Revised Common Rule
Important changes to Human Subjects Research to address 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,|
|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)||Texas A&M 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 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.
|New and Revised Definitions (45 CFR 46.102)||Texas A&M 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)||Texas A&M 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 publicly 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)||Texas A&M 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)||Texas A&M 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 publicly 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 Texas A&M 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)||Texas A&M 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 Texas A&M 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)||Texas A&M 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; Texas A&M will apply this provision to federally funded research, only. Texas A&M 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.|
Exempt research is a specific sub-set of human subjects research that is defined in section 46.104 of the Common Rule (2018 Requirements (2018 Common Rule) | HHS.gov). Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories found in the federal regulation.
Studies that qualify for exemption must be submitted to the IRB for review before starting the research. Pursuant to Texas A&M policy, investigators do not make their own determination as to whether a research study qualifies for an exemption — the IRB issues exemption determinations.
There is a separate IRB application form in iRIS (https://iris.tamu.edu) for studies that could qualify for exemption. To activate the exempt form, select “Yes” in section 4.3 of the application. The exempt application is designed to help investigators determine if their research fits into one of the 2018 Common Rule exemption categories and reduces the number of fields that need to be completed on each application. Researchers have the ability to expand each exempt category so all questions are visible before making a category selection.
Although the 2018 Common Rule lists eight exemption categories, Texas A&M has opted to implement categories 1 through 6 at this time. Categories 7 and 8 require broad consent. Texas A&M University has not implemented broad consent.
Ethical Guidelines for Informed Consent
The Texas A&M Federal wide Assurance (FWA) assures the federal Office of Human of Human Research Protections (OHRP) that all human subjects research conducted by this institution regardless of support will be guided by the principles found in the Belmont Report for protecting the rights and welfare of human subjects.
The Belmont principle of Respect for Persons generally requires that subjects be given the opportunity to choose whether or not to participate in research. For this reason, voluntary informed consent should be obtained from participants for any exempt research where the investigator will be collecting data through interaction or intervention with participants. For exempt research studies that will collect data through interaction or intervention with participants, the Texas A&M IRB expects that researchers provide participants with consent information that includes, at a minimum:
- An explanation that they are being asked to participate in a research study.
- The identity and affiliation of the researcher(s).
- A clear description of the study procedures
- Provisions to maintain privacy/confidentiality and who will have access to data
- How data will be used in the future, when applicable.
- A statement that participation in the research is voluntary.
- Information about any payments to participants, when applicable.
- Contact information for questions and concerns about the research.
Exempt Determinations are valid for 3 years from the determination date. Studies that qualify for an exemption do not undergo continuing review or the annual administrative check-in process. However, researchers are expected to submit a Study Completion/Closure Report when research activities are complete. Any exempt study that is more than 30 days past the determination end-date is subject to administrative closure by the IRB.
Modifications to Exempt Research
Modifications to exempt studies are limited. Exempt research is not meant to include umbrella studies or studies that will undergo significant changes. Minor changes are allowed so long as the research remains minimal risk and stays within the boundaries of the previously determined exemption categories.
Examples of Minor Changes that are Permitted on Existing Exempt Research
- Correcting grammatical or typographical errors on study documents seen by participants
- Minor corrections to survey/interview questionnaires
- Using a new survey hosting platform (e.g., Qualtrics, mTurk, Prolific)
- Changes in payments to participants
- Adding new recruitment materials (e.g., flyers, email recruitment script)
- Adding a translated document that was previously approved
- Updating study personnel
- Increasing number of participants
- Adding a funding source
- Adding an additional site
Any proposed change that increases the risks to participants, changes the study design, changes the research questions/hypothesis or adds vulnerable populations will likely require a new IRB application.
Examples of Changes That Will Likely Require a New IRB Application or Different Level of IRB Review:
- Adding sensitive questions to a survey or interview process (e.g. questions regarding illegal activities; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation).
- Major revisions to the consent process and/or document
- Adding new experiments or testing a new hypothesis
- Adding deception or using incomplete disclosure
- Changes to the data protection plan which may affect confidentiality.
- Adding procedures that do not fit within the exemption categories.
- Adding new types of participants to the study that include vulnerable populations (e.g., adding children, individuals with cognitive impairments, prisoners, etc.)
Exempt studies may also be subject to the HIPAA Privacy Rule. For instance, a study involving medical record review to gather a dataset that would be eligible for Exemption Category 4 involves access to Protected Health Information (PHI) and should request a waiver of HIPAA authorization.
Limted IRB Review
Exempt categories 2 and 3 may require Limited IRB review. Limited IRB Review is a new type of review required by the revised 2018 Common Rule. The IRB has to determine if there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data when 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.
Restrictions on Exemptions
Studies that are greater than minimal risk do not qualify for exemption.
Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].
Exemption 2(iii) and Exemption 3 do not apply to research with children.
Exemptions other than Exemption Category 6 do not apply to FDA-regulated research.
See table below for a list of the Exempt Research Categories [45 CFR 46.104] with additional guidance.
|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 Texas A&M 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 biospecimens. 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; orIdentifiable 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||(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 non-research 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. (4) (iii) Research use of identifiable information regulated under HIPAA is only applicable within a covered entity and does not apply to HIPAA information that is disclosed to a non-covered entity. 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).||Texas A&M University has not implemented broad consent. 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.||Texas A&M University has not implemented broad consent. 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.|
General Requirements for Informed Consent (DHHS 45 CFR 46.116)
Basic elements of Informed Consent
Additional element of Informed Consent, as applicable
Additional Consent requirements for FDA regulated research/clinical trials under ICH-GCP
Additional NIH Consent Requirements
DHHS 45 CFR 46.116
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.”
|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://grants.nih.gov/policy/humansubjects/coc/suggested-consent.htm||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.
- 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