Revised Common Rule

Important changes to Human Subjects Research to address the revised Common Rule

 

Temporary Freeze on New Initial IRB Applications

Exceptions to the Freeze

Applicability of the Revised Common Rule

Summary of Key Changes to the Common Rule & TAMU Implementation Plan

Revised Exempt Categories

Informed Consent Guide for all Non-Exempt Human Subjects Research

TAMU Guidance for Continuing Review & Annual Administrative Check-In 

 

 

 Temporary Freeze on New Initial IRB Applications

The implementation date for the revised Common Rule is January 21, 2019. Because the revised rule does not provide for a transitional period, the IRB is implementing a freeze on new initial IRB applications effective January 1, 2019 that will continue until January 21, 2019

The freeze does NOT impact existing research that has already received IRB approval.  There are also a number of exceptions to the freeze (see below). 

The IRB is making an effort to process currently submitted initial applications prior to January 21, 2019. 

All new initial applications submitted on or after January 21, 2019 must follow the revised Common Rule and/or the TAMU HRPP updated requirements which allow maximum flexibility.

Exceptions to the Freeze 

Investigators should continue to submit personnel changes, amendments, continuing reviews and reportable safety or compliance events for any study that has already received IRB approval.

New research projects that have funding or other significant deadlines prior to January 21, 2019 will be accepted for processing.

Please note that any study that receives IRB approval prior to January 21, 2019 will remain under the current Common Rule and will not be transitioned to the revised Common Rule.

Applicability of the Revised Common Rule

 

Research Type

Conversion status of existing research approved or exempted before Jan. 21, 2019 New Research approved or exempted on or after
Jan. 21, 2019

FDA Regulated

Conversion 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 conversion of already approved research to the revised Common Rule. Federal research approved prior to Jan. 21, 2019 will remain under the ‘old’
Common Rule: 45 CFR 46 (2009)
All federally funded research must follow the revised 2018 Common Rule (July 19,
2018.)

DOJ Research

Conversion is not applicable. DOJ research must continue to follow the ‘old’ Common Rule 45 CFR 46 (2009) until
DOJ becomes signatory to the revised rule.

*unregulated

 

*All other non-federal, non-FDA research

There will be no conversion of already approved research to the revised Common Rule or hybrid policy. Research approved prior to Jan. 21, 2019 will remain under the ‘old’ Common Rule: 45 CFR 46 (2009) TAMU will follow a hybrid policy to maximize flexibility by choosing many of the
least restrictive requirements from both the ‘old’ Common Rule (2009) and the
revised Common Rule (2018).
Texas A&M University IRBs will not convert exiting studies to the revised Common Rule. All studies approved prior to January 21, 2019 will remain regulated by the current (2009) Common Rule until closure of the studies. This is due to the volume of studies and additional documentation needed from the investigators and the IRB to meet the requirements of conversion to the revised Common Rule.
 

Summary of Key Changes to the Common Rule and TAMU Implementation Plan

  
New and Revised Definitions (45 CFR 46.102)  TAMU Implementation Actions Impact on Investigators

Exclusions to Research:

  • Scholarly and journalistic activities (e.g. oral history, journalism, biography, legal research and historical scholarship;
  • Public health surveillance activities when conducted, supported, requested or authorized by a Public Health Authority;
  • Collection and analysis of information, specimens, or records, by or for a criminal justice agency for certain criminal justice or investigative purposes;
  • Certain authorized operational activities for national security purposes;

 

Addition of Clinical Trial:

Clinical trial means 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 effects of the interventions on biomedical or behavioral health-related outcomes.

Revision to Human Subject:

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.

Revision to Intervention

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.

Addition of Identifiable Biospecimen:

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.

Addition of Public Health Authority:

Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

Addition of meaning of written or writing:

Written, or in writing, for purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.

Note: this definition was updated to recognize the use of electronic consent and electronic signature

SOPs and guidance will be updated to include the new or revised definitions.

