What is an IRB and who or what would be involved in this type of decision making process?

This section is based on experience with US IRB. Check if your IRB has a submission form that pre-specifies the information they want to see. These are typically found on each IRB’s website along with templates for consent forms and other helpful documents. With the revised Common Rule, some universities such as MIT have changed the application and forms (e.g., closure, adverse event, etc.). Please download these forms directly from the your IRB's site rather than using old versions you have on hand.

Contents of a proposal

The information required is very similar across most proposals.

1. Research objectives and purpose: Be brief on the purpose or scientific background of the study. A comprehensive literature review is not required. Make this accessible to a well-educated lay person.
2. Procedures of the study: Be detailed. The IRB tends to care most about the "how." This is partly because the first review is not done by a researcher but by an IRB officer. They may request a lot of detail upfront in order to avoid additional back and forth for the Board member who will review the protocol. Walk through what the subject experiences in the study step-by-step, including duration of participation and location. Let someone else read what you wrote to see if they understand your study procedures.
   • Submit all the interview guides, survey instruments, and recruitment materials you want to use, and provide translations. Translations may need to be certified; ask the IRB about that.
   • Describe the consent procedure in full and submit the consent form exactly as you plan on using it. Waivers or alterations of consent/assent may require additional materials. Once approved, the consent form cannot be changed without an amendment so it's worth putting some work into this (see next section and our resource on intake and consent processes). You may need to use the IRB-stamped form.
   • Data handling: An important risk of study participation for subjects is that their personal data is exposed in some way. Make sure you have good procedures for both physical and electronic data protection, including storing data in locked files and clearly stating the timeline and process for storage/destruction of personal information. Moreover, make sure you describe in the consent form to whom and how the subjects' data will be accessible. State clearly which specific information will not be shared with others. This is particularly important if you intend to publish the study data (which most researchers now want to do). Make sure you describe how you will de-identify the data and use language in the consent form that does not prevent you from publishing the de-identified data later on. See the “Permission to publish” section of our data publication resource for sample consent language that permits subsequent data publication.
   • Deception and debriefing: The IRB will need a good explanation if you need to withhold information from subjects or deceive them. Some journal referees have rejected papers that they perceive to contain unnecessary deception. If you do use deception, the IRB will likely require that you debrief subjects afterwards and explain the true study purpose or procedures to them. A good rule of thumb is that the subjects will need enough information about the risks, costs, and benefits so that they can make an informed decision if they want to participate; everything else will require special reasons and/or a debriefing.4
3. Study participants: Describe exclusion/inclusion criteria and justifications.
   • Are you working with vulnerable populations (children, prisoners, pregnant, mentally disabled, or developmentally challenged individuals), and if so, why?
   • Subject numbers: you cannot use more subjects than you originally planned to enroll unless you submit an amendment. If you are not sure of the final subject numbers, provide an upper bound estimate. There is no penalty for surveying fewer subjects than stated, but IRBs do not like to see approved subjects exceeded.
   • For an RCT, describe the selection method for treatment and control groups.
4. Risk assessment: Explain all the potential risks for the subjects and how you are guarding against them.
   • IRBs will read this very closely and they may come up with risks that you feel are remote. You may be required to safeguard in some way against such identified risks.
   • Whatever risks and benefits you identify you need to mention in your consent form (see below and in our Define consent and intake process resource). 

Some additional hints, based on experience:

• There may be elements of your study that change later. If these changes are not substantial, you should write your protocol to allow for them. For example, you may want to adjust the amounts paid to subjects, change your estimate of how long it takes to conduct a survey, or rephrase some survey questions. If you get a reasonable range of options for these fields approved in your initial application then making the needed adjustments will be easy. For changes not written into the protocol always submit an amendment (and wait for approval) before implementing them in the field, even changes as small as the contact information on a consent form.
• Similarly, if you plan to choose between two different procedures, say, based on piloting results, you may request approval for both of them, and explain that you will choose one (and how). This can save you time later on. 
• Note that even if you do not identify any risks, IRBs may still require you to mention risks and benefits in the consent form, e.g., by saying "there are no risks or benefits to you from this study." There is no need to try and bend over backwards to convince yourself, the IRB, or the subjects that there is absolutely zero risk. Depending on your study population and context, this can make subjects actually more suspicious or at least confused: if there are no risks, and so far the study sounded completely harmless, why is this explicitly mentioned? Thus, on balance it is actually not necessarily going to reduce participation or harm your relationship with the subjects if you mention small risks. It can help the subjects see that you thought carefully about this but that these are the only risks you came up with. 

Procedure for informed consent

Normally, written, signed consent is required from all study subjects.

Consent procedures for research involving minors are more complicated, so you should check with your IRB on the specifics. Depending on the age of the child (typically seven or older) children have to give assent to study procedures that involve them, though the method of obtaining assent will vary depending on age. In addition, parent(s) have to consent to research involving their children. If the study involves more risk, both parents' consent may be required. MIT requires that research involving minors have written informed consent of a parent as well as the suitably documented assent of the minor, if the child is over seven years old. 

