Common Rule Changes

Changes to regulations governing human subjects research, as outlined in 45 CFR 46 (also known as the Common Rule) were published in the Federal Register in January 2017. The majority of rule changes took effect January 21, 2019. The amended rules are the first significant changes to these regulations since 1991.

Summary of Changes

  • Went into effect January 21, 2019 
  • Consent forms longer than 4 pages must begin with a concise and focused presentation of the key information. The IRB will not require already-approved studies to re-consent, except when other significant changes would require re-consent.
  • Updates to the Exempt Categories:
    • (1) Research, conducted in established or commonly accepted educational settings
      • NEW: A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators
    • (2) Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) of adults (no children)
      • NEW: The scope will be expanded to include the collection of sensitive and identifiable data. However, the following is not allowed:
        • Interventions
        • Collection of biospecimens
      • NEW CATEGORY: (3) Research involving benign behavioral interventions with adult subjects (no children) if the subjects prospectively agree to the intervention and information collection
        • Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing (e.g., online game, solve puzzles, decide how to allocate a nominal amount of cash)
        • The research may not involve deception unless prospective agreement
    • (4) Secondary research uses of identifiable private information or identifiable biospecimens
      • NEW: Prospective data review
    • (5) Research and demonstration projects that are conducted or supported by a Federal department or agency
      • NEW: A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.
    • (6) Taste and food quality evaluation and consumer acceptance studies
      • NO CHANGES

Note: Categories 7 and 8 below were added, but are not being utilized by MSU at this time.

  • NEW CATEGORY: (7) Storage or maintenance of identifiable data/specimens if IRB conducts a limited review
    • Broad consent is required
  • NEW CATEGORY: (8) Secondary research for which broad consent is required if consent is obtained (documented or waived) and IRB conducts a limited review
    • Limited IRB Review is to ensure that adequate provisions are in place to protect privacy and confidentiality
    • Continuing review is no longer required for minimal risk research (expedited, limited IRB review, or any research limited to analysis of identifiable data)

Additional Information

Investigator Resources

Help for those conducting human subjects research.

OHRP has released new decision charts consistent with the 2018 Requirements to aid in deciding if an activity is research involving human subjects that must be reviewed by an IRB.

Research participant resources

Questions

Can I be on a project at another institution?

In order to approve the involvement of an MSU researcher at another institution in a project deemed by the MSU IRB to constitute human subjects research, the MSU IRB will need a copy of the other institution's IRB approval or a decision from their IRB that review and approval is not required.

Do classroom projects require IRB approval?

Only projects that meet the regulatory definition for human subjects research require IRB approval. Research is defined as a "a systematic investigation...designed to develop or contribute to generalizable knowledge." The regulations hinge on your intent - if your intent is to contribute to generalizable knowledge (such as disseminating your findings through publication or presentation), your project requires IRB approval.

However, if the project is conducted as a classroom project only, and there is no intent to use the findings from the project outside the classroom, IRB approval is not required.

Do MSU Extension Services projects need IRB approval?

There are often questions and misconceptions regarding the need for IRB approval of MSU Extension Services projects. The MSU IRB provides the following information as a resource for Extension personnel who are unsure as to whether their projects require IRB approval.

  1. Extension projects, as in any other field, require IRB approval when the project meets the regulatory definitions for human subjects research.  The relevant definitions from the regulations (45 CFR 46.102, https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937c d9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1102) are included below:

(l) Research means a systematic investigation, including research development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (The regulations also outline activities deemed
not to be research in this definition. Please visit the link above to see those activities.)

(e)(1) Human subject means a living individual about whom an investigator (whether professional
or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(2) Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
(3) Interaction includes communication or interpersonal contact between investigator and subject.
(4) Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
(5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
(6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

A few points concerning these definitions:

  • The confusion specific to Extension projects comes with the fact that Extension to a large part is "service." However, the regulations state specifically that service programs are research under these regulations if the definition is otherwise met (see 45 CFR 46.102(l) above)
  • Additionally, the regulations hinge on intent. If your intent is to conduct a service program and not to use any such information gathered in the conduct of that program for research purposes (e.g., publication, presentation, etc.), IRB approval is not needed because the project does not meet the regulatory definition of "research." However, if you have the intent to use the resultant data from your evaluation for research, the regulations apply and you must have IRB approval prior to conducting the research.
  • There are also misconceptions in regard to exemption of Extension projects from IRB regulations. There are exempt categories of research defined in the regulations. However, these exemptions relate to the specific research methods and the inherent risks involved. Extension projects are not explicitly exempted from the regulations or requirements for IRB review. The determination as to the level of review must be made with an understanding of these regulations. Additionally, this determination should not be one made by the investigators themselves.

