Human Research Protection Program (HRPP) & Institutional Review Board (IRB)

COVID-19 Announcement

The Baptist HRPP continues to monitor the COVID-19 situation. Researchers are advised to plan now for emergency scenarios that may include, but are not limited to, a decrease in the availability of lab personnel, possible disruptions in laboratory supply chains, as well as a total suspension of all research activities. It should be emphasized that while we hope contingency measures will not be needed, proper planning reduces the impact, should it become required.

Be sure to make Continuity Plans

Consider operational impacts from disruptions both upstream and downstream of the research site. At a minimum, sites should operationally consider:

Create a staffing and essential duty coverage plan: prepare for a reduced number of staff by cross training personnel on essential functions.
Create an emergency contact list: Review and update contact information for personnel and key contacts. Ensure proper distribution of the list.
Should word be given, prepare personnel to work remotely: Consider performing work amenable to remote support off site. Ensure personnel have the appropriate home infrastructure to do so.
Lab equipment: Determine if there is any equipment that cannot be shut down and equipment that requires routine monitoring such as liquid nitrogen tanks, and freezers. How will they be monitored?
Supply Chain: Ensure that adequate supply of materials is on hand or accessible. Identify alternative vendors in the event of shortages.

General Guidance

In the presence of the COVID-19 pandemic, revisions in human subject research studies may be warranted to minimize risk to subjects, as the Code of Federal Regulations at 45 CFR 46.111 and 21 CFR 56.111 requires that “Risks to subjects are minimized.”
Changes/Modifications to a study may be necessary to eliminate apparent immediate hazards, such as:
1. Replacing in-person visits with remote options such as telephone visits or use of digital technology;
2. Eliminating study visits/procedures that do not impact subject safety or the integrity of the data;
3. Incorporating screening procedures to identify COVID-19 exposure.
Subjects may be informed of changes in the research via a revised consent form or by way of notification that is not a new consent form, such as an addendum consent, information sheet, letter, etc.
Any changes/modifications to a study should be submitted to the Baptist IRB via the Application to Amend an Approved Protocol or Consent Form.
Please note that federal regulations do allow for modifications to be implemented prior to IRB approval only when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)). Consequently, revisions necessary to protect the welfare of subjects may be implemented immediately while awaiting IRB approval.
If modifications to a study are implemented prior to IRB approval (see item #5 above), such an event is considered a deviation from the IRB approved protocol and you should make the appropriate documentation in the research records. In addition, if such a protocol deviation (a) has harmed or has posed a significant risk of substantive harm to the individual research subject or (b) has compromised the scientific integrity of the data collected for the study, then a report of such a protocol deviation should be submitted to the Baptist IRB.
Research procedures that are intended to directly benefit the subjects should continue as necessary to protect the welfare of subjects. These procedures include administration of treatments, diagnostic procedures, monitoring procedures, etc. that are performed as components of approved studies.
Research procedures that are not intended to directly benefit research subjects should be revised or halted as follows:
1. If research procedures that are not intended to directly benefit subjects can be performed without interpersonal contact (e.g., administration of health questionnaires by phone), then revisions should be submitted to the IRB to conduct these interactions through alternative modalities.
2. If research procedures that are not intended to directly benefit subjects can only be performed with interpersonal contact, then they should be stopped unless appropriate revisions to these procedures can be implemented to minimize the risk of transmission of COVID-19 between subjects and research staff.
3. Recruitment for non-therapeutic research studies should be halted.
4. Studies that involve ONLY research procedures that are not intended to directly benefit subjects and involve ONLY research procedures that require interpersonal contact should be halted until further notice.
Policies of Baptist-affiliated clinical sites regarding COVID-19 that affect the conduct of human research must be followed. Any revisions of approved research procedures necessitated by these policies may be implemented immediately and submitted for IRB review and approval.
The FDA issued guidance regarding the conduct of clinical trials during the COVID-19 (coronavirus) pandemic at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials

COVID-19 IRB Applications

Due to the tremendous number of inquiries regarding the conduct of chart review studies for COVID-19, all requested COVID-19 studies will undergo scientific review prior to IRB review. Studies will be reviewed for Significance and Approach.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? (NIH, 2020)

Approach (Study Design and Methods)

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? (NIH 2020)

Note: In the case of duplication, investigators will be encouraged to collaborate.

Baptist Memorial Health Care Institutional Review Board

The Baptist Memorial Health Care Corporation-Institutional Review Board (Baptist IRB) is a committee of physicians, statisticians, researchers, community advocates and others that ensures a clinical trial is ethical and the rights of study participants are protected.

By federal regulation, all clinical trials in the U.S. must be approved by an IRB before they begin. At Baptist, the IRB initially approves and periodically reviews the research in order to protect the rights of human participants.

All research studies performed using any Baptist facility must be reviewed by the Baptist IRB. All research proposals must be submitted to the IRB two (2) weeks prior to the next scheduled meeting (see schedule below). Four (4) weeks prior to study expiration date is suggested for renewals. Please download the appropriate documents for your submission.