Human Subjects Research Policy Update Naomi Coll Director of Research Policy and Compliance
Major Policy Updates 1. Continuing review (annual renewal) is no longer required for minimal risk research 2. New requirements for informed consent 3. Revised and new exempt review categories 4. Review by a single IRB is required for some federally-funded multisite studies 5. New definitions affecting the scope of activity and populations subject to regulation 6. Activities that meet the definition of human subjects research are subject to IRB oversight
There will be little to no change to policy on research involving: Greater than minimal risk to subjects Drugs/biologics/devices (FDA-regulated) Collection of biospecimens Prisoners Children General process for conducting IRB review/exemption
Why is the policy changing? The policy changes correspond to the revised Common Rule regulations. The U.S. Department of Health and Human Services (HHS) and 15 other Federal Agencies are signatories to the Federal Policy for the Protection of Human Subjects (the Common Rule ). All research supported by any of the Common Rule agencies is subject to the regulations. Lehigh University has adopted an equivalent policy that extends to all human subjects research, regardless of funding source, conducted by Lehigh University faculty, staff, and students.
When is the policy changing? The revised federal Common Rule is effective January 19, 2018. In order to ensure compliance with the correct set of applicable regulations, the corresponding institutional policy will also change effective January 19, 2018.
Continuing review (annual renewal) is no longer required for minimal risk research Current, open minimal risk studies (i.e. initially approved by expedited review) will transition at next renewal. The IRB may require CR for certain minimal risk studies, e.g. if they involve special populations. If so, this will be communicated to the researcher during the initial approval process. Projects initially approved by the full board (i.e. greater than minimal risk research) do not require annual renewals once subject interaction is complete.
Continuing review (annual renewal) is no longer required for minimal risk research Researchers are still required to submit all Amendments and Unanticipated Problems Reports (UPRs) to the IRB. When the researcher is not required to submit a continuing review, the Research Integrity office will initiate a check-in at one year and ask: Is the study still open? Have any amendments not submitted? Have any UPRs not reported?
Continuing review (annual renewal) is no longer required for minimal risk research: What do you have to do now?: Nothing differently: submit your next continuing review before your study expires. The IRB will transition it to the new rule and will notify you if it is approved without an expiration date. The new rule will be applied to new applications once it takes effect on January 19, 2018. The IRB will notify you if your research is approved without an expiration date. Once your new application or continuing review is approved, you must still submit amendments and UPRs, and the IRB will email you to check-in about once per year.
New Requirements for Informed Consent Final consent forms that are over 4 pages long will require a concise summary of study activities, risks, and benefits presented first in the consent form. A revised template is available on the IRB website. Existing studies affected by the new requirement will transition at the next renewal or consent-related amendment after January 19, 2018.
There are several new elements of informed consent: Required: disclosure that de-identified data or biospecimens may be shared for future research (or not). As applicable: Biospecimens will be used for commercial profit and whether subjects will share in profit. Clinically relevant results will be returned. Research will involve whole genome sequencing. A revised template is available on the IRB website. Researchers may still request a waiver or alteration of the required elements of informed consent with their IRB application (process does not change).
New requirement for waiving/altering informed consent: In order to approve a request for a waiver or alteration of informed consent for research involving identifiable data or biospecimens, the IRB must find that it is impracticable for the research to be conducted with de-identified data or biospecimens. IRB application forms and approval criteria worksheets have been revised to include this requirement and IRB will begin applying it Jan. 19, 2018.
New requirement for waiving/altering requirement to document informed consent: The IRB may approve a request to waive or alter the requirement to document informed consent (i.e. a signed consent form) for minimal risk research in communities or with cultural groups where signing documents is not the norm. There must be an appropriate alternative mechanism or documenting that consent was obtained. IRB application forms and approval criteria worksheets have been revised to include this requirement and IRB will begin applying it Jan. 19, 2018.
Revised and new exempt review categories There are three different levels of IRB review: exempt, expedited, and full committee. The updates include revisions to existing exempt categories and a brand new exempt category for benign behavioral interventions. The full text of the new exempt categories and requirements are available on the IRB website.
Exemption 1 Educational New language added to existing exemption Now must consider the adverse impact on student learning of required content, or on assessment of educators.
