IMPORTANT UPDATES

This page contains important updates and announcements from the Mercer University Office of Research Compliance (ORC) and Institutional Review Board (IRB). This page will be updated if/when guidance is issued from OHRP and when additional policies have changed. During this transitional period, the ORC website will be undergoing revisions to ensure the information we present to investigators accurately reflects Common Rule changes. As we update our site, please continue to visit this page for the most current information regarding upcoming dates and changes to federal regulations that may affect your research.

If you have questions, please contact the Mercer University Office of Research Compliance by phone (478) 301-4101 or by email ORC_Research@Mercer.edu.

Upcoming Dates

The following dates are subject to change.

Effective dates for federal regulations are still being determined. Please visit this page for updates regarding delays and any changes to implementation dates.

January 25, 2018

Effective date of the NIH's Single IRB Policy for NIH funded research

May 28, 2018

Revised Mercer University Protocol Forms and Applications take effect (following this date, versions of forms and applications dated prior to January 2018 will no longer be accepted - revision/version dates are located in the bottom left corner of all Mercer Protocol Forms and Applications)

July 19, 2018

2018 Common Rule takes effect

January 2020

Single IRB (sIRB) requirements take effect

For upcoming meeting dates and submission deadlines, please see the IRB Meeting Schedule.

Changes to the Common Rule - Effective July 19, 2018

Final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") were issued by the U.S. Department of Health and Human Services (HHS) on January 18, 2017. On January 17, 2018, the HHS and 15 other federal departments and agencies announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date to the Common Rule.

Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

Summary of Key Changes

Continuing Review

The Revised Common Rule removes the requirement for continuing review for some minimal risk research and for full-board research that is in long-term follow-up or data analysis only. For details, see Changes to Continuing Review.

Exempt Research

The Revised Common Rule broadens the types of research that qualify for exemption. Several exemption categories have ben revised and new exempt categories have been added. For more information on these new and revised categories, see Changes to Exempt Research.

REMEMBER:
Exempt Research is that which the IRB has determined Exempt from Further Review. Even if you believe your study qualifies for exemption, you must still submit an application for IRB review. Exempt Research may not begin until the PI receives an exemption letter from the IRB.

 

Informed Consent

Effective July 19, 2018, the requirements for informed consent will change, with the addition of:

  • "Key Information" to be presented at the beginning of the consent form
  • New consent elements
  • Changes to waiver criteria and documentation (plus other process changes)
  • A "broad consent" option for unspecified future use of identifiable data/biospecimens

The purpose of these changes is to enhance the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used. For more information, see Changes to Informed Consent.

For Clinical Studies: The 2018 regulations mandate that specified clinical trial consent forms be posted on a government website (ClinicalTrials.gov). The post must take place no more than 60 days after the last study visit by any subjects.

 

Single IRB Review

U.S. Institutions engaged in cooperative (multi-site) research must rely upon approval by a single IRB. The lead IRB is determined via proposal by the lead institution subject to acceptance of Federal Department or agency supporting the research.

The NIH's Single IRB Policy for NIH funded research takes effect on January 25, 2018. Applications submitted in response to the January 25, 2018 due date or after or contract proposals submitted in response to a solicitation published on or after January 25, 2018 that involve multi-site human subjects research should comply with the NIH's Single IRB Policy.

Single IRB Review, as required by the Common Rule, will be effective January 2020.

Additional Changes

Our Standard Operating Procedures (SOPs), Protocol Forms and Applications, Templates, and Guidance Documents are currently being revised to reflect the recent changes to the Common Rule. Be sure to visit the Mercer Protocol Forms and Applications section of our site to download the latest versions of our documents as they become available.

Until July 19, 2018, the Mercer University Institutional Review Board will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations. Please continue to visit this page for updates about the implementation of the 2018 revised Common Rule.

Back to Top

Changes to Continuing Review

The Revised Common Rule removes the annual renewal requirement for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data. This requirement has also been removed for full-board research that is in long-term follow-up or data analysis only.

