WCG IRB Guide for Researchers

Chapters

1. 1 Working with WCG IRB for IRB Review – An Overview New protocols submitted to WCG IRB for review (that are not eligible for expedited review) are assigned for review based on the next available panel meeting. U.S. panels meet daily. Reviews for investigators at Canadian locations are assigned to the Canadian panel; therefore, a protocol taking place in both the United States and Canada will […]
2. 2 Exemptions In addition to IRB review, WCG IRB offers a service to determine if research is exempt from, or does not require, IRB review. Research that is not a clinical investigation of an FDA-regulated product (drugs, devices, biologics, food including supplements, cosmetics, etc.) may not require IRB review. Projects that do not require IRB review include […]
3. 3 Submitting Documents for IRB Review Set up an account or log in to ClinSphere® eReview Manager to submit a new study. (Clients who use IRBNet to submit should submit new studies through there.) Please note we do not accept submissions via fax or postal mail. If you need assistance submitting, contact clientcare@wcgclinical.com. If a submission is made and we are […]
4. 4 Materials Required for Initial Review The following is a general list of items required by WCG IRB to begin the review process for a research study.  Items Required for All Initial Review Requests  (Federal regulations do not recognize coprincipal investigators; therefore, if two PIs plan to share oversight of a single study, the Board requires a completed submission form for […]
5. 5 Regulations Affecting Clinical Research, Including HIPAA: The Regulatory Framework Within Which WCG IRB Functions WCG IRB Compliance Statement: WCG IRB is duly constituted and has written procedures in compliance with requirements defined in 21 CFR Parts 50 and 56, 312, 812, 45 CFR 46 and ICH Guidelines relating to Good Clinical Practice. WCG IRB’s mission is to ensure that research is conducted ethically according to the principles of the […]
6. 6 Conflicts of Interest To meet the needs of its clients and comply with the Department of Health and Human Services (HHS) guidance entitled “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” WCG IRB has established a policy for reviewing financial conflicts of interest of investigators, research staff and institutions (WCG IRB defines […]
7. 7 The Informed Consent Process The informed consent process is central to the ethical conduct of research. It is an ongoing conversation between the human research participant and the researchers that begins before consent is given and continues until the end of the participant’s involvement in the research (see consent process diagram, below). There are various tools for the investigator […]
8. 8 HIPAA Authorization HIPAA stands for the Health Insurance Portability and Accountability Act. The privacy rule within this regulation outlines the standards for privacy for individuals and confidentiality of individually identifiable health information. The specific regulations for HIPAA are in Title 45 CFR 160 and 164. Clinical investigators need to assess if they are a covered entity as […]
9. 9 Assent When a participant may not be able to legally consent to research participation, a Legally Authorized Representative (LAR) provides the consent for the participant. However, WCG IRB usually also requires that participants who are not able to consent for themselves assent to participation if possible. “Assent” means a participant’s affirmative agreement to participate in research. […]
10. 10 The Consent Form The primary informed consent tool that involves both the researcher and the IRB is the consent form. This document is used in all research for which there is no approved waiver of consent. Thus, most research will involve use of an IRB approved consent form. An approved consent form must comply with several regulatory requirements:
11. 11 WCG IRB Policy on Consent Forms The IRB will require consent forms approved with new protocols starting March 1, 2024, to start with a concise summary/key information section at the beginning of the consent form, along with requiring any other applicable additional elements of consent under the common rule. If a consent form is submitted without these elements, the Board will […]
12. 12 Assent Forms When an adult participant is not able to legally consent to participate in the research, a Legally Authorized Representative (LAR) provides the consent for the participant. For children, parents or guardians provide consent for minor children. However, WCG IRB usually also requires that both incapable adults and children assent to participation if possible. Assent requires […]
13. 13 Review of “e-Consent” (electronic consent) Forms Electronic consent (“e-consent”) via web applications and/or electronic tablets such as an iPad is growing in popularity. FDA has issued guidance titled Use of Electronic Informed Consent. Electronic consent is a broad term and can describe the exact representation of the IRB-approved document on an electronic device as well as refer to a consent process […]
14. 14 Bring-Your-Own-Device (BYOD) for data collection WCG permits participants to utilize their own device, such as a smartphone or tablet, for completion of electronic patient-reported outcomes (ePRO) data. Sponsors are required to provide only name(s) of the validated patient-reported outcomes (PRO) surveys/questionnaires utilized in their proposed study. A copy of unvalidated or customized PRO surveys/questionnaires must be only provided for review.
