. CassiDe Street
      Section Manager, HRPP
      806-834-2285
      casside.street@ttu.edu
Applicability of the Final Rule based on Funding Source
Funding  Common Rule - existing research approved or exempted before Jan. 19, 2019 Final Rule - approved or exempted on or after Jan. 19, 2019 
 FDA Regulated Transition is not applicable. Research must continue to follow FDA Regulations: 21 CFR Part 50 and Part 56.
Federal Research
(except DOJ)
There will be no transition of already approved research to the revised Common Rule. Federal research approved prior to Jan. 19, 2019 will remain under the Common Rule: 45 CFR 46 (2009) All federally funded research must follow the revised 2018 Final Rule (Jan. 19,
2019).
 DOJ Research Transition is not applicable. DOJ research must continue to follow the Common Rule 45 CFR 46 (2009) until DOJ becomes signatory to the revised rule.
SUMMARY of CHANGES
Exempt Categories

REVIEW PROCESS

  • Exempt review will remain the same.
  • Addition of Limited Review
    • Data can include identifiers if the research is little to no risk.
    • Limited review must be done by an IRB member to determine that there are adequate provisions for protecting privacy and confidentiality.

UNCHANGED

  • Category 1: Established or Commonly Accepted Educational Settings
  • Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies

 REVISED

  • Category 2: Educational Tests, Survey Procedures, Interview Procedures or Observation of Public Behavior
    • Limited review is required if identifiers are collected.
  • Category 4: Secondary Research for Which Consent is Not Required
    • Data or specimens no longer have to be existing.
  • Category 5: Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency
    • Must be publicly posted.

 REMOVED

  • Category 3: Elected or Appointed Public Official(s)/Federal Statute(s)

ADDED

  • • Category 3: Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects
    • o Limited review is required if identifiers are collected.
    • o Limited review is required if deception is a part of data collection. The participants must prospectively agree that they will be unaware of or misled regarding the nature or purpose of the research.
  • Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required
    • o Limited review is always required.
    • o Broad consent is appropriately documented, or waiver of documentation is appropriate
    • o If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
    • o Additional safeguards have been included in the study to protect the rights and welfare of vulnerable populations
  • Category 8: Secondary Research for Which Broad Consent is Required
    • o Limited review is always required.
    • o Researcher agrees to not return individual results to the participant as part of the study plan.

** Consultation with the HRPP Manager or the IRB Chair is required before completing IRB application for Exempt Category 7 and 8. Requesting more guidance from OHRP.

Renewal/Continuing Review
Renewals are conducted at least once a year until the research has been completed and the IRB protocol has been closed.
Common Rule

Final Rule

Renewals Required

  • Expedited Approved before 1/19/2019
  • Full Board

Renewals Required

  • Full Board

HRPP Administrative Check-In

  • Exempt

HRPP Administrative Check-In

  • Exempt
  • Limited Review
  • Expedited
** Researchers are still obligated to submit/report modifications, incidents, and study completion no matter the review type. IRBs that remain active are subject to audit by the IRB.
Consent Process & Form

RE-ORGANIZATION of CONSENT INFORMATION

  • The consent must begin with a concise and focused presentation of key information most likely to assist with making a decision about participation.
  • Key information must be organized and presented in a way that facilitates comprehension and not merely a list of facts.

ADDITION of REQUIRED ELEMENT of CONSENT

  • One of the following statements must be included in the consent process for limited review, expedited review, or full board review that involves the collection of identifiable private information or identifiable biospecimens:
    • Identifiers will be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative.
    • Participant's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

ADDITION of ADDITIONAL ELEMENTS of CONSENT

  • A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  • A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.
  • For research involving biospecimens, whether the research will or might include whole genome sequencing.

WAIVER of CONSENT

An IRB may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant's legally authorized representative, if either of the following conditions are met:

  • The researcher will obtain information through oral or written communication with the prospective participant or legally authorized representative.
  • The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

WAIVER of WRITTEN CONSENT

  • Added - If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
  • If a waiver of written consent is not obtained, then a copy of the informed consent needs to be provided to the participant.

ELECTRONIC SIGNATURES

  • Electronic signatures are a recognized form of a signature.

BROAD CONSENT (Exempt Categories 7 & 8)

  • Required Elements of Broad Consent:
    • A description of any reasonably foreseeable risks or discomforts to the subject.
    • A description of any benefits to the subject or to others that may reasonably be expected from the research.
    • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
    • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
    • A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
    • A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
    • A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
    • A statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
    • A statement that such results may not be disclosed to the subject;
    • An explanation of whom to contact for answers to questions about the subject's rights and about storage and use of the subject's identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.
  • Additional Elements of Consent:
    • A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
    • For research involving biospecimens, whether the research will or might include whole genome sequencing.
  • If an individual was asked to provide broad consent and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.
Cooperative Research

Mandates the use of a Single IRB for federally funded cooperative research.

  • This regulation will go into effect on January 20, 2020.