Institutional Review Board (IRB)

Submitting a Protocol

What Should Be Submitted to the IRB

Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize. In addition to covering traditional biomedical studies, legal obligations to protect human subjects also apply, for example, to research that uses:

• Human subjects to test devices, products or materials that have been developed through research or to evaluate environmental alterations, for example, habitat modifications.
• Data collected through intervention or interaction with individuals. Intervention includes not only physical procedures (like drawing blood), but also manipulation of a subject's environment and some observations.
• Private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question. Examples include student records and medical records.
• Bodily materials such as cells, blood or urine, tissues, organs, hair, and nail clippings even if you did not collect these materials. (Such research may be considered exempt if materials are not personally identifiable and if the materials were collected prior to the initiation of the research project.)
• Studies conducted to gain generalizable knowledge about categories or classes of subjects such as employees, students, and/or patients. This includes a doctoral dissertation and a master's thesis.

Types of IRB Review

• Full Board (Standard Review): Review of proposed research at a convened meeting where a valid quorum of IRB members is present.
• Expedited Review: Review of proposed research by the IRB Chair or a designated voting member or group of voting members, rather than by the entire IRB Committee. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
• Exemption: A research project is exempt from the requirement for IRB approval when it is determined that the only involvement of human subjects is in one of the categories listed under 45 CFR 46 Section 101(b)(1)-(6) and 21 CFR 56. 104(d). Human subjects regulations do not apply to exempt projects. Any research project involving human subjects thought to be exempt must be submitted to the IRB for determination of exempt status.

RASCAL Tutorial

Educational Training can be taken at anytime on the RASCAL website.

1. Go to the Rascal home page at https://www.rascal.columbia.edu.
2. Select 'Testing Center' under 'Compliance'.
3. Log in with your UNI and password.
4. Click on "Course Listing" and select from the following courses:

• TC0018 - Rascal Training: How to use Consent Form Builder
• TC0017 - Rascal Training: How to do Human Subjects Protocols

Creating a New Protocol

Developed by an IRB Board member and researcher, this manual details all of the steps necessary to accurately and completely "translate" a protocol into RASCAL. It is extremely comprehensive and user friendly:
User's Guide to the RASCAL IRB Module

Tips for Efficient IRB Review

Initial Submission:

• Complete all screens in RASCAL that are appropriate for a given study before submitting the protocol via RASCAL.
• Attach all relevant material, e.g., funding proposal (grant or contract), sponsor protocol, investigator brochure (if the study involves an investigational drug), study instruments [i.e., questionnaire(s) or survey(s)], IND/IDE documentation, non-CU site approvals (e.g., permission to conduct the study).
• Check "Cancer Center" in the Facilities section if the protocol is, in any way, cancer-related. This check-off routes the protocol to the Cancer Center's Protocol Review and Monitoring Committee (PRMC). The PRMC must review all cancer-related research even if it is NOT conducted at or by the Cancer Center.
• Verify that information is consistent between documents, e.g., is the number of subjects listed on the data sheet the same as the number in the protocol and/or the consent form?
• Name only one individual as Principal Investigator. This person must be a Columbia faculty of Instruction or Research.
• Have all research personnel complete or update "Personal Information" in RASCAL. Use faculty titles, rather than clinical appointments.
• Ensure that all personnel have completed required training (i.e., CU GCP for Columbia faculty/staff). If non-CU research personnel are involved in the conduct of the research, attach a certificate of completion for equivalent training.
• If requesting an exemption, thoroughly review the exemption categories to ensure that the protocol is eligible for exemption. Consult the IRB staff if necessary. If exemption is requested and the protocol is determined to be ineligible for exemption, it will have to be returned to the investigator to remove the exempt declaration.
• Clearly identify the nature of the data collection, i.e., state whether it is anonymous, de-identified, coded, or non-coded. Explain what mechanisms are in place to protect private, identifiable information.
• Describe in detail how subjects will be recruited (e.g., who will introduce the prospective subject to the study). Attach all advertisements, recruitment letters or other materials that will be used for the recruitment of subjects (e.g., videos, scripts for radio ads, etc.).
• Construct and/or attach all applicable consent documents, (e.g., consent form(s), parental permission form, assent, information sheet), or provide a justification if requesting a waiver of consent in accordance with 45 CFR 46.116(d).
• Include details of appropriate additional protections if subjects may be considered a vulnerable population, e.g., how capacity to consent will be determined, what procedures will be implemented to avoid coercion or undue influence factors.
• Answer all questions on the Protocol-Specific Conflict of Interest form before "signing" the form.
• Attach a cover letter if the protocol includes any factors that may not be self-evident (e.g., eligibility for review per the terms of a cooperative amendment, collaborative relationships, unique funding arrangements, issues that may arise during the review that have been resolved by a specific CU IRB during the review of a similar protocol, etc.)

