Standard Operating Procedures

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1 Standard Operating Procedures Ffff H a r v a r d L o n g w o o d M e d i c a l A r e a Office of Human Research Administration 90 Smith St. Suite 335 Boston, MA /

2 SOP: Definitions HRP-001 6/10/2013 D. Wolf D. Wolf 1 of This policy establishes the definitions followed by the human research protection program. 2.1 None. 3.1 Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject s participation in the research, whether or not considered related to the subject s participation in the research. 3.2 Allegation of Non-Compliance: An unconfirmed assertion of Non-Compliance. 3.3 Community Based Participatory Research (CBPR): CBPR includes community members in all aspects of research including the conception, design, analysis and dissemination of the research. This approach to research engages community partners in collaboration with researchers to solve problems relevant to human health in communities. 3.4 Continuing Non-Compliance: A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance. 3.5 Experienced IRB Member: An IRB member is considered experienced if the member has three years of IRB experience (serving as an IRB member or working in the field of human research administration) and is considered to be knowledgeable by the IRB chair. 3.6 Expiration Date: The first date that the protocol is no longer approved. The date after the end date of the approval period. 3.7 ESTR: Electronic Submission, Tracking & Reporting system for Harvard investigators and IRBs. 3.8 Designated Reviewer: The IRB chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Committee Reviews. 3.9 Finding of Non-Compliance: Non-Compliance in fact Human Research: Any activity that either: Is Research as defined by DHHS and involves Human Subjects as defined by DHHS; or Is Research as defined by FDA and involves Human Subjects as defined by FDA Human Subject as Defined by DHHS: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through Intervention or Interaction with the individual, or (2) information that is both Private Information and Identifiable Information. For the purpose of this definition: Intervention: Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject s environment that are performed for research purposes Interaction: Communication or interpersonal contact between investigator and subject Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record) Identifiable Information: Information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information). 1 The terms Human Subject Research, Research Involving Human Subjects, Human Participant Research, Research Involving Human Participants, Clinical Research, Clinical Investigation, Clinical Study and similar phrases are considered to be synonyms for the term Human Research.

3 SOP: Definitions HRP-001 6/10/2013 D. Wolf D. Wolf 2 of Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used Immediate Family: Spouse, domestic partner; and dependent children Institutional Official: HSPH: Associate Dean for Research (ADR) is designated as the Institutional Official (IO) HMS/HSDM: Chief Research Operations Officer of Harvard Medical School (HMS) is designated as the Institutional Official (IO) IRB Review Specialist: An OHRA Staff, who is an experienced IRB member and Certified IRB Professionals (CIP). IRB Review Specialist is a Designated Reviewer that conducts Non- Committee Review Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the participant's participation in the research procedure(s) Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests For research involving prisoners Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons Non-Committee Review: Any of the following: Determination of whether an activity is Human Research Determination of whether Human Research is exempt from regulation Reviews of non-exempt research using the expedited procedure Determination of which subjects can continue in expired research Non-Compliance: Failure to follow applicable regulations/directives, or the requirements or determinations of the IRB OHRA: Office of Human Research Administration that consists of IRB Operations and Quality Improvement Program (QIP). OHRA supports, manages and oversees all human research conducted by faculty, staff and students of Harvard Medical School (HMS), Harvard School of Dental Medicine (HSDM) and Harvard School of Public Health (HSPH) Related to the Research: A financial interest is Related to the Research when the interest is in (1) the sponsor of the research; (2) a competitor of the sponsor of the research; (3) the product or service being tested; or (4) a competitor of the product or service being tested Research as Defined by DHHS: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Research as Defined by FDA: Any experiment that involves a test article and one or more human subjects, and that meets any one of the following: Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice; 2 The phrase ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests should not be interpreted to include the inherent risks certain categories of subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).

4 SOP: Definitions HRP-001 6/10/2013 D. Wolf D. Wolf 3 of Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit Restricted: Applies to investigators or research staff members who are delinquent in meeting IRB requirements Serious Adverse Event: Any Adverse Event that (1) results in death; (2) is life-threatening (places the subject at immediate risk of death from the event as it occurred); (3) results in inpatient hospitalization or prolongation of existing hospitalization; (4) results in a persistent or significant disability/incapacity; (5) results in a congenital anomaly/birth defect; or (6) based upon appropriate medical judgment, may jeopardize the subject s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition Serious Non-Compliance: Non-Compliance that affects the rights or welfare of participants Suspension of IRB Approval: An action of the IRB, IRB chair, OHRA Director or Institutional Official and/or designee to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review Termination of IRB Approval: An action of the IRB to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review Unanticipated Problem Involving Risk to Participants or Others: Any information that is (1) unanticipated; (2) related or possibly related to participation in the research; and (3) indicates that participants or others are at increased risk of harm. 4.1 Individuals writing policies and procedures are to indicate terms defined in this policy with a double underline. 4.2 Individuals using policies and procedures are to consult this policy for the definitions of double underlined terms. 5.1 Not applicable. 6.1 None CFR CFR 50.3, 21 CFR , 21 CFR 312.3, 21 CFR 812.2(a). 21 CFR 812.3(p)