The revised definitions will be applicable to all new non-FDA regulated research including federally funded or unfunded research as of Jan. 21, 2019.

Investigators need to be aware of changes to definitions that may affect the inclusion or exclusion of certain activities as research.

Any study meeting the definition of Clinical Trial has additional requirements.

The revised Common Rule emphasizes protecting the rights and confidentiality of subjects related to their identifiable private information or identifiable specimens.

New and Revised Exempt Categories (45 CFR 46.104)

TAMU Implementation Actions Impact on Investigators

Category 1:

Restriction added to prevent adverse impact on students or educators in research involving normal educational practices;

Category 2:

Expanded to include research using visual or auditory recordings; surveys and interviews cannot include research interventions or children; identifiable information must have Limited IRB Review;

Category 3:

Changed to research involving benign behavioral interventions with adults; no deception unless subject prospectively agrees; limited to verbal or written responses or audiovisual recording; data is de-identified or must have Limited IRB Review.

Benign Behavioral Interventions are defined as brief in duration, harmless, painless, non-invasive, no significant adverse lasting impact and not offensive or embarrassing.

Category 4:

Secondary research of identifiable private information or identifiable specimens if there are no identifiers or the data is already regulated through HIPAA; Data or specimens no longer have to be existing;

Category 5:

Federal Agency Research or Demonstration Projects; now must be publically posted;

Category 6:

Taste and Food Quality Evaluation and Consumer Acceptance Studies; (no change)

Category 7:

New category for storage or maintenance of identifiable private information or identifiable biospecimens for secondary research where broad consent and Limited IRB Review is required.

Category 8:

New Category for secondary research that uses identifiable information and biospecimens obtained through broad consent requiring Limited IRB Review.

SOPs and guidance will be updated to include the new or revised exemption categories.

The revised categories will be applicable to all new non-FDA regulated research including federally funded or unfunded research as of Jan. 21, 2019.

Investigators
should become familiar with the new exemption categories to know which ones may
require additional provisions for an Exemption Determination.

Continuing Review Changes (45 CFR 46.109)

TAMU Implementation Actions Impact on Investigators
Continuing review is no longer required for many categories of minimal risk research.

SOPs and guidance will be updated to change the requirements for continuing review on at least an annual basis to an Annual Administrative Update process.

The Annual Administrative Update process will be applicable to all new non-FDA regulated research including federally funded or unfunded research as of Jan. 21, 2019.

AAHRPP accreditation element II.2.f.2 requires accredited organizations to use an alternative administrative process to maintain oversight of research if continuing review is eliminated.

 

The Annual Administrative Update process will ask the investigators a few key questions that will be processed by the HRPP staff and will not require IRB review unless issues are identified.

Although, the regulations no longer require continuing review for certain categories of minimal risk research the investigators must be aware that the following requirements are still intact:

  • Any changes to the research must be submitted to the IRB for review and approval prior to implementation;
  • Unanticipated problems or other reportable events as described in SOP HRP-029 must be reported to the IRB within 5 days of learning about the incident;
  • Notifying the IRB of study completion;
  • All FDA regulated research and any study greater than minimal risk still requires annual continuing review.
  • Continuing Review is still required for all research approved before January 21, 2019 up until notifying the IRB of study closure;
  • Upon initial review of any protocol, an IRB member may still request annual continuing review of any research if it would enhance the protection of subjects and the rationale is documented in the IRB records.

Informed Consent Changes (45 CFR 46.116)

TAMU Implementation Actions Impact on Investigators

There are several changes to informed consent such as:

The Reasonable Person Standard:

  • The subject or Legally Authorized Representative must be provided the information a reasonable person would want to make a decision about participation in research;

 

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.

