Release Notes Version 1.5

December 4, 2006

Spreadsheet of 1.5 Form Changes

Expand/Collapse Application Form Changes

Click here for a spreadsheet listing all of the questions and logic in the Application, AE/ORIO and SCR forms with Release 1.5 changes highlighted in yellow.

  • New logic in the forms may require that study teams enter additional information on submissions currently in process.
  • The option of selecting "Not Available Electronically," to indicate that hard copy documents will be provided to the IRB, has been removed in the following sections:
    • 1-1 Standard Study Information
      • 1-1.4.1 IRB documentation outlining the previous review outcome
    • 1-5 HUD
      • 1-5.12 Humanitarian Device Exemption (HDE) documentation
    • 1-6 PRC documents
      • 1-6.0 Scientific Protocol
    • 2 Sponsor Information
      • 2.4 Supporting documentation - external
      • 2.7 Supporting documentation - internal
    • 3-1 Performance Sites
      • 3-1.8 Site approval documentation
    • 5.1 Scientific Protocol
      • 5.1 Scientific protocol
    • 11-2 Confidentiality
      • 11-2.1 Certificate of Confidentiality
    • 27. Deception
      • Debriefing document
    • 29 Survey
      • 29.12 Survey instrument

In the Standard Study Information section:

  • Questions 1-1.3 and 1-2.1 now default to the PI's department instead of the person who created the application.
  • Question 1-1.4 - question reworded for clarification - "Has this study been previously disapproved by any UM or non-UM IRB?" instead of "Has this study been previously submitted to this or any other UM or non-UM IRB for approval?"
  • Question 1-2.2 - question reworded for clarification - "Affirm that separate IRB approval will be obtained for any research study or activity directly involving human subjects (or their identifiable information)" phrase in parentheses was changed from "conducted under the purview of this application."

In the PRC/CPC PRC Information section:

  • Question 1-6.3 - Changed question to: "Does this trial require Cancer Center Resources (patients, space, CTO, biostatistics, IDS, CCCores)?" and added upload question for CTRAC application.

In the External Sponsor Detail section:

  • The word "Support" has been changed to "Sponsor/Support" throughout the form for clarity.
  • Question 2.2. - Changed Column Head in External Sponsor Table search results to "Sponsor ID" from "ID".
  • Question 2.2.4 - Added "(if assigned)" to question.
  • Question 2.4 - question reworded for clarification - Upload all of the following documents that apply:
    • Grant (- question added - required for "Government - Federal" sponsor types)
    • Contract application (- question added - required for "Government - Federal" sponsor types)
    • Sponsor budget (- question added - required for use of GCRC resources)
    • Sponsor application
    • PAF
    • Most recent competing renewal application

In the University of Michigan Study Functions section:

  • Question 3.1 - the selection "Observation" was changed to "Observation of behavior (direct or indirect)".

In the Research Design section:

  • Question 5-1.4 - Changed text to: "Briefly outline the special expertise and qualifications of the PI, Co-Investigators, and/or Faculty Advisors to conduct and/or oversee the particular procedures or activities involved in this particular study."
  • Question 5.2 - reworded and moved from Section 8 for better flow and branching logic - "Will the involvement of ANY subjects in this study be limited to analysis of their existing data or specimens (other than any potential informed consent process, there will be no DIRECT interaction/intervention with these subjects. Involvement for these subjects is limited to analysis of subject data in existing databases, data sets, medical records, and/or specimens from banks or repositories?"
  • Question 5.3 - moved from Section 8 for better flow and branching logic - "Will the study involve recruitment and/or participation of subjects in order to produce new data (e.g., surveys, interaction, and intervention)? [Require sections 8-3 and 11-3]"
  • Questions 5-1.1 through 5-1.6 - Objective, Specific Aims, Background, Study Team Expertise, Methodology, Statistical Design questions all moved from the first page of Section 5 to Section 5-1. By splitting Section 5, certain users (Cancer Center) will be allowed to skip Section 5-1.

In the Benefits and Risks section:

  • Question 6.3 - changed wording of first paragraph to read: "Provide a description of the foreseeable risks to the subjects. (Rarely is a study completely risk-free. Consider physical, psychological, social/reputation, legal, financial, privacy risks, etc.)"

In the Special Considerations section:

  • Section 7 - Questions have been reordered and grouped into three sections: Section 7, Section 7-1, and Section 7-2. Splitting this section allows Data Analysis Only users to skip certain questions (see table below).

