I'D LIKE TO WELCOME EVERYONE TO THIS OHRP LIVE WEBCAST ON THE GUIDANCE ON COVID-19. I HOPE EVERYONE AT HOME IS HEALTHY AND STAYING SAFE. MY NAME IS YVONNE LAU AND HERE WITH MY COLLEAGUES [LISTING NAMES] . THEY'RE ALL PARTICIPATING WITH ME IN THE LIVE WEBCAST TODAY. BEFORE I GO FURTHER I'D LIKE TO THANK NIH FOLKS FOR HELPING SUPPORT THE WEBCAST. WE REALLY RELY ON THEIR TECHNICAL SKILL WITH THIS TECHNOLOGY. SO OHRP PUBLISHED THE GUIDANCE ON RESPONSES TO COVID-19 A FEW WEEK BACK AND THE GOAL OF THIS WEBCAST IS TO GO OVER THE KEY POINTS MADE IN THE GUIDANCE AND TO RESPOND TO SOME OF THE QUESTIONS WE HAVE RECEIVED THROUGH THE OHRP MAILBOX. SO FOR THIS LIVE WEBCAST, WE WON'T BE TAKING ACTUAL LIVE QUESTIONS AND WITH THAT IN MIND I'M GOING PASS THIS TO MY DIRECTOR JERRY TO SAY A FEW WORDS. >> THANK YOU, YVONNE. THANK YOU, EVERYBODY. THANK YOU FOR JOINING THE WEBINAR. I WANT TO IN PARTICULAR NOTE WHAT'S ON THE SLIDE HERE WHICH IS ONE OF OUR KEY MESSAGES. WE'RE OF COURSE GOING THROUGH AN EXTRAORDINARILY UNUSUAL TIME. IT'S VERY CHALLENGING CONDUCTING OUR LIVES BUT WE'RE CERTAINLY AWARE IN THE OHRP ABOUT THE PARTICULAR CHALLENGES THAT MANY INSTITUTIONS AND PEOPLE ARE GOING THROUGH IN TERMS OF CONDUCTING RESEARCH WITH HUMAN SUBJECTS. WE APPRECIATE ALL THAT AND UNDERSTAND IT CAN BE COMPLICATED AND IN PARTICULAR NOTE THE SECOND BULLET POINT ON THE SLIDE THAT WE'RE GOING TO BE TAKING INTO ACCOUNT THE SPECIFIC CIRCUMSTANCES THAT WE'RE UNDER AND WE'LL USE AVAILABLE FLEXIBILITY IN DECISION MAKING AS WE GO FORWARD IN TERMS OF COMPLIANCE AND RELATED ISSUES. AGAIN, THANK YOU ALL FOR JOINING THE WEBINAR. STAY HEALTHY, BE WELL AND LET ME HAND IT BACK TO YVONNE. >> THANK YOU VERY MUCH, JERRY. SO I THINK WE'LL GO AHEAD WITH THIS FIRST PART OF THE LIVE WEBCAST. SO THE PLAN IS TO PROVIDE YOU WITH AN OVERVIEW OF THE KEY POINTS THAT WERE DESCRIBED IN THE GUIDANCE. SO THE OHRP GUIDANCE WAS ISSUED APRIL 9, A FEW WEEKS BACK, AND HERE IS THE LINK ON THE SLIDE YOU CAN USE TO ACCESS THE ACTUAL GUIDANCE. WHEN YOU GO ON TO THE OHRP HOME PAGE, THERE ARE SOME MOVING CAROUSELS YOU CAN ALSO CLICK ON THE FIRST ONE AND IT WILL TAKE YOU TO ALL THE COVID-19 RELATED INFORMATION. . SO WE ARE GOING TO COVER SIX TOPICS HERE TODAY AND THIS IS THE LIST YOU CAN SEE HERE. SO FIRST OF ALL, WE UNDERSTAND THAT FOR THE PURPOSE OF MAKING DIAGNOSIS CLINICALLY AND FOR PUBLIC HEALTH PURPOSES THERE'S MANY TESTS AND ACTIONS BEING UNDERTAKEN FOR THESE PURPOSES. SOMETIMES THEY MAY INVOLVE RESEARCH SUBJECTS. WE WANT TO MAKE SURE PEOPLE UNDERSTAND THAT THE FACT THAT RESEARCH SUBJECTS MAY BE INVOLVED IN SOME OF THESE PUBLIC HEALTH ACTIONS OR ACTIONS TAKEN FOR CLINICAL PURPOSES DO NOT THEN MAKE THE ACTIVITIES RESEARCH ACTIVITIES THAT WOULD REQUIRE IRB REVIEW. SO THE IMPORTANT THING WOULD BE WHEN YOU ARE FACED WITH THESE SORT OF ACTIONS, THINK ABOUT WHAT THE PURPOSE IS, WHY THIS ACTIVITY IS BEING CONDUCTED. SO FOR EXAMPLE, MANDATORY CLINICAL SCREENING FOR COVID-19 FOR ALL THOSE THAT COME INTO AN INSTITUTION INCLUDING RESEARCH SUBJECTS. THE FACT THESE ACTIVITIES INCLUDE RESEARCH SUBJECTS DOES NOT MAKE THE CLINICAL SCREEN SOMETHING IRB NEEDS TO REVIEW. THE OTHER IS SHARING RESULT A PUBLIC HEALTH AUTHORITY OR RESEARCH SUBJECTS. THE FACT YOU SHARE THE RESULTS WITH RESEARCH SUBJECTS DO NOT AUTOMATICALLY MAKE THEM RESEARCH ACTIVITIES THAT NEED IRB REVIEW. PLEASE NOTE THERE MAY BE OTHER PERMISSIONS OR NOTICE THAT ARE NECESSARY UNDER APPLICABLE LAW OR POLICY. SO THERE ARE ALSO CERTAIN PUBLIC HEALTH SURVEILLANCE ACTIVITIES THAT MAY BE CONSIDERED RESEARCH BUT I WOULD EXCLUDE IT FROM BEING CALLED RESEARCH UNDER THE COMMON RULE. SO THESE EXCLUDED ACTIVITIES, THE MAIN THING YOU NEED TO KNOW ARE THAT IF THEY ARE -- IF THESE ARE ACTIVITIES THAT ARE EXCLUDED, THEY DO NOT NEED TO COMPLY WITH ANY OF THE PROVISIONS IN THE COMMON RULE. I WANT TO SAY CERTAIN ACTIVITIES COME UNDER THE EXCLUSION AND WE'LL BE DISCUSSING THESE. IT IS NOT WHEN YOU CALL SOMETHING SURVEILLANCE OR THAT SOMETHING IS DONE FOR SURVEILLANCE THAT THESE ACTIVITIES WILL BE AUTOMATICALLY EXCLUDED