5 SOP: Observation of the Consent Process HRP-012 5/06/2013 D.Wolf D. Wolf 1 of This procedure establishes the process to observe the consent process. 1.2 The process begins when the IRB determines that the consent process should be observed. 1.3 The process ends when the IRB determines that the consent process no longer should be observed. 2.1 None. 3.1 The IRB may consider observation of the consent process when: The IRB needss verification from sources other than the investigator that no material changes have taken place since prior IRB review There are allegations or findings of Non-Compliance The nature of the research indicates that the consent process can be improved through observation. 3.2 The IRB designates who conducts the observation. The IRB may have the observation conducted by: QIP staff IRB staff IRB members A person recommended by the investigator An independent person hired by the IRB, but paid for by the investigator s funds. 4.1 The person designated to conduct the observation of the consent process carries out these procedures. 5.1 Observe the consent process and determine whether the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant or the participant s Legally Authorized Representative, and that informed consent was freely given by the participant or the Legally Authorized Representative If no, indicate that consent is not legally effective and the prospective participant may not be entered into the research If yes, document in writing that the consent process was observed and that informed consent was freely given by the participant or Legally Authorized Representative. 6.1 None.

6 SOP: Legally Authorized Representatives, Children, and Guardians HRP-013 5/06/2013 D. Wolf D. Wolf 1 of This policy provides applicable definitions to meet DHHS and FDA requirements when the research is conducted in Massachusetts: Legally authorized representative Children Guardian 2.1 None. 3.1 Under DHHS and FDA regulations a legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject s participation in the research procedure(s). Unless the IRB has waived the requirement to obtain consent, when research involves adults unable to consent, permission must be obtained from a legally authorized representative. When research is conducted in Massachusetts the following individuals meet this definition: For medical research and minimal risk non-medical research: A health care agent as defined in M.G.L. c. 201D A guardian as defined in 115 CMR 10.02, M.G.L. c , 6A, 6B. ( Individual, organization or agency, if any that has been appointed legal guardian of the person found to be incompetent by a court of competent jurisdiction. ) A responsible party as defined in M.G.L. c. 201D, For all other research, legal counsel has to determine that the individuals proposed to serve as legally authorized representatives meet the federal definition of legally authorized representative. 3.2 For research outside Massachusetts, a determination of who meets the DHHS and FDA definitions of legally authorized representative is to be made with consultation from legal counsel. 3.3 Under DHHS and FDA regulations children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. Subpart D of the DHHS must be applied if and only if an individual involved in the research meets this definition. When research is conducted in Massachusetts all individuals under the age of 18 years meet this definition with the following exceptions: Emancipated minors, defined as individuals who meet one of the following criteria, do not meet the DHHS and FDA definition of children : (M.G.L. c F) Married/widowed/divorced; A parent; A member of the armed forces; Living apart from parents and managing his or her own finances; or In the case of a female, pregnant or believes herself to be pregnant, unless the procedures involved in the research include abortion as described below Individuals under the age of 18 when the research procedures are limited to: Diseases dangerous to the public health; Drug dependency (but not alcohol dependency) Pregnancy, unless the procedures involved in the research include abortion as described below.

7 SOP: Legally Authorized Representatives, Children, and Guardians HRP-013 5/06/2013 D. Wolf D. Wolf 2 of Exception: If the research procedures involve abortion, a female under the age of 18 who is not and has never been married meets meet the DHHS and FDA definition of children. (M.G.L. c S) 3.4 For research outside Massachusetts, a determination of who meets the DHHS and FDA definitions of children is to be made with consultation from legal counsel. 3.5 Under DHHS and FDA regulations a guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. When research involves children and parental permission is required, consent may only be obtained from parents (biologic or adoptive) or a guardian as defined by DHHS and FDA regulations. When research is conducted in any jurisdiction and permission for a child to participate in research is to be obtained from an individual other than biological or adoptive parents, the individual providing such permission must provide written documentation of the legal ability to consent to the child s general medical care. A copy of this documentation is to be kept with the consent document in the investigator s files. 4.1 Investigators are to follow this policy when obtaining permission for adults unable to consent or children to take part in research. 5.1 None. 6.1 None.