15. 15 Certificates of Confidentiality (CoC) A CoC helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Research studies that are funded by NIH are automatically issued a […]
16. 16 WCG IRB Policy on Pregnant Partners Effective Aug. 1, 2022, WCG policy on collection of outcome data on partners of study participants has changed. WCG policy is now as follows: the collection of outcome data on partners of study participants who become pregnant does meet the HHS definition of research, as it is a systematic investigation designed to develop or contribute […]
17. 17 Requirements for Human Research Protection Training WCG IRB requires investigators to verify on the initial review submission form and each Continuing Review Report form that each member of the research team has successfully completed training in human research protection. Your institution may have additional training requirements, please check with your institutional official.Please note that HIPAA training or prior research experience alone […]
18. 18 Special Considerations for Drug Research: Do You Need an IND WCG IRB’s Initial Review Submission Form asks for information about an IND. As a general rule, WCG IRB requires that a sponsor or investigator obtain an IND from FDA for clinical investigations involving drugs or dietary supplements. However, if the investigation uses a marketed drug, the sponsor or investigator may propose that the investigation is […]
19. 19 Special Considerations for Device Research: IDE, NSR (Nonsignificant risk) and IDE Exempt The FDA regulations establish additional requirements on the part of the IRB for the review of studies using medical devices. Before reviewing research involving a device (or devices), the Board must identify and evaluate the regulatory status of the device(s), such as determining whether the device study qualifies as a Non-Significant Risk (NSR) Device study, […]
20. 20 Special Considerations for Behavioral Research WCG IRB reviews behavioral research. Behavioral research is non-clinical research and is oftentimes qualitative rather than quantitative. When submitting behavioral research, provide a detailed protocol, a description of the protections of confidentiality that will be used, and a description of the consent process.  Also, if deception is involved, the submission must also include a description […]
21. 21 Special Considerations for Federally Funded Research FWAs The submission form will prompt you to provide the appropriate, required documentation for review of research involving an FWA. When an institution (a legal entity) receives federal funding for research, the institution usually must obtain an assurance as required under section 45 CFR § 46.103 of the Common Rule. Each separate legal entity that […]
22. 22 IND Exemptions and Compounded Drug Research For a clinical investigation to be exempt from IND requirements, the drug product must be lawfully marketed in the United States and meet all conditions outlined in 21 CFR 312.2(b). Research involving modifications to the lawfully marketed drug may also be IND-exempt, provided they do not introduce risks exceeding those associated with the product’s standard, […]
23. 23 Utilization of Third-Party Resources Such as Person Locating Services for Collection of Long-Term Follow-Up (LTFU) Data At times, a sponsor or other entity will establish a Long-Term Follow-Up (LTFU) plan in order to assist in obtaining data about the research participants in a protocol. The LTFU plan is usually described in the protocol and may be limited to one country or conducted across multiple countries. The plan is normally executed by […]
24. 24 Single Patient Case Reports – Dissemination of Clinical Study Data by Investigators for Education and Research Purposes Investigators may present data from an individual patient from their clinical practice as a case study analysis/report in the format of a presentation or a journal article. The investigator must protect the participant’s privacy and confidentiality by taking appropriate measures during dissemination. The case study analysis/report does not meet the regulatory definition of research (45 […]
25. 25 Special Considerations for Multi-Center Studies Each individual submission for a multi-center study must be accompanied by a completed initial review submission (through ClinSphere® eReview Manager or IRBNet). Any site submission lacking a complete submission form, current CV and license, or proof of a current medical license (when applicable) may not be scheduled for review until the missing information is submitted. […]
26. 26 Consent Forms for Multi-Center Research When first submitting a consent form for a multi-center protocol, sponsors and CROs should clearly identify all placeholders for site-specific information within the template consent form. Placeholders should be formatted using red font and enclosed in brackets (e.g., [Insert Site Name]). Providing clearly formatted placeholders supports accurate and efficient incorporation of site-specific details. Please note […]