FROM THE COMMON RULE. THEY'RE LIKELY TO BE MANY SURVEILLANCE ACTIVITIES THAT STILL MEET THE DEFINITION FOR RESEARCH UNDER THE COMMON RULE AND DO NOT MEET THE CRITERIA TO BE EXCLUDED FROM BEING CONSIDERED AS RESEARCH UNDER THE EXCLUSION PROVISION. THOSE MIGHT STILL NEED TO FOLLOW PROVISIONS IN THE COMMON RULE. OF COURSE, PLEASE NOTE THERE MAY BE OTHER REGULATIONS LIKE FDA REGULATIONS, OTHER POLICIES AND STANDARDS THAT MAY STILL APPLY TO THOSE ACTIVITIES, THOSE PUBLIC HEALTH SURVEILLANCE ACTIVITIES THAT CAN BE EXCLUDE FROM THE COMMON RULE. NOW, LET'S MOVE FORWARD AND TALK ABOUT THIS PUBLIC HEALTH SURVEILLANCE EXCLUSION FOUND IN THE REVISED COMMON RULE AT [LISTING RULE] SO PUBLIC HEALTH SURVEILLANCE ACTIVITIES INCLUDE THE COLLECTION AND TESTING OF BIO SPECIMENS, CONDUCTED, SUPPORTED, REQUESTED, ORDERED OR AUTHORIZED BY A PUBLIC HEALTH AUTHORITY. SO SOME ACTIVE TEST LIMB -- ACTIVITIES ARE LIMITED TO THOSE NECESSARY TO ALLOW A PUBLIC HEALTH AUTHORITY TO DO THESE THINGS, IDENTIFY, MONITOR, ASSESS OR INVESTIGATE POTENTIAL PUBLIC HEALTH SIGNALS ON OUTBREAKS AND SO ON. YOU CAN READ THROUGH THE LIST. SUCH ACTIVITIES INCLUDE THOSE ASSOCIATED WITH PROVIDING AWARENESS AND PRIORITY DURING THE CAUSE OF AN EVENT OR CRISIS LIKE THE ONE WE ARE EXPERIENCING NOW. THE REGULATIONS DO NOT DEFINE WHAT CONSTITUTES PUBLIC HEALTH SURVEILLANCE ACTIVITIES AND PROVIDE SCAM -- EXAMPLES. YOU CAN SEE THE SCOPE COULD BE BROAD. THESE ARE THE KEY WORDS FOR THE PROVISION. THEY NEED TO BE PUBLIC HEALTH SURVEILLANCE ACTIVITIES AUTHORIZED BY PUBLIC HEALTH AUTHORITY AND THEY ARE LIMITED ONLY TO THOSE ACTIVITIES NECESSARY GENERALLY TO ALLOW TO PROVIDE DIRECT INFORMATION INFORMING THE PUBLIC HEALTH AUTHORITY FOR DECISION MAKING AND FOR ACTION. SO WHILE THE REGULATIONS ACTUALLY DO NOT HAVE A DEFINITION FOR PUBLIC HEALTH SURVEILLANCE ACTIVITY, IT DOES ACTUALLY HAVE A DEFINITION FOR PUBLIC HEALTH AUTHORITY. YOU CAN SEE IT HERE. AGAIN, YOU CAN SEE IT IS QUITE BROAD. SO THE PUBLIC HEALTH AUTHORITY MEANS AN AGENCY OR UNITED STATES OF THE TERRITORY OR POLITICAL SUBDIVISION, SETS -- ETCETERA OR PERSON OR A GRANT OR A CONTRACTOR AGENT OR EMPLOYEES OF THE PUBLIC HEALTH AUTHORITY. IMPORTANT THING TO NOTE IS PUBLIC HEALTH AUTHORITY IS AN ENTITY RESPONSIBLE FOR PUBLIC HEALTH MATTERS AS PART OF ITS OFFICIAL MANDATE. SO FOR OUR PURPOSES, CDE, NIH ARE CONSIDERED PUBLIC HEALTH AUTHORITY. SO HERE'S AN EXAMPLE OF WHAT MIGHT FALL UNDER THE PUBLIC HEALTH SURVEILLANCE EXCLUSION. SO FOR EXAMPLE, IF A PUBLIC HEALTH AUTHORITY AUTHORIZES GENERAL SCREENING, SAY USING NASAL SWAPS OR FOR COVID-19 FOR PUBLIC HEALTH PURPOSES THEY CAN INCORPORATE THESE INTO AN EXISTING STUDY FOR EXAMPLE ONE THAT FOLLOWS FOR RESEARCH OR OTHER RESPIRATORY ILLNESS AND THE RESEARCHERS CAN THEN USE THIS EXCLUSION BECAUSE AS WE'VE NOTED THE SCREENING WAS DONE FOR PUBLIC HEALTH SURVEILLANCE PURPOSE. RESULTS WOULD BE USED TO INFORM THE PUBLIC HEALTH AUTHORITY AND IT HAS BEEN AUTHORIZED BY A PUBLIC HEALTH AUTHORITY. SIMILARLY, IF CDC AUTHORIZES THE TESTING OF ANTIBODIES IN BLOOD COLLECTED IN THE PASSING SIX MONTHS TO INFORM PEOPLE INVOLVED IN THE RESEARCH STUDY FOR SEASONAL FLU, FOR EXAMPLE, AND THE CDC WANTED TO DO THIS TESTING TO PROVIDE INFORMATION ON THE EXTENT OF EXPOSURE OF COVID-19 IN THE GENERAL POPULATION PEOPLE IN THIS POPULATION WHO MAY HAVE SYMPTOMS SO THAT WOULD ALSO POTENTIALLY COULD BE A PUBLIC HEALTH SURVEILLANCE ACTIVITY THAT WOULD BE EXCLUDED. ALL RIGHT. NOW THAT WE HAVE EXPLAINED THAT EXCLUSION, LET'S MOVE ON TO ANOTHER POINT AND THAT IS THE LEGALLY REQUIRED REPORTING. I'M SURE THAT IN THE CURRENT CRISIS MANY OF YOU WERE AWARE THAT THE KEY PROVISION TO DEAL WITH THIS CRISIS IS BEING ABLE TO MAKE DIAGNOSIS AND FINAL PEOPLE WHO HAVE THE COVID-19 AND DO CONTRACT TRACING. THERE ARE LAWS IN PLACE THAT REQUIRE THE PROVISION AND THE SHARING OF INFORMATION EVEN WHEN SOMETIMES THESE MAY BE INDIVIDUALLY IDENTIFIABLE INFORMATION. SO WHEN REQUIRED BY LAW, SUCH INFORMATION EVEN IF THEY RELATE TO RESEARCH SUBJECTS, COVID-19 SITUATION, THEY NEED TO BE REPORTED TO A PUBLIC