8 SOP: Incoming Items Directed to the IRB HRP-020 5/06/2013 D. Wolf D. Wolf 1 of This procedure establishes the process to triage information submitted to the IRB. 1.2 The process begins when any communication is received by the IRB. 1.3 The process ends when an IRB staff member determines the appropriate action for the received information. 2.1 None. 3.1 None. 4.1 IRB staff members carry out these procedures. 5.1 Submission is routed and assigned to IRB Review Specialists through Electronic Submission, Tracking & Reporting (ESTR) system. 5.2 If the information represents a request to withdraw from consideration a new protocol or modifications to an approved protocol Update the protocol record in ESTR Follow the SOP: IRB Records. 5.3 If the information represents a request for an approval (approval of new research, continuing review of research, or modification to previously approved research) or a determination whether an activity is exempt Human Research or is not Human Research: Update the protocol record in ESTR Follow the SOP: Pre-Review. 5.4 If the information represents a response to modifications required to secure approval: Update the protocol record in ESTR Follow the SOP: Modifications Required to Secure Approval. 5.5 If the information represents a notification of completion of required HRPP training update ESTR and set the training expiration date to three years after the completion date 5.6 If the information represents an investigator s request to continue participants in expired research: Update the protocol record in ESTR Have the IRB chair follow SOP: Expiration of IRB Approval. 5.7 If the information represents an item that does not fit into the above categories: Update the protocol record in ESTR (if applicable) If the information represents a question, concern, or complaint: Document the nature of the question, concern, or complaint and the contact information of the person contacting the IRB Answer any questions that are basic or general in nature. For more complicated questions, take a message and consult with the IRB Administrative Chair, QIP Director, and/or OHRA Director to identify the best course of action for the questions concerns, and/or complaints Follow SOP: New Information. 6.1 SOP: Expiration of IRB Approval.

9 SOP: Incoming Items Directed to the IRB HRP-020 5/06/2013 D. Wolf D. Wolf 2 of SOP: IRB Records. 6.3 SOP: Modifications Required to Secure Approval. 6.4 SOP: New Information. 6.5 SOP: Pre-Review. 7.1 None.

10 SOP: Pre-review HRP-021 5/06/2013 D. Wolf D. Wolf 1 of This procedure establishes the process to pre-review a request for approval (approval of new research, continuing review of research, or modification to previously approved research) or a determination whether an activity is exempt Human Research or is not Human Research. 1.2 The process begins when the IRB receives a request for approval. 1.3 The process ends when the information has been placed on the queue for an IRB meeting or has been provided to a Designated Reviewer. 2.1 None. 3.1 None. 4.1 IRB Review Specialists carry out these procedures. 5.1 Use the WORKSHEET: Submission Materials and to review the application materials. 5.2 If the information is not complete, contact the investigator and offer the opportunity to provide additional information If the investigator will not provide additional materials, update the system and note that the submission was withdrawn If the investigator will provide additional materials, continue processing. 5.3 If the investigator or research staff member is Restricted, contact the investigator. Explain that the investigator or research staff member is Restricted, give reasons, and indicate that if the protocol goes to the IRB and the activity is Human Research, the IRB policy is to not approve the research except where necessary to maintain protection of current participants If the investigator will not take steps to remove the Restricted status, update system and note that the submission was withdrawn If the investigator will take action, continue processing. 5.4 Evaluate the most likely level of review: If the request can be handled as a Non-Committee Review and the investigators and research staff are not Restricted, Follow the SOP: Non-Committee Review Preparation Otherwise put in the queue for a convened IRB meeting. 6.1 SOP: Non-Committee Review Preparation. 6.2 WORKSHEET: Submission Materials. 7.1 None.

11 SOP: Modifications Required to Secure Approval HRP-022 5/06/2013 D.Wolf D. Wolf 1 of This procedure describes the process to handle investigator submissions of modifications required to secure approval. 1.2 The process begins when modifications required to secure approval are received by the IRB. 1.3 The process ends when the acceptance or rejection of the modifications is provided to the investigator. 2.1 None. 3.1 The IRB reports its findings and actions to the investigator. 3.2 These reporting procedures are to be completed within ten business days of receipt of the modification. 4.1 IRB Review Specialists carry out these procedures. 5.1 If the investigator requests a review by the convened IRB, place on the schedule for review by a convened IRB and take no further action under this procedure. 5.2 Otherwise follow SOP: Non-Committee Review Preparation. 6.1 SOP: Non-Committee Review Preparation CFR (b)(4)(i) CFR (a)(1)

