Additional Resources for Preparing IRB Protocols

There are many types of protocols that are submitted to the IRB. Some are for a summer research project or a senior thesis, and others are from Faculty with research Collaborators at other Institutions around the globe. All researchers who will interact with participants or have access to participant’s data must be listed on the IRB, so some IRB protocols need Amendments to add new researchers every year. Any changes in a protocol for working with participants also requires submission of Amendments. Expedited and Full Board Protocols have expiration dates and need to be renewed. The Axiom Mentor system will send alerts about such Renewals. All IRB Protocols should consider the way participants are provided Study Information about the research project and the Consent Process. Only Adults over 18 years of age can give consent to participate in a study. Research with Vulnerable Populations including Prisoners and Minors requires extra precautions. Protecting all participant’s Anonymity, and Securing and Encrypting Data they provide is essential. The ability to globally recruit Participants via Online Services introduces a spatial and temporal divide between participants and researchers, but in no way reduces our commitment to ensure ethical treatment, respect, and legal protection of participants.


Amendments and Renewals

When a protocol is approved by the IRB, specific researchers are named who have access to the data and procedures are codified.  For Expedited  and Full Board reviews, expiration dates are set and any changes to the research team or the protocols requires an Amendment to be filed with the IRB. Amendments and extensions for IRB protocols can be submitted by the PI via the Axiom Mentor IRB Management system.

Collaborations with other Institutions

Ceding IRB review with Institutional Authorization Agreements (IAAs)

In many studies there are investigators from more than one institution, each of which has an IRB. While each IRB could review the study separately, it is common for one IRB to cede their review to another IRB using an Institutional Authorization Agreement (IAA). This is faster and simpler than completing extra IRB reviews that are in theory redundant. Pomona regularly does IAA agreements with other schools both within the Claremont Consortium and beyond. IAAs within the consortium are a bit faster and easier as the parties involved work together regularly, but the process is the same regardless. In these cases it is essential to figure out which institution will do the IRB review and which will cede the review. Usually the home of the primary PI will lead the review.

Consent Process, Study Information, Waivers

Participants (human subjects) must be informed and consent to be used in a study. Typically investigators create a study information sheet and consent form that fully describes the goals of the study, the roles of the participants, potential risks and benefits for participants, any compensation provided for participants, clear guidelines that participation is voluntary, and resources for participants who wish to learn more or who have questions or concerns about the study. The Pomona IRB provides a sample template for creating a study information and consent form.

In some cases, giving a full description of the study would negate the ability to complete the study.  In such cases, investigators can apply for waiver or alteration of informed consent. In such cases it is best to provide a debriefing for participants upon completion of the study.

Regulatory Criteria for Waiver of Consent: Taken from the Revised Common Rule 45 CFR 46.116 (f) and (d); 45 CFR 46.117 ©

General waiver or alteration of consent—(1) Waiver. An IRB may waive the requirement to obtain informed consent for research under paragraphs (a) through (c) of this section, provided the IRB satisfies the requirements of paragraph (f)(3) of this section (please see link to Common Rule document above). If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens.

(2) Alteration. An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth in paragraphs (b) and (c) of this section provided the IRB satisfies the requirements of paragraph (f)(3) of this section. An IRB may not omit or alter any of the requirements described in paragraph (a) of this section. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required under paragraph (d) of this section.

(3) Requirements for waiver and alteration. In order for an IRB to waive or alter consent as described in this subsection, the IRB must find and document that:

(i) The research involves no more than minimal risk to the subjects;

(ii) The research could not practicably be carried out without the requested waiver or alteration;

(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Information for Working with Minors

Only Adults over 18 years of age can give consent to participate in a study.  Parents and Guardians are required to give consent when participants are younger than 18 years of age.  While studies with children are important the level of protections must be significantly higher in this situation.  As a result all studies with minors as participants must go through Full Board Review and Pomona College has developed an additional  IRB Children Investigator Checklist [doc] which should be completed and included with these protocols.

Working with Human Subjects via Online Services

It has become commonplace now to use the internet to mediate interactions between human subjects (participants) and researchers.  Currently, the dominant mechanism for this is via the Amazon MTurk marketplace, which is used in this section as an example, although the same guidelines would apply to any remote mass system for working with human subjects.  On the plus side, these systems simplify recruitment of large numbers of participants, and enables some individuals to easily find large numbers of opportunities to earn income as participants in studies.  On the downside, there are concerns with the quality of the data obtained from participants who may not feel the same level of commitment as traditional participants due to the lower levels of connection, and there is the risk that researchers may dehumanize the participants and not live up to the standards of treatment and respect required by the IRB to protect human participants.  MTurk functions as a virtual labor market where registered Workers complete online Human Intelligence Tasks (HITs) for pay. During registration, all MTurk Workers are required to electronically sign a Participation Agreement confirming that they are at least 18 years of age. Likewise, individuals must register as MTurk Requesters to post HITs and collect data from consenting Workers.

For internal HITs, MTurk provides a template for the construction of surveys run directly on Amazon (Mason & Suri, 2011). However MTurk workers may be identifiable when HITs are internally run, and are thus not truly anonymous.  Researchers may choose to use MTurk as a recruitment tool, but embed a link within the system that redirects workers to complete online surveys via a separate, external site managed by the Researchers, such as Qualtrics. For Workers who choose to complete external HITs, survey data are never available to Amazon MTurk and can be considered to be generally anonymous if the external site is properly set up to be anonymous.

One attraction of using MTurk is that you can get large numbers of participants very easily.  MTurk workers respond to financial incentives in the MTurk marketplace.  Researchers must fairly and accurately estimate the time required for the MTurk workers to complete the required tasks and set the participant compensation accordingly.  MTurk workers are real people who deserve the same protections as all other human participants, even if researchers never have direct exchanges with them.  In setting compensation for MTurk workers, the Pomona IRB requires the procedures be tested on local subjects with no prior affiliation to the research program to calculate the time required to complete the tasks before determining the expected time commitment and final compensation for MTurk workers.