HEALTH AUTHORITY. THIS IS THE CASE EVEN WHEN SUCH REPORTING IS INCONSISTENT WITH THE STUDY'S CONSENT FOR OR IN THE CERTIFICATE OF CONFIDENTIALITY. WE WANT TO MAKE THIS CLEAR SO PEOPLE UNDERSTAND EVEN IF THE LEGALLY REQUIRD REPORTING MAY BE INCOMPATIBLE WITH SOME STATEMENTS WITH THE CONSENT FORM OR CERTIFICATE OF CONFIDENTIALITY THE REPORTING MAY BE DONE. IN SUCH CIRCUMSTANCES, WE DO ADVISE INVESTIGATORS SHOULD CONSIDER INFORMING THE PARTICIPANT OF THE REQUIRED REPORTING OF RESULTS. WHEN THERE IS NO LEGAL REQUIREMENT HOWEVER, OR THE REPORTING TO BE DONE, THEN INVESTIGATIONS SHOULD GO TO THE RESEARCH SUBJECTS AND ASK FOR THEIR CONSENT TO DO SO. THE NEXT POINT IS TO REMIND EVERYBODY THAT THERE IS INHERENT FLEXIBILITY BUILT INTO THE REGULATIONS WHETHER IT'S THE OLD COMMON RULE OR THE REVISED NEW COMMON RULE. FOR INVESTIGATORS TO BE ABLE TO IMPLEMENT CHANGES IN A TIMELY FASHION PRIOR TO IRB REVIEW AND APPROVAL. HOWEVER, IT IS IMPORTANT TO REMEMBER THAT INVESTIGATORS ARE ONLY ALLOWED TO MAKE CHANGES THAT ARE NECESSARY TO ELIMINATE THE APPARENT AND IMMEDIATE HAZARDS TO THE SUBJECT. I JUST WANT TO MAKE CLEAR WHILE THIS IS ON THE ONE HAND A USEFUL FLEXIBILITY ESPECIALLY IN CONFRONTING THE CHALLENGES WE FACE WITH THE COVID-19 CRISIS IT'S IMPORTANT TO NOTE IT IS NOT -- THIS FLEXIBILITY IS NOT A CART BLANCHE FOR ANY CHANGES TO THE STUDY CERTAINLY NOT DONE FOR THOSE TO ELIMINATE IMMEDIATE HAZARDS TO THE SUBJECTS. SO WHEN INVESTIGATORS MAY BE [INDISCERNIBLE] WITHOUT PRIOR APPROVAL FROM IRB THEY SHOULD BE CAREFUL THEY MEET THE CRITERIA DESCRIBED HERE AND WOULD BE PREPARED TO JUSTIFY THEM TO THE IRB. ALL THESE CHANGES SHOULD BE REPORTED BACK TO THE IRB WHEN POSSIBLE. AND THIS CRITERIA IS NOT MET THEN THAT MAY BE A POSSIBILITY THEY CONSIDER THESE AS RATHER THAN MODIFICATIONS TO PROTOCOL THEN DEVIATIONS TO THE PROTOCOL. WE DO ENCOURAGE THAT INVESTIGATORS ALSO CONSIDER USING THE OPPORTUNITY FOR THE IRB REVIEW AND APPROVAL OF CHANGES AS A WAY TO THINK ABOUT TO HAVE MORE INPUT INTO HOW THE CHANGES THEY WOULD LIKE TO IMPLEMENT MIGHT IMPACT ON THE RESEARCH SUBJECTS IN A MORE BROADER PERSPECTIVE NOT JUST IN TERMS OF THINKING ABOUT WHAT IS IMMEDIATELY NEEDED. SO WE CAN UNDERSTAND MANY CHANGES ARE BEING MADE TO RESEARCH PROTOCOL AS WE CONFRONT THE CHALLENGES TO THIS COVID-19 CRISIS. SO SOME OF THESE FALL WITHIN AND CAN BE AND THE LAST FLEXIBILITY CAN BE USED BUT MANY NEED TO BE SUBMITTED TO THE IRB FOR REVIEW AND APPROVAL. WE WANT TO REMIND INVESTIGATORS THEY DON'T NEED TO WAIT UNTIL THE NEXT CONTINUING REVIEW TO SUBMIT CHANGES. IN FACT, THEY SHOULD PROBABLY CONSIDER TALKING TO THE IRB AND TELLING THE IRB ABOUT THE CHANGES EARLY ON. WE ARE ALSO AWARE THAT IRBs BECAUSE OF CHANGES THAT NEED TO BE MADE IRBs ACROSS THE NATION ARE PROBABLY SWAMPED AT THE MOMENT AND MANY WOULD PROBABLY WANT TO TRY TO USE EXPEDITED REVIEW MECHANISM TO DO WITH MANY OF THE CHANGES. WE WANT TO REMIND IRB THEY MAY USE AN EXPEDITED REVIEW PROCEDURES IF THE CHANGES ARE MINOR. NOW,O OHRP HAS RECEIVED QUITE A FEW QUESTIONS ON WHAT WOULD BE CONSIDERED MINOR CHANGES IN APPROVED RESEARCH. I'M NOT GOING ELABORATE ON THESE NOW BUT MY COLLEAGUE WILL TALK ABOUT THESE LATER DURING THE QUESTION AND ANSWER SESSION. SO AS RESEARCHERS AND INSTITUTIONS MAKE CHANGES TO THEIR STUDIES AND THERE'S ALSO THE QUESTION OF WHAT KIND OF SITUATIONS REPORTING TO OHRP BE REQUIRED. WE WANT TO REMIND PEOPLE IT'S ONLY THE IRBs EXTENSIONS OR TERMINATIONS OF APPROVED RESEARCH REQUIRED TO BE REPORTED TO OHRP SO INVESTIGATORS AT THE TERMINATIONS OF INVESTIGATORS MAKE DON'T NEED TO BE REPORTED TO OHRP. I THINK THOSE WERE THE POINTS MENTIONED IN THE OHRP GUIDANCE IN RESPONSE TO COVID-19. HERE'S A LIST OF THE INFORMATION THAT MAY BE USEFUL TO YOU THOUGH WE'RE NOT RECEIVING QUESTIONS DURING THIS LIVE WEBCAST, WE'LL JUST BE ANSWERING THE QUESTIONS THAT HAVE ALREADY COME IN, HOWEVER, WE DO CONTINUE TO WELCOME PEOPLE TO SUBMIT QUESTIONS TO US. AU CAN SUBMIT YOUR QUESTIONS AT OHRP.gov AND JOIN THE LIST SERVE TO RECEIVE INFORMATION FROM OHRP FIRST-HAND AND I'VE INCLUDE THE