IRB Forms

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Below are forms and templates you may need.

Note that these are in development and may be revised. Please contact the IRB with questions or requests for additional forms.

Revised Protocol Form

Works best with Adobe Acrobat.

Download blank IRB protocol here
Old protocol form

Please only use this for existing or ongoing protocols. All new protocols should use the revised protocol form. This form will no longer be supported, updated, or modified.

Download here.

Consent form

The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). Also see OHRP Informed Consent Tips.

The regulations require that the following information must be conveyed to each participant regardless of study procedures (any exceptions to this must be approved by the IRB):

  • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental
  • a description of any reasonably foreseeable risks or discomforts to the participant
  • a description of any benefits to the participant or to others which may reasonably be expected from the research
  • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant
  • a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained
  • for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
  • an explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related injury to the participant
  • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

If you are collecting identifying information or biospecimens, including names and signatures on consent forms or other intake materials, please describe what will be done with the information, how long it will be stored and for how long (including if/when it will be destroyed), how you will protect privacy/confidentiality

Download Template

Download Consent form Template
consent waiver and sample consent script

There are three scenarios wherein waiving documented (written) consent is allowed. In each, the risk level of the study must be "no more than minimal," and obtaining written consent is not practical or possible. Waiver of consent can be obtained for exempt, expedited, or full-board review studies.

  • The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. For example, you are interviewing youth engaging in high-risk behavior and the link to this study could pose harms to their legal or social standing.
  • The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context. For example, you are conducting a verbal survey or interview and it would not be possible or practical for every participant to receive and send back a consent form.
  • The subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects.

In all scenarios, the participant must be asked if they would like a copy of the consent information (and a consent summary must be available). Their decision prevails whether the researcher provides them a copy or not (i.e., you cannot force them to take a copy).

Below is a sample waiver of consent documentation and consent script. Please complete both and return with your protocol form.

Waiver of consent process

In certain cases, federal regulations allow the IRB to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and other limited circumstances.

All four of these conditions must be met and documented clearly for general research:

  1. the research involves no more than minimal risk to  subjects;
  2. the waiver or alteration will not adversely affect the rights and welfare of  subjects;
  3. the research could not practicably be carried out without the waiver or alteration; and
  4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

For research in emergency situations (which, almost by definition, are high risk and require full-board review), a limited number of conditions can be result in fully waived consent. This applies to research that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects’ medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. This waiver applies to research involving adults or children, but does not apply to research involving pregnant women, human fetuses, neonates of uncertain viability, and nonviable neonates, or prisoners.

for research with children (waiving consent/parental permission)

Under 45 CFR 46.116(c), an IRB may waive the requirement for obtaining informed consent or parental permission or approve a consent or parental permission procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that the following two criteria are satisfied:

  1. the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

    • public benefit or service programs;
    • procedures for obtaining benefits or services under those programs;
    • possible changes in or alternatives to those programs or procedures; or
    • possible changes in methods or levels of payment for benefits or services under those programs; 45 CFR 46.116(c)(1).

    Note that this criterion means that only public benefit or service program research activities that are under state or local authority meet this criterion; similar research conducted under federal authority would not qualify here and is treated elsewhere in the regulations. Research conducted by or subject to the approval of only a private entity also would not qualify.

  2. the research could not practicably be carried out without the waiver or alteration (45 CFR 46.116(c)(2)).

  3. This criterion means that the practical circumstances of the research are such that the research is not feasible if the informed consent of the subjects must be obtained. For example, a study of identifiable private information about program benefit recipients using 20-year-old records might meet this criterion, if current contact information for those recipients is not available.

  4. The IRB determines that a research protocol is designed to study conditions in children or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and the following 2 additional criteria are also met:

    1. An appropriate mechanism is in place to protect the children, and
    2. The waiver is not inconsistent with federal, state, or local law (45 CFR 46.408(c)).

  5. The choice of an appropriate substitute mechanism (for example, appointing a child advocate or an assent monitor) for protecting children participating in research would depend on the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and the child’s age, maturity, status, and condition (45 CFR 46.408(c)).

