The Revised Common Rule

What is The Common Rule?

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was charged in 1974 to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that such research is conducted in accordance with those principles. In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, which identifies three fundamental ethical principles for all human subjects research -- respect for persons, beneficence, and justice.

Based on the Belmont Report and other work of the National Commission, the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies.

In 2015 HHS issued a Notice of Proposed Rulemaking (NPRM), seeking comments on proposals to comprehensively revise the Common Rule.  This NPRM sought comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule was an effort to modernize, simplify, and enhance the current system of oversight.

The result of this work, the Revised Common Rule, was published in 2017 and implemented, after several delays, on the general compliance date of January 21, 2019.

(excerpted from the Office of Human Research Protections OHRP website)

January 21, 2019: Compliance Date of Final Revisions to the Federal Policy for the Protection of Human Subjects

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule).  These revisions became effective in 2018, so although the general compliance date was advanced to January 21, 2019, the regulations are referred to as the "Pre-2108 Requirements" and the "2018 Requirements."

As the Food and Drug Administration (FDA) has not yet revised its regulations, and the Department of Justice (DOJ) has not signed onto the revised Common Rule, the Pre-2018 Requirements currently apply to research that is FDA-regulated or DOJ-supported.

The general compliance date for the Revised Common Rule is January 21, 2019.

All Columbia research initially approved on or after January 21, 2019 is subject to the revised 2018 requirements.
  • The term "2018 Requirements" refers to the Common Rule as published in the July 19, 2018 edition of the e-Code of Federal Regulations. The 2018 Requirements were originally published on January 19, 2017 and further amended on January 22, 2018 and June 19, 2018. The 2018 Requirements may also be referred to as the “2018 Rule” and the "revised Common Rule."
Impact on Ongoing Research:  All Columbia research approved prior to January 21, 2019 remains subject to the pre-2018 requirements.
  • The term "pre-2018 Requirements" refers to subpart A of 45 CFR part 46 (i.e., the Common Rule) as published in the 2016 edition of the Code of Federal Regulations. The pre-2018 Requirements were originally promulgated in 1991, and subsequently amended in 2005. The pre-2018 Requirements may also be referred to as the “pre-2018 Rule” and the "pre-2018 Common Rule."
  • Protocols approved prior to January 21, 2019 are identified as "Legacy protocols" within the electronic submission system, Rascal.

The 2018 revisions have been made to Subpart A only. Subparts B, C and D remain in effect for all applicable protocols approved before, on or following January 21, 2019. (For more information see: How do the updates to the Common Rule affect the HHS subparts?)

Implementing the New Regulations at Columbia

Keep checking! As the Revised Common Rule is implemented, new guidance and information will become available.

New consent templates, revised policies, information sessions and workshops, and other news about the revised Common Rule will be posted online, and sent out via the HRPO/IRB listserv.

Templates and Documents: New information, consent templates and updated policy and procedures:


Informational and Educational Resources:


  • Questions?:
  • For assistance with any questions, call the HRPO/IRB at 212-305-5883 or email IRBOffice@columbia.edu
  • For assistance on questions from the Morningside campus, call 212-851-7040 or email askirb@columbia.edu 

Not getting updates? Join the HRPO/IRB listserv by emailing IRBOffice@columbia.edu

Revisions to the Rascal IRB module, released on January 21, 2019, will accommodate protocols that were approved prior to January 21, 2019 ("Legacy protocols") and protocols approved on or after January 21, 2019.

Legacy protocols will open in a Rascal environment which continues to follow Pre-2018 Requirements, Any content that includes questions related to the new 2018 Requirements will be appropriately identified and will not be required fields for completion.  Modifications and renewals will be made following the Pre-2018 requirements up until the time a protocol is closed.

New protocols, approved after January 21, 2019, will open in a Rascal environment where the 2018 requirements have been incorporated in all of the instructions, content and procedures.