  • Research approved after July 19, 2018: New Minimal Risk Research will not automatically undergo Continuing Review by the IRB unless the research is FDA-regulated. However, the IRB maintains the authority to require continuing review under special circumstances (i.e., conflict of interest, compliance concerns).
  • Ongoing Research: Ongoing research approved prior to July 19, 2018 will continue to adhere to Pre-2018 Common Rule Regulations until the next annual renewal. Following approval to continue research, governing regulations will be determined by the IRB on a case-by-case basis.

 

NOTE: The Investigator is still responsible for the following activities, even though continuing review is not required:

  1. Submitting adverse events and other unanticipated problems,
  2. Seeking IRB approval for Investigator changes,
  3. Protocol amendments,
  4. Recruitment materials, etc., and
  5. Notifying the IRB when the research is complete.

 

 

Back to Top

Changes to Exempt Research

Effective July 19, 2018 the federal government will change the types of human subjects research that qualifies as exempt. "Exempt" human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving human subjects falls into one or more specific exemption categories as defined by the Common Rule.

  • Exempt projects are not subject for continuing review
  • Amendments are required only if changes to the project could alter the exempt determination
  • An exempt determination does not lessen the investigator's ethical obligations, including the completion of human subjects protections training

Each exempt category is described below. Click on an exemption category to expand or collapse its description. For each category, the regulatory text is in blue, and clarifications follow.

EDUCATIONAL EXEMPTION

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.

What's New: A new ineligibility criterion has been added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.

Most educational research on regular and special educational instructional strategies, and research on the effectiveness of, or comparison among, instructional techniques, curricula, or classroom management methods may be exempt under this category.

Changes to this exempt category include the caveat that there must not be any impact of subject's opportunity to learn or any negative impact if the research involves an evaluation of the instructors. If the research involves significant time and attention away from the delivery of regular curriculum or withholding of standard educational content, this exemption would not apply. Also, there must be protection against negative impact on employment if instructors are being evaluated. Research involving randomization to an unproven educational technique, or research conducted by supervisors involved in employment decisions may not be approvable under this exemption.

Applicability to vulnerable populations:
  • Pregnant women may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is eligible for this exemption.

SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR

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.

What's New: The scope has been expanded to include the collection of sensitive and identifiable data. However the following is not allowed:
  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)

This exemption category involves several changes from pre-2018 rules. The wording of this exemption was changed to clarify that the category applies to research that only involves interactions. Additionally, the use of potentially sensitive information might be allowable if appropriate protections are in place and the IRB conducts a new process called "limited IRB review."

This category involves interactions (verbal and written responses) and data collection only. The data collection can include audio or video recordings. Research involving "interventions" would not be approvable under this category. Interventions include manipulation of the environment or physical procedures to collect information, such as a cheek swab.

Applicability to vulnerable populations:
  • Pregnant women may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is eligible for this exemption only when it relates to educational tests or observations in which the investigators don't participate in the activities being observed. Additionally, children are not eligible for this exemption if the project requires limited IRB review.

BENIGN BEHAVIORAL INTERVENTION (NEW)

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:
  (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.

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.

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.

What's New: This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement. However, the following is not allowed:
  • Research with children
  • Deception, unless prior agreement is obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)
  • Linking to additional personally-identifiable data

This exempt category is completely new in the 2018 revisions to the federal regulations. There are limits on the interventions that are considered "benign" and requirements on IRB review of this type of research.

Applicability to vulnerable populations:
  • Pregnant women who are adults may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is not eligible for this exemption.
  • Research involving decisionally-impaired persons is not eligible for this exemption.

SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS)

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 non-research activities, if the research generates identifiable private information that is or will be maintained or information technology that is subject to and in compliance with applicable federal privacy standards found in the E-Government Act, Privacy Act and the Paperwork Reduction Act.