27. 27 National Ad Campaigns/ Advertisements for All Investigators Sponsors and CROs will benefit from submitting advertising and other recruitment materials with the initial review submission, as later submissions incur a fee for review. Please review the guidance in the section of this Guide outlining best practices for submitting ads and other subject facing materials. Audio and video recordings must be accompanied by the […]
28. 28 Special Considerations for Participants Who Do Not Speak English: Translations All consent forms and other participant materials must be in a language easily understood by the participant, and all translations must be approved by WCG IRB. If you are enrolling non-English speaking participants, you must have plans for conducting the consent discussion in the language understandable to the participant, and for ongoing communication with the […]
29. 29 Special Considerations for Site Investigator’s (PI) Employment Status The employment relationship of the PI with the institution/site will be evaluated on a case-by-case basis, if the PI is not a full-time employee of the institution. The PI may hold an independent contractor role and may still provide oversight of the study. The Board will evaluate this in the context of the proposed study.
30. 30 Special Considerations for Enrollment of Wards of the State Our initial review submission forms ask sites if they plan to enroll wards of the state. Federal regulation 45 CFR § 46.409 outlines special requirements for the involvement of wards in research.  Sites that plan to enroll wards may be required to provide a plan for appointing an advocate for each participant.  Some state and […]
31. 31 Special Considerations for Canadian Research The WCG Canadian Panel is located in Vancouver, Canada. Its membership is compliant with the requirements outlined in the Division 5 regulations of Health Canada. The Panel is able to review research for Canadian sites that do not need to use their own local Research Ethics Board (REB). For more information about the Canadian Panel, […]
32. 32 Special Consideration: Nursing Magnet Designation WCG IRB has consistent membership and involvement by at least one nurse in the governing body responsible for the protection of human participants. A nurse Board member is always present and in voting status when a nursing protocol is reviewed. Our records indicate that the majority of our meetings have either a nurse member or […]
33. 33 Special Considerations for Single Patient Expanded Access/Compassionate Use When appropriate  — and with approval from FDA, the manufacturer and an IRB —  patients with no other options can gain access to experimental drugs and medical devices. Because insurance typically does not cover expenses associated with approval process, many patients can’t afford what they consider a last chance for hope. WCG IRB provides single […]
34. 34 For Review of Single-Patient Expanded Access WCG IRB does not charge for review of single patient treatment use of a drug or device. FDA maintains a 24-hour phone number for questions about emergency and compassionate use: Office of Crisis Management & Emergency Operations Center: 866-300-4374. The Process for Single-Patient Expanded Access Requests (Drugs/Biologics) Single-patient expanded access requests are processed differently, using […]
35. 35 IRB Transfers An IRB transfer happens when a study that has been approved by another IRB is transferred to WCG IRB. Transfers happen for a variety of reasons — if an investigator decides to change IRBs for some reason, if a local IRB is closing, or if the study is at an institution that has recently signed […]
36. 36 The Review Process: Board Actions The Board may take a variety of actions upon review of a submission. Approve When the Board takes an “approve” action on new research (or a change in research), it is accepting oversight (or continued oversight) of the research and allowing the research to go forward as approved. When the approval is based on Board-required […]
37. 37 Changes to Research/ Additional Document Submissions Whenever a change to the protocol or consent form is proposed, the change must be reviewed and approved by WCG IRB before being implemented, unless a serious safety concern requires immediate implementation by the investigator, or if the change is a non-substantive formatting change to an already IRB-approved consent form as described in the section […]
38. 38 Delegation of Principal Investigator (PI) responsibilities during a Leave-of-Absence (LOA) During any period of unavailability, the principal investigator (PI) should delegate responsibility for study oversight to an appropriately qualified research staff person, typically a sub-investigator (SI).  Planned leave of less than one month does not require a management plan to be submitted to the IRB. Planned leave of one to three months is generally acceptable […]