Section 7 Reordering - (Analysis Only Sections highlighted in yellow)

Category

Old Question #

New Question#

Requires Section #

Specimens

7.3

7.1

18

Genetic Analysis

7.4

7.2

20

Secondary Data Analysis

7.5

7.3

24

HIPAA

7.6

7.4

25

Epidemiological

7.7

7.5

26

Foreign

7.11

7.6

30

Commercial Development

7.13

7.7

  

Payments

7.1

7-1.1

13

Health-care

7.2

7-1.2

14

Deception

7.8

7-1.3

27

Internet

7.9

7-1.4

28

Survey

7.10

7-1.5

29

Audio-visual

7.12

7-1.6

31

Drugs

7-1.1

7-1.7

15

Placebo

7-1.3

7-1.8

17

Stem Cells

7-1.4

7-1.9

19

DSMP

7-1.8

7-1.10

32

Devices

7-1.2

7-2.1

16

Radiation

7-1.5

7-2.2

21

Transplants

7-1.6

7-2.3

22

Gene Transfer

7-1.7

7-2.4

23
  • Question 7-1.2 - Reworded text of question to read: "Will subjects undergo healthcare-related treatments or procedures (standard of care and/or experimental) as part of the study intervention?"
  • IRB Flint studies are no longer routed to skip Section 7-1.

In the Subject Recruitment section:

  • Question 8-3.1 - four new selection options added to subject pools used for recruitment:
    • UM Human Research Recruiting Registry (e.g., Engage - http://www.med.umich.edu/engage/)
    • Department or unit-specific research recruiting registry (provide UM IRB project number below)
    • Patients or their medical records from the UM Health System or any other UM health care provider (e.g., School of Dentistry, University Health Service, University Center for Language and Literacy)
    • M-CARE, M-CAID, MHIC or MHMC members. Patients of non-UM physicians, dentists, or other health care providers or facilities
    • Also a new text field has been added for users to provide related UM IRB project number or subject pool description.
  • New Question 8-3.6 - "If Web pages will be used, provide the Web address (URL) for the location where the pages will be posted (also upload the content of the pages below)"

Section 9-1 and subsequent detail pages for vulnerable populations will be skipped when users indicate that they're not interacting with subjects in question 5.2 .

In the Subject Populations section:

  • Question 9-1.1 - selection option added to Subject Populations: "Unknown unspecified population".
  • Updated text in Section 9-1 about what sections are required (see table below):
Old Selection Wording New Selection Wording
Children (Minors under the age of 18) [Require Sections 33 and 41] Children (Minors under the age of 18) [Require Sections 33 and 41 or Section 33-1 for analysis only studies ]
Viable neonates [Require Sections 33 and 41] Viable neonates [Require Sections 33 and 41 or Section 33-1 for analysis only studies .]
Neonates of uncertain viability and/or non-viable neonates [Require Section 34] Neonates of uncertain viability and/or non-viable neonates (do not check this box if the research is solely retrospective. For retrospective research regarding neonates of uncertain viability, check the box for 'children'. See Help for additional information.) [Require Section 34 . ]
Individuals and/or Products Involving Human In Vitro Fertilization Individuals and/or products involving human in-vitro fertilization
Pregnant women and/or fetuses [Require Sections 35 and 41] Pregnant women and/or fetuses [Require Sections 35 and 41or Section 35-1 for analysis only studies ]
Lactating women [Require Section 36] Lactating women [Require Section 36 studies involving interaction/intervention .]
Women of child-bearing potential [Require Section 37] Women of child-bearing potential [Require Section 37 studies involving interaction/intervention ]
Prisoners (If the research includes a study population that is likely to become incarcerated during the conduct of the research, also select this category) [Require Sections 38 and 41] Prisoners (If the research includes a study population that is likely to become incarcerated during the conduct of the research, also select this category) [Require Section 38 for all studies. Require Sections 38 and 41 for studies involving interaction/intervention ]
Cognitively impaired adults [Require Sections 39 and 41] Cognitively impaired adults [Require Sections 39 and 41 studies involving interaction/intervention .]
College students [Require Sections 40 and 41] College students [Require Sections 40 and 41 for direct interaction studies ]
Economically or educationally disadvantaged persons [Require Section 41] Economically or educationally disadvantaged persons [Require Section 41 for direct interaction studies .]
Patients of the study team [Require Section 41] Patients of the study team [Require Section 41 for direct interaction studies ]
Employees, students or trainees of the study team [Require Section 41] Employees, students or trainees of the study team [Require Section 41 studies involving interaction/intervention .]
Family members of the study team [Require Section 41] Family members of the study team [Require Section 41 studies involving interaction/intervention ]

In the Informed Consent section:

  • Question 10-1.4 - selection option added to anticipated costs to subject: "Cost of routine health care that would be incurred for this condition if the subject were not participating in the research study".

