Consent Template Instructions for Simple Minimal Risk Social, Behavioral, and Educational Research (SBER) Studies
Looking for guidance on what information belongs in the informed consent for your minimal-risk social, behavioral, or educational research study? We’ve got you covered, with a helpful tool for determining what information must be included in your informed consent form, answering where, when, and how.
This template provides guidance to researchers on informed consent in SBER studies. The content below describes key information and elements that must be included in consent forms.
Simple Minimal Risk Social, Behavioral, and Educational Research (SBER) studies may include studies involving surveys, interviews, or focus groups.
If a study is exempt, consent may be streamlined; but at a minimum, should include the following elements:
- A statement expressing the fact that the proposed activities involve research;
- A description of the procedures to be performed;
- That participation is voluntary, and individuals are free to withdraw at any time;
- The name of, and contact information for, the principal investigator (PI).
If the study is non-exempt, the informed consent form requires additional elements, described below.
Key Information Section
The Key Information section of the consent form is a regulatory requirement that cannot be waived, altered, or omitted. It is a concise and focused presentation of the main points that are necessary to allow participants to understand what the study is about, and why they may or may not want to participate.
The Key Information section must include the following items:
- The fact that consent is requested for research, and that participation is voluntary;
- The purpose of the research, the length of time the individual will be expected to participate, and the study procedure to be followed;
- The reasonably foreseeable risks, or any potential discomforts, that the individual might experience in relation to their participation in the research;
- The benefits to the prospective participants (if there are none, please state this) and the possible benefits to others (or society) that may reasonably be made possible by the research; and,
- Appropriate alternative procedures or courses of treatment (if any); this is most likely not relevant to simple minimal risk SBER studies).
Detailed Information Section
If you complete the Key Information section and find that it sufficiently captures the important details about the study, and that the related Detailed Information section would be wholly duplicative of the Key Information section, then the Detailed Information section may be shortened to include only additional elements required to satisfy the regulatory requirements.
The following elements must be included in addition to those addressed by the Key Information section:
⊕ The extent, if any, to which records identifying the participant will be kept confidential.
⊕ One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- If identifiers are removed from your identifiable private information (or identifiable biospecimens, when applicable) that are collected during study participation, that information (or those biospecimens) may be used for future research studies, distributed, or shared with another investigator for future research studies without additional requests for your consent, [OR]
- Your identifiable private information or identifiable biospecimens that are collected as part of this research study will not be used, distributed, or shared for additional research studies, even if all of your identifiers are removed.
⊕ Contact information related to the following:
- How to contact the research team regarding questions, concerns, or complaints about the research
- Whom to contact in the event of a research-related injury to the participant
- How to contact someone independent of the research team (i.e., the institutional review board [IRB] or research compliance office) regarding questions, concerns, or complaints about the research; questions regarding participants’ rights and welfare; to obtain additional information; or to offer input
⊕ If the study is funded by the National Institutes of Health (NIH) and/or if a Certificate of Confidentiality (CoC) is obtained, you will need to include information about that CoC.
⊕ If the Health Insurance Portability and Accountability Act (HIPAA) is applicable, note that a separate authorization is required.
⊕ If the research is funded by an agency with specific requirements (e.g., NIH, National Science Foundation (NSF), or Department of Justice (DOJ), please include any funding-specific language related to the disclosure of results, conflicts of interest (COI), etc.
⊕ If there is a COI, include specific language addressing the COI management plan.
If you have questions, or would like to provide feedback, please email us at Regulatory@catalyst.harvard.edu.