Exemption 2 Surveys/Interviews/Educational Tests/Public Observation New language added to existing exemption The collection of sensitive and identifiable data may qualify for exempt review, if the IRB confirms that there are adequate privacy and confidentiality protections in place.
Exemption 2 Surveys/Interviews/Educational Tests/Public Observation continued Exempt category 2 will not apply for research involving any of the following: Interventions Collection of biospecimens Linking to additional personally identifiable data Children except for educational tests or some public observations
Exemption 3 Benign Behavioral Interventions Brand new exempt category! Research involving benign behavioral interventions and collecting and recording data from adults. Benign behavioral interventions are: Brief in duration Harmless and painless Not physically invasive Not likely to have significant adverse impact on subjects Not offensive or embarrassing
Exemption 3 Benign Behavioral Interventions continued Information collected in conjunction with a benign behavioral intervention may be collected via: Surveys or interviews (verbal or written responses) Data entry Observation (including audiovisual recording) Exempt category 3 is not applicable if data is collected via physical procedures, i.e. there can be no: Physical sensors (blood pressure monitors, EEG, FitBits, etc.) Minimally invasive procedures (blood draw, saliva collection)
Exemption 3 Benign Behavioral Interventions continued Examples of benign behavioral interventions: Solving puzzles under various noise conditions Playing an economic game Being exposed to stimuli such as color, light, or sound (at safe levels) Performing cognitive tasks
Exemption 3 Benign Behavioral Interventions continued Because researchers must obtain prospective agreement to participate from subjects, a consent process is required. Deception is not allowed, unless the subjects prospectively agrees to deception. Debriefing is strongly encouraged. Collecting sensitive and identifiable data may be exempt if the IRB confirms there are adequate privacy and confidentiality protections in place.
Exemption 4 Secondary Research with Identifiable Private Information or Identifiable Biospecimens Heavily modified version of the existing exemption 4 No longer limited to retrospective data review. Secondary research with identifiable private information or identifiable biospecimens, when consent is not required, if any of the following apply: Publicly available. Info is recorded by investigator so that identities cannot be ascertained directly or indirectly, and subjects will not be contacted or re-identified. Secondary use of identifiable protected health information is permitted if it is covered by HIPAA and does not leave the institution.
Revised Exemptions Broad Consent The revised Common Rule refers to Broad Consent - consent for storage and secondary research with identifiable private information or biospecimens. Lehigh University is not offering broad consent related exemptions (7 and 8) at this time: Broad consent requires institutional level tracking of individuals who decline. There is no federal guidance on applying broad consent. Investigators can continue to use identifiable private information or biospecimens either by following current practices, or opting to code them instead.
Revised Exemptions What do you have to do now? Revised application forms that include the new exempt categories were posted on January 10, 2018. The IRB is able to apply new exemptions on January 19, 2018 meaning that if your exempt application is reviewed on or after that date, we will apply the new rules. Exempt research approved prior to January 19, 2018 is subject to the current rules. The new exempt rules only effect new studies existing minimal risk studies that were approved via expedited review will not be converted to exempt.
Review by a single IRB is required for some federally-funded multisite studies Common Rule agency-sponsored research with multiinstitutional collaborators must be reviewed by only one IRB, which will serve as the IRB of record for all collaborators. Required January 25, 2018 for NIH; January 2020 for all other Common Rule agencies. LU already has a single IRB review process in place (IRB Authorization Agreements for Human Subjects Research under IRB Guidance ). There will be no change, other than to require an IAA when necessary.
Revised definition: vulnerable populations Revisions to the regulations and policy clarify that vulnerability to coercion or undue influence, and no other considerations related to vulnerability, are the focus of IRB review. Refers to one s ability to make an informed decision about participating in research. References to pregnant women and handicapped individuals have been removed. Subpart B of the federal regulations has not been updated to correspond, so research with pregnant women, fetuses, and neonates is still subject to the additional requirements in Subpart B. Term mentally disabled persons replaced with individuals with impaired decision making ability.