In the Confidentiality/Security section:

  • Section 11 - Confidentiality/ Security - Questions have been reordered and grouped into five sections for better flow and branching logic:
    • Section 11 - Confidentiality/ Security
    • Section 11-1 - Identifiable Data
    • Section 11-2 - Certificate of Confidentiality
    • Section 11-3 - End of Subject Participation
    • Section 11-4 - Bank/Repository Detail
  • New Question 11-1.4 - Will individually identifiable sensitive data be accessed, collected, used, maintained, or disclosed in the study? Sensitive data is defined in the University's Standard Practice Guide, SPG #601.12. It includes personal identifiable information about employees, students, and patients of the University.
    • 11-1.4.1 - Will a continuous, periodic, or automatic feed of sensitive data be set up to provide data directly from any University information system (e.g., M-Pathways, U-M Data Warehouse, CareWeb)?
      If yes, list each of the systems involved and briefly describe the data feed and reasons it is needed.
    • 11-1.4.2- Will sensitive data be accessed by individuals who are not University employees?
    • 11-1.4.3- Will sensitive data be stored on or accessed from computer equipment that is not maintained and supported by a University IT services provider (e.g., MAIS, MCIT, MSIS) - such as home computers, grant-funded computers, etc.?
    • 11-1.4.4 - Will sensitive data be stored on portable devices (e.g., laptops, PDAs, flash drives) in unencrypted form?

  • Question 11-3.1 - moved from 6.7 for better flow - "What specific criteria will be used to prematurely end a particular subject's participation in the study (e.g., predetermined safety endpoints, unexpected clinically significant findings, situations of distress or adverse events)? (If covered in attached document, indicate specific location. Failure to do so may result in delays in the review process or return of the application.)."
  • New Question - 11-3.2 - If a participant withdraws from the research, what is the plan to use, disclose, store, or destroy the participant's data?
  • New Question - 11-4.5 - Is the subject required to participate in the bank or repository as a condition of participating in the research?
    • If yes, provide a justification for conditioning participation in the research on inclusion of data or specimens in the bank or repository. If the information is included in the attached protocol, please indicate section.
  • Question 11.2 - question reworded for clarification - "How will the research records and data be protected against inappropriate use or disclosure, or malicious or accidental loss or destruction? Records and data include informed consent documents, case report forms or study flow sheets, survey instruments, database or spreadsheet, screening logs or telephone eligibility sheets, web based information gathering tool, audio/video/photo recordings of subjects, labeled specimens, data about subjects, subject identifiers, etc. Select all that apply:
    • Locked office
    • Locked cabinet or storage unit
    • Restricted access
    • Destruction of source data immediately after data collection (e.g., to preserve anonymity of a vulnerable population)
    • Restrictions on copying study-related materials
    • Access rights terminated when authorized users leave the project or unit
    • Secure laptop
    • Individual ID plus password protection
    • Routine electronic back up
    • Disaster recovery plan
    • Encryption of digital data
    • Network restrictions
    • No non-UM devices are used to access project data, or any that are used to access project data use secure connections to communicate with U-M services (e.g. VPN - "virtual private network")
    • Security software (firewall, anti-virus, anti-intrusion) is installed and regularly updated on all servers, workstations, laptops, and other devices used in the project
    • Safe disposition/destruction of data or devices, as appropriate (e.g., shredding paper documents, destroying disks or thumb drives, secure erasure of electronic media)
    • Additional protective measures or special circumstances

In the Drugs, Biologics, Nutritional Supplements or Other Products section:

  • Question 15.3.14 - Added "concomitant medical use" to list of FDA- approved agents used "off-label" (i.e., in an unapproved dose, route of administration, population, disease, in concomitant medical use, etc.)

In the Devices section:

  • Removed Question 16.2.10.1 - Has this device been designated as a "510(k) device?"
  • Removed Question 16.2.20.1 - Has this device been designated as a "510(k) device?"
  • New Question 16.2.24 - FDA Approved Devices - Upload any supporting documentation here.

In the Biological Specimens section:

  • Question 18.1.4 - question reworded for clarification - "Non-blood specimens obtained directly from subjects for the purpose of this research study (NOT from specimens removed for medically indicated reasons)"
  • Question 18.1.7 - question reworded for clarification - Who will collect the biological specimens from the subjects? Specify source name and primary contact (e.g., directly from physician, UMHS clinical pathology labs, UMHS delivery rooms, remote institutions, etc.)
  • Question 18.1.11 - selection option added for biological specimen repositories: "Pathology Department Paraffin Archive" and an additional question: "If 'Pathology Department Paraffin Archive' is selected, describe the study team's arrangement to use the archive for the purposes of this research."

In the Genetic Analysis section:

  • Typos and incorrect logic in the validations rules on questions in section 20 have been fixed.