Passive or implied consent: full documentation of consent is not always necessary, but an implication of consent may be permissible. The term "passive" or "implied" consent is not officially sanctioned; however, it is practicably used frequently. A common example is online surveys in which a statement informing the participant that their continued participation in the study constitutes consent. This procedure does not require an additional form. However, other conditions in which consent could be obtained, but the researcher would not be able to obtain it, would require greater oversight and justification.

Policy on Translation and Translation Certification Form

Translation Policies

The requirements regarding obtaining IRB approval for translated documents varies depending on the level of risk of the research. Researchers should describe in their submission form whether translated documents and which language(s) will be appropriate for the prospective participants. Regardless of the level of risk, it is recommended that English versions of documents be approved prior to translating, minimizing the number of iterations of translations. If modifications are necessary to the form, it is expected that these modifications will be applied to all forms and all languages; we suggest holding off translation procedures until the forms are settled. All final translated documents must be submitted to the IRB.

Translations for Minimal Risk Research

The qualifications of the translator should be provided (e.g. native speaker, academic degrees, certified translator, etc.) to the IRB, using the Translation Certification form, when foreign language versions of project documents are provided. The translations should be consistent to the English versions in both content and format. Translators must sign the Translation Certification form indicating that they have carried out the translation to the best of their ability.

Translations for More than Minimal Risk Research

For projects involving greater than minimal risk to participants, the IRB requires that the researchers either use certified translators (with a letter of certification from the translator or translation service) or that a “back-translation” by a different translator than the one who performed the original translation be provided. The back-translation (back into English) serves to ensure that the non-English version contains all of the key elements of the English version.

The translated documents (forward and back), as well as documentation of the qualifications of each translator, must be submitted to the IRB for final approval.

Use of a Qualified Translator

The IRB requires the use of a qualified translator. Rather than limiting researchers by having very specific qualifications for translators, the term “qualified” is left open so that researchers have flexibility and the IRB can make a case-by-case determination as to whether the qualifications of the translator/verifier are sufficient based on the project and the specific project documents. For example, the IRB would not expect researchers to use someone who is a native Spanish speaker but has no medical background to translate a complicated clinical trials consent form. If this person does not have a good understanding of medical terminology, then they might not provide an adequate translation of the informed consent. On the other hand, a medical student, physician, experienced nurse, etc. who is a native speaker would potentially be appropriate for translating the informed consent. If the project involves a survey (e.g. about how they view the services they receive, what toothpaste they use, etc.) where the risks are minimal and the research design is very simple, then a native speaker without a scientific/medical background would probably be qualified to translate the informed consent form.

The IRB requires a Translation Certification form be submitted with all foreign-language translations of consent forms, recruiting materials and other project documents. This form attests to the validity of the translation and includes a statement of the English and foreign-language qualifications of the translator.

Research staff may serve as translators, but it is encouraged to have an outside translator to reduce potential bias.

The IRB may invite a consultant to review the translated materials to determine cultural appropriateness.

Download Translator Certification Form

 

IRB Authorization Agreement

An Institutional Review Board (IRB) Authorization Agreement (IAA) is an arrangement between two entities conducting research involving human participants that designates a single IRB for review purposes. This type of agreement permits an organization with a Federalwide Assurance (FWA) to apply its FWA to another organization. Essentially, this arrangement designates one institution's IRB as the reviewing IRB for the study. These agreements are designed to reduce the regulatory load by consolidating IRB review and approval to a single entity. IAAs are also known as IRB of Records in some contexts. Upon the execution of an IAA, a primary IRB, or a single IRB of Record, is appointed.

To submit one of these, fill the appropriate form in and have it signed by the signatory authority of the IRB at the other institution. To get the appropriate signature here, submit it to the IRB and the Chair will facilitate the appropriate signature here.

If OW is to be the IRB of record (i.e., get approved here and another institution relies on us):

 

If OW is relying on a different IRB (i.e., get approved there and we rely on their IRB):