LINK FOR THE DISASTER GUIDANCE FOR YOUR PREFERENCE AND LIKE I SAID, IF YOU GO TO THE HOME PAGE OF OUR WEBSITE WHERE YOU SEE THE ROTATING CAROUSEL, YOU'LL BE ABLE TO GO FROM THERE TO A COVID-19 WHERE YOU FIND RELEVANT POSTS. TODAY'S WEBCAST WILL BE AIR -- ARCHIVED THERE AND SLIDES DOWNLOADED FROM THAT WEBSITE. I'LL SEE IF MY COLLEAGUES HAVE ANYTHING TO SAY AT THIS POINT IN TIME, IF NOT WE'LL GO AHEAD AND START THE QUESTION AND ANSWER SESSION. WE'LL START WITH A SIMPLE QUESTION ABOUT REPORTING TO OHRP ESPECIALLY WHEN MANY STUDIES ARE BROUGHT TO A HOLD AT ONE TIME AND WANT TO KNOW IF REPORTING CAN BE DONE IN A FORM OF A BLANKET NOTIFICATION TO OHRP AND IF SO WHAT INFORMATION SHOULD BE INCLUDE? I'LL ASK MY COLLEAGUE, LISA BUCHANAN TO TELL US ABOUT THIS. >> THANK YOU. YOU CAN IN FACT SUBMIT A BLANKET REPORT TO OHRP WHEN GROUPS OF STUDIES HAVE BEEN SUSPENDED OR HALTED AS A RESPONSE OF THE COVID-19 PANDEMIC. THE TYPES OF INFORMATION HOWEVER, YOU SHOULD INCLUDE IN THE REPORT SHOULD BE SPECIFIC ENOUGH TO DETERMINE WHAT STUDIES AT THAT INSTITUTION WERE AFFECTED BY HALTING SO INFORMATION SUCH AS ALL STUDIES OR A PARTICULAR SET OF STUDIES SUCH AS ALL CLINICAL STUDIES SHOULD BE INCLUDED IN THE REPORT AND MAINTAINED AT THE INSTITUTION. ANOTHER QUESTION RECEIVED ALONG THOSE LINES IS WHAT IF OTHER FEDERAL DEPARTMENTS OR AGENCIES ARE INVOLVED ARE ENOUGH TO SEND NOTIFICATION TO OHRP? INSTITUTIONS STILL WOULD NEED TO SEND REPORTS OR NOTIFICATIONS TO AGENCIES AND DEPARTMENTS IN ORDER TO MEET THEIR REGULATORY REQUIRED OBLIGATION TO REPORT. HOWEVER, WE ARE WORKING TO COMPILE A LIST OF EACH OF THE CONTACTS FOR THE AGENCIES AND MAKING THAT AVAILABLE ON OUR WEBSITE AT SOME POINT IN THE NEAR FUTURE SO THAT YOU CAN HAVE EASY ACCESS TO THE CONTACTS AND E-MAILS OF INDIVIDUALS AT THOSE AGENCIES. >> THANK YOU, LISA. SO THE PANDEMIC HAS PRESENTED MANY CHALLENGES TO ONGOING RESEARCH AND RESEARCHERS HAVING TO MAKE CHANGES TO STUDIES THE QUESTIONS OF WHAT CONSTITUTE MINOR CHANGES SO RESEARCH STUDY SAY KEY QUESTION IN IRB WHEN THEY CAN DECIDE THE MECHANISM TO REVIEW THE STUDIES THEY'RE PRESENTED WITH. I HAVE DIRECTOR JULIE HERE. SHE WILL TELL US A LITTLE BIT ON HOW SHE THINK ABOUT MINOR CHANGES. >> HI, EVERYONE. THANK YOU, YVONNE. SO ONE THING TO NOTE IS THAT THERE IS NO DEFINITION OF MINOR CHANGES IN THE REGULATIONS. SO IRBs HAVE SIGNIFICANT AMOUNT OF LEEWAY TO DECIDE WHAT CHANGES CAN BE CONSIDERED MINOR. ANOTHER THING TO KEEP IN MIND IS THE CHANGES ARE NOT LIMITED TO THE REGULATION ARE MORE RISK IN NATURE. SO THIS IS DIFFERENT FROM THE OTHER PROVISION IN OUR REGULATIONS RELATED TO THE REVIEWERS RESEARCH UNDER THE EXPEDITED REVIEW MECHANISM WHERE THE RESEARCH HAS TO INVOLVE NO MORE THAN MINIMAL RISK AND BE ON THE EXPEDITED REVIEW LIST. SO THIS IS A WAY DIFFERENT PROVISION OF THE RULE. WHAT WE'VE SAID IN RESPONSE TO QUESTIONS WE'VE RECEIVED ABOUT HOW IRB SHOULD THINK ABOUT WHAT CONSTITUTE A MINOR CHANGE IS THEY SHOULD LOOK AT THE STUDY THAT WAS PREVIOUSLY APPROVED, THE NATURE OF THAT STUDY AND ASSESS THE CHANGE BEING PROPOSED RELATIVE TO THE PREVIOUSLY APPROVED RESEARCH TO SEE HOW THE CHANGE RELATES TO THE ALREADY-APPROVED STUDY. ONE THING TO KEEP IN MIND IRRESPECTIVE IF THE CHANGE IS CONSIDERED MINOR OR NOT, THE CHANGE COULD AFFECT THE RISK-BENEFIT RELATIONSHIP OF THE STUDY ITSELF AND THE IRB MAY WANT TO ASSESS THE APPROVABILITY OF THE STUDY IS IN SOME WAY AFFECT THE CHANGE THAT'S BE PROPOSED. I'M DRAWING MANY OF THE THINGS I'M SAYING FROM A LETTER THAT WROTE TO MCI BACK IN 2008. OBVIOUSLY NOT IN THE CONTEXT OF THE COVID-19 WE'RE GRAPPLING WITH NOW BUT MANY OF THE POINTS CAN BE EXTRAPOLATED INTO THIS CONTEXT. SO YOU CAN TAKE A LOOK AT THAT LETTER ON THE WEBSITE AND IF YOU HAVE TROUBLE FINDING IT IF YOU'LL FURTHER REACH OUT TO US VIA THE MAILBOX YVONNE REFERENCED PREVIOUSLY. THE OTHER POINT I WANTED TO TOUCH ON RELATED TO MINOR CHANGES IN RESEARCH HAS TO DO WITH A QUESTION THAT WE RECEIVED ABOUT MINOR CHANGES TO AN EXEMPT STUDY. KEEP IN MIND WITH REGARD TO THE EXEMPTIONS IF THE CHANGES PROPOSED BY THE INVESTIGATORS