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IRB Review: It Helps to Know the Regulatory Framework

Behavioral and social scientists have complained over the years that federal human subject regulations place needless restrictions on their research.

I disagree. In the six years I spent as an IRB chairperson and the 12 years I spent as a federal regulator in the Office for Protection from Research Risks and its successor, the Office for Human Research Protections (OHRP), my experience has been that the regulations are extremely flexible and should present no impediment to well-designed behavioral and social science research.

It is true that in order for the system to work, IRB members must have sufficient knowledge of social science methodology to objectively assess the potential risks and benefits of proposed research. Where this is lacking, behavioral and social scientists should lobby to gain more representation on the IRB or to establish an IRB dedicated solely to social and behavioral research.

At the same time, investigators must demonstrate a knowledge of regulatory requirements and address the concerns that IRB members are likely to raise. Investigators who can present their research within the regulatory framework and anticipate the concerns of the IRB are more likely to have their proposals approved expeditiously.

An understanding of four regulatory elements – exemptions, expedited review, informed consent waivers, and risk reduction – can help investigators begin to do so more effectively. These elements are described below.

EXEMPTIONS
Much social and behavioral research is exempt from the regulations governing research [45 CFR 46.101(b)]. Investigators need to present their research in way that makes the applicability of the exemption clear to the reviewing official. The exemptions most frequently applied to social and behavioral research are described below.

Exemption 1 - Research conducted in established or commonly accepted educational settings that involves normal educational practices.

Exemption 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or the observation of public behavior, unless: (a) information is recorded in an identifiable manner (either directly or indirectly using codes or other identifying links); and (b) disclosure of the information would place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. The research is exempt unless both (a) and (b) apply. However, research involving survey or interview procedures with children is not exempt; and research involving observation of the public behavior of children is not exempt if the investigator participates in the actions being observed.

Exemption 4 - Research involving the collection or study of existing data, documents, records, or specimens, if: (a) the sources are publicly available; or (b) the information is recorded by the investigator in such a manner that subjects cannot be identified, either directly or through identifiers or codes linked to the subjects. “Existing” means the data have already been collected for some other purpose at the time the research is proposed. Investigators with legitimate access may view identified information but may not record identifiers or codes that link private information to individual subjects. Even a brief recording of identifiers or codes disqualifies the exemption.

EXPEDITED IRB REVIEW
Minimal risk research that fits one of nine specified categories may be reviewed by the IRB utilizing expedited procedures [45 CFR 46.110]. Expedited review categories that lend themselves to social and behavioral research are described below.

Expedited Category 5 - Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes. There are two categories here: (a) research involving materials that have already been collected (for any purpose) at the time the research is proposed, or (b) research involving materials that will be collected in the future for a non-research purpose.

Expedited Category 6 - Collection of data from voice, video, digital, or image recordings made for research purposes.

Expedited Category 7 - Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. This category covers a wide range of social and behavioral research activities when they present no greater than minimal risk to subjects. Examples include research on perception, cognition, motivation, identify, language, communication, cultural beliefs or practices.

WAIVER OF INFORMED CONSENT
IRBs have the authority to waive informed consent requirements where four criteria have been satisfied [45 CFR 46.116(d)]:

  1. The research presents no more than minimal risk to subjects;
  2. The waiver will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver; and
  4. Where appropriate, the subjects will be provided with additional pertinent information after participation.

Waivers of informed consent are possible in much social and behavioral research. The investigator needs to address each of the four criteria in detail so the IRB can confidently approve the waiver. The regulations do not recognize “passive” parental consent for involvement of children in research. Investigators wishing to use “passive” consent procedures must request that the IRB waive informed consent requirements as described above.

Investigators should distinguish waiver of informed consent from waiver of written documentation of consent. An IRB may waive the usual requirement for a signed consent document, while preserving the requirement to obtain consent, if it determines either of the following [45 CFR 46.117(c)]:

  1. That the only record linking the subject and the research would be the consent document and the principle risk would be the potential harm resulting from a breach of confidentiality, or
  2. That the research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside the research context.

RISK REDUCTION
IRBs must ensure that risks to subjects are minimized. Investigators need to incorporate risk reduction strategies into their research designs, thereby acknowledging foreseeable risks in the research proposal and describing how these risks will be managed and reduced. For example, if breach of confidentiality is a risk, investigators need to described detailed mechanisms to prevent such a breach. If research might cause subjects emotional stress, mechanisms need to be described to alleviate that stress. Careful, up-front planning of effective risk reduction strategies often goes a long way in reducing IRB concerns.

WORDS OF ADVICE
Want to make the IRB review process painless and efficient? Here are some things to keep in mind:

  1. Academic freedom notwithstanding, remember that there is no constitutional right to conduct human subject research – it’s a privilege, pure and simple.
  2. View it from the subject’s perspective – recognize the psychological and social risks, as well as the risks to dignity, that may be involved in your research, develop effective strategies to minimize that risk, and describe those strategies fully in your proposal.
  3. Learn the regulations so you can present issues in terms that IRB members will understand. Serving on an IRB is a great way to do this.
  4. When in doubt, ask someone knowledgeable. Don’t be misled by incomplete or inaccurate information about IRB expectations or requirements. If no one at your institution has the expertise, call OHRP or e-mail me at thomas.puglisi@us.pwcglobal.com.
Observer Vol.14, No.5 May/June, 2001

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