Protocol and Informed Consent
The IRB Protocol is the most important document submitted to the IRB. It provides detailed information about the research project which allows the IRB to review and evaluate it according to the federal criteria for approval (see Criteria for IRB Approval of Research). You will need to ensure that the research design is consistent with UNM IRB policies and guidance.
Use the Protocol Template in the IRB Library as a starting point for drafting a new IRB Protocol and use the blue reference text as a guide to what the IRB looks for when reviewing research. Here are some key points to remember when developing a study protocol:
- The blue help text serves as guidance for researchers when developing the protocol for submission to the IRB. Delete all blue text prior to submission.
- Always keep a version-dated electronic copy. This is also available in your project within IRBNet. You will need to modify this copy when making changes or updates to the protocol.
- If you believe your activity may not be human subjects research (HSR), contact the OIRB prior to developing your protocol.
- Note that, depending on the nature of your research, certain sections of the template may not be applicable to your study. Indicate this in the section as appropriate by inserting “not applicable.” Do not leave any section blank.
- Inclusion Criteria should be specific for any of the following populations that may be included in the research. These populations have regulatory implications.They may be vulnerable because of participation in the research, and so may require additional protections. Provide justification if your study includes any of the following populations:
- Children (<18 years of age, depending on state or territory)
- Pregnant women
- Individuals with intellectual disabilities
- Adults unable to provide legally effective consent
- Non-English speaking individuals
Tips and Tricks for successful protocol writing:
- Writing a protocol is different than writing a prospectus, proposal, grant, or other research plans. We do not recommend that you copy and paste from these documents.
- The protocol is a detailed process document (like a recipe). The IRB is interested in the step by step of the conduct of the research and all interactions with study participants and their data.
- Your responses under each section should be concise. Once you communicate your idea, even if it is one or two sentences, nothing additional is needed.
- In most cases, the IRB does not require more than 1-2 paragraphs of "background." Again, please do not copy and paste directly from proposal documents.
- Each section covers a different aspect of the project, which means that you do not need to repeat yourself throughout the document. If you find that you repeat the same content in multiple sections, this is an indication that you should come in for a consult.
- Once you have completed the protocol, consider having someone not involved in the conduct of the research read it for clarity. This can help identify inconsistencies or missing details and ultimately save time during IRB review.
- The protocol should cover the human subjects components of the research, you do not need to include the researcher's personal timeline (e.g. dissertation proposal, defense, etc.) when describing the research process.
What is informed consent? Discussion and documentation
Informed consent is a process, not a form
As a researcher, it is your responsibility to educate prospective participants about the purpose of the study and its risks and benefits, to obtain their consent before involving them in your research, and to keep them informed as the research proceeds. This is the informed consent process. Information may be provided to the potential participant as a document that may or may not require a signature, a script that is read to the participant prior to proceeding with a telephone survey, a paragraph to be read prior to completing an online survey or a hybrid of the above.
In the consent form(s), participants should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the researcher, sponsor, or institution (or its agents) from liability for negligence. Federal regulations and University policy also require that researchers seek informed consent only under circumstances that provide the prospective participant (or representative) sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence, defined as any act of persuasion that over-comes the free will and judgement of another.
It is essential that informed consent discussions are conducted and documents are written in plain language that participants can understand. UNM IRB has specific policies regarding the recruitment and informed consent of non-English speaking and child participants. The consent document(s) should always be revised if there are changes in the project that might affect the participant (such as new procedures or newly identified risks) or when additional information will improve the consent process. If appropriate, participants who have previously provided informed consent may need to be notified of changes in the study protocol and/or consent document(s).
Obtaining a participant’s signature and date on a consent form is important, but it is just one step in the continuous process of informed consent. Informed consent is about people's understanding and willingness to participate in your study; signing a form is the most common way to document that participants have that understanding and willingness. Prospective participants in a research study must understand the purpose, the procedures, the potential risks and benefits of their involvement, and any alternatives to participation (such as the intervention being available outside of the research context). While a consent document that gives this information, and more, is a vital part of the process, the opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary. When enrolling children in your research, both the child and his/her parent are involved in the informed consent process. Instead of a consent form, children consent using an assent form.
Use one of the Consent and/or Assent Form templates in the IRB Library to create a consent form. Note that consent forms must contain all of the required elements of consent as provided in the template. All consent forms should also include a version date. IRB approved consent forms will be stamped and published in IRBNet with effective and expiration dates; Use only the approved, stamped consent form to enroll study participants.
Informed Consent and Documentation Waivers
An IRB may waive the requirement to obtain informed consent or approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. In most cases, this occurs when the participant is not directly involved in the research procedures (e.g. record review, secondary data analysis) provided the researcher justifies and the IRB finds and documents that:
- The research involves no more than minimal risk to the participants.
- The waiver or alteration will not adversely affect the rights and welfare of the participants.
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
In most cases, informed consent must be documented (obtain signature and date from participant). However, in some cases, waiver of documentation of consent (no signature) is appropriate and allowed. In order for the IRB to waive the requirement of a participant’s signature, one of the following conditions must be justified in the IRB protocol:
- The research presents no more than minimal risk of harm to participants; that the only record linking the participant and the research would be the consent document; and the principal risk could cause potential harm resulting from a breach of confidentiality. Each participant will be asked whether s/he wants documentation linking her/him with the research, and the participant's wishes will govern; or
- The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context (such as surveys or interviews).
If the documentation requirement is waived, the IRB may require the researcher to provide participants with a written statement regarding the research (i.e. a consent form with no signature lines).
Note: If requesting any type of waiver from the IRB, justifications must be provided in the IRB Protocol with direct reference to the criteria listed above.
Workshop: Protocol & Consent
The OIRB offers a workshop on writing the protocol and consent form. Check the events calendar for upcoming workshops and to sign-up for a workshop, email IRBMainCampus@unm.edu with which workshop you want to attend and the date. Researchers should take the protocol & consent form workshop when they are ready to start crafting these documents. This workshop will explain how to effectively prepare these documents for the IRB audience. The workshop will cover:
- A detailed discussion of the protocol and consent form
- Explaining the sections of each and what information the IRB needs to conduct a review
- Using the protocol as a tool throughout research development
- A discussion of how the documents are intertwined and how a research design decision in one portion of the research can change how other parts of the documents need to be written
- Pro tips for writing a clear, concise protocol for a successful IRB review/li>