39. 39 A Change of Principal Investigator Please note that if the current investigator has not been overseeing the study, WCG IRB will also need to know how long the PI has been gone, why the PI left, who has been overseeing the study in the PI’s absence, and if there have been any participant safety concerns during this time. The Board […]
40. 40 Updated Drug Brochures, DSUR, DSMB reports, and other Reports When WCG IRB receives an updated Drug Brochure, prescribing information, DSMB report, or annual/final report, the IRB will review the submission and apply any resulting action automatically to all investigator sites associated with the affected protocol(s). IRB approval indicates that the document has been reviewed and is on file for the research. How WCG IRB […]
41. 41 Additional Changes Which Require Submission to WCG IRB Contact Updates When research is submitted to us for review via one of our portals (ClinSphere® eReview Manager or WCG IRBNet) the submitter defines who on their team will have access to the outcome documents in the portal – adding and removing access over the life of the research as appropriate.  The Contact Information Update […]
42. 42 Participant Recruitment Materials and Practices Participant Recruitment Practices Recruitment plans sometimes include the use of Referral Fees or Finder’s Fees. These are payments to someone who is not a member of the study team (for example, a physician with a practice near the study site) paid in return for assistance in finding potential study participants. In general, fees that are […]
43. 43 Requirements for Screening Materials The Board recommends that submitted screening materials should conform to the following:   Introductory Statement: Sample Introductory Statement: [Thank you for calling] (or) [We are returning your call] about a research study we will be doing.  The purpose of the study is [briefly describe study – such as, “. . . to evaluate the safety and […]
44. 44 Terms of Use Documents As noted above under “Materials Required for Initial Review,” materials to be provided to participants require IRB review. When research studies involve the use of digital technology, there may be Terms of Use or similar, otherwise named articles to which participants are required to agree if they are to be in the research. Often, these […]
45. 45 Review of “Generic” Materials “Generic” materials include items that an investigator wishes to use outside of the context of a specific protocol, or materials that a sponsor/CRO/SMO would like to use that do not identify any one specific investigator and/or protocol, and do not include research procedures. Common types of generic materials include: Changes to approved generic materials must […]
46. 46 Expiration and Renewal of Generic Materials Approved generic items are generally valid for one year. When the anniversary date approaches, WCG IRB staff will contact the submitter and inquire if renewal is desired. WCG IRB will conduct an annual review of the item if a response is not received by the date cited in the correspondence to ensure continued use is […]
47. 47 IRB Reporting Requirements Submit promptly reportable information via ClinSphere® eReview Manager or IRBNet. Promptly reportable information should be submitted within five days of becoming aware of the event (calendar days). If there is a delay, please include an explanation for the delayed reporting. The following are reported by a submission of a promptly reportable information submission: The following […]
48. 48 Planned Deviations Please note that planned deviations should be submitted to WCG IRB as a change in research for federally funded research and FDA drug and biologic studies. If the research is federally funded, conducted under an FWA, or is a clinical investigation of a drug or biologic, then all planned protocol deviations must be submitted to […]
49. 49 Overview of Continuing Review Activities and Required Reports During the initial review of a protocol, the Board makes a determination regarding the required frequency for reporting information related to the research. FDA regulations regarding continuing review require an IRB to conduct continuing review of the research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR […]
50. 50 Contacts for Continuing Review Form Notifications For new initial review site submissions, all site level contacts receive notification when the site level continuing review report form is due. For new initial review protocol submissions, all sponsor and CRO contacts receive notification when the protocol level continuing review report form is due, if one is required. Although notifications regarding the continuing review […]
51. 51 Site Reporting Completed Site Continuing Review Report Forms (CRRFs) provide the IRB with the study-related data necessary to monitor the progress of the research at sites. Identifying information including investigator name, sponsor name, protocol number and the “sequence” number of the form is listed at the top of each form. The CRRF is sent out approximately 86 […]