SIGNIFICANT CHANGES

IRB Review

Annual continuing review requests are no longer required for certain studies. Eligible studies include those that:

  • Were reviewed by an expedited review process, unless the reviewer justifies why continuing review would enhance protection of subjects
  • Have progressed to the point that they involve only data analysis or “accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care”
  • Were reviewed by the IRB in accordance with the limited IRB review procedures described in 2018 requirements

A brief progress report that will be reviewed administratively will be required. Reasons for this include the need to:

  • Account for active research
  • Track recruitment
  • Update personnel

The 2018 Requirements eliminate the requirement in the pre-2018 Requirements that grant applications or proposals for research undergo IRB review and approval for the purpose of certification. Certain sections of the grant may be requested, however, if deemed necessary. Elimination of this requirement is not expected to reduce protections for human subjects because the research study (e.g. a research protocol) would remain subject to the requirement for IRB review and approval.

The 2018 Requirements at 45 CFR 46.103(d) require certification when the research is supported by HHS, and applicability of the regulations is not otherwise waived under 45 CFR 46.101(i) or the study is not exempted under 45 CFR 46.104. For such research, institutions must certify that each proposed research study covered by an OHRP-approved assurance and by 45 CFR 46.103 has been reviewed and approved by an IRB. Such certification must be submitted as prescribed by the federal department or agency component supporting the research. Under no condition shall research covered by 45 CFR 46.103 be initiated prior to receipt by HHS of the certification that the research has been reviewed and approved by the IRB.

Thus, for research to which the 2018 Requirements apply, the IRB must review and approve such research (e.g., a research protocol) for certification; however, the IRB no longer is required to review and approve the research grant application or proposal.

Limited IRB Review for Exempt Research (46.104)

The 2018 Rule institutes a new process "Limited IRB Review" to provide a special review for certain activities including the collection of sensitive, identifiable data that are now allowable under certain parts of Exemption #2 and Exemption #3, as well as for Exemptions #7 & #8, but are required to receive a Limited IRB Review for privacy/confidentiality protections.

(Please note: at the current time Columbia has no plans to review under exemption categories #7 and #8.)

Informed Consent

For a printable document with a side-by-side comparison of Pre-2018 and 2018 informed consent requirements please click here.


Changes to the Consent Process and Forms

The revised Common Rule includes changes to the General Requirements for Informed Consent that are intended to promote autonomy.  Accordingly, all non-exempt new protocols submitted for review and approval on or after January 21, 2019 must include the new consent requirements. In particular, the description of the informed consent process on the Recruitment and Consent page in Rascal should consider the additional New General Requirements for Informed Consent (see below) and the consent forms/information sheets submitted with new protocols for approval on or after January 21, 2019 must include the new basic (see below)  and additional (see below) elements of consent for consideration by the IRB. 

We strongly encourage all consent documents for new protocols submitted before January 21, 2019 to include these elements to facilitate review and approval of your protocol in compliance with the 2018 requirements in the event the protocol is approved on or after January 21, 2019. 

 Subsection 46.116(a)(4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.   

Subsection 46.116(a)(5)(i) 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. This part of the informed consent must be organized and presented in a way that facilitates comprehension. 

Subsection 46.116(a)(5)(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

And, when a short form consent process is used - Subsection 46.117(b)(2) A short form written informed consent form stating that the required elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative and that the key information required by 45 CFR 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided.

In addition to the existing basic elements of informed consent, the following must be included in the consent form/information sheet, if applicable:

To satisfy the requirements of 46.116(a)(5)(i), a new section presented at the beginning of the consent document should include "key information" that provides a concise summary of the research study.

  • For Rascal generated consent forms, the section should be placed in the “General Information” section until such time as a new section in Rascal has been created.
  • For non-Rascal generated consent forms, the section should be placed after the study title and PI contact information. 
  • For more information see instructions for "Key Information for Informed Consent"

In addition to the existing basic required elements of consent, one of the following statements (45 CFR 46.116(b)(9)) must be added if the research involves the collection of identifiable private information or identifiable biospecimens:

  1. A statement that identifiers might 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, if this might be a possibility; or
  2.  A statement that the subject’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.