In the RDRC/SHUR Information section:

  • Questions 21-2.1 - answering "0" as the number of patients no longer requires you to answer 21-2.1.1 about their age.
  • New Question 21-3.1.2 - Has an Investigational New Drug (IND) application been filed for this radiopharmaceutical? If yes, provide answers to the following:
    • 21-3.1.2.1 Indicate the IND number:
    • 21-3.1.2.2 Indicate the Institution:
  • New Question 21-3.1.3 - Indicate the Active Ingredient and Quantity (milligrams) to be administered.
  • New Question 21-3.1.4 - Indicate the total activity of each radioisotope per administration (injection, IV, oral, etc).
  • New Question 21-3.1.5 - Indicate the total activity of each radioisotope to be administered.
  • New Question 21-3.1.6 - What, if any, toxic or pharmacological effects may occur? (NOTE: If study is being performed under 21-1.3(c), evidence must be presented that there will be no pharmacological effect in human subjects. In addition, references for pharmacological dose data must be listed below.)
  • New Question 21-3.1.7 - Attach pharmacological dose calculations based on data available from published literature or from other valid human studies.
  • New Question 21-3.1.8 - Route of Administration: Submit data for other absorbed radiation doses that result from this experimental protocol [fluroscopic or radiographic x-rays, transmission scans, cat scans (CT), bone densitometer (Dexa Scan), etc]. (Exclude absorbed radiation doses resulting from clinically indicated procedures. In selecting experimental subjects, investigators should consider all previous exposures.)
  • New Question 21-3.1.9 - Submit data for other absorbed radiation doses that result from this experimental protocol [fluroscopic or radiographic x-rays, transmission scans, cat scans (CT), bone densitometer (Dexa Scan), etc).  (Exclude absorbed radiation doses resulting from clinically indicated procedures.  In selecting experimental subjects, investigators should consider all previous exposures.)
    • 21-3.1.9.1 - Fluroscopic or radiographic dose (mrem):
    • 21-3.1.9.2 - Transmission scan dose or cat scan (CT) dose (mrem):
    • 21-3.1.9.3 - Bone densitometer (Dexa Scan) dose (mrem):
    • 21-3.1.9.4 Other:
    • 21-3.1.9.5 - Indicate the total number of doses to be administered to the same patient: The doses listed for this radioisotope will be administered over a period of ___ weeks.
  • New Question 21-3.1.10 - Add the Detail File (DF) for this radiopharmaceutical.
  • New Question 21-3.3 Add the dosimetry table for each radiopharmaceutical to be received by subjects.

In the HIPAA U-M Covered Components section:

  • Section 25 - HIPAA U-M Covered Components - Questions have been reordered and grouped from four sections into six sections for better flow and branching logic:
    • Section 25 - HIPAA U-M Covered Components - New Question determines which HIPAA questions must be answered
    • Section 25-1 - Protected Health Information (PHI) / HIPAA - Moved from Section 25
    • Section 25-2 - HIPAA Authorization Waiver Request - Moved from Section 25-1
    • Section 25-3 - Certification for Review of Data Preparatory to Research - New Section
    • Section 25-4 - Limited Data Set - Moved from 25-3 and reworded
    • Section 25-5 - Deidentified Data Set - New Section

In the Protected Health Information/HIPAA section:

  • New Question 25.1 - Is any investigator, co-investigator, or other member of the research team who may access identifiable data affiliated with any of the following entities, or will any research data be contributed by one of the following entities?
    Select all that apply:
    • University of Michigan Health System (including hospitals and health centers, medical school, M-CARE, MVN, MHC, joint ventures)
    • School of Dentistry
    • School of Nursing Nurse-Managed Centers
    • UM-Flint Urban Health and Wellness Center
    • University Health Service
    • Institute for Human Adjustment
    • UM Autism and Communication Disorders Center
    • UM Employee Benefits (only those units that manage UM health benefit plans, including medical, dental, vision, and healthcare FSAs)
    • None of the above
  • Removed Section 25-2 - Certification for Research on Decedents' Information
    • Removed Question 25-2.1 - Affirm that the study team will maintain documentation verifying the subjects were deceased at the start of the study.
    • Removed Question 25-2.2 - Will data containing PHI be shared outside of the covered entity?
    • Removed Question 25-2.2.1 - If yes, affirm that disclosures of PHI outside the covered entity will be tracked and reported according to guidelines published by institutional privacy officials.
  • New Sub-Section 25-3 - Certification for Review of Data Preparatory to Research. Completion of this section is required based on the response provided to question 25-1.3.2.
    • New Question 25-3.1 - Affirm that the PHI will be used only for one or more of the following purposes:
      • To determine whether the proposed project is feasible, or to assist in the design of the project. In either case, the study team will not record any PHI reviewed for this purpose into a dataset that may later be used for the project itself.
      • To ask potential subjects whether they want to consider participating in the study. In this case, the study team will record only name and contact information and will not use this information for any other activity.
    • New Question 25-3.2 - Confirm that no PHI will be removed from the U-M covered component during this review preparatory to research. This information may not be sent off-site to anyone, even a sponsor or consultant or vendor helping with or monitoring the study. Note: individuals outside the U-M covered component, including sponsors, consultants, and monitors, may review the information on-site.
    • New Question 25-3.3 - Will individuals outside the U-M covered component review the information on-site?
    • New Question 25-3.3.1 - If yes, affirm that disclosures of PHI outside the U-M covered component will be tracked and reported according to guidelines published by the U-M HIPAA privacy office.
  • New Question 25-5.1 - Affirm that the deidentified data set will NOT include ANY of the following information about subjects, or their relatives, employers or household members:
    • Names
    • Address, city, and other geographic information smaller than state (3-digit zip code is acceptable if it includes more than 20,000 people; otherwise, use "000")
    • Telephone, fax numbers, e-mail addresses, web URL addresses, IP addresses
    • Social security number, medical record number, health plan beneficiary number, any account number, certificate, or license number
    • Vehicle identifiers and serial numbers, including license plate numbers
    • Device identifiers and serial numbers
    • Biometric identifiers (e.g., fingerprints, voice prints) DNA is not considered a biometric identifier for HIPAA purposes of HIPAA
    • Full-face photographs and any comparable images
    • Any other unique identifying number, characteristic, or coded