12 SOP: New Information HRP-024 5/06/2013 D. Wolf D. Wolf 1 of This procedure establishes the process to manage information reported to the IRB to ensure that information that represents Non-Compliance, Unanticipated Problems Involving Risk to Participants or Others, Suspensions of IRB Approval, and Terminations of IRB Approval are managed to protect the rights and welfare of participants. 1.2 The process begins when the IRB receives a report of new information form. 1.3 The process ends when the information item is determined not to represent a problem that requires management, is managed administratively, or referred to the convened IRB for review. 2.1 None. 3.1 The IRB staff or the IRB chairs may request assistance from the Quality Improvement Program (QIP) to gather additional information when in their opinion additional information is needed to answer a question required by this SOP. 3.2 Protocol history is maintained in system. 3.3 OHRA will promptly notify the federal department or agency funding the research of any for cause investigation of that research by another federal department or agency or national organization For Department of Defense (DOD) research the report is sent to the DOD human research protection officer. 3.4 The organization will promptly notify the Department of Defense (DOD) if the IRB of record changes. 4.1 The IRB staff members carry out this procedure. 5.1 Review each item of information and answer the following questions: (See attached flowchart for a diagram of the flow of this procedure.) Is this an Allegation of Non-Compliance? Is this a Finding of Non-Compliance? Is this an Unanticipated Problem Involving Risk to Participants or Others? Is this a Suspension or Termination of IRB Approval? 5.2 If the IRB staff member is unable to answer a question, consult the OHRA Director or IRB chair 5.3 If the OHRA Director and/or IRB chair is unable to answer a question, follow the SOP: Investigations. 5.4 If the answer is no to all questions, skip section 5.5 and continue with section If the answer is yes to one or more questions, then follow the corresponding sections below: Allegations of Non-Compliance: Determine whether each Allegation of Non-Compliance has any basis in fact If yes, follow the procedures under Findings of Non-Compliance If no, follow any other corresponding sections Findings of Non-Compliance: Determine whether each Finding of Non-Compliance is Serious Non-Compliance or Continuing Non-Compliance If no, follow the procedures under Non-Serious/Non-Continuing Non- Compliance If yes, follow the procedures under Serious or Continuing Non-Compliance Non-Serious/Non-Continuing Non-Compliance

13 SOP: New Information HRP-024 5/06/2013 D. Wolf D. Wolf 2 of Work with the individual or group responsible for the Non-Compliance to develop and implement a suitable corrective action plan If unable to work with the individual or group responsible for the Non- Compliance to develop and implement a suitable corrective action plan, consider the Non-Compliance to be Continuing Non-Compliance and follow the procedures for Serious or Continuing Non-Compliance Serious Non-Compliance; Continuing Non-Compliance; Suspension of IRB Approval; Termination of IRB Approval; or Unanticipated Problem Involving Risk to Participants or Others Complete Section 1 of CHECKLIST: Review of Information Items Place on the IRB agenda as an item of Serious Non-Compliance; Continuing Non-Compliance; Suspension of IRB Approval; Termination of IRB Approval; or Unanticipated Problem Involving Risk to Participants or Others. 5.6 If in the opinion of the IRB staff member reviewing the new information the rights and welfare of participants might be adversely affected before the convened IRB can review the information, contact the IRB chair to consider a Suspension of IRB Approval following the SOP: Suspension or Termination of IRB Approval. 5.7 If the notification involves a subject becoming a Prisoner in a study not approved by the IRB to involve Prisoners: Confirm that the subject is currently a Prisoner If the subject is currently not a Prisoner no other action is required Consider whether stopping all research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated subject until the regulatory requirements for research involving Prisoners are met or until the subject is no longer a Prisoner would present risks to the subject If the subject s involvement in the research cannot be stopped for health or safety reasons, do one of the following: Keep the subject enrolled in the study and review the research for involvement of Prisoners. If the research is subject to DHHS oversight, notify OHRP Remove the subject from the study and provide the study intervention as clinical care or compassionate use If the subject s involvement in the research can be stopped, inform the investigator that all research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated subject must be stopped immediately until the regulatory requirements for research involving Prisoners are met or until the subject is no longer a Prisoner, For Department of Defense (DOD) research promptly report all decisions to the Department of Defense (DOD) The Department of Defense (DOD) must concur with the IRB before the subject can continue to participate while a prisoner. 5.8 Take any additional actions required to resolve any concerns or complaints associated with the information. 5.9 If the information does not involve a Serious Non-Compliance; Continuing Non-Compliance; Suspension of IRB Approval; Termination of IRB Approval; or Unanticipated Problem Involving Risks to Subjects or Others and a response is expected, complete and send a TEMPLATE LETTER: Review of Information Item to the person submitting the information..

14 SOP: New Information HRP-024 5/06/2013 D. Wolf D. Wolf 3 of WORKSHEET: Review of Information Items 6.2 SOP: Investigations. 6.3 SOP: IRB Records. 6.4 SOP: Suspension or Termination of IRB Approval. 6.5 SOP: Directed Audit 6.6 TEMPLATE LETTER: Review of Information Item CFR (b) CFR (b)(5), 45 CFR (a)

15 SOP: New Information HRP-024 5/06/2013 D. Wolf D. Wolf 4 of Flowchart* *Reporting to OHRP only when the study is HHS funded or supported.