Individuals unsure as to whether IRB approval is needed for their project should contact their HRPP administrator.

Because of the questions surrounding the roles of IRBs and Extension agencies, the Journal of Extension published a few years ago several articles on IRB requirements as they relate specifically to Extension. These articles can be found on the JoE website at https://www.joe.org/journal-search.php by searching for the term "irb."

One of those articles, "What Cooperative Extension Professionals Need to Know About Institutional Review Boards" (Weigel, et. al, https://www.joe.org/joe/2004october/tt1.php) notes the following:

"Cooperative Extension is part of a university system and therefore falls under the same research policies and guidelines as other university units. Typically, if an Extension professional intends to publish or present the information gathered in the form of journal articles, trade articles, bulletins, fact sheets, workshops, or presentations, the project should first be approved by the IRB at the professional's institution. Information collected with no intent to publish it and used merely to evaluate the effectiveness of a program is usually not required to be reviewed by an IRB."

Do Oral History projects need IRB approval?

There are often questions and misconceptions regarding the need for IRB approval of oral history projects. The MSU IRB provides the following information as a resource for individuals who are unsure as to whether their projects require IRB approval.

The IRB defines as its purview those projects which meet the definition of human subjects research from the Common Rule, that is those projects that are conducted for the purpose of contributing to generalizable knowledge.

Oral history projects, as in any other field, require IRB approval when the project meets the regulatory definitions for human subjects research. The relevant definitions from the regulations (45 CFR 46.102, https://www.hhs.gov/ohrp/regulations-and-policy#46.102) are included below:

(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Consistent with any other method of inquiry, only those oral history projects that meet the regulatory definition of research found at 45 CFR 46.102(d) fall under the purview of the IRB. For example, while a survey conducted for research purposes qualifies as human subjects research and would require IRB approval prior to its administration, a survey conducted strictly for institutional effectiveness would not qualify as human subjects research and would not need IRB approval. Likewise, an oral history project conducted for research purposes would require IRB approval.

As always, please feel free to contact a member of the HRPP staff if you have any questions or if we can be of any assistance.

Do pilot studies require IRB approval?

Projects that meet the regulatory definitions for research and human subject require IRB approval. The definition of research includes “research development, testing and evaluation,” so if the pilot activities also meet the definition for human subject – namely, obtaining information about a living individual through intervention or interaction, or private identifiable information about a living individual – those activities require IRB approval.

Does my project require IRB approval?

All projects that meet the regulatory definitions for research and human subject require IRB approval.

If you have any questions about whether your project meets the definition of human subjects research, you should contact a member of the IRB staff.

How do I find information on IRB/human subjects training?

We offer live and online training options to accommodate your schedule. Please visit the ORC website for IRB/Human Subjects training information. There you will find step-by-step instructions on how to complete the training. You can also check your training records to see when your training expires.

How do I submit a project to the IRB for review?

You will need to complete and submit a protocol in the myProtocol system for review. Be sure to use Firefox, and thoroughly answer each question in the protocol application and submit all pertinent supporting materials.

Is there any grace period for conducting research after the IRB expiration date of my project?

For non-exempt projects, there is no grace period.  Per Federal Regulations and MSU Policy, all research on the project must halt until you have secured continuing IRB approval.

Research activities include but are not limited to the following: recruitment, enrollment, advertisements, consent, interactions and interventions, and collection or analysis of data. Research may only proceed prior to securing continuing IRB approval if the IRB Chair finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. Enrollment of new subjects cannot occur after the expiration of IRB approval.