In the Internet / Email section:

  • Question 28.4.1 - "Explain consultation over the Internet or via email," is now required.

In the Survey Research section:

  • Question 29.13 - moved from 11.4 for better flow - Will the research involve the use of focus groups?
  • Moved the following phrase to just before 29.14 - "If any material is likely to be disturbing, please answer the following:"
  • Question 29.3 - reworded to: "Is the design or development of this survey instrument dependent on receipt of funding or hiring of personnel?"
  • Question 29.3 - changed "contacts" to "interactions."

In the Vulnerable Subjects Details section:

  • In sections 33, 33-1, 35, 35-1, and 38, the following text was added: "Final approval of this application may require additional approval at the federal level. Contact the IRB office for more information."
  • New Sub-Section 33-1 - Children Regulatory Categories - Allows Data Analysis Only users to fill out only required questions.
  • New Sub-Section 35-1 - Pregnant Women and/or Fetuses Regulatory Categories - Allows Data Analysis Only users to fill out only required questions.
  • Question 35.7 - removed the word "placenta" from the question.

In the GCRC Information section:

  • New Question 42.0 - Select your study type:
    • Category A - Research Subjects
      • Stays or visits are solely for research purposes
      • Research was initiated by the investigator
      • GCRC grant or PI's research grant is responsible for all hospitalization costs
      • Includes rare diseases/orphan studies
    • Category B - Research Service Subjects
      • Subjects require visits or stays for diagnosis or treatment and are participating in research
      • Subject or insurance is responsible for cost of standard of care services (i.e. non-research care)
      • Ancillary services that are performed solely for research are charged to the GCRC and do not appear on the subject's hospital bill
    • Category A & B - For Multi-Arm studies only, where at least one arm is category A and at least one arm is category B (see above definitions)
    • Category D - Industry-Initiated Research
      • Research was initiated by industry
      • Industry is responsible for all charges
      • Study account has its own 7000 account number, project/grant number and short code
  • Removed Question 42.1.9--The following options have been eliminated from the list of possible answers to this question:
    • Internet posting for recruitment
    • SPSS
    • BioDBx
  • End of Application - now labeled Section 44 for consistency.
  • On the Conflict of Interest form, question C.1 regarding income over $1000, if the PI answers yes, C.1.1 is now required.
  • On the Amendment form, the list of AE/ORIOs in AME 1.6.1 no longer displays AE/ORIOs that are in a state of "withdrawn".
Expand/Collapse AE/ORIO Form Changes
  • Results from Question 32-1.2 of the application ("Indicate the AE reporting timetable that will be used to report adverse events to the IRB") are listed on the first and main pages of the AE/ORIO form.
  • In the Standard Study Information section, the AE/ORIO Submission types and date the subject was enrolled in study have been moved to the Report of Adverse Event section, where the former AE/ORIO Submission Types "Adverse event(s) involving subjects or others under the oversight of non-UM investigator(s) and non-UM investigator(s) and non-UM IRB (e.g. 'sister site' in a multi-site study)" and "Adverse event(s) occurring in an unrelated study involving an agent, procedure, or device used in this study" were combined into one selection.

On the first page of the AE/ORIO form, you can choose to report either an AE or ORIO:

  • 1.2 Type of Report--choose one:
    • Adverse Events Report
    • Other Reportable Information or Occurrence (ORIO)

In the Report of Adverse Event section, you can specify Serious or Non-Serious Events.