16 SOP: Investigations HRP-025 5/06/2013 D. Wolf D. Wolf 1 of This procedure establishes the process to conduct investigations by appointing an Investigative Committee. 1.2 The process begins when the IRB staff members and chair cannot answer a question required by SOP: New Information. 1.3 The process ends when the investigation is complete and the answer has been provided to the OHRA Director. 2.1 None. 3.1 The investigation committee may request assistance from the Quality Improvement Program (QIP) to gather additional information. 4.1 The OHRA Director: In consultation with the IO, appoints the members of the investigative committee based on the expertise and background needed to answer the question Appoints a chair of the investigative committee Charges the investigative committee with the question to be answered. 4.2 The investigative committee carries out these procedures within 60 days. 4.3 Investigative committee members make their decisions based on a preponderance of the evidence. 4.4 Investigative committee decisions are made by majority vote. 4.5 Individuals being interviewed may have counsel present. However, counsel cannot address the investigative committee. The investigative committee, by a vote of the majority, may exclude counsel when in the opinion of the investigative committee that person s presence is disruptive. 5.1 Notify the investigator that an investigation is being conducted, the question to be answered, and the time frame for completion. 5.2 Determine what information to gather and what individuals to interview. 5.3 Gather information and interview individuals. 5.4 If the investigative committee believes that a transcription of the interviews will be required to make a proper decision, the investigative committee may request a court stenographer to record all interviews. 5.5 Repeat information gathering and interviews until a decision can be made. 5.6 The investigative committee provides a written report of the decision to the OHRA Director. 6.1 SOP: New Information. 6.2 SOP: Directed Audit. 7.1 None

17 SOP: Suspension or Termination of IRB Approval HRP-026 5/07/2013 D. Wolf D. Wolf 1 of This procedure establishes the process for someone other than the convened IRB to institute a Suspension of IRB Approval or a Termination of IRB Approval. 1.2 The process begins when the OHRA Director institutes a Suspension of IRB Approval or a Termination of IRB Approval. 1.3 The process ends when the Suspension of IRB Approval or a Termination of IRB Approval has been placed on the agenda for review by the convened IRB. 2.1 None. 3.1 The Institutional Official may suspend or terminate IRB approval for research for any reason. 3.2 The IRB chair may institute a Suspension of IRB Approval when in the opinion of the IRB chair participants may be at risk of adverse effects on their rights and welfare before action may be considered by the convened IRB. 3.3 The OHRA Director may institute a Suspension of IRB Approval or Termination of IRB Approval for any reason. 3.4 The Institutional Official, IRB chair, or OHRA Director may request assistance from the Quality Improvement Program (QIP) to gather additional information when in their opinion additional information is needed to answer a question required by this SOP. 4.1 The individual instituting a Suspension of IRB Approval or Termination of IRB Approval follow these procedures. 5.1 Notify the investigator of the Suspension of IRB Approval or Termination of IRB Approval by preparing and sending TEMPLATE LETTER: External Report along with the reasons for the decision. 5.2 Ask the investigator for a list of participants currently involved in the research. 5.3 Ask the investigator whether any actions are required to protect those participants rights and welfare. 5.4 Consider whether any of the following additional actions are required to protect those or other participants rights and welfare: Transferring participants to another investigator Making arrangements for clinical care outside the research Allowing continuation of some research activities under the supervision of an independent monitor Requiring or permitting follow-up of participants for safety reasons Requiring adverse events or outcomes to be reported to the IRB and the sponsor Notification to current participants Notification to former participants. 5.5 Refer to the IRB staff to place on the agenda of the next IRB meeting for review. 6.1 TEMPLATE LETTER: External Report CFR (b)(3), 21 CFR CFR (b)(5)(ii), 45 CFR (a), 45 CFR

18 SOP: Designated Reviewers HRP-030 6/10//2013 D. Wolf D. Wolf 1 of This procedure establishes the process for the IRB chair to designate IRB members, other than IRB Review Specialist who can conduct Non-Committee Reviews. 1.2 The process begins when the IRB chair designates an Experienced IRB Member to conduct Non-Committee Reviews. 1.3 The process ends when the IRB member has been noted in the IRB roster to conduct Non-Committee Reviews. 2.1 None. 3.1 IRB Review Specialist is a Designated Reviewers by Definition (HRP-001). 4.1 IRB staff members carry out these procedures. 5.1 Obtain the name of the Experienced IRB Member designated to conduct Non-Committee Reviews. 5.2 Verify that the IRB member is an Experienced IRB Member 5.3 Update the DATABASE: IRB Roster to indicate that the IRB member has been designated to conduct Non-Committee Reviews. 6.1 DATABASE: IRB Roster CFR (b) CFR (b).