In addition to the existing additional elements of consent, the following elements should be added as applicable (45 CFR 46.116(c)(7) - (9)):

  • 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; and
  • - For research involving biospecimens, whether the research will (if known) 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).

Completing a concise summary of "Key Information about this research study"

This section of the consent should include a concise summary of the key information that a reasonable person would want to know, in order to help potential research subjects understand why they might or might not want to participate. It is expected that this initial presentation of the key information will be relatively short and should be limited to no more than 1 or 2 pages for consent forms that includes more than 20 pages. For shorter consent forms, this summary should be less than 1 page. Straightforward consent (and assent) forms for non-complex protocols (e.g., that do not contain a complicated methodology) and that are 5 pages or less in length would generally not require a summary of key information. These consent forms are to be presented and organized in a way that facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate

Some of the information provided in this section may not need to be repeated in the subsequent sections and reference to additional information in other sections can be made. For some studies, it might be possible to incorporate all required elements into this section, as long as the presentation of that information remains concise and focused. For example, if the study poses no or limited risk and those risks are described in this section, they do not have to be repeated in the RISKS section of the consent form. However, studies with extensive risk profiles for example, should elaborate upon the risks in the RISKS section of the consent form.

This summary should include the most pertinent fact-specific information about this study and should address the following items:

  • That consent is being sought for research and that participation is voluntary
  • A brief summary of the purposes of the research
  • A brief description of the main study procedures (for example, tasks the subject will have to complete, activities the subject will have to avoid). [When writing this section, consider providing responses to the following questions: What are themain reasons a subject will want to join this study? What are the main reasons a subject will not want to join this study? Describe the main things the study will require of the subject (for example, study procedures, tasks the subject will have to complete, activities the subject will have to avoid)]
  • Duration of participation
  • The most likely risks or discomforts to the prospective subject; [for clinical trials, this section should not list all the risks but identify the risks that would be of highest significance to the subject population, similar to the information that a doctor might deliver in the clinical context in telling a patient how sick the chemotherapy drugs will make them, but with a particular emphasis on how those risks are changed by participating in the study.] 
  • The most likely benefit(s), if any
  • Appropriate alternative procedures or courses of treatment, if any that might be advantageous to the potential subject. [When writing this section, consider providing responses to the following questions: What impact will participating in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?  How will the subjects’ experience in this study differ from treatment outside of the study? In what ways is this research novel?]

Example template language: 

The purpose of this study is…

The procedures in this study are …    We will ask you to do…  The time frame for the study is… The detailed information in sections XX and XX below gives full instructions, and the full schedule for visits is in section XX.

The reasons you might not want to participate in this study are…  Risks include… All of the known risks are listed in section XX.

The reasons you might want to participate in this study are… For a complete description of possible benefits, please see Section XX below.

Instead of volunteering for this study, you have other choices… You can choose to get treatment from your doctor or clinic, or from [name/clinic]. You can find out if there are other studies that may be of more interest to you [add how to find out]. If you decide to take part in the study, it should be because you really want to volunteer. You can choose to withdraw at any time during the study.  If you choose not to volunteer you will not lose any services, benefits, or rights you would normally have.

If you are interested in learning more about this study, please read the details below.

Changes to Waiver of Informed Consent Criteria (46.116(f))

The 2018 Requirements add an additional criterion (to the four existing criteria) that a justification must be provided that the use of identifiable private information or identifiable biospecimens could not be practicably carried out without using such information/specimens in the identifiable form.

Changes to Waiver of Documentation of Consent (46.117(c))

An added criterion allows waiver of documentation of consent if subjects are members of a distinct cultural group or community in which signing forms is not the norm (provided there is an appropriate alternative mechanism for documenting that consent was obtained, and the study presents no more than minimal risk.

Keep in mind that if your consent process involves enrolling individuals orally, you must document in the consent process/subject record that the elements of informed consent required in §46.116 were presented orally to the subject or the subject's legally authorized representative, and that the key information required by §46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided.

Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted under the 2018 Requirements as an alternative to the informed consent requirements. It provides for a one time consent, with specified consent elements,  for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. (46.116(d))

Refusal of broad consent eliminates future waiver of consent by the IRB.