Revised definition: clinical trial Federally-sponsored 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 those interventions on health-related biomedical or behavioral outcomes. Requires public posting of consent form (e.g. on clinicaltrials.gov). As of early 2017, Good Clinical Practice (GCP) training and clinicaltrials.gov registration and reporting is required for NIH-supported Clinical Trials. See GCP Training for NIH-Supported Clinical Trials
Revised definition: human subjects New language added Living individuals about whom an investigator obtains info or biospecimens through intervention or interaction, and uses, studies, or analyzes the info or biospecimens OR obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens
Definition: research Unchanged: Research is a systematic investigation designed to develop or contribute to generalizable knowledge New - the regulations specify what is not research: Scholarly or journalistic activities oral history, journalism, biography, literary criticism, legal research, historical scholarship when the collection of information is focused on the individual, and the activity does not otherwise qualify as a systematic investigation designed to develop or contribute to generalizable knowledge.
Activities that meet the definition of human subjects research are subject to IRB oversight Historically, LU policy required IRB review for work that does not meet federal definition of HSR, including: Institutional research, QA/QI collecting sensitive data Students undertaking a systematic investigation, producing a design or protocol for research, sampling a population, reporting findings Class projects involving research with people outside of class Activity that was not a systematic investigation designed to develop or contribute to generalizable knowledge, but the researcher had some intent to publish results
Activities that meet the definition of human subjects research are subject to IRB oversight Lehigh s new policy will apply to activities that meet the DHHS or FDA definition of human subjects research: Research: Systematic investigations designed to develop or contribute to generalizable knowledge. Human subjects: Living individuals about whom an investigator obtains info or biospecimens through intervention or interaction, and uses, studies, or analyzes the info or biospecimens OR obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens. FDA: the use of drugs or devices in human subjects, and/or the collection of data from humans for submission to FDA. Please contact Research Integrity if you believe your activity may HSR per the FDA.
Definition: systematic Systematic means that the activity involves a system, methodical procedure, design, or plan.
Definition: generalizable Generalizable means that conclusions, facts, or principles derived from particulars (individuals, medical records, etc.) that are applicable to or affect a whole category and enhance scientific or academic understanding. The information is broadly applicable or useful outside of the institution.
Definition: designed Designed in this context refers to the purpose of the activity: Activities that are exploratory or intended to train students are not designed to produce generalizable knowledge.
Definition of human subjects research Publication or intent to publish is not part of the definition of human subjects research. Intent to publish may signify that generalizable results are anticipated. Activities that do not otherwise meet the regulatory definition of research will not be considered subject to IRB oversight even if published or intended for publication.
Definition of human subjects research Typically HSR: doctoral dissertations, honors or graduate theses, pilot studies, clinical investigations, behavioral and social science studies, epidemiological studies, and human genetic research. Not typically HSR: class-related research activities involving research methodology and course-assigned data collection, quality assurance or quality improvement activities, repository research, tissue banking/databases with stored data or materials, case reports, and institutional, internal, or social process research.
Definition of human subjects research Review the IRB website What Types of Activities Require IRB Review Students should confer with faculty advisors when determining if their activity is subject to IRB oversight. Contact Research Integrity for help determining if IRB review is required. We will provide written determinations by request.
When student, class-related, or internal research activity is not subject to IRB oversight It is the responsibility of faculty and staff to ensure that research activity presents minimal risk to participants, is conducted ethically, and complies with all other institutional and departmental policies. When a proposed student activity presents greater than minimal risk, the faculty advisor is required to seek the advice of the Research Integrity office. Ethical Issues in Research provides guidance on incorporating human subjects protections into all research activities, regardless of whether they are subject to IRB review.
When student, class-related, or internal research activity is not subject to IRB oversight Unregulated greater than minimal risk activity: The Belmont Report is the ethical foundation for the federal regulations and Lehigh s institutional policy. The ethical principle of beneficence holds that the benefits of research must be maximized, and the risks minimized. Any activity that presents significant risks to subjects but little or no potential to benefit the individual and/or society at large is not ethical and may not be conducted by Lehigh faculty, staff, or students regardless of whether the activity meets the definition of research and is subject to IRB review.
Questions? Contact: Naomi Coll Director of Research Policy and Compliance nac314@lehigh.edu 610-758-2985