 

New Elements of Informed Consent:

  • Statements regarding the use of private information or identifiable biospecimens, any future research and whole genome sequencing;
  • Statement about commercial profit and any sharing of the profits;
  • A statement about whether or not the subjects will receive clinically relevant results;

 

Posting of Consent on Website:

  • Studies meeting the definition of clinical trial must post a consent form on a publically available Federal website;
  • Posting must occur no later than 60 days after the last study visit by any subject and may not be made any earlier than the day of the last visit by any subject.

 

Consent for Screening Procedures Changed:

  • IRBs may approve a research proposal for obtaining information or biospecimens for screening, recruiting or determining study eligibility subjects without informed consent if the information is obtained through oral or written communication with the subject; or the investigator obtains identifiable private information or identifiable specimens by accessing records or stored specimens;

 

Broad Consent for Secondary Research:

  • Broad consent is a means of enabling subjects to agree to a range of possible secondary uses of their identifiable private information or biospecimens in future research
  • Institutions must have a verified means of tracking declines and changes;
  • When broad consent is used the IRB can no longer use waivers to cover those that did not consent.
Broad consent is optional and no requirement to implement.

SOPs and guidance will be updated to include the new or revised elements and information requirements.

The changes to informed consent will be applicable to new federally funded research, only, as of Jan. 21, 2019.

The new consent requirements will not apply to non-federal (unregulated) or FDA regulated research.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

Broad consent will not be implemented at this time. Additional guidance from OHRP and university officials is needed prior to consideration of this process.

Most of research at TAMU is minimal risk and accompanied by consent documents that are 3 or 4 pages or less.

The changes required by the revised rule will have minimal impact on research that is considered minimal risk. 

Investigators conducting federally funded research must comply with the consent provisions as stipulated in the revised consent section 46.116 as of Jan. 21, 2019.

Investigators conducting clinical trials should become familiar with the required changes.

Written Documentation of Consent (45 CFR 46.117) TAMU Implementation Actions Impact on Investigators
Electronic signatures are now recognized as written or in writing.

SOPs and guidance will be updated to address electronic signatures for all categories of research.

The use of electronic signatures should be consistent with university SAPs and TAMU IT requirements.

FDA research must meet electronic signature requirements found in 21 CFR Part 11.

Investigators will no longer need to request a waiver of written documentation of consent when the research utilizes electronic signatures

Cooperative Research (45 CFR 46.114)

TAMU Implementation Actions Impact on Investigators
  • Mandates the use of a Single IRB for cooperative research that involves more than one U.S. institution;
  • IRB reliance agreements have additional requirements to document the responsibilities of each party.

This regulation will go into effect on January 20, 2020;

TAMU will apply this provision to federally funded research, only.

TAMU will join consortiums such as SMART IRB to facilitate the single IRB review process.

The primary or lead institution may name the single IRB but the federal agency approval is required.

Federal agencies can make exceptions if single IRB review is not appropriate for the context.

Federal grants may have to budget for single IRB review expenses.

 

Revised Exempt Categories

What does Exempt mean?

  • The research is exempt from the requirements of the Common Rule
  • However, certain categories of exemptions are not completely exempt from the Common Rule. Categories 2, 3, 7 & 8 may now require limited IRB review.
  • Exempt from the Common Rule does not mean exempt from other applicable requirements such as HIPAA, FERPA, and TAMU policies

Who can make the determination that research is Exempt?

  • Investigators are required to send their research to the IRB through an iRIS application for an exemption determination.

What are some of the new terms included in the revised Common Rule that apply to Exemptions?