19 SOP: Non-Committee Review Preparation HRP-031 6/10/2013 D. Wolf D. Wolf 1 of This procedure establishes the process to prepare for a Non-Committee Review. 1.2 The process begins when an IRB Review Specialist identifies an application as being possibly eligible for Non-Committee Review. 1.3 The process ends when the IRB Review Specialist assigns the study in ESTR for Non-Committee Review. 2.1 None. 3.1 None. 4.1 IRB staff members carry out these procedures. 5.1 Refer to the Department Assignment and select a Department-assigned IRB Review Specialist If a Department-assigned IRB Review Specialist is not available, other IRB Review Specialist can serve as the Designated Reviewer or schedule the protocol to be reviewed by the convened IRB. 5.2 Prepare a packet of materials in ESTR (or make the materials available) that includes all information that would have been provided to any IRB member. 5.3 Add to the packet or make available: CHECKLIST: Non-Committee Review. 5.4 Add to the packet or make available when appropriate: CHECKLIST: Human Research Determination CHECKLIST: Exemption Determination CHECKLIST: Eligibility for Review Using the Expedited Procedure (Initial and continuing review) CHECKLIST: Eligibility for Review Using the Expedited Procedure (Modifications) CHECKLIST: Information Security Level Determination. 5.5 For modifications required to secure approval add to the packet or make available: Copy of all IRB meeting minutes relevant to the submission Copy of previous CHECKLIST: Non Committee Review. 5.6 Place a copy of all correspondence in the protocol file. 6.1 CHECKLIST: Non Committee Review 6.2 CHECKLIST: Human Research Determination 6.3 CHECKLIST: Exemption Determination 6.4 CHECKLIST: Eligibility for Review Using the Expedited Procedure (Initial and continuing review) 6.5 CHECKLIST: Eligibility for Review Using the Expedited Procedure (Modifications) 6.6 CHECKLIST: Information Security Level Determination 6.7 DATABASE: IRB Roster CFR (b) CFR (b).

20 SOP: Non-Committee Review Conduct HRP-032 6/11/2013 D. Wolf D. Wolf 1 of This procedure establishes the process for an IRB Review Specialist to conduct a Non-Committee Review. 1.2 The process begins when the IRB Review Specialist is assigned the submission in ESTR. Note that as per the OHRA-HLMA policies, for submissions that undergo Non-Committee Review, the IRB Review Specialist completes both the pre-review and designated review. 1.3 The process ends when the IRB Review Specialist (Designated Reviewer) completes the review and issues the determination letter in ESTR. 2.1 None. 3.1 Designated Reviewers cannot disapprove research. 4.1 The Designated Reviewer carries out these procedures. 5.1 Take ownership of the submission in ESTR via the Assign IRB Contact activity. 5.2 Review the submission for completeness and accuracy If changes/additional information are not needed, submit the pre-review (step 5.3) If changes are needed or additional information required, request clarifications via the Request Pre-Review Clarification activity. Once changes are submitted, review them and if no further changes/clarifications are needed, submit the pre-review (step 5.3). 5.3 If prepared to move the submission to the next phase of review, submit the pre-review in ESTR (via the Submit Pre-Review activity) by indicating the responsible regulatory oversight and selecting special populations, determinations and waivers (if applicable), initial risk level determination and type of research. In addition, any missing materials and suggested contingencies should be noted and relevant supporting documents (if any) should be attached. If there are special populations, determinations and waivers, complete the corresponding checklist(s) needed to document that review: Authorization / Waiver of Authorization (HIPAA) - Use the CHECKLIST: HIPAA Waiver of Authorization to document a waiver or alteration of HIPAA authorization Children or children who are wards of the state - Use CHECKLIST: Research Involving Children when research involves children as subjects (including children who are wards of the state) Cognitively impaired adults - Use CHECKLIST: Research Involving Cognitively Impaired Adults when research involves cognitively impaired adults as subjects FERPA - Use WORKSHEET: FERPA Compliance to determine whether personally identifiable information can be released from student educational records. Note that this worksheet does not need to be completed or retained Harvard students - No checklist needed Neonates of uncertain viability - Use CHECKLIST: Research Involving Neonates of Uncertain Viability when research involves neonates of uncertain viability as subjects Non-significant risk device - Use CHECKLIST: Non-Significant Risk Device when research involves an abbreviated IDE Non-viable neonates - Use CHECKLIST: Research Involving Non-Viable Neonates when research involves non-viable neonates as subjects Pregnant Women - Use CHECKLIST: Research Involving Pregnant Women when research involves pregnant women as subjects.

