As discussed in the July 2, 2018 issue of ORC News, the revised Common Rule is effective January 21, 2019; however, institutions may implement three burden-reducing provisions beginning July 19, 2018. The IU HRPP has decided to implement these provisions and transition research to the revised Common Rule requirements beginning July 19, 2018, in order to decrease burden on the research community.
The Common Rule requirements apply only to federally-regulated research (i.e. federally-funded and any research subject to regulation by a Common Rule agency). IU HRPP Policies apply the Common Rule protections to all research, with some very minor differences, and apply other relevant requirements based on additional federal regulations, state law, and institutional policy. Research conducted at IU and its affiliates must be conducted in accordance with IU HRPP Policies.
Newly-revised IU HRPP Policies are effective July 19, 2018. The new policies clarify previous requirements and incorporate the revised Common Rule requirements listed below. The revised policies and a summary of changes are available at Research - Human Subjects & IRB: Policies, Procedures and Regulations. Please carefully review the summary of changes documents and any revised IU HRPP Policies which are relevant to your research.
The following changes are being implemented effective July 19, 2018. These requirements will be applied to all new studies approved on or after this date and will be applied to previously-approved research at time of renewal. Please note that some changes, noted below, DO NOT apply to research subject to FDA or VA regulations.
Informed consent changes The following three new elements of informed consent must be included in the informed consent document and presented to potential subjects, when applicable:
- Whether research information may be deidentified and used for future research
- Whether commercial profit is expected and, if so, whether profits may be shared with subjects (previously included in the consent template)
- For research involving biospecimens, whether the research will involve whole genome sequencing
The informed consent template at Research - Human Subjects & IRB: Forms & Templates includes proposed language for each of these new elements. New studies approved on or after July 19, 2018, must include these elements in the consent document (if applicable to the research). For previously-approved research, the informed consent document may need to be revised at time of renewal. Future enrolled subjects should be consented using the revised consent document, but previously enrolled subjects do not need to be re-consented using the revised consent document.
Research which is requesting a waiver of informed consent must meet one additional criterion. Specifically, if the research involves use of identifiable information or biospecimens, the investigator must justify that the research could not practicably be carried out without the use of identifiers. New studies approved on or after July 19, 2018, requesting a waiver will provide this information via the revised KC IRB Questionnaires. Previously-approved research conducted under a waiver of consent will be asked to update the applicable KC IRB questionnaire to include this information at time of renewal. An IRB reviewer will reconsider the waiver of consent in light of the new information to ensure the waiver continues to be appropriate. The additional waiver criterion will not be applicable to research subject to VA regulations at this time.
Renewal is no longer required for the following research, unless the IRB specifically requests otherwise:
- Expedited research
- Full Board research which has progressed to the point where research procedures are limited to accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care (i.e. long-term follow-up) or data analysis only
Annual renewal will continue to be required for all research subject to FDA or VA regulations. If renewal is required, KC IRB and the approval letter will display an expiration date and renewal reminders will be sent.
Over the next few weeks, the expiration date will be removed from all research listed as Data Analysis Only which is not subject to FDA or VA regulations. These studies will not require renewal going forward and will not be reviewed by HSO or IRB until closure. Amendments and reportable events must continue to be submitted per IU HRPP policy as usual until the study is closed. All research, regardless of funding or level of review, should be closed in KC IRB when complete.
Additional impacts on federally-funded research
In addition to the above changes, several more changes affect only federally-funded research:
- The IRB is no longer required to review the federal grant application or proposal; as such, study teams do not need to submit the grant application or proposal with the IRB application. Federally-funded research which is subject to VA regulations must continue to submit the grant application or proposal until further notice.
- Informed consent must begin with a concise and focused presentation of key information which participants want in order to make a decision (e.g. statement that the project is research and that participation is voluntary and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment). The informed consent template includes proposed language for the concise presentation/summary. If the IRB finds the consent document is already concise as written, no additional summary will be needed.
- The informed consent statement must also include a statement indicating whether clinically relevant research results will be disclosed to subjects and, if so, under what conditions.
- All federally-funded research must comply with the revised Common Rule by January 21, 2019. At time of initial review or renewal, HSO staff will ensure the research is in compliance and document compliance in the approval letter.