Pre-IRB Review Pediatric Human Subjects Checklist: This checklist was created by the Department of Pediatrics to facilitate the Department's review of human subjects research. 

Resubmitting in RASCAL in response to IRB Correspondence:

• Respond via correspondence; be sure to address all questions and concerns.
• Revise the protocol, consent forms, or other documents as necessary.
• Reattach all consent forms built in RASCAL that were detached for editing.
• Archive any superceded attached documents.
• Archive all HIPAA Forms (they should be forwarded to the Privacy Board).
• Remember to approve and resubmit the protocol in addition to answering correspondence.

Consent Forms

Tips to facilitate efficient IRB review using the RASCAL Consent Form Builder:

Benefit to using the RASCAL Consent Form Builder: As soon as the status of the protocol changes to "approved", the consent form will receive the IRB approval stamp electronically and can immediately be printed by the researcher.

• Create a generic form once; copy and edit as necessary for each study.
• Utilize the three ways to insert text: a) select sample text; b) copy/paste from another document; c) type.
• Typing or copying text: remember that the Consent Form Builder is a web program and recognizes only basic formatting.
• Inserting text from a sample consent: All text related to one element of consent or topic (e.g., Procedures, Risks, etc.) can be copied into their respective field in the RASCAL Consent Form Builder.
• Bolding of headings: RASCAL automatically bolds the headings of the elements of consent (e.g., Purpose and Procedures, Risks, Benefits, etc.), when the consent is created utilizing the Consent Builder.
• Additional headings of a given element of consent or topic (e.g., Risks of Pregnancy under Risks) should be entered in the sub-heading field in RASCAL.
• Otherwise, inserting an entire consent form into a field in the RASCAL Consent Form Builder, go to Layout and enter a "0" into all fields other than the one that contains the consent form. This process will not print the headings in bold. This process is not recommended by the IRB as it would decrease comprehension of the consent document.
• Be familiar with the required elements of informed consent, and include the additional elements when appropriate.
• Review the "Helpful Consent Form Information" available from the Consent Form menu.
• Read the general instructions in each section of the consent builder. These will guide you to submit a consent form to the IRB more successfully.
• Ensure that information in the consent form is consistent with that in the protocol and all other study-related documents.
• Maintain a 6th-8th grade language level throughout the form. See the IRB's Tips for Increasing Comprehension of Informed Consent Documents.
• Maintain the same voice (second person; e.g., "you") throughout the consent form.
• Select signature lines cautiously, i.e., include either "study participant" or "study subject" but not both. Remove any unnecessary or inappropriate signature lines.
• Minimally, a consent document that will be signed should have the following lines for signature and date: 1) Signature of the Subject or Participant; 2) Signature of the Person Obtaining Informed Consent; and 3) Investigator's signature.
• The Signature of the Subject or Participant may not be appropriate for all assent forms.
• After attaching the consent form to a protocol and before submitting it to the IRB, print it out and read it through to evaluate layout, appearance, flow of text, language level and accuracy. Ensure that all required elements of consent are included or justify the removal of any element of consent in the Subjects page of the protocol.
• If a consent form includes a chart or table, move the chart or table into a separate document that will be used as an addendum to the consent. Attach the addendum in RASCAL and explain in a cover letter that the attachment should be considered as part of the consent form.
• If an approved consent document needs to be translated into another language, the investigator can grant access of the consent document within RASCAL to the individual who will conduct the translation. For example, if a consent form needs to be translated into Spanish, the investigator can grant access to an individual in the Hispanic Research & Recruitment Center (HRRC). Alternatively, one can attach a scanned copy of the translated form(s) stamped by the HRRC.
• If similar text is used or required by several investigators or throughout a department, provide the sample text to the IRB. The IRB will consider such requests and revise sample text in the Consent Builder accordingly.
• Contact the RASCAL help-line if technical assistance is required (whenever you are unable to perform any function in the Consent Form Builder or manipulate or edit any text).
• Contact the IRB office if questions regarding institutional policy and/or federal regulations arise during construction of the consent form.