21 SOP: Non-Committee Review Conduct HRP-032 6/11/2013 D. Wolf D. Wolf 2 of Prisoners - Use CHECKLIST: Research Involving Prisoners when research involves prisoners as subjects Students - No checklist needed Waiver of consent documentation - Use CHECKLIST: Waiver of Written Documentation of the Consent Process when research involves the waiver of written documentation of consent Waiver/alteration of the consent process - Use CHECKLIST: Waiver or Alteration of Consent Process when research involves waiver or alteration of the consent process. 5.4 Select the Designated Reviewer (IRB Review Specialist) via the Assign Designated Reviewer activity If any changes/additional information are required at this stage, request clarifications via the Request Clarification by Designated Reviewer activity. Once changes are submitted, review them and if no further changes/clarifications are needed, submit the designated review (step 5.6) If changes/additional information are not needed, complete the designated review (step 5.6). 5.5 Complete the designated review (via the Submit Designated Review activity) by indicating the determination, review level, and risk level, approval interval and data security level (for initial applications and continuing renewals only). If modifications are required (i.e. for a Modifications Required to Secure Approval determination), they should be described and any relevant supporting documentation should be attached. Relevant worksheets should be reviewed for guidance, but do not need to be completed or retained Not Human Research - Review the WORKSHEET: Human Research Determination to determine whether the activity is Human Research Exempt Human Research - Review the WORKSHEET: Exemption Determination to determine whether the Human Research meets the exemption criteria and the organization s ethical requirements Human Research approved using the expedited procedure - Review WORKSHEET: Criteria for Approval and Additional Considerations and WORKSHEET: Eligibility for Review Using the Expedited Procedure to determine whether the Human Research can be approved. 5.6 If consultation is needed follow SOP: Consultation to the IRB CHECKLIST: HIPAA Waiver of Authorization CHECKLIST: Research Involving Children CHECKLIST: Research Involving Cognitively Impaired Adults CHECKLIST: Research Involving Neonates of Uncertain Viability CHECKLIST: Non-Significant Risk Device CHECKLIST: Research Involving Non-Viable Neonates CHECKLIST: Research Involving Pregnant Women CHECKLIST: Research Involving Prisoners CHECKLIST: Waiver of Written Documentation of the Consent Process CHECKLIST: Waiver or Alteration of Consent Process WORKSHEET: FERPA Compliance WORKSHEET: Human Research Determination WORKSHEET: Exemption Determination WORKSHEET: Criteria for Approval and Additional Considerations

22 SOP: Non-Committee Review Conduct HRP-032 6/11/2013 D. Wolf D. Wolf 3 of WORKSHEET: Eligibility for Review Using the Expedited Procedure SOP: Consultation to the IRB CFR (b) CFR (b).

23 SOP: IRB Meeting Preparation HRP-040 6/13/2013 D.Wolf D. Wolf 1 of This procedure establishes the process to prepare for a convened IRB meeting. 1.2 The process begins the day after the submission deadline, approximately fifteen business days before a meeting date. 1.3 The process ends when agenda items have been assigned through ESTR and where applicable, packets have been placed in the mail for delivery to IRB members. 2.1 None. 3.1 At least one IRB member or consultant is responsible for scientific/scholarly review of research. 3.2 Protocols are reviewed by IRB members and consultants with sufficient expertise. 3.3 When IRB members review research that involves vulnerable participants, at least one individual who is knowledgeable about or experienced in working with such participants will be present at the meeting. 3.4 IRB members are provided sufficient information so that each member can provide an opinion on whether the regulatory criteria for approval are met. 3.5 Alternate IRB members serve the same function as other IRB members, except that if the alternate IRB member and the regular IRB member for whom the alternate member is substituting are both present, only one member may vote. 3.6 Agenda materials are provided to all IRB members at least 5 business days before convened meetings. 4.1 IRB staff members carry out these procedures. 5.1 Confirm which IRB members (regular, alternate, and chairs) will be present at the meeting. 5.2 Consult the current IRB roster to be aware of the experience, expertise and representational capacity of the IRB. 5.3 Review all submissions placed on the queue for a convened IRB meeting. 5.4 Prepare an agenda for the meeting Assign a scientific/scholarly (primary) reviewer to each agenda item who has scientific/scholarly expertise in the area of the research Assign a secondary reviewer to each agenda item. 5.5 Use the CHECKLIST: Evaluation of Quorum and Expertise to ensure that the meeting will be appropriately convened and to ensure the IRB will have the appropriate expertise for each protocol If the meeting will not meet the quorum and expertise requirements, take steps to obtain the required attendance members and consultants or cancel the meeting Follow the procedures in SOP: Consultation to the IRB to obtain consultants. Note any consultants on the agenda. 5.6 Upload agenda to meeting workspace within ESTR. 5.7 Assign Designated Reviewers within ESTR to each agenda item 6.1 CHECKLIST: Evaluation of Quorum and Expertise. 6.2 SOP: Consultation to the IRB CFR (b)