For projects granted an Exempt Determination, further oversight by the HRPP is not required.

MSU's Federalwide Assurance Number

MSU's Federalwide Assurance number with OHRP is FWA00000203.

MSU's DoD-Navy FWA Addendum number is DoD N-A3034.

What if something about my project changes from the IRB approved protocol?

For non-exempt projects, if anything about your protocol changes (such as personnel, location, number of participants, procedures, etc.), you must obtain IRB approval of those changes prior to implementation unless they are necessary to eliminate apparent immediate hazards to the subject.  You should complete the modification in the myProtocol system for review.

For projects granted an Exempt Determination, further oversight by the HRPP is not required. Therefore, when an exemption has been granted, the HRPP will inactivate that study in the myProtocol system. While the study has been inactivated, it means that recruitment, enrollment, data collection, and/or data analysis can continue, but personnel and procedural amendments to the study are no longer required. However, if at any point the risk to participants increases, you must contact the HRPP immediately with that information.

What is the difference between a "waiver of consent" and a "waiver of documentation of consent"?

There are two distinct regulatory requirements for the consent process. First, specific elements of consent must be included in the consent process. Secondly, the consent process must be documented with a signed consent form unless specific criteria are met. If you wish to not include a specific element of consent, or feel you shouldn't obtain consent at all, you should request a waiver of consent from the IRB. If you will have some type of consent process, but will not ask participants to sign a consent form, you should request a waiver of documentation of consent.

Who is an immediate family member and what is a financial interest?

  • "Immediate Family" means spouse and dependent children.
  • "Financial Interest Related to the Research" means any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual's immediate family:
    1. Ownership interest of any value including, but not limited to stocks and options exclusive of interests in publicly-traded, diversified mutual funds.
    2. Compensation of any amount including, but not limited to honoraria, consultant fees, royalties, or other income.
    3. Proprietary interest of any value including, but not limited to, patents, trademarks, copyrights, and licensing agreements.
    4. Board or executive relationship, regardless of compensation.

Any member of the research team who has a financial interest or has an immediate family member with a financial interest in the research must submit a Financial Interest Disclosure Form to the IRB (File not found).

Will I need to attend the IRB meeting to present my project?

Not all projects are reviewed by the convened IRB. There are categories of research in the regulations that may be reviewed administratively (by a member of the IRB staff) or via expedited review (by one member of the IRB). If your study goes to the convened IRB, you will be invited to attend the meeting to answer questions. However, attendance of the meeting is not mandatory. Meeting dates and associated submission deadlines can be found online at https://orc.msstate.edu/human-subjects/hrpp-irb.

Is my project eligible for an Exempt Determination?

The Common Rule regulations define certain categories of research that are eligible for exemption from some of the usual regulatory requirements for human subjects research. These projects receive an Exempt Determination at MSU.

Advantages of Administrative Review include the following

  • Abbreviated consent requirements
  • Reviewed only by the IRB staff rather than being sent to one or more board members for Expedited or Convened IRB Review.
  • If the project is found to be non-Exempt (meaning it does not qualify for Administrative Review) you will be asked by the IRB Staff to answer additional questions about your research that are required for Expedited and Full Board review.
  • Projects undergoing review for an Exempt Determination must fall entirely into one or more of the following categories. The following tool is meant only to assist investigators in determining if their project is likely to be eligible for an Exempt Determination. You may also call the HRPP Staff for assistance in determining whether your project is Exempt and eligible for Administrative Review.
  • By clicking on any of the following categories, you will be taken through a series of questions to help you determine if that category applies. You may select more than one category if applicable.

If you have any questions about whether your project meets the definition of human subjects research, you should contact a member of the HRPP staff.

Questions

What is the difference between a "waiver of consent" and a "waiver of documentation of consent"?

There are two distinct regulatory requirements for the consent process. First, specific elements of consent must be included in the consent process. Secondly, the consent process must be documented with a signed consent form unless specific criteria are met. If you wish to not include a specific element of consent, or feel you shouldn't obtain consent at all, you should request a waiver of consent from the IRB. If you will have some type of consent process, but will not ask participants to sign a consent form, you should request a waiver of documentation of consent.