The revised Common Rule includes a new "Key Elements" section and a rearrangement of content that is designed to facilitate a potential subject's decision of wheter to participate. Under the revised 2018 Common Rule, the requirements for informed consent have changed, with the addition of: 

• "Key information" to be presented at the beginning of the consent form
• New consent elements
• Changes to waiver criteria and documentation (plus other process changes)
• A "broad consent" option for unspecified future use of identifiable data/bio-specimens

There are exceptions to the need for written consent. These may be important if the written consent procedure deters or prevents subjects from participating in the research. Examples could be subjects who cannot read, who do not want to be linked with their study answers, or who are in a rush and do not want to sign unfamiliar documents before studying them carefully. 

Some of the alternatives available for such cases are:

• Oral consent with a witness (witness signature replaces subject signature)
• Waivers of written consent (replaced by an oral procedure), especially in the case of minimal risk
• Consent from only one or none of the child's parents (e.g., unavailable parents or risks from involving the parents, e.g., in cases of abuse)
• Waivers of assent (e.g., if the child is too young or incapable of assenting)

See Human Subjects Decision Chart 13: “When Can Informed Consent Be Waived or Altered Under 45 CFR 46.116(f)?” for more details.

In our experience, for studies involving young students, where getting every parent to consent would be impossible, typically the head of school consents for all students. Examples of such scenarios include boarding schools or when it is likely parents will not all read or return the forms and when the study consists of non-invasive research such as math games conducted on school time. For high school students involved in educational interventions, both students and the head of school (or parent) provide legal binding consent. 

An important provision of US law is a so-called Certificate of Confidentiality, which prevents law enforcement from accessing research data by subpoena for the purpose of criminal persecution.5 The National Institutes of Health offers helpful resources on what a certificate of confidentiality is and answers some frequently asked questions about how it works. The law on certificates of confidentiality was originally conceived to allow research on illegal drug use by Vietnam veterans without compromising subjects or deterring them from participating. These certificates can help a researcher protect their subjects and assure subjects of the confidentiality of their responses. For some background, see for example Wolf et al. (2015, 76 pages).

More details on informed consent are covered in J-PAL's Define intake and consent process resource.

Consent Forms

MIT has useful guidelines on providing and communicating adequate information and ensuring comprehension when obtaining informed consent. In particular, the language researchers use in their consent forms should be simple and clear. They include the following:

• Wording should be understandable to those with an 8th grade reading level.
• Avoid technical language or jargon.
• Use commonly recognizable terms.
• Explain terms that may not be easily understood.
• When minors are involved, use age-appropriate language.
• Note that one needs explicit permission from the IRB to obtain verbal consent, in place of the usual written consent, even if the survey is conducted over the phone. See Transitioning to CATI: Checklist and Resources for additional adaptations that should be made for phone surveys

Researchers should at a minimum include the following in their consent forms, even if an oral consent: 

1. A brief explanation of the purpose of the study 
2. That subjects can stop at any time or choose not to answer any questions they want 
3. A local contact and phone number/email for questions. 

Subjects should get a copy of the consent form with this information. They should also receive a link to the local university's IRB office in case they have concerns they do not want to voice to the study researchers, e.g., “If you feel you have been treated unfairly, or you have questions regarding your rights as a research subject, you may contact the Chairman of the Committee on the Use of Humans as Experimental Subjects, MIT, Room E25-143b, 77 Massachusetts Ave, Cambridge, MA 02139, phone +1-617-253-6787."

MIT has consent templates on their website that researchers can use. The consent templates have also undergone changes with the Common Rule revisions. Check with your IRB with questions about modifying a consent template provided by MIT or another institution.

If you plan to collect personal data from participants residing in the European Union you should include additional language in your consent forms, in accordance with the European Union's General Data Protection Regulation (GDPR). This should include information on how long you will retain subjects' information, whether their personal information will be transferred to the US (which may not offer the same level of protection as the EU), etc.

You should review the Annotated informed consent checklist, based on the OHRP checklist, to make sure you are including all elements of informed consent in your form. The checklist document contains information on:

• The various exceptions to written consent above, 
• Elements of a written consent statement, and 
• Sample language that makes sure J-PAL data management and data publication requirements are met and the study data can be published in de-identified form.

Broad Consent

The Revised Common Rule allows "Broad Consent" in lieu of informed consent. Broad consent is obtained only with respect to storage, maintenance, and secondary research use of individuals' identifiable data without obtaining additional consent. You are not required to obtain informed consent through broad consent; this is simply an option that is now available to researchers.

Broad consent under Common Rule has several mandated elements, including:

• A general description of the types of research that may be conducted with the identifiable private information.
• Whether sharing of identifiable private information might occur.
• Types of institutions or researchers that might conduct research with the identifiable private information.
• Description of the period of time that the identifiable private information may be stored and maintained and description of period of time that they may be used for research.

You can find the complete list of mandatory elements to broad consent on the HHS website.

If an individual refuses to provide broad consent, the researcher can choose to de-identify the subjects' data to conduct further research. Your IRB can provide guidance on institutional policies regarding refusals, including on re-requesting broad consent or obtaining informed consent.

Not all IRBs have implemented use of Broad Consent. Be sure to check with your IRB to understand whether this option is available for your research. Implementing Broad Consent requires careful thought about the language of the consent form. When the IRB evaluates secondary research proposals, it must determine that the proposed secondary research is within the scope of the identified types of research in the original consent form.

Who is involved in IRB?

What is an IRB and what is its purpose?

Who is responsible for IRB approval?

How does the IRB process work?