24 SOP: IRB Meeting Preparation HRP-040 6/13/2013 D.Wolf D. Wolf 2 of CFR (b)

25 SOP: IRB Meeting Conduct HRP-041 6/07/2013 D.Wolf D. Wolf 1 of This procedure establishes the process to conduct convened meetings. 1.2 The process begins when the IRB members gather for a convened meeting. 1.3 The process ends when the meeting is adjourned. 2.1 None. 3.1 The IRB reviews research in accordance with the applicable regulatory criteria for approval. 3.2 The IRB chair votes as a regular member. 3.3 If quorum is lost during a meeting, the IRB cannot take votes until the quorum is restored, even if more than half of the members are still present. 3.4 Substantive changes or requirements, requests for more information for IRB consideration, and other issues related to the criteria for approval require review and approval by the convened IRB. 3.5 Minor or prescriptive changes or requirements may be reviewed for approval by the IRB chair. 3.6 The worksheets and checklists described in WORKSHEET: Review Materials and listed below in Section 6: MATERIALS are provided to IRB members in advance of meetings per SOP: IRB Meeting Preparation to conduct meetings and meet regulatory requirements 4.1 The IRB chair carries out these procedures. 4.2 Primary and secondary reviewers lead IRB members through consideration of the regulatory criteria for approval. 5.1 Call the meeting to order. 5.2 Ask IRB members whether anyone has a conflicting interest in any item on the agenda. Note this on the agenda. 5.3 Ask IRB members whether anyone has questions regarding the Expedited Studies Approved in the last 45 days Report. 5.4 For each business item: Table the item when notified by IRB staff when requirements for review of a specific item as defined in CHECKLIST: Evaluation of Quorum and Expertise are not met If there are IRB members with a conflicting interest, invite the IRB to ask questions of those members and then ask those members to leave for discussion and voting If there is a consultant present, ask the consultant to present their review to the IRB If a consultant provided written information to the IRB, present that information to the IRB Have the primary and secondary reviewers present their reviews to the IRB Note any contingencies required by IRB staff Have the primary and secondary reviewers lead the IRB through the review as described below Open the floor for additional discussion Review any modifications required by the IRB to secure approval to ensure that the IRB staff has recorded them Entertain a motion Call for a vote Only IRB members may vote If a member and an alternate are both present, only one may vote.

26 SOP: IRB Meeting Conduct HRP-041 6/07/2013 D.Wolf D. Wolf 2 of Consultants may not vote For a motion to be approved, it needs the approval of more than half of the members present at the meeting. (If there are 10 or 11 members present at the meeting, 6 votes are required for approval, which is greater than 5 and 5.5, respectively.) Re-invite IRB members with a conflicting interest back into the meeting Provide any written information provided by a member or consultant to the IRB staff. 5.5 For each protocol requesting approval have the primary reviewer: Use the CHECKLIST: Criteria for Approval and Additional Considerations and all referenced checklists (listed below) to have the convened IRB determine which regulatory criteria are met, which are not met, and which would be met if the investigator modified the protocol as requested by the IRB Restate the IRB s consensus regarding protocol specific findings justifying a determination when required by a checklist Make a motion for one of the following actions: Approve (with a specific continuing review interval for initial or continuing review): Made when all criteria for approval are met Modifications Required to Secure Approval (with a specific continuing review interval for initial or continuing review): Made when IRB members require specific modifications such that the Designated Reviewer can determine whether an investigator has made the required changes without judging whether a change meets the regulatory criteria for approval. When making this motion, the assigned reviewers restate the modifications required by the IRB members and the IRB members reasons for those changes Tabled: made when the IRB cannot approve the research at a meeting for reasons unrelated to the research, e.g., loss of quorum Defer: Made when the research does not qualify for Approval or Modifications Required to Secure Approval and the IRB has recommendations that might make the protocol approvable. When making this motion, the assigned primary reviewer describes the IRB members reasons for the decision and describes recommendation(s) to make the research approvable Disapprove: Made when the research does not qualify for Approval or Modifications Required to Secure Approval and the IRB has no recommendations that might make the protocol approvable. When making this motion, the assigned primary reviewer describes the IRB members reasons for the decision. The investigator is provided an opportunity to respond to the IRB in person or in writing. 5.6 For each unanticipated problem involving risk to subjects or others, serious or continuing noncompliance item, or suspension or termination of IRB approval, have the primary reviewer: Use the CHECKLIST: Review of Information Items to have the convened IRB make any necessary determinations Make a motion reflecting any actions required by the IRB members. 5.7 If the IRB approves a motion involving a Suspension of IRB Approval or Termination of IRB Approval follow SOP: Suspension or Termination of IRB Approval. 5.8 Temporarily adjourn the meeting when notified by IRB staff that quorum has been lost. 5.9 Adjourn the meeting when there is no further business. 6.1 WORKSHEET: Advertisements

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