52. 52 Sponsor Reporting Before each annual review, WCG IRB sends out a Protocol Continuing Review Report (PCRR) to the sponsor or CRO contact that we have on file. The PCRR is designed to collect protocol-wide data as recommended in the FDA guidance document titled “IRB Continuing Review after Clinical Investigation Approval.” In this guidance, FDA recommends several times […]
53. 53 Delinquent Progress Reports WCG IRB will continue to follow-up with the investigators, sponsors and CRO contacts to facilitate timely receipt of a continuing review reports. If a completed form is not received by the due date, approximately 10 days after the due date, a “past due” notification is sent. The Board may take action to suspend or terminate […]
54. 54 Supporting Documentation Submitting with Continuing Review Reports Documents submitted with continuing review reports may be processed separately and incur additional charges. For example, such documents could include, but are not limited to, press releases (see additional section related to press release in this guide), DSMB reports, updates, protocol revised consent, modified recruitment materials. If the research includes a data monitoring committee/data safety […]
55. 55 Definition of Screen Failures and Withdrawals Report the number of screen failures and withdrawals on the Site Continuing Review Reports according to the following definitions. WCG IRB acknowledges that the definitions for these terms vary across the industry, but please apply the following definitions when reporting to WCG IRB:  As long as the numbers are reported consistently from one form to […]
56. 56 Study Renewal vs. Closure Sites receive a WCG IRB Site Continuing Review Reports when the expiration date is approaching. Federal regulations allow the IRB to perform continuing review of the research within 30 days before the IRB approval period expires and retain the anniversary of the expiration date of the initial IRB approval as the expiration date of each subsequent one-year […]
57. 57 Study Closure WCG IRB considers the study open at a site until a study closure report is received. A study closure report may be submitted when  WCG IRB will close the study upon receipt of the closure report. Submit closures via ClinSphere® eReview Manager (IRBNet clients can access a closure form from their IRBNet forms library.) To […]
58. 58 Study closure WCG IRB closes studies and provides a confirmation of closure as outlined below: and A notification like the one pictured below will be posted to ClinSphere® eReview Manager or IRBNet when WCG IRB has closed the study (a.k.a. protocol) in our system: Please note that each Certificate of Action (COA) states “…the individual and/or organization […]
59. 59 Requesting Re-opening of Studies and/or Sites: To request that your closed, previously approved study and/or site be re-opened, email your request and any related documentation to clientcare@wcgclinical.com for processing.   If you have questions about fees associated with re-opening your study and/or site, contact Client Care at 855-818-2289 or clientcare@wcgclinical.com.
60. 60 Site Visits Federal Regulations grant IRBs the authority to observe the consent process and the research (21 CFR 56.109(f) and 45 CFR 46.109(g).  WCG IRB conducts the following types of site visits: Sites receive a site visit confirmation notice soon after the site visit has been scheduled.  The notice provides the time of the visit, the basis […]
61. 61 Fees WCG IRB charges fees to cover the costs associated with the Board’s review and the related administrative responsibilities. Fees do not influence the decisions of the Board, and the same fee is charged regardless of the action taken by the Board (fees are not billed until the Board review has occurred).  A copy of our […]
62. 62 Reconsiderations In accordance with 21 CFR §56.109(e) and 45 CFR §46.109(d), WCG IRB notifies investigators in writing of the Board’s decision to approve or disapprove proposed research activities, or of modifications required to secure approval. Disapproval notifications include a statement of the reasons for the Board’s decision and offers an opportunity to address the Board in […]
63. 63 WCG IBC Services Human gene transfer (HGT) is a growing, promising area of medical research studying drug products that incorporate engineered or artificial DNA or RNA. Clinical trials involving HGT products must meet the specific oversight requirements found in the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines). Before clinical research subject to the NIH […]
64. 64 Disclaimer The purpose of this guide is to provide you with information about WCG’s processes. We will from time to time amend or update the guide. We will strive to keep the guide current but cannot warrant its accuracy. The material provided is intended for informational purposes only and should not be used as a substitute […]