- Studies taking place at Harvard University and which offer direct therapeutic to participants or those studies where stopping procedures would cause harm to the study subject. We do not expect many studies that are reviewed by the HUA IRB to qualify for this exception. For health and safety, changes to protect study subjects can be instituted immediately; please submit a Report of New Information (RNI) to the IRB to report the temporary modifications within five business days.
- Studies taking place at Harvard University which DO NOT offer direct therapeutic to participants or those studies where stopping procedures would NOT cause harm to the study subject and do not wish to pause, submit a modification to the IRB to change your study procedures to no face-to-face interactions with study subjects (see “Submitting a Modification” below).
Studies that DO NOT involve face-to-face interactions with participants such as studies conducted electronically or via telephone or involving secondary data analysis may continue.
Although the default for all research involving in-person contact is to be paused, the university has established a sequence of in-person research resumption phases with timing based on governmental policies and the state of the disease, the health care system, and society at large.
The below chart will assist you in determining which studies may continue, which studies will still be paused, and the next steps that will need to be taken depending on the current in-person research resumption phase.
| Status | Type of Study | Face to Face Interaction? | Includes Direct Therapeutic Benefit? | Would Stopping Cause Harm to Subjects? | Modification Required? |
Should Study Be Paused? |
|---|---|---|---|---|---|---|
|
Ongoing study (already has IRB approval) |
Yes | Yes | Yes |
Changes to protect study subjects can be instituted immediately; please submit a Report of New Information (RNI) to the IRB to report the temporary modifications within five business days. If change is NOT to protect study subjects, a modification must be submitted to the IRB prior to implementing the change. We will be prioritizing modifications that pertain to COVID-19 (see “Submitting a Modification” in the FAQ’s). Must have current IRB approval in place. |
No, if all approvals are in place and all safety guidlenies are followed |
|
Ongoing study(already has IRB approval) |
Yes, and has NOT received appropriate resumption approval from School/Department |
No | No |
Modification not applicable. |
Yes, study should be paused until all approvals are in place. |
|
Ongoing study(already has IRB approval) |
Yes, but will move to no in-person contact. |
No | No |
To change procedures to no in-person contact, a modification to the IRB is required. We will be prioritizing modifications that pertain to COVID-19 (see “Submitting a Modification” in the FAQ’s). Must have current IRB approval in place. |
Yes, study should be paused until further notice UNTIL procedures are changed to no in-person contact. |
|
|
Ongoing study(already has IRB approval) |
No | No | No |
Modification not required but must have current IRB approval in place. |
No pause needed; study may continue |
|
|
New study (still needs IRB approval) |
No | No | No |
Modification not applicable but must have current IRB approval in place. |
No pause needed; study may proceed. |
|
|
New study (still needs IRB approval) |
Yes, and has NOT received appropriate resumption approval from School/Department. |
No | No |
Modification not applicable. |
Yes, study should be paused until all approvals are in place. |
|
|
New study (still needs IRB approval) |
Yes, and HAS received appropriate resumption approval from School/Department. |
No | No |
Modification not applicable but must have current IRB approval in place. Only study procedures approved by School/Department may occur. |
No, if all approvals and safety guidelines are followed. |