ARE STILL IN KEEPING WITH ALL THE ASSOCIATIONS WITH THE EXEMPTION THE RESEARCH CONTINUES TO BE EXEMPT UNDER THE REGULATION. SO THERE'S NO IRB REQUIREMENT WHETHER THE CHANGES ARE MINOR OR NOT OR EVEN FOR THE IRB TO REVIEW THOSE CHANGES AND IF IT'S THE SORT WHERE IT NO LONGER MEETS THE EXEMPTIONS THE IRB WOULD NEED TO REVIEW AND APPROVE THE RESEARCH POTENTIALLY UNDER AN EXPEDITE RED VIEW MECHANISM IF THE RESEARCH IS ONE OF THE EXPEDITE RED VIEW CATEGORY -- EXPEDITED REVIEW CATEGORIES. BACK TO YOU. >> I TURNED OFF MY SPEAKER FOR A MINUTE BECAUSE MY CAT WALKED IN. IF YOU HEAR MEOW, I HOPE YOU LIKE CATS LIKE ME. LET'S MOVE TO THE NEXT QUESTION. SO NASOPHARYNGEAL SWABS HAVE BEEN COMMON TO DETECT COVID-19 INFECTION. MANY ASKED US IF A SWAB IS A NON-INVASIVE PROCEDURE UNDER THE EXPEDITED CATEGORY 3 OF BIO LOGICAL SPECIMEN. I'LL TURN IT OVER TO JERRY TO ANSWER THIS. >> THANK YOU, YVONNE. THIS HAS BEEN A FAIRLY COMMON QUESTION. WE HAVE A LOT OF PEOPLE ASKING ABOUT THIS. I WANT TO START OUT BY POINTING OUT MANY OF THESE STUDIES WILL BE UNDER FDA'S JURISDICTION IN TERMS OF THE STUDIES UNDER FDA RESTRICTION THERE'S SPECIFIC PROVISION SPELL OUT WHEN CERTAIN TYPES OF ACTIVITIES ARE OR ARE NOT INVASIVE. IF YOU'RE POSSIBLY UNDER FDA'S JURISDICTION YOU SHOULD CHECK WITH FDA OR YOUR FDA EXPERTS TO FIGURE OUT WHAT THE ANSWER IS IN TERMS OF THIS. WE'RE NOT GOING TO OPINE ON THE FDA SIDE OF THINGS. WHAT I DO WANT TO COMMENT ON IS SAY YOU'VE DETERMINED A PARTICULAR CONTEXT YOUR STUDY IS NOT SUBJECT TO THE FDA RULES RELATED TO PROTECTING RESEARCH SUBJECTS. IF THE ONLY ISSUE YOU HAVE IS THE COMMON RULE IN PARTICULARLY HHS COMMON RULE AND YOU'RE ASKING HOW DOES THAT APPLY TO THE USE OF THESE NASOPHARYNGEAL SWAPS AND ON THE HHS SIDE UNLIKE AGAIN LIKE THE FDA RULES THEY DON'T HAVE SPECIFIC PROVISIONS TO TELL YOU WHEN AN PARTICULAR ACTIVITY IS CONSIDERED TO BE INVASIVE OR NON-INVASIVE. ALL WE HAVE IS THE WORDING OF THE EXPEDITED CATEGORY 3 WITH A BUNCH OF EXAMPLES. IT'S PRETTY MUCH OPEN AND WE DON'T HAVE GUIDANCE ON THIS POINT. SO WHAT THIS MEANS AGAIN PUTTING ASIDE FDA ISSUES ASSUMING YOUR STUDY IS OPPORTUNITY TO THE COMMON RULE AND NOT THE FDA SIMILAR RULES, THE BOTTOM LINE IS THAT ACTUALLY IRBs HAVE A GREAT DEAL OF LATITUDE IN DETERMINING, FOR EXAMPLE, THAT THE USE OF NASOPHARYNGEAL SWABS WOULD BE CONSIDERED NON-INVASIVE OR NOT. THAT'S PRETTY MUCH IT FROM OUR SIDE OF THINGS. AGAIN, IF YOU HAVE ANY QUESTIONS WHETHER YOUR STUDY IS SUBJECT TO THE FDA RULES YOU SHOULD FEEL FREE TO CHECK WITH OUR FDA COLLEAGUES. I WILL HAND IT BACK OVER TO YVONNE. >> SO DIAGNOSIS ARE VALUABLE FOR STUDYING COVID-19. WHAT ARE THE COMMON RULE REQUIREMENTS FOR DOING RESEARCH WITH THESE SPECIMENS? DO RESEARCHERS NEED TO GET INFORMED CONSENT SINCE IT MAY BE HARD TO GET THESE DAYS? WE GET QUITE A FEW QUESTIONS RELATED TO THAT AND I'LL PASS IT ON TO MY COLLEAGUE TO ANSWER THE QUESTIONS. I WANT TO LET YOU KNOW, WE'RE ONLY AT 1:30 SO GO FOR IT. >> THANK YOU. I'LL TRY TO TALK ABOUT A NUMBER OF SCENARIOS IN WHICH PEOPLE ARE INTERESTED IN DOING RESEARCH INVOLVING BIO SPECIMENS. FOR THE MOST PART, I'M GOING TO BE TALKING ABOUT WHAT IS USUALLY CALLED SECONDARY RESEARCH. THAT IS RESEARCH INVOLVING BIO SPECIMENS AND PERHAPS INFORMATION AS WELL THAT WERE ORIGINALLY COLLECTED FOR SOME OTHER PURPOSE, FOR EXAMPLE, FOR CLINICAL PURPOSES OR FOR SOME OTHER RESEARCH STUDY. IF INVESTIGATORS WISH TO GO TO AN INSTITUTION AND OBTAIN A LEFTOVER SPECIMEN FOR SECONDARY RESEARCH PURPOSES, IF THE INSTITUTION SIMPLY TURNS OVER THOSE SPECIMENS AND THE INFORMATION IN NON-IDENTIFIABLE FORM AND ACCORDING TO THE COMMON RULE, THIS IS TECHNICALLY NOT CONSIDERED TO BE HUMAN SUBJECTS RESEARCH SO THE REQUIREMENTS OF THE COMMON RULE DO NOT APPLY AND INFORMED CONSENT IS NOT A REGULATORY REQUIREMENT. THEN THERE'S ANOTHER CIRCUMSTANCE WE GOT QUESTIONS ABOUT RELATED TO COVID-19 IN WHICH INVESTIGATORS ARE INTERESTED IN GETTING LEFT OVER SPECIMENS AND INFORMATION ABOUT SUBJECTS OR PATIENTS AND ALSO INTERESTED IN FOLLOWING THOSE PATIENTS TO COLLECT TO GET ADDITIONAL INFORMATION