  • Limited IRB Review
    • This is a new category of IRB review carried out by an experienced member of the board. Limited IRB review applies to four exempt categories: 2, 3, 7 and 8.
    • Limited IRB review is making and documenting the determination required by 46.111(a)(7), to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens in the proposed research.
  • Benign Behavioral Interventions
    • This term applies to exempt category 3.
    • Benign behavioral interventions are defined as: brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on subjects and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
  • Secondary Research
    • Secondary research refers to research use of information or biospecimens for a purpose other than the original purpose(s) for   which it was collected, such as:
      • Research projects other than the proposed one, or
      • Non-research purposes (e.g., clinical care)
    • Research involving interactions or interventions with  human subjects to collect information or biospecimens for the proposed research is never secondary research;
    • Data or specimens collected specifically for use in the proposed research is not secondary use even if all the collection activities occur at other institutions.
  • Broad Consent
    • Broad consent is used as a means of enabling subjects to agree to a range of possible secondary uses of their identifiable private information or biospecimens in future research:
      • This includes the storage, maintenance, and secondary research use of identifiable  private information or identifiable biospecimen
      • The information or biospecimens are currently being collected for  a different research study, or for non-research  purposes (clinical care).
    • Broad consent must contain all the information described in 45 CFR 46.116;
    • The use of broad consent is completely optional and no institution is required to implement broad consent;
    • Texas A&M University does not have plans to implement broad consent at this time until further guidance has been provided by OHRP. Many other academic or medical institutions are waiting for further guidance, too.
    • The IRB is not allowed to issue waivers of consent when subjects decline to sign broad consent.
    • Institutions must have adequate means of tracking refusals and withdrawals of consent.
Category Regulation Changes and Clarifications
1

(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. 

Link to OHRP SACHRP guidance on Exempt Categories 1 and 2: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-november-13-2018/index.html

  • A restriction was added to prevent the research from taking time or attention away from the regular curriculum, which could have a negative or adverse impact on the student’s education or the teacher’s evaluation.
  • This exemption can only be used for research about normal educational practices;
2

(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 Sec. __.111(a)(7).

  • The word ‘only’ was added to clarify that interactions involving educational tests, surveys, interviews and observation of public behavior cannot include interventions;
  • The research cannot be damaging to ‘educational advancement’ was added as a restriction.
  • The category was expanded to now allow visual or auditory recordings;
  • Recorded data must be de-identified; or
    • Identifiable data is allowed for adults if there is no increased risk of any type of harm; or
    • The IRB conducts limited IRB review for privacy and confidentiality protections.
  • Children are not allowed if the investigator  participates in the educational tests or the observation of public behavior;
  • Children are not allowed in survey or interview research;
  • Researchers cannot record the identity of children or retain a code or link to their identity.
3

(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 Sec. __.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.

Link to OHRP SACHRP guidance on Exempt Categories 3: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-b-august-2-2017.html

  • This category was changed to research involving benign behavioral interventions with adults;
  • No deception is allowed unless the subject prospectively agrees that they will be unaware of or misled regarding the nature and purpose of the research;
    • Researchers should include debriefing after the study for any activity that includes deception.
  • Data can only be collected using verbal or written responses or audiovisual recording; Data cannot be recorded using sensors, trackers, swabs or devices applied or used on subjects.
  • Data must be de-identified; or Identifiable data is allowed for adults if there is no increased risk of any type of harm or the IRB conducts limited IRB review for privacy and confidentiality protections.
  • Brief in duration means a few minutes and total time cannot exceed a few hours; the intervention does not have to occur in a single session but should occur on a single day.

(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 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.

  • Secondary research refers to research use of information or biospecimens for a purpose other than the original purpose(s) for which it was collected such as:
    • Research projects other than the proposed one, or
    • Non-research purposes (e.g., clinical care)
    • Data or specimens collected specifically for use in the proposed research is not secondary use even if all the collection activities occur at other institutions.
    • Sometimes secondary use is not humans subjects research.

 

  • Data or specimens no longer have to be existing.
  • Research use of identifiable information regulated under HIPAA requires an existing written Authorization or existing Waiver of Authorization, Data Use Agreement or Business Associate Agreement if the data is not recorded without identifiers, codes or links.
  • Investigators must not attempt to re-identify or contact the research subjects.
5

(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.