Columbia has no plans to implement broad consent at this time.

In accordance with the 2018 requirement 46.116(h) below, for federally-sponsored clinical trials,* a copy of the consent form must be posted on a “Federal Web site that will be established as a repository for such informed consent forms.” 

At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).  HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement. 

Please click here for instructions on Uploading a  Clinical Trial Informed Consent form to Regulations.gov and Uploading a Clinical Trial Informed Consent form to ClinicalTrials.Gov


*(OHRP defines a clinical trial as: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to   evaluate the effect of the interventions on biomedical or behavioral health-related outcomes.”

46.116(h):

(h) Posting of clinical trial consent form. (1) For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.

(2) If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.

(3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

Definitions

Definition of Human Subject

Pre-2018 Rule

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.

Revised Common Rule

 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.

Definition of Research

Pre-2018 Rule

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

Revised Common Rule

There is no change to the definition of research in the revised common rule.

However, the following activities are now deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Exemptions - New and Revised

For a printable document with a side-by-side comparison of Pre-2018 and 2018 exemption requirements please click here.


Limited IRB Review for Exempt Research (46.104)

The 2018 Rule institutes a new process "Limited IRB Review" to provide a special review for certain activities including the collection of sensitive, identifiable data that are now allowable under certain parts of Exemption #2 and Exemption #3, as well as for Exemptions #7 & #8, but are required to receive a Limited IRB Review for privacy/confidentiality protections.

(Please note: at the current time Columbia has no plans to review under exemption categories #7 and #8.)

Exempt Research and Prisoners (46.104(a)(2))

Under the Pre-2018 Rule, exemptions do not apply to research involving subjects in Subpart C. The 2018 Rule remains the same for research focused on a prisoner population, but adds an exception for research aimed at involving a broader subject population that only incidentally includes prisoners.

Exemption #1 (46.104(d)(1))

Revisions to Exemption #1 provide a clarification on risk (the revisions are bolded):

(1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exemption #2 (46.104(d)(2))

Revisions to Exemption #2 specify research activities that can be reviewed under this category and adds a provision for Limited IRB Review for protocols collecting sensitive and identifiable information (the revisions are bolded):

(2) Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

Exemption #3 (46.104(d)(3))

Exemption #3 is completely new. It provides criteria for research involving benign behavioral interventions, and includes Limited IRB Review for protocols collecting sensitive and identifiable data:

(3)(i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

(B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or

(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

(ii) For the purpose of this provision, 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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Exemption #4 (46.104(d)(4))

Revisions to Exemption #4 specify that research activities are no longer limited to retrospective data review and permit secondary use of identifiable protected health information (PHI) with HIPAA privacy board review (the revisions are bolded):

(4) Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Exemption #5 (46.104(d)(5))

No substantive changes were made to Exemption #5. The revisions reflect clarifications to and changes in organization of the material (the revisions are bolded):

(5) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Exemption #6 (46.104(d)(6))

No changes were made to Exemption #6:

(6) Taste and food quality evaluation and consumer acceptance studies:

(i) If wholesome foods without additives are consumed, or

(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exemptions #7 and #8 (46.104(d)(7) and (8))

Exemptions #7 and #8 are both completely new.

At the current time Columbia has no plans to review under these exemption categories.

Exemption #7 involves storage and maintenance of identifiable data and/or biospecimens for future research collected under broad consent (i.e. creation of a repository) and requires Limited IRB Review.

(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

Exemption #8 involves the use of biospecimens collected under broad consent and requires Limited IRB Review.

(8) Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d);

(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;

(iii) An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Cooperative Research

All federally funded studies where more than one site is conducting the same protocol must be reviewed by a Single IRB (sIRB).  Use of a sIRB for review of cooperative research funded by other Common Rule agencies will be required by January 20, 2020. (§46.114(b)) More information about the sIRB process at Columbia is available here.

§46.114(b)  Cooperative research (full text):

(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.

(b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

(2) The following research is not subject to this provision:

(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or

(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.

(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.