Tips for Increasing Comprehension of Informed Consent Documents:

All informed consent documents not created in RASCAL should be printed on CUMC letterhead or include information identifying the institution and research team or center. One inch margins are to be used on either side and on the bottom with 1.5 inches at the top. The type size to be used should be 12 point. Number all pages and use a header beginning with the second page of the document.

The document should be written at the eighth grade reading level. Suggestions for meeting an eighth grade reading level include:

Use one or two syllable words whenever possible
Write short sentences and paragraphs
Define all medical or technical terms in lay language
Organize information in sections with clear headings
Print all headings in bold
Use spacing to emphasize important concepts
Avoid contractions such as don't

Address the consent document to the reader by using the active voice and the word "you" throughout, i.e. "You are being asked to take part in a research study . . ."

Detailed information on do's and don'ts, complex drug dosing, and concomitant medications should not be included in a consent form. This information could be in a separate information sheet for subjects.

Providing information in a question and answer format is one method of increasing comprehension. This format is particularly useful when the study procedures are complex and the target subject population has a below average education or reading level.

Include version number and/or version date on each version of a consent document.

IRB Terminology Related to Informed Consent:

• The Consent Process: The informed consent process involves an ongoing dialogue between the subject and the investigator that continues until the subject's participation is complete. People who agree to participate in research must first understand and agree to volunteer based on the information provided to them by the researcher. That information must include details about the research, how long it will last, how many visits it will take, and all the risks and benefits. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence. Upon meeting with a potential subject, an investigator must first determine whether he or she is capable of giving consent. If so, the consent process begins by discussing the purpose, risks, and benefits of participation, following which the subject must be allowed sufficient time to consider all options and ask questions. The investigator must ensure that information is conveyed in a manner that the subject can easily understand and make sure the subject has understood the information provided before obtaining the subject's voluntary informed consent to participate in the research protocol. In this ongoing process of consent, Investigators must maintain the dialogue with subjects by answering additional questions, by providing additional information as it becomes available, and by reaffirming the subject's willingness to participate throughout the study.



• Vulnerable Populations: There may be some subjects who require special considerations, such as children, prisoners, cognitively impaired individuals, economically/educationally disadvantaged individuals and others. Consideration for the protection of these "vulnerable populations" is integral to IRB review.



• Consent Form: A written document that embodies the elements of informed consent required by 45CFR46.116. This form may be signed by (or read to) the subject or the subject's legally authorized representative. The investigator must give either the subject or the representative adequate opportunity to read the consent form and ask questions about the research before the subject or the representative signs the consent form or provides verbal consent to participate in the research protocol. Note:Only consent forms that have been previously submitted to and approved by the IRB may be used.



• Assent: Agreement by an individual not able to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.



• Parental Permission: A form signed by one or both parents agreeing to enroll their child in research. The parental permission must include all the elements of consent and a copy must be provided to the parent(s).



• Information Sheet: Document provided to research subject that contains the elements of informed consent but does not require a signature. Used either in exempt research, (in which informed consent is not required but may be desirable) or when written documentation of informed consent has been waived by the IRB in accordance with 45CFR 46.117(c).



• Legally Authorized Representative: An individual authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. In New York State, an LAR is a parent of a minor or a court appointed guardian.

Federal Regulations governing informed consent:

General Requirements for Informed Consent
Waiver of Elements of Informed Consent
Waiver of Documentation of Informed Consent