LATER ON AND ANALYZE THAT INFORMATION ABOUT THOSE INFORMATION THE ORIGINAL SPECIMENS AND INFORMATION OBTAINED AND LATER INFORMATION. THIS CIRCUMSTANCE IS WHAT FREQUENTLY HAPPENS IS INSTITUTIONS RELEASES THE INFORMATION TO THE INVESTIGATORS WITH A CODE ATTACHED TO THE INFORMATION THAT ALLOWS THE INSTITUTION RELEASING THE INFORMATION IDENTIFYING WHO THE PATIENT IS BUT THE INVESTIGATORS DON'T HAVE THE KEY TO THE CODE SO THEY DON'T HAVE A WAY OF IDENTIFYING SUBJECTS. SO LONG AS IT IS TRUE THE SOURCE INSTITUTION ONLY PROVIDES THE COVID-19 MATERIAL, HAS NO OTHER INVOLVEMENT RESEARCH ACTIVITY AND IT IS ALSO TRUE THAT RELEASING INSTITUTION AND THE INVESTIGATORS HAVE AN AGREEMENT THAT UNDER NO CIRCUMSTANCES WILL THE CODE BE BROKEN TO ALLOW THE INVESTIGATORS TO IDENTIFY THE PATIENTS, THEN OHRP ALSO CONSIDERS THIS TO BE RESEARCH THAT DOES NOT INVOLVE HUMAN SUBJECTS. SO ONCE AGAIN, THE REQUIREMENTS OF THE COMMON RULE DO NOT APPLY. THERE IS NO REQUIREMENT FOR INFORMED CONSENT. THIS PROCESS DOES ALLOW THE SOURCE INSTITUTION TO CONTINUE RELAEFG ADDITIONAL INFORMATION -- RELEASING ADDITIONAL INFORMATION ABOUT THE TREATMENT OF THE PATIENT AND PERHAPS ADDITIONAL SPECIMENS COLLECT FROM THAT PATIENT IDENTIFYING THE INFORMATION AND SPECIMENS TO THE ORIGINAL CODE FOR THE INFORMATION OR BIO SPECIMENS THAT WERE RELEASED IN THE FIRST GO SO THAT THE PATIENT'S TREATMENT CAN BE TRACKED OVER TIME. BUT STILL ALLOWING THIS TO BE NOT HUMAN SUBJECTS RESEARCH. ALL OF WHAT I SAID IS IN OHRP GUIDANCE ABOUT COVID-19 IFORMATION OR SPECIMEN USE AND AVAILABLE ON OUR WEBSITE. IT WAS A DOCUMENT THAT WAS RELEASED IN 2008. IT IS ALSO THE CASE THAT SECONDARY RESEARCH INVOLVING BIO SPECIMENS CAN BE CARRIED OUT IN CIRCUMSTANCES WITH THE INVESTIGATORS ACTUALLY GO TO THE SOURCE INSTITUTION AND TEMPORARILY HAVE ACCESS TO IDENTIFYING INFORMATION RELATED TO THE SPECIMENS AND THE INFORMATION. BUT IF THE INVESTIGATORS RECORD THE INFORMATION AND OBTAIN THE SPECIMENS WITHOUT RECORDING ANY IDENTIFYING INFORMATION ABOUT THOSE PATIENTS, THEN SECONDARY ANALYSIS OF BIO SPECIMENS AND MATERIALS THAT WERE OBTAINED IN NON-IDENTIFIABLE FORM FROM THE SOURCE INSTITUTION FALLS UNDER AN EXCEPTION OF THE COMMON RULE THAT HAS CHANGED IN THE NEW REVISED RULE AND IF YOU LOOK ABOUT CODED INFORMATION OR SPECIMENS, ACTUALLY, THE DESCRIPTION OF THAT EXEMPTION IS ONLY ACCURATE FOR THE OLD COMMON RULE. THE NEW EXEMPTION ALLOWS FOR IS THE EXEMPTION TO COVER INFORMATION THAT DON'T YET EXIST AT THE TIME THE RESEARCH IS PROPOSED. SO ONE COULD CREATE A RESEARCH STUDY WHERE ONE ANTS PATS OBTAINING INFORMATION AND SPECIMENS THAT HAVE NOT YET BEEN COLLECTED AND HAVE THAT RESEARCH STUDY FALL UNDER THE EXEMPTION. UNLIKE THE ACTIVITY THAT INVOLVES THE USE OF CODING, OF COURSE, WOULD BE THE CASE FOR THIS EXEMPTION THE INVESTIGATORS WOULD NOT BE ABLE TO GO BACK AND OBTAIN INFORMATION ABOUT THE SAME PATIENTS AT A LATER TIME BECAUSE THEY WOULDN'T HAVE ACCESS TO THE CODES AND BE ABLE TO REIDENTIFY -- RE-IDENTIFY FORMER PATIENTS. WE'VE ALSO BEEN ASKED ABOUT THE CIRCUMSTANCES IN WHICH THE INVESTIGATORS RECEIVING BIO SPECIMENS AND INFORMATION FOR A RESEARCH STUDY SIDE THEY WOULD ACTUALLY LIKE TO ASK THE SOURCE INSTITUTION TO COLLECT ADDITIONAL SPECIMENS AND INFORMATION FOR THE RESEARCH STUDY. IF THAT'S THE CASE AND THE INVESTIGATORS ARE ASKING THE SOURCE INSTITUTION TO COLLECT ADDITIONAL INFORMATION AND/OR B B BIOSPECIMENS FOR A RESEARCH PURPOSE AND TURN IT OVER TO INVESTIGATORS, NOW WE'RE TALKING ABOUT NON-EXEMPT HUMAN SUBJECT RESEARCH AND ALL THE STANDARD REQUIREMENTS OF THE COMMON RULE DO APPLY. IF THERE ARE CONCERNS ABOUT INFORMED CONSENT AND THERE'S OPTIONS AND THE FIRST IS TO OBTAIN INFORMED CONSENT OF THE PROSPECTIVE SUBJECTS OR THE STANDARD REQUIREMENTS OF SECTION 116, OR IF THE PATIENT IS INCAPABLE OF PROVIDING INFORMED CONSENT IT MAY BE POSSIBLE TO PROVIDE INFORMATION OF THE LEGALLY AUTHORIZED REPRESENTATIVE OF THE PATIENT OR DEPENDING ON THE CIRCUMSTANCES AND DETAILS OF THE RESEARCH STUDY, IT MAY BE POSSIBLE TO GET AWAIVER OF INFORMED CONSENT THROUGH THE