What's New: The scope of this exemption has been expanded to allow:
  • Prospective data review
  • Maintenance of identifiers, if all study data is protected health information (PHI)
  • Research that is conducted by, or on behalf, of a Federal department/agency or using government-generated or government-collected information obtained for non-research activities
The 2018 changes significantly broaden the type of secondary research that can be done under this exemption category:
  • The requirement that all study data be existing at the time of IRB submission has been eliminated. Data under this exemption may be both retrospective and prospective.
  • The requirement that the study involves data only has been eliminated. The research may also involve the use of specimens.
  • Creating a de-identified dataset for analysis is still an approvable option and continues to be the most straight-forward approach.
  • If investigators need to retain data that contains any HIPAA elements or need to retain a linking list, then appropriate HIPAA protections could make the project approvable. Depending on the circumstances of the data, the HIPAA protections might include a Business Associate Agreement, a Data Use Agreement or a waiver of HIPAA authorization with accounting of disclosures.
  • Certain sources of publicly available data require the recipient to sign an agreement outlining restrictions on access, use, security and transfer. Most often, those agreements will need review by the university's general counsel or authorized official.
It is important to note that Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records, or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another approval path would be required.
Applicability to vulnerable populations:
  • Data/specimens from pregnant women would be allowed.
  • Data/specimens from prisoners could be allowed as long as the research was not designed to recruit prisoners and prisoners were only incidental subjects of the research.
  • Data/specimens from children would be allowed.
  • Data/specimens from persons with decisional impairment would be allowed.

PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS)

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. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website 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.

What's New: A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

The scope of this category has been broadened. Prior rules required that the Federal demonstration projects be conducted by the Federal agency. This category has been updated to allow projects that are simply funded by a Federal agency. The scope has been expanded to include purposes not only to study and evaluate but also to improve these programs. Note that projects eligible for this exemption will be posted on a Federal website.

TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

Taste and food quality evaluation and consumer acceptance studies: if wholesome foods without additives are consumed, or 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 and Safety and Inspection Service of the U.S. Department of Agriculture

What's New: Unchanged

This exemption category was not changed in the revised Common Rule. Note that it is the only exemption that is allowable for FDA-regulated research.

Applicability to vulnerable populations:
  • Pregnant women may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is eligible for this exemption.
  • Research involving decisionally-impaired persons could be allowed if their inclusion was justified.

STORAGE/MAINTENANCE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH "BROAD CONSENT" (NEW)

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 §___.111(a)(8).

What's New: This new exemption allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with "Broad Consent" for future secondary use research.

This exemption is new with the 2018 Common Rule. At this time, it will NOT be implemented at Mercer University.

Applicability to vulnerable populations:
  • Pregnant women may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is eligible for this exemption.

USE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH "BROAD CONSENT" (NEW)

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 §___.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 §___.117;
  (iii) An IRB conducts a limited IRB review and makes the determination required by §___.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 479
  (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 any legal requirements to return individual research results.
   

What's New: This new exemption allows for secondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with "Broad Consent."

This exemption is new with the 2018 Common Rule. At this time, it will NOT be implemented at Mercer University.

Applicability to vulnerable populations:
  • Pregnant women may be included in this type of research.
  • Research that targets a prisoner population is not eligible for this exemption. The exemption is allowable if the research is aimed at a broader population and only incidentally includes prisoners.
  • Research involving children is eligible for this exemption.

Changes to Informed Consent

The Informed Consent changes are intended to "modernize, strengthen, and make more effective" the current system of oversight under the Federal Policy for the Protection of Human Subjects. These revisions aim to better protect human subjects involved in research, facilitate research, remove ambiguity, and reduce regulatory burden.

Impact on Research:
  • The Pre-2018 Common Rule regulations apply to research approved or determined to be exempt before July 19, 2018
  • The 2018 Revised Common Rule (Final Rule) regulations apply to research approved or determined to be exempt on or after July 19, 2018
  • The regulations which apply to studies initially approved under the Pre-2018 Common Rule and renewed after July 19, 2018 will be determined on a case-by-case basis by the Mercer University IRB
If the Mercer University IRB applies the Final Rule to research initially approved under the Pre-2018 Common Rule, the research must comply with ALL Final Rule requirements (specific parts of the Pre-2018 and Final Rule regulations cannot be applied to a study - it is all or none).

