Initial Application

Risk/Benefit Assessment for adults and/or children: Evaluate the risk to the participants within the data set.

Participant age range: Age range of participants within the data set. If the exact age range is unknown, please indicate whether participants will be adults and/or children.

Target population(s): Specify whether any of the populations are excluded or targeted. If they will not be excluded or targeted, select permitted.


Description of research: Identify the purpose for which the data was collected.

External Research or Recruitment Site(s): If the data was collected at an external site, include information in this section. If the data originated from another institution or organization, documentation of permission for use of the data from the appropriate authority may be required (e.g., data use agreement).

Subject Population: A description of the characteristics of the participants whose data will be included. A total enrollment number is not required for studies of existing datasets.

Consent Process:

  1. Obtaining consent: Describe how consent will be obtained for the new use of the data. This section should not explain how consent was obtained for the original data collection, but should indicate whether a reasonable participant would find that the current project was described to them in the original consent language.
  2. Waiving consent: If the study meets the criteria for a waiver of consent [§46.116(d)]: An explanation as to why it would be impossible to obtain consent from everyone in the data set or how obtaining consent would increase the risks to those individuals.

Assent Process: The above instructions for addressing the issue of consent apply.
Methods and Procedures: Describe the methods used for the collection and analysis of the pre-existing data, not the original data. This section should not describe the methods for the original data collection, but should instead include a brief explanation of the purpose of the original collection (e.g. the data was originally collected as part of a class project; medical record; Medicare prescription drug surveillance; etc.).
Risks and Benefits: Describe the risks and benefits of the new analysis, not the original data collection.

Consent Document

Purpose: Identify the purpose of the secondary data analysis.
Activities and Time: Clarify that participating will involve no additional time, as the data was previously collected. This section should briefly identify the purpose of the original data collection. Sample sentence: We are asking your permission to use the information collected as part of your class project in a new research study. Your participation would be limited to providing permission for the use of the existing data; it will not involve additional time on your part.
Risks: Identify the risks of the secondary data analysis, not the original data collection procedures. The risk of a breach of confidentiality may apply if individual identifiers exist.
Benefits: Identify the benefits of the secondary data analysis, not the original data collection procedures.

Recruitment Materials

There are no unique requirements for the recruitment materials. However, please consider using a statement similar to the following: We are asking you to give permission for us to use your data collected for ____ in our research project. Participation will involve no additional time.