PROVISIONS OF SECTION 116F. THERE IS AN ADDITIONAL PROVISION FOR RESEARCH INVOLVING AN EMERGENCY WAIVER OF INFORMED CONSENT YOU CAN FIND INFORMATION ABOUT ON OUR WEB PAGE. BUT AT LEAST BY MY MEETING, IT SEEMS TO ME TO BE FAIRLY CLEAR THAT IF WE'RE JUST TALKING ABOUT THE ANALYSIS OF SPECIMENS AND INFORMATION RESEARCH STUDY WITHOUT THERE BEING AN INTERVENTION TO BENEFIT THE SUBJECTS OF THE STUDY, THEN THE EXISTING EMERGENCY WAIVER PROVISION WOULD NOT BE A SUITABLE AVENUE FOR A RESEARCH STUDY WHERE WAIVER WAS IMPOSSIBLE. THERE WOULD NEED TO BE AN ADDITIONAL SECRETARIAL WAIVER ISSUED FOR RESEARCH STUDY THAT CONSISTED ONLY OF THE SECONDARY -- WELL, CONSISTED ONLY OF THE ANALYSIS OF OBTAINED SPECIMENS AND INFORMATION WITHOUT THERE BEING ANY TREATMENT INTERVENTION AND CIRCUMSTANCES WHERE INFORMED CONSENT WAS NOT POSSIBLE OR WAIVER OF INFORMED CONSENT UNDER THE ORDINARY PROVISIONS OF 117 WERE ALSO NOT APPROPRIATE. SO I THINK THAT'S A QUICK OVERVIEW OF THE VARIOUS OPTIONS FOR WHAT ARE GENERALLY SECONDARY RESEARCH STUDIES INVOLVING BIO SPECIMENS AND MATERIALS. SO I'LL HAND IT BACK TO YVONNE FOR THE NEXT QUESTION. >> THANK YOU FOR THE DETAILED EXPLANATION ABOUT THE POSSIBILITY FOR USING BIOSPECIMENS IN SECONDARY RESEARCH. I THINK MANY ARE FINDING DATA FROM THE MEDICAL RECORDS OF PATIENTS WITH COVID-19 REPRESENT AN INVALUABLE SOURCE OF INFORMATION TO LEARN ABOUT THE DISEASE SINCE WE KNOW SO LITTLE ABOUT IT. I WONDER IF THERE ARE RELATED EXEMPTIONS TO HELP FACILITATE SOME OF THE RESEARCH. I'LL PASS IT ON TO MY COLLEAGUE, LAUREN, TO TALK ABOUT THE HIPAA EXEMPTION. >> THIS DOVETAILS NICELY. THE QUESTION IS ARE THERE EXEMPTIONS THAT MAY NOT BE ABLE TO FACILITATE THE SECONDARY RESEARCH RELATED TO COVID-19. AND SO I WILL TURN EVERYONE'S ATTENTION TO EXEMPTION CATEGORY 4 IN THE REVISED COMMON RULE AND ALSO IN THE OLD COMMON RULE BUT IT'S BEEN REVISED SLIGHTLY IN THE NEW COMMON RULE SO THERE ARE I GUESS MORE OPTIONS FOR PEOPLE TO DO SECONDARY RESEARCH. SO SPECIFIC LI, I'M GOING TO TURN YOUR ATTENTION TO ONE OF THE D4 TRIPLE I I'VE BEEN CALLING THE HIPAA EXEMPTION AND I HAVE MY REGS IN FRONT OF ME SO I'M LOOKING DOWN A LITTLE BIT. WHAT THAT BASICALLY SAYS IS RESEARCH THAT INVOLVES ONLY INFORMATION, COLLECTION AND ANALYSIS INVOLVING INVESTIGATORS' USE OF IDENTIFIABLE HEALTH INFORMATION WHEN THE USE IS REGULATED UNDER HIPAA. FOR THE PURPOSE OF HEALTH CARE OPERATION OR RESEARCH AS THE TWO ARE DEFINED BY HIPAA OR PUBLIC HEALTH ACTIVITY OR SERVICESDESCRIBED AS UNDER THE -- DESCRIBED UNDER THE HIPAA REGULATIONS. THAT'S THE BASIC SCOPE OF EXEMPTIONS. MOST COMMONLY WHAT THAT'S GOING MEAN IF YOU'RE A HIPAA-COVERED ENTITY AND FOLLOWING THE EXEMPTIONS HOW DO DO RESEARCH OR PUBLIC HEALTH ACTIVITIES UNDER HIPAA, YOU DON'T ALSO HAVE TO FOLLOW THE COMMON RULE. SO ONE THING TO KEEP IN MIND IS ONE EXEMPTING DOESN'T WAIVE OBLIGATIONS OR YOU'RE EXEMPT FROM HIPAA, WHEN WHEN YOU'RE FOLLOWING THE HIPAA REGULATIONS AND A HIP PA-COVERED ENTITY THERE'S RESOURCES ON THE OFFICE OF CIVIL RIGHTS WEBSITE ON HIPAA I RECOMMEND PEOPLE TAKE A LOOK AT. THE OCR Q&As HAVE A GREAT JOB WALKING PEOPLE THROUGH HOW TO CONDUCT RESEARCH UNDER HIPAA OR WHAT STEPS TO TAKE UNDER HIPAA. THE EXEMPTING DOES SAYS IN THE CASE WHERE THE HIPAA PRIVACY PROTECTIONS RIN PLACE, YOU DON'T -- ARE IN PLACE, YOU DON'T HAVE TO HAVE THE COMMON RULE PROTECTIONS IN PLACE BECAUSE THE HIPAA PROTECTIONS ARE SUFFICIENT TO PROTECT THE SUBJECTS IN THIS CIRCUMSTANCE. SO IN TERMS OF SHARING DATA ACROSS HOSPITAL CENTERS OR OTHER COVERED ENTITIES AND RESEARCHING ON THE DATA THE BIGGEST EXEMPTION YOU'LL BE LOOKING AT IS EXEMPTION CATEGORY 4 AND THE TRIPLE I. ONE OTHER THING TO NOTE AGAIN IS HIPAA IS SPECIFIC TO ACTIVITIES INVOLVING INFORMATION NOT BIOSPECIMENS. SO IN THIS CASE WE'RE NOT TALKING ABOUT THE ANALYSIS OF THE BIO SPECIMENS NECESSARILY. WE'RE TALKING ABOUT INFORMATION THAT MIGHT HAVE BEEN GENERATED FROM THAT ANALYSIS NOW IN THE PATIENT RECORD FILE AND YOU WANT TO DO RESEARCH ON THE RECORDS NOT SPECIFICALLY THE BIOSPECIMENS. THAT'S ONE OTHER THING TO KEEP IN MIND AND