KEY CHANGES

Revisions to the Informed Consent sections of the Common Rule affect the consent process and the informational substance contained therein (46.116) and the requirements for informed consent forms (46.117). Key changes to consent include:
  • New "key information" requirements for the content, organization, and presentation of information and the process to facilitate a prospective subject's decision about whether to participate in research
  • New consent elements
  • A broad consent option for unspecified future use of identifiable data/biospecimens
  • Changes to waiver and alteration criteria for consent
  • New consent provision for screening, recruiting, or determining eligibility
  • New requirement to post Clinical Trial Consent Form to a federal website (ClinicalTrials.gov)
  • Changes to Consent Forms

 

FDA HARMONIZATION

The FDA plans to update its regulatory language in accordance with the 21st Century Cures Act (2016) requirement for the Secretary of HHS to harmonize the differences between 45 CFR 46, Subpart A, and the U.S. Food and Drug Administration (FDA) human subject regulations. The FDA is expected to issue its own NPRM for 21 CFR 50 and 56 and eventually a Final Rule containing different requirements for waivers, consent process, and consent form language

Institutions, IRBs, and investigators must comply with FDA and HHS regulations (Pre-2018 or Revised 2018 version as applicable) when both apply.

 

KEY INFORMATION

Common Rule revisions to section 46.116 are intended to faciliate a prospective subject's or legally authorized representative's understanding of the reasons why an individual might or might not want to participate in the research.

A new approach to consent is requiring that the key information essential to decision making receive priority by appearing at the beginning of the consent form and being presented first in the consent discussion.

This new requirement states that the informed consent process must begin with key information and that this part of the informed consent be "organized and presented in a way that facilitates comprehension."

The preamble of the Final Rule lists five (5) factors as suggested "key information" that would likely assist a potential subject in understanding the nature of the project and in determining participation:
  1. The fact that consent is being sought for research and that participation is voluntary
  2. The purposes of the research, expected duration of the prospective subject's participation, and procedures to be followed in the research
  3. The reasonably foreseeable risks or discomforts to the prospective subject
  4. The benefits to the prospective subject or others that may reasonably be expected from the research
  5. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject
"REASONABLE PERSON" REQUIREMENT
In addition to the key information requirement, the Revised Common Rule also requires that subjects be provided with the information that a "reasonable person" (undefined) would want to have. Responsibility remains for the investigator to:
  • Provide more information when requested by subjects
  • Make sufficient time and opportunity to discuss the research
  • Answer questions to improve a subject's understanding

For certain types of research (e.g., research for which there is reason to believe some subjects will find the research controversial or objectionable), a robust description of the research will be required to meet this reasonable person standard.

There is currently no federal (including Office for Human Research Protections [OHRP]) guidance defining the terms, "Key Information" or "Reasonable Person." Further federal guidance that will explain what these terms mean and how to achieve the goal along with what qualifies as a concise and focused presentation is expected at a later date.

ELEMENTS OF CONSENT

General requirements for informed consent remain essentially intact. There have been no changes to the eight previous basic informational elements of consent, but a new requirement has been added.

New Requirement for Informed Consent Form Language
Added at 46.116(b)(9) is a new requirement to include one of two statements about the collection of private information or identifiable biospecimens for future research:
  • Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or
  • The subject's information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
No changes to the six previous additional informational elements of consent, but three new requirements were added:
  • 46.116(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.
  • 46.116(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.
  • 46.116(c)(9) - For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human geneline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

BROAD CONSENT - 46.116(d) (NEW)

Broad Consent is defined as, "seeking prospective consent to unspecified future research."

Under the current regulations, secondary research use of identifiable data/biospecimens is permissible through study-specific consent, by obtaining an IRB waiver of consent, or by removal of identifiers.

In the revised Common Rule, Broad Consent is permitted as an (optional) alternative consent process for use only for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens for future, unspecified research. Broad consent is NOT a waiver.

To utilize Broad Consent, study personnel and/or the unit/biorepository responsible for the storage of the identifiable data/biospecimens are required to:
  • Identify the types of research that may be conducted with the data/biospecimens;
  • Record and track who has agreed to or refused broad consent; and
  • To track the terms of consent to determine whether proposed future secondary research use falls within the scope of the identified types of research.
At this time, the Mercer University IRB will NOT implement the new regulatory Broad Consent option as an informed consent process. Exemptions 7 and 8, which rely on Broad Consent, also will not be implemented.

WAIVER OR ALTERATION OF CONSENT - 46.116(e) and (f) (NEW)

Under 46.116(e), the Final Rule added a new waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials.