  • New Question - 1-1.1 Adverse Event types:
    • UM Serious Adverse Events Report
    • UM Non-Serious Adverse Events Report
  • Question 1-3.1 - Now displays all selections that have been checked and unchecked on the form.
  • Changed order of Questions 2.1.12, 3.2.12, 4,2.9, and 5.2.10 on Adverse Event form to put upload before the date of primary document.
  • New Section - 2. UM Serious AE Reporting Form:
    • 2.2 UM Serious Adverse Events
    • 2.3 UM investigator's overview assessment of new and/or updated information in this submission.
      An 'overview assessment' should address the following if they apply:
      • Explain how AEs included in this report impact the study
        List any AEs that the UM investigator believes the IRB should give special attention and explain why
      • List any AEs recorded as 'unrelated' in 2.2 that the UM investigator believes were caused by participating in the study even if not caused by the drug, device, or other intervention under direct study
      • List any AEs on which the UM PI and an oversight body disagree (e.g the sponsor's opinion of seriousness, relatedness, or expectedness differs from the UM PI's). Provide the event numbers and explain the disagreement.
      • Explain voluntary holds or urgent changes that will be initiated on any part of the study because of the AEs included in this report. Provide a description of the changes and rationale.
        NOTE: Solely referring to uploaded document(s) or other sections without providing an overview is not acceptable.
    • 2.4 Are subjects still being recruited at any of these sites?
    • 2.5 Are subjects still participating or being monitored at any of the sites listed in 2.4?
    • 2.6 Indicate which of the following parties, identified as providing additional monitoring in the currently approved data and safety monitoring plan, will be notified of this event. If this has changed, describe the change in Additional Information below and complete and submit an eResearch Amendment Application.
    • 2.7 Will any changes/amendments be made to the research because of information included in this report (including informing currently enrolled subjects and/or those who have completed the study)?
      Note - amendments cannot be made as part of this report. In order to amend items checked below, go to the study's home work-space and complete an amendment (click on the Amendment activity in the lower left of study's home workspace).
    • 2.7.1 If yes, indicate all aspects of the research that will be changed:
      • Select all that apply:
        • Risk Assessment
        • Informed Consent Document
        • Informed Consent Document with re-consenting of all previously enrolled subjects
        • Informed Consent Document with re-consenting of previously enrolled subjects still receiving research intervention or investigational agents
        • Intervention or investigational agents
        • Protocol
        • Investigator's Brochure
        • Other
        • If Other, please specify:
    • 2.7.2 If applicable, indicate the revised risk assessment that will be made on an amendment application:
    • 2.8 Additional information: Provide additional pertinent information. If you require documentation of IRB submission for any information not requested/required in other fields, enter it here.
  • Question 2.1 Removed: General Information
  • Question 2.1.1 Removed: Date range of adverse event occurrence(s)
  • Question 2.1.2 Removed: Date range reported to UM study team
  • Question 2.2 Removed: Indicate the total number of reported adverse events in each of the following categories:  If the seriousness of any adverse event is not indicated on the external report, the PI is responsible for assessing the seriousness. 
  • New Questions in 2.2 UM Serious Adverse Event Detail
    • 2.2.1 Provide unique identifier for this event
    • 2.2.8 Is this event expected?
      If UM PI and oversight entity disagree about this assessment, explain in 2.3.
    • 2.2.8.1 If yes, indicate how the event meets the UM definition of expected by checking all that apply below:
      • Informed consent document(s) for this study
      • IRB application for this study
      • Grant application or study agreement
      • Protocol or procedures for this study
      • Investigator's brochure or equivalent (for FDA regulated drugs or devices)
      • DSMB/DSC Reports
      • Published literature
      • Other
      • If Other, please specify
    • 2.2.8.2 If item(s) checked have not been previously provided to the IRB, upload them here (Uploading documents here does not preclude the requirement for an amendment or ORIO if such is required by IRB guidance or policy).
Expand/Collapse SCR Form Changes
  • In the Study Activity Status section, the following selections have been reworded for clarity:
    • 1.1 Characterize the ongoing study activity--choose one:
      • Renewal - study activity continues to include ongoing or future research interaction/intervention with subjects or collection of identifiable private information.
      • Renewal - activity limited to subject follow-up and analysis of identifiable data. All research intervention has been completed. Interaction is limited to follow-up activities only. Data continues to contain subject identifiers or links.
      • Renewal - activity limited to analysis of de-identified data. All research interaction and intervention with subjects or collection of identifiable private information has been completed. The subject identifiers held by the study team (including links and lists) have been destroyed.
      • Termination Report. The study is completed; there is no further subject recruitment, follow-up, or data analysis.
  • In the Study Activity Status section, the following new selections are available:
    • 1.1 Characterize the ongoing study activity--choose one:
      • Renewal - umbrella project. The study lacks immediate plans for involvement of human subjects, their data, or their specimens.
    • Question 2-2 - If there are more than 2 performance sites, the totals are now calculated correctly.
    • Question 2-3.1 - The table for reporting subject enrollment by ethnicity and race has been updated to validate that the number of subjects indicated in the first section of the table (ethnic/gender) matches the second section (race/gender). If these totals do not match, an error message should display.
    • Question 2-4.4 - Removed Total external adverse events to date. The AE totals are now found in the AE Summary Report.
    • Section 3.4 - the link to the AE Detail Report now opens in a separate window.
    • Question 3-4.4 removed - "Complete the table below with totals of external adverse events not reported in eResearch."
    • Adverse Events now appear in pre-submission state in the SCR workspace summary.
    • Study team and sponsor detail items no longer print in the printer-friendly version of SCR.
Expand/Collapse Letters & Notification Changes
  • Posted correspondence notifications now include the text of the correspondence.
  • Changes required notifications now list required changes.
  • Reviewer notifications indicate the role of the assigned reviewer (Primary, Secondary, etc.), the committee and the meeting date.
  • Notifications now include improved instructions for accessing the submission and for contacting the MAIS Help Desk.
  • The following notifications have been added:
    • To PI/study team when a submission is received by a core or ancillary committee
    • To PI/study team when a study is disapproved by an ancillary committee
    • When submissions are withdrawn, a notification is now sent to all ancillaries and core committees that had previously received the submission.
    • To Flint and Dearborn IRBs when a new unassigned application is received
  • All notifications now include the name of the PI and the name and ID of the study.
  • The "Create New User" activity now allows new users to be selected to be cc'd on email notifications.
  • Title and HUM number of parent project is included on notices for all associated submissions (Amendments, SCRs, AEs). Current state of submission is included in notification where relevant.
  • PRC Review Complete reminders at 30 and 60 days will not be sent when a submission utilizes CTO resources in question 1.6.4.
  • Letter templates have been rewritten and reformatted.
  • All approval letters now display the following:
    • approval date of the submission
    • current approval period
    • expiration date
  • Identified issues will now populate in "Action Deferred" and "Approved with Contingencies" letters.
  • The date display on the workspace and in the approval letters is more consistent.
  • Identified issues are now sorted by section in the "Approved with Contingencies" letter.
  • The "Action Deferred Pending Study Team" letter now contains identified issues as well.
  • Formatting issues in outcome letters have been fixed.
Expand/Collapse PI & Study Team Process and Workspace Changes
  • AE/ORIO Process & Workspace Changes
    • Multiple Adverse Events of the same type can be reported with one Adverse Event submission.
    • Previously submitted Adverse Events that are not currently under review can be modified and resubmitted. A list of previously submitted AEs will appear under the AE/ORIO tab on the approved study home page where they can be opened and edited.
    • A new AE Summary report, which shows the total number of serious and non-serious adverse events by their type, is also available from the AE/ORIO tab.
    • Only the necessary pages in the form are displayed in the navigation dropdown list.
    • All Adverse Events are routed for review at the time of submission and not held for the next Scheduled Continuing Review (SCR).
    • Serious and non-serious Adverse Events have been separated to allow single member review of non-serious Adverse Events.
    • A change tracking tab has been added to the AE/ORIO workspace. You can now view changes made to AE under the change tracking tab.
  • All study team members who have edit rights (question 1.6 in the application in the study team detail page) now also have the ability to submit changes. PI remains the only one who can submit the application at pre-submission and PRC Review Complete state.
  • Added "Initial Study Approval Date" and "Current Approval Period" to Summary Info in the Study Workspace.
  • The PRC ID has been added to all application/amendment workspaces.
  • Documents uploaded to section 42, GCRC Information, are now listed in the Supporting Documents section of the Documents tab on the study workspace.
  • The Continuing Reviews tab has been added to the Not Regulated workspace.
  • The word "applications" has been removed from personnel workspace tabs to avoid confusion.
  • Added a "View Study" button to the "Not Regulated" workspace.
  • In the Interested Party home workspace, the search/filter function has been added to all tabs.
  • PI and study teams will now receive an email notification if their application has been disapproved by an ancillary committee.
  • PIs and study team members now receive a notification when their study has been received by a core or ancillary committee.
  • The approval and expiration date now appear next to each approved (watermarked) document in the Currently Approved Documents under the Documents tab.
  • The gold navigation bar in the workspace now reads "All Submissions" instead of "All Studies."
  • Added Business Phone and Business Fax fields to the Account Information Verification page.
