Private Information or Biological Specimens in Human Subjects Research

Questions and Answers Table of Contents

How do I know if I am conducting human subjects research?

Investigators conduct human subjects research if they obtain data by intervention or interaction with a living person or obtain individually identifiable private information about a living person. Click on the glossary links in blue for definitions of these terms.

For more help, see Are You Conducting Human Subjects Research? and the Office for Human Research Protections decision chart Is an Activity Research Involving Human Subjects? Also see FAQs from Applicants Human Subjects Research and FAQs About Research Using Human Specimens, Cell Lines or Data on the Office of Extramural Research's Web site.

What is a human subjects exemption?

A human subjects exemption removes the need to comply with some or all of the human subjects reporting requirements in 45 CFR Part 46, even though the research is considered to be human subjects.

Usually, exemptions don't apply to research funded by NIAID. In other words, most NIAID-funded research is either "human subjects" or "not human subjects" and is not exempt.

To learn more about exemptions, see Chart 2: Is the Research Involving Human Subjects Eligible for Exemption Under 45 CFR 46.101 (b)? on the Office for Human Research Protections' Web site. Also visit NIAID's tutorial pages Is Your Research Exempt? and Key Points to Remember About Human Subjects Exemptions.

If you've looked through NIH and NIAID guidance and still think your research may be exempt, work with your institution. Contact your program or project officer if you need additional assistance.

If your research is exempt, you still check "yes" for human subjects research in the box on the application face page or cover component of the PHS 398 or SF 424.

If you are not conducting human subjects research, exemptions do not apply to you.

Am I conducting human subjects research if I'm using samples from unidentified people?

Generally, if you are not collecting specimens from living people and do not have access to identifiers for the specimens, you are not conducting human subjects research. See the December 30, 2004, Guide notice for details. Also see FAQs About Research Using Human Specimens, Cell Lines or Data on the Office of Extramural Research's Web site.

What is coded private information?

Coded private information is a person's name, social security number, or other identifiable private information that is replaced with a code, e.g., number, letter, or symbol. Investigators are generally considered to be conducting human subjects research if they interact or intervene with living people and can individually identify them directly or through a coding system.

For more information, read the Are You Conducting Human Subjects Research? tutorial page and Human Subjects questions and answers page on our Web site. To learn more about privacy information, see our Privacy, Conduct, Conflict of Interest, and Clinical Research Ethics questions and answers.

If I receive coded information derived from human subjects, and the person who collected the specimens is also collaborating on the study, am I conducting human subjects research?

Yes.

If I receive discarded surgical specimens that are not coded, with no identifying information or way to trace it back to the subject, am I doing human subjects research?

No.

If I obtain surgical specimens from a colleague, enter into an agreement prohibiting my access to any identifying information, and do not involve the colleague in my study, am I conducting human subjects research?

No.

If I receive coded surgical specimens from a colleague who obtained the specimens from living people but has no role in my research, and we make an agreement prohibiting my access to the key to the code, am I conducting human subjects research?

No.

If I use leftover human specimens to conduct an in vitro diagnostic device study, do I need to get informed consent?

It depends on whether they are individually identifiable. See the FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.

What are some examples of situations that are and are not human subjects research?

1. Dr. Smith is working with unidentified human specimens provided by a colleague.

Most likely, Dr. Smith's research would not be considered human subjects because he did not collect the specimens for his study, no identifiers existed when he received the specimens, and the colleague is not involved.

2. Dr. Jones obtained publically available human specimens to conduct her research.

The study is not considered human subjects research because the specimens were publically available.

3. Dr. Maple collected specimens from patients, coded the data, and locked away his key to the code.

a) If he is using the specimens to conduct research, is Dr. Maple doing human subjects research?

Yes. He would be considered doing human subjects research since he interacted with the patients and collected the specimens. No one on the application, including Dr. Maple, can know the identities of the patients.

b) If Dr. Maple provides the coded data to Dr. Oaks, along with an agreement stating that Dr. Oaks will never have access to the code's key, and Dr. Maple does not collaborate on the study, is Dr. Oaks doing human subjects research?

No, because Dr. Oaks did not interact with the patients and has no key to the code or access to identifying information.

Is research on any tissues, cells, or fluids considered human subjects research?

All research involving samples obtained from human subjects, including tissues, cells, or fluids can be considered human subjects research if the samples are identifiable.

What are the best approaches for restricting access to human subjects information and ensuring that it's unidentifiable?

Some examples are:

• Ensuring the key to the code is destroyed before research begins.
• Having a nondisclosure agreement between the provider and investigator.
• Setting up IRB policies that prohibit release of the key to the code.
• Having other legal requirements that prohibit release of the key.

If I am the principal investigator, do I need a written agreement prohibiting my access to the key to the code?

Though it's a good idea to have a written agreement, the Office for Human Research Protections just requires that an agreement exists. It does not mandate that the agreement is in writing.

Who determines if research that involves coded data or specimens is human subjects?

Applicant institutions designate a group, typically the institutional review board, to make that determination.

NIH recommends that investigators are not given this authority. It is difficult to determine if research is considered human subjects because of the many variables involved. Even slight variations in the way data and specimens are collected can change the answer.

Can my institution provide guidance about whether my research is considered human subjects, or should I contact someone at NIAID?

It's up to institutions to create policies that will instruct applicants on how to follow the Office for Human Research Protections' Guidance on Research Involving Coded Private Information or Biological Specimens and obtain approval.

So work with your institution to resolve your questions. Additionally, you may contact your NIAID program or project officer.

What are the requirements for the Health Insurance Portability and Accountability Act?

See Does NIH have requirements for HIPAA? in the Human Subjects questions and answers.

Where can I find more guidance on research involving coded information?

See Office for Human Research Protections' (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens. To help determine how this applies to your research, go to OHRP's decision chart Does Exemption 45 CFR 46.101(b)(4) (for Existing Data Documents and Specimens) Apply?

For more help, see Are You Conducting Human Subjects Research? and the decision tree for Research Involving Private Information or Biological Specimens.

Where can I find more NIH information about human subjects research?

Visit the Frequently Asked Questions section of Research Involving Human Subjects on the Office of Extramural Research's Web site.

What if my question wasn't answered here, or I'd like to suggest a question?

Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.