Under 46.116(f), four existing waiver conditions remain unchanged. An additional criterion was added for research involving accessing or using private information or identifiable biospecimens and requires that the research could not practicably be carried out without accessing or using such information or biospecimens in an identifiable format.

Non-identified information should be used whenever possible to respect subjects' interests in protecting the confidentiality of their information and biospecimens.

Note: HIPAA requirements still apply - including asking for a HIPAA waiver.

A waiver of informed consent for the secondary use of identifiable private information/biospecimens (not covered by Broad Consent) must justify why the use of identifiers is necessary to carry out the research.

FOR BROAD CONSENT
  • The IRB cannot waive informed consent under broad consent, or omit or alter any of the required broad consent elements
  • If an individual was asked to provide broad consent and refused to consent, the IRB cannot waive consent

SCREENING, RECRUITING, OR DETERMINING ELIGIBILITY - 46.116(g) (NEW)

This new consent provision addresses privacy issues regarding waivers of informed consent to obtain information or biospecimens for screening, recruiting (contracting), or determining the eligibility of prospective subjects.

The previous requirement for IRBs to waive informed consent was inconsistent with FDA regulations and determined to be unnecessary for protecting subjects. Under 46.116(g), the use of identifiable information/biospecimens to identify potential subjects is now allowed without informed consent when one of the following two conditions has been met:
  1. The information will be obtained by communicating with the prospective subject.
  2. The information will be obtained by accessing records or stored biospecimens.

Under these circumstances, a waiver of consent will no longer be needed for screening activities. This is not a waiver of the consent requirement but rather an exception to the requirement.

POSTING OF CLINICAL TRIAL CONSENT FORM - 46.116(h) (NEW)

For federally-sponsored clinical trials, a copy of an IRB-approved version of the consent form used for enrollment purposes must be posted to a "publicly available, federal website."

For clinical trials conducted through Mercer University: ClinicalTrials.gov

POSTING REQUIREMENTS:
  • The consent form must be posted after the trial is closed to recruitment and NO later than 60 days after the last study visit by any subject (as required by the protocol). The responsibility for posting the consent form is on the awardee or the federal department or agency component conducting the study. [46.116(h)(1)]
  • The redaction of proprietary or institutionally sensitive information of portions of consent forms is allowed. [46.116(h)(2)]
  • Only one unsigned version (not necessarily the final) of the consent form for each clinical trial must be posted on the federal website.
    In accordance with the new "single IRB review" requirement, only one posting is required for each multi-institution study. [46.116(h)(3)]
It is not required that a version be posted for each study site nor for each class of subjects taking part in the study (e.g., posting both for adults and for children)

CHANGES TO CONSENT FORMS

Important changes to consent forms, signatures, and waivers under the Revised Common Rule include:
  • Electronic Signatures - Now specifically allows electronic signatures and specifies that a written copy must be given to the person signing the consent form.
  • Short Form Requirements - Requires that, when using the short form, the consent form must begin with a concise and focused presentation of the key information to assist a prospective subject in making a decision. This subsection requires that this part of the consent form must be organized in a way that facilitates comprehension.
  • Additional Waiver of Documentation - Allows a waiver of requiring subject's signature on the consent form if the subjects are members of a cultural group or community in which signing forms is not the norm.

Revised informed consent forms and templates are coming soon. Mercer University's Office of Research Compliance is currently in the process of updating all IRB documents to reflect the changes to the Common Rule. Visit our Informed Consents page to view and download the latest versions of our consent forms and templates as they become available. Before submitting a consent form with your application, check the revision date listed on the bottom left-hand corner of the document. Any document with a version/revision date prior to January 2018 will soon be updated.

Effective May 28, 2018: Informed Consent Forms dated earlier than January 2018 will no longer be accepted with IRB protocol applications. If you are not using a Mercer University informed consent template to create your ICF, the document you submit MUST conform to the 2018 Common Rule "Key Information" requirement regarding the organization and presentation of your research study information.
 

CITI Final Rule Resources (webpage) - CITI Program has created resources to help the research community understand the revisions to the Common Rule issued on January 2017 and set to take effect in July 2018. Their available resources were developed with the assistance of expert authors and peer reviewers. CITI will continue to add resources to this site throughout the year.