(ii) [Reserved]

  • Researchers will not likely use this category (unless under an explicit Federal contract) as it allows the federal government to examine its public benefit and service programs.
  • The research or demonstration project must be posted on a federal website before involving human subjects.
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.

There are no changes to exempt category 6.
7

(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 Sec. __.111(a)(8).

  • This is a new category that can only be used when broad consent is in place. It allows the storage and maintenance of private identifiable data or specimens.
  • Broad consent does not allow the IRB to waive consent if someone refuses to participate or withdraws their consent;
  • The IRB must conduct limited IRB review and confirms that broad consent was obtained, there is documentation of consent or a waiver of documentation, and adequate privacy and confidentiality protections are in place.
8

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 Sec. __.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 Sec. __.117;

(iii) An IRB conducts a limited IRB review and makes the determination required by Sec. __.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.

  • This is a new category that requires broad consent to be in place. It allows secondary analysis of existing private identifiable data and identifiable biospecimens without additional consent if broad consent was obtained in accordance with the criteria established at 45 CFR 46.(d); and
  • The IRB conducts limited IRB review; and confirms that broad consent was obtained, there is documentation of consent or a waiver of documentation, and adequate privacy and confidentiality protections are in place.
  • The investigator may not return the results of the research to the subject except when required by law.

 

Informed Consent for all Non-Exempt Human Subjects Research

 

DHHS 45 CFR 46.116

*General Requirements for Informed Consent: Applicability
(a) (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative unless the IRB has approved a waiver or alteration of informed consent. All Research

(a) (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.

All Research
(a) (3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative All Research
(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. All Federally funded or supported research
approved on or after 1/21/2019
(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 All Federally funded or supported research
approved on or after 1/21/2019
(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. All Federally funded or supported research
approved on or after 1/21/2019
(a) (6) No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. All Research
(h) Clinical trials are required to post an IRB approved consent document on a Federal website when the clinical trial is closed to recruitment but no later than 60 days after the last subject's last study visit required by the protocol. All Federally funded or supported research
approved on or after 1/21/2019
*Basic elements of Informed Consent that must be provided to participants unless the IRB has approved a waiver or alteration of Informed Consent: Applicability
(c) (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental; All Research
(b) (2) A description of any reasonably foreseeable risks or discomforts to the subject; All Research
(b) (3) A description of any benefits to the subject/others that may reasonably be expected from the research; All Research
(b) (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; All Research
(b) (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; All Research
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; All Research
(b) (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; All Research
(b) (8) 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; and All Research

(b)  (9)One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:

a.  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

b. 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

All Federally funded or supported research
approved on or after 1/21/2019
*Additional elements of informed consent that must be provided when appropriate to participants, as applicable: Applicability
(c) (1) A statement that the particular treatment or procedure may involve risks to the subject (or to  the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable; All Research
(c)  (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent; All Research
(c) (3) Any additional costs to the subject that may result from participation in the research; All Research
(c) 4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; All Research
(c) (5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject in a timely manner. All Research
(c) (6) The approximate number of subjects involved in the study; All Research
(c) (7) 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; *All Research
(c) (8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and *All Research
(c) (9) 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). *All Research
 

FDA 21 CFR 50.20 and 25

Good Clinical Practice ICH E6 (R2)

*Additional consent requirements that must be provided to participants for FDA regulated research or clinical trials subject to ICH-GCP E6 (R2) requirements, as applicable:

Applicability

A statement about the possibility that the FDA may inspect the study records should be included in the confidentiality section;

FDA Research

A statement that data collected on the subject until the point of withdrawal will remain as part of the study records and may not be removed;

FDA Research
Applicable clinical trials must include the statement: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You
can search this Web site at any time.”
FDA Research
The investigator will ask a subject who is withdrawing from study procedures whether the subject wishes to provide further data collection associated with their routine medical care. FDA Research
A statement about IRB approval of the research. FDA/GCP research
The probability of randomization to different study groups and an explanation of randomization. FDA/GCP research
The reasonably foreseeable risks or inconveniences to an embryo, fetus, or nursing infant. FDA/GCP research
The subject’s responsibilities in the trial; FDA/GCP research

Information about payment  or reimbursement including but not limited to amount, schedule of payment and any anticipated prorated amount.