  • The state previously named "Complete Application" is now named "PRC Review Complete."
  • Instructional text now appears beneath status bar in PRC Review Complete state, to explain what this state means.
  • A printer-friendly version of the amendment cover sheet is now available in the amendment workspace.
  • The following text has been added (in red) to the "Post Correspondence" activity:
    • "Revised documents that were originally uploaded in the application should not be uploaded here; these documents should be uploaded to the appropriate section of the application."
Expand/Collapse Review Commitee Process & Workspace Changes
  • The Committee Review process has been redesigned and a new Reviewer Checklist form contains the information that each reviewer is required to review.
  • For each submission type, a link to the printer friendly version has been added on the "View Agenda by Reviewer" and "View Agenda by Submission Type" in the meeting workspace.
  • Under the Agenda tab in the meeting workspace, the "view" link next to each agenda item has been removed.
  • In the Reviewer Checklist the Approval Period is set to "12 months" by default.
  • Removed ability for Core Committee Members to create new meetings (Core Staff still have the activity available).
  • The description for the "Minor Changes" expedited category has been updated to the following: "Minor changes are those that would not materially affect the assessment of risks and benefits of the research (OHRP Institutional Review Board Guidebook)."
  • An Expedited Reviewer no longer has the option for "Disapproved," "Disapproved-Final" and "Table" motions.
Expand/Collapse Core Staff Process & Workspace Changes
  • A "History" tab has been added to the committee workspace.
  • The "Finalize Documents" activity now allows each document to be individually managed with specific approval and expiration dates in a single action. All informed consent and recruitment documents are included.
  • In the activity window for the "For IRB Office Staff Only" correspondence activity, it previously incorrectly stated that Committee Members could view the internal IRB Office correspondence. The text has been corrected.
  • When "Correct Required Core Committee" is selected, it updates the IRB selection in the application, and clears owners so that the application is immediately sent to the proper IRB for processing.
  • Record Committee Decision Activity in Meeting workspace has been redesigned to look more like the Record Committee Decision activity in all other submission types.
  • The reviewer name is no longer visible to other Core Committees.
  • When Staff select a "Not Regulated" category at the validate step, text for the selected category auto-populates into the Not Regulated letter template.
  • A new activity called "Not Regulated Determination" allows approval for amendments and renewals that are not regulated - similar to "Approve and Make Exempt" activity.
  • A free text field has been added to the Send Back for Ancillary Committee Review activity. The activity record now displays under the Correspondence tab and is viewable to the study team.
  • Added "Update Meeting History" activity to the following states: "Not Regulated," "Exempt Approved," and "Exempt Approved-Initial."
  • PRC Staff now have a PRC Summary Report available under the Reports tab for Amendments.
  • Added "Confirmed and Declined Attendance" to the Committee Member Detail Page.
  • Core Committee can now see all of the previous contingencies and reviews in the All Reviews tab.
  • Exempt Determination option is now available for Amendments and SCRs.
  • "Remove from Agenda" activity is now available in the state "Core Staff Review".
  • Added "Changes to Sponsor (not including Federal sponsors)" to categories of Administrative Review for Amendments.
  • An Expiration Date column now appears under all tabs in the workspace.
  • Changed text on "Record Expedited (Single Member Reviewer) Decision". Removed Review type from forms.
  • Revised "Remove from Agenda" text as follows: "Remove from agenda does not remove the reviewer. To remove reviewers perform full committee and select the reviewer for deletion."
  • Inbox Staff Notes are cleared and recalculated as submissions move between Core Committees in the workflow.
  • The "Not Regulated" and "Exempt" activities are no longer available to PRC and GCRC.
  • The words "Agenda" and "Minutes" are now bold at the top of the View Agenda and View Printable Minutes documents.
  • The duplicate of the option "resubmission" in the "Add to Agenda" dropdown list has been removed.
Expand/Collapse Ancillary Committee Process & Workspace Changes
  • Ancillary Committees now have a "Manage Documents" activity which can be used to post documents in the application workspace that are not uploaded by the study team in the application itself (e.g. the IDS fee sheet).
  • A validation rule has been added to the Issue Ancillary Committee Approval activity to not allow the ancillary committee that requested changes to issue their approval until the study team has submitted the changes to that ancillary committee.
Expand/Collapse Institutional Biosafety Committee (IBC)
  • The IBC registration form and approval workflow process has been added to eResearch.
  • Features of the new IBC module include:

    • New for PIs

    • Electronic registration forms; one registration for each PI
      • Changes made to original registration via amendment
    • Electronic submissions, review, and approval
    • Electronic signatures
    • Email notifications
    • Electronic approval letters

    New for Committee Members

    • Online reviews
    • Communicate requested changes to PI via eResearch
    • Private communications
    • Aggregate reporting
    • Committee meeting management