WITH THAT I'LL TURN IT BACK TO YVONNE. >> THANK YOU, LAUREN. SO WE'VE ALMOST COME TO THE END OF THIS Q&A SESSION. WE HAVE ONE MORE QUESTION THAT'S MORE GENERAL AND WE RECEIVED QUESTIONS ABOUT THE WORK OF THE SINGLE IRBs AND THE RELATIONSHIP OF SINGLE IRBs WITH THE LOCAL SITES. WITH THE CRISIS DIFFERENT THINGS ARE HAPPENING AND DIFFERENT LOCALES AND INSTITUTIONS ARE HAVING TO MAKE DECISIONS QUICKLY SO HOW DO THEY COORDINATE AND WHAT MIGHT BE IN THE COMMON RULE REGULATIONS THAT COULD HELP INFORM SOME OF THE THINGS THE COMMUNICATIONS NEED TO GO BETWEEN SINGLE IRBs AND THE LOCAL SITE. SO WITH THAT I'M GOING PASS TO IRENE, MY COLLEAGUE, TO SAY A FEW WORDS FROM THE PERSPECTIVE OF THE IRBs AND THE LOCAL SITES. PLEASE TAKE IT FROM HERE. WE DON'T HEAR YOU. >> THE DECISIONS AFFECTING LOCAL SITES. DURING THE COVID-19 CRISIS WHEN MAKING DECISIONS ABOUT CHANGES OR SUSPENSIONS THE SINGLE IRB SHOULD TAKE INTO CONSIDERATION THE SITUATION THE LOCAL SITES TO BETTER UNDERSTAND HOW CHANGES OR SUSPENSIONS MIGHT AFFECT THESE LOCAL SITES. THERE SHOULD BE CLOSED COMMUNICATION BEFORE SWEEPING DECISION MADE BY THE SINGLE IRB. IN TERMS OF CHANGES LOCAL SITES MIGHT BE INITIATING AND MIGHT NEED TO INITIATE RAPIDLY, IF YOU REFER TO THE 2018 REQUIREMENTS OF A SIMILAR PROVISION AND THE PRE-2018 REQUIREMENTS IN 46103, ABOUT CHANGES THAT INVESTIGATORS MIGHT MAKE EVEN BEFORE THEY GET APPROVAL FROM IRBs, FOR EXAMPLE, AND ELIMINATE HAZARDS TO THE SUBJECT OTHERWISE INVESTIGATORS MUST OBTAIN PRIOR APPROVALS FROM IRBs. ALSO, IF YOU REFER TO THE 2018 REQUIREMENTS WITHIN 45CFR46112 AND SIMILAR PROVISION IN THE PRE-2018 REQUIREMENTS WHERE RESEARCH AS APPROVED BY IRBs MAY BE SUBJECT TO FURTHER APPROPRIATE REVIEW AND APPROVAL OR DISAPPROVAL BY OFFICIALS OF THE INSTITUTION. AND LASTLY, AS IN OHRP RECOMMENDATION IS A SO-CALLED BEST PRACTICE RECOMMENDATION IT'S PRUDENT TO ESTABLISH CLOSED COMMUNICATIONS WEN THE SINGLE IRB -- BETWEEN THE SINGLE IRBs AND THE LOCAL SITES. THAT I'LL TURN IT OVER TO YOU. >> ALL RIGHT. I THINK THIS BRINGS US TO THE END OF THIS OHRP LIVE WEBCAST ON RESPONSE TO COVID-19. WE HOPE THAT YOU HAVE FOUND THE INFORMATION WE PROVIDED TO BE HELPFUL. PLEASE CONTINUE TO SEND US QUESTIONS YOU MIGHT HAVE IN DEALING WITH SITUATIONS YOU ENCOUNTER THESE DAYS. YOU CAN SEND THESE QUESTIONS TO OHRP AT HHS.gov. WE ENDEAVOR TO TRY TO RESPOND TO YOU WITHIN A FEW DAYS. YOU ARE ALSO WELCOME TO VISIT OUR WEBSITE FOR RESOURCES RELATED TO RESPONSES TO COVID-19 AGAIN ON OUR HOME PAGE YOU CAN CLICK ON THE FIRST IMAGE ICON AND IT WILL TAKE YOU TO THE COVID-19 PAGE WHILE CONTINUE TO ADD RELATED RESOURCES THERE. FOR EXAMPLE, THEY MENTIONED A CORRESPONDENCE WE SENT TO NCI IN 2008. WE WILL ADD TO THIS PAGE SO AS TO ACCESS THE INFORMATION. I ALSO WANT TO DRAW YOUR ATTENTION TO OTHER RESOURCES ON OUR WEBSITE UNDER THE LUMINARY LECTURER'S SERIES. FOR EXAMPLE, WE HAVE VIDEOS OF PEOPLE, EXPERTS IN THE RESEARCH COMMUNITY TALKING ABOUT A VARIETY OF SUBJECTS THAT MAY BE OF RELEVANCE FOR YOU DOING YOUR JOB THESE DAYS RECENTLY WE PUT ON A VIDEO BY MEGAN ON ELECTRONIC INFORMED CONSENT AND I KNOW A LOT OF YOU ARE ACTUALLY HAVING TO DO RESORT TO DOING ELECTRONIC INFORMED CONSENT AND APART FROM THAT VIDEO THERE'S LINKS TO THE E-CONSENT GUIDANCE DOCUMENT AND SO FORTH. DO HAVE A LOOK AROUND ON OUR WEBSITE FOR VARIOUS RESOURCES THAT COULD BE OF HELP TO YOU. WE ALSO MENTIONED THERE ARE NEW PROVISIONS AND EXEMPTIONS FOR THE REVISED COMMON RULE. AGAIN, WE HAVE THE REVISED COMMON RULE GATEWAY PAGE TO FIND Q&As AND ANSWERS TO QUESTIONS AND IF YOU HAVE A PROBLEM FINDING ANY INFORMATION FEEL FREE TO REACH US AT OHRP.gov. SO I HOPE EVERYBODY WILL CONTINUE TO BE HEALTHY AND STAY SAFE AT HOME AND FINALLY, ONCE AGAIN I'D LIKE TO THANK MY NIH COLLEAGUES FOR SUPPORTING THIS VIDEO AND I'VE BEEN DOING THE TALKING SO I DON'T ACTUALLY KNOW HOW THIS IS BEING BROADCAST OUT. I HOPE THE SOUND AND VISUAL QUALITY HAVE BEEN ACCEPTABLE. WITH THAT, THANK YOU FOR JOINING US ON THE LIVE WEBCAST AND HOPE TO SEE YOU SOON AGAIN EITHER VIRTUALLY OR IN PERSON. THANK YOU VERY MUCH.