FDA/GCP research
When there is no intended clinical benefit to the subject, a statement that indicates such. FDA/GCP research
A statement that regulatory authorities may be granted direct access to study records or medical records without violating confidentiality to the extent permitted by applicable laws and the subject or their legally authorized representative is authorizing such access by signing the consent document. FDA/GCP research

A statement that records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are   published, the subject’s identity will remain confidential.

FDA/GCP research
Additional NIH Consent Requirements Applicability

NIH expects researchers will inform participants about the protections afforded by the Certificate and any exceptions to that protection. See suggested language on NIH website:

https://humansubjects.nih.gov/coc/suggested-consent-language

NIH Research
The informed consent documents are to be consistent with the data use on studies involving the NIH Genomic Data Sharing (GDS) Policy.  NIH expects investigators to obtain consent to share participants' genomic and phenotypic data broadly through databases. Include language to specify if the data will be shared via unrestricted- or controlled-access databases, or both NIH Research
NIH Funded Clinical Trials clinical trials statement regarding registration and results posting on Clinicaltrials.gov; and the  posting of an IRB approved consent document on a public federal government website after the recruitment closes, and no later than 60 days after the last subject’s last study visit; NIH Research

* The IRB may require additional elements in the informed consent if it will enhance the protection of subjects regardless of category, funding agency or no funding.

 

 

TAMU Guidance for Continuing Review and Annual Administrative Check-In

 

  • As part of Texas A&M University’s Flexibility Policy, the HRPP will implement an Annual Administrative Check-in for certain minimal risk categories of research that do not require continuing review under the revised Common Rule. 
  • The Annual Administrative Check-in will ask a few key questions that will be processed by the HRPP staff and will not require IRB review unless issues are identified.  
  • The Annual Administrative Check-in will be processed through iRIS. 
  • Upon initial review of any protocol, the regulations allow an IRB member to request annual continuing review of any research if it would enhance the protection of subjects and the rationale is documented in the IRB records. 
  • AAHRPP accreditation element 11.2.f.2 requires accredited organizations to use an alternative process to maintain oversight of research if continuing review is eliminated.

 

Research Type Continuing Review Required Annual Administrative Check-in Required

 

 

 

GREATER than MINIMAL RISK

 

 

 

  • The continuing review requirements for any research determined to be greater than minimal risk remain unchanged.
  • Investigators are required to submit a continuing review no less than annually as determined by the IRB.

 

 

 

Not Applicable

 

 

 

 

 

 

 

FDA REGULATED

 

 

 

  • The continuing review requirements for FDA regulated research remain unchanged.
  • Investigators are required to submit a continuing review no less than annually as determined by the IRB.
  • Research must continue for follow FDA regulations:

       21 CFR Parts 50 & 56

 

 

 

 

Not Applicable

 

 

 

FEDERAL RESEARCH - Minimal Risk (except DOJ)

 

Not Applicable

An Annual Administrative Check-in with a few key questions will be required until study closure; Iris will notify investigators of due date.

 

 

 

DOJ Research

  • The continuing review requirements for DOJ regulated research remain unchanged at this time.
  • Investigators are required to submit a continuing review no less than annually as determined by

 

 

Not Applicable

(DOJ has not become a signatory to revised Common Rule)

 

*UNREGULATED MINIMAL RISK RESEARCH

 

Not Applicable

An Annual Administrative Check-in with a few key questions will be required until
study closure; Iris will notify investigators of due date

 

Exempt Research

 

Not Applicable

An Administrative Check-in with a few key questions will be required every 3 years until study closure. Iris will notify investigators of due date.

* All other non-federal, non-FDA research