Ashoka University

Categories of Review

The United Stated Federal Policy for the Protection of Human Subjects was published in 1991(revised significantly in 2018) and Code for Federal Regulations (CFR)46 Subpart A (also called the “Common Rule”) is a document defining the rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. It governs the Institutional Review Boards (IRBs) for oversight of human research. The “Common Rule” is the reference point for ethics by which most research with human subjects is held and conducted globally and by which most IRBs worldwide define their policies and procedures. This document captures the key points from the “Common Rule” relevant for the Ashoka IRB’s policy.

The key contribution of the Common Rule has been the establishment of criteria which must be taken into account by any responsible IRB to ensure that human research ethics are adhered to. It lays down the level of scrutiny that an IRB must impose on a research depending on the potential risk to human subjects as well as the level of vulnerability of the study subjects. These screening criteria are to determine the category of IRB review which is applicable to the proposed study. Read more under General Information to understand what constitutes risk.

Please review the table given below to understand the criteria to determine which category of review is applicable to the proposed study and access, complete and submit the appropriate application form listed in the table below. The categories detail different levels of foreseeable risk to human subjects. In case risks to potential study subjects are deemed to be negligible or minimal, the research project may be exempt from IRB review. However please note that even in case of determination of minimal risk, an application to the IRB is still required to confirm the level of risk by the IRB committee as well.

LIST 1 Data Type	Category of Review
Publicly available data online with no identifiers [1]	EXEMPT
The research does not… involve neonates, pregnant women, seriously ill, prisoners, mentally compromised adults, or those under the age of 18. involve the collection or recording of behavior which, if known outside the research, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. involve the collection of information regarding sensitive aspects of study participants’ behavior (e.g., drug, sexual behavior etc.). involve deception.[2] any foreseeable risk to the subject.[3]	EXEMPT
Research conducted in normal educational settings and involving normal educational practices (e.g., classroom management methods, curriculum design etc.) not likely to adversely impact students' learning or educators’ assessment. Classroom instructor should not be in the study team. Research where information is recorded anonymously[4], employing survey or interview procedures, observation of public behavior, educational tests (cognitive, diagnostic, aptitude, achievement) outside normal educational settings, or behavioral interventions. All survey/interview/observational research where elected/appointed officials or candidates for public office serve as subjects and the research topic is related to their official capacity. Research involving the collection or study of existing data, documents or records, all of which are either publicly available or the information is recorded anonymously⁵. Research (including demonstration) subject to the approval of Government Departments, and designed to study, evaluate, or otherwise examine (i) public benefit programs; (ii) procedures for obtaining benefits under those programs; (iii) alternatives to those programs or procedures. Research involving taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods which contain additives at or below levels found to be safe by the Food Safety and Standards Authority of India (FSSAI).	EXEMPT
For all of the above complete & submit the form titled: Exempt Application Form Ashoka IRB.docx
LIST 2 Data type	Category of Review
The research… does not involve neonates, pregnant women, seriously ill, prisoners, mentally or cognitively compromised adults. does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. does not involve the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug use, sexual behavior etc.). The procedures of this research present no more than minimal risk to the subject[5].	EXPEDITED
Research involving existing identifiable data, documents or records where these materials, in their entirety, have been collected prior to the research for a purpose other than the proposed research. These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio or-videotapes, names will be recorded, even if they are not directly associated with the data). Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. Research on individual or group characteristics or behavior (perception, cognition, surveys, interviews, and focus groups) as follows: (a)Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation; (b) Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio or videotapes, names will be recorded, even if they are not directly associated with the data). Any research involving deception must methodologically justify use of deception and de-briefing procedures must be outlined in detail. Research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where the research remains active only for the purposes of data analysis; or (c) where the IRB has determined that the research involves no greater than minimal risk and no additional risks have been identified; (d) where no subjects have been enrolled and no additional risks have been identified.	EXPEDITED
For all of the above complete & submit the form titled: Expedited Application Form Ashoka IRB.docx
LIST 3 Data type	Category of Review
The research involves neonates, pregnant women, the seriously ill, or mentally or cognitively compromised adults or prisoners as subjects. The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior). The procedures of the research involve more than minimal risk to the subject (where more than minimal risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests). Any research which does not fall into any of the categories explicitly identified as qualifying for Exempt or Expedited status.	FULL
For all of the above complete & submit the form titled: Full Application Form ASHOKA IRB.docx

[1] Data obtained online where a login is required are not considered publicly available. In case of social media sites, their specific privacy policies apply to data mined from them.

[2] Deception occurs when a researcher/investigator proffers false information to study participants or intentionally misleads them about key aspect(s) of the research. (also referred to as "active deception.") Incomplete disclosure occurs when an investigator withholds information about the specific purpose, nature, or other aspect of the research and this may or may not be considered deception. The primary concern for researchers is assessing the balance between how and to what extent the deception in a given study affects the subject's ability to give informed consent and its judicious use or potential necessity for unbiased research in specific cases.

[3] Foreseeable risk refers to the probability or likelihood of injury, harm or damage that a reasonable person should be able to anticipate given circumstances and context of the study. Negligible Risk research is where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is not more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not considered negligible risk. Inconvenience is less serious than discomfort. Examples of inconvenience may include completing an online anonymous survey containing non-sensitive questions, observing people using a public space or analysing de-identified datasets. By comparison, examples of discomforts may include minor side-effects of medication, the discomforts related to measuring blood pressure, and anxiety induced by an interview. (CFR)

[4]Human subjects cannot be identified and linked to information offered by